Practice Management

Isotretinoin is one of the most highly regulated dermatologic medications on the market. The main reason for regulation through the US Food and Drug Administration (FDA)–managed iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) is to minimize the drug’s teratogenic potential, as isotretinoin can cause profound birth defects. The program originally categorized patients into 1 of 3 categories: (1) females of reproductive potential, (2) females not of reproductive potential, and (3) males. Unless the patient commits to abstinence, the program required female patients of childbearing potential to be on 2 forms of birth control and undergo regular pregnancy testing before obtaining refills. Over the last few years, the American Academy of Dermatology Association (AADA) has been advocating for changes to the iPLEDGE system. Proposed changes have included decreasing attestation frequency for patients who cannot get pregnant, increasing contraception counseling and options, and changing enrollment guidelines to encompass all gender and sexual minorities. As of December 13, 2021, the iPLEDGE system changed enrollment categories to reflect the AADA’s wishes and rolled out gender-neutral categories for enrollment in iPLEDGE. This change will simplify and enhance patients’ experience when starting isotretinoin.

Developing Inclusive iPLEDGE Categories

In recent years, dermatologists and patients have viewed these strict gender-based categories as limiting and problematic, especially for their transgender patients and female patients of childbearing potential who exclusively engage in intercourse with cisgender females. The United States has more than 10 million LGBTQIA+ citizens and an estimated 1.4 million adults who identify as transgender individuals, rendering the previously established gender-binary iPLEDGE categories outdated.^1,2

As a result, over the last few years, dermatologists, LGBTQIA+ allies, and patients have urged the FDA to create a gender-neutral registration process for iPLEDGE. With support from the AADA, the new modifications were approved for implementation and include 2 risk categories: (1) people who can get pregnant and (2) people who cannot get pregnant.³

As exciting as these changes are for the future of dermatologic practice, the actual transition to the new iPLEDGE system was described as a “failure, chaotic, and a disaster” due to additional changes made at the same time.⁴ The iPLEDGE system was switched to a new website administered by a different vendor and required providers to confirm each patient online by December 13, 2021. In addition, the new system required pharmacists to obtain risk management authorization via the iPLEDGE REMS website or by calling the iPLEDGE REMS center before dispensing isotretinoin. This overhaul did not work as planned, as the new website was constantly down and it was nearly impossible to reach a contact over the telephone. The complications resulted in major disruptions and delayed prescriptions for thousands of patients nationwide as well as a great disruption in workflow for physicians and pharmacists. The AADA subsequently met with the Isotretinoin Products Manufacturers Group to create workable solutions for these issues.

On January 14, 2022, the FDA posted updates regarding access to the iPLEDGE system. They have worked with the Isotretinoin Products Manufacturers Group to create workable solutions for patients and physicians while transferring the patients’ information to the new database. Their solution includes allowing physicians to send patients login links through their email to access their account instead of waiting for the call center. The majority of iPLEDGE users now have access to their accounts without issues, and the gender-neutral guidelines have been in place since the original change.

Impact of iPLEDGE Categories on Transgender Patients

These changes specifically will improve the experience of transgender men and cisgender women who are at no risk for pregnancy and could be subjected to monthly pregnancy testing when it is not medically necessary.

Consider the following patient scenario. A transgender man presents to your dermatology office seeking treatment of severe nodulocystic acne. He was placed on hormonal replacement therapy with exogenous testosterone—injections, oral pills, topical gel, topical patches, or subdermal pellets—to achieve secondary sex characteristics and promote gender congruence. The patient mentions he has been amenorrheic for several months now. He has tried many topical acne treatments as well as oral antibiotics without much benefit and is now interested in enrolling in iPLEDGE to obtain isotretinoin. With the prior iPLEDGE registration packets, how would this transgender man be classified? As a female with childbearing potential due to his retained ovaries and uterus? What if he did not endorse engaging in sexual intercourse that could result in pregnancy?

Transgender patients have unique and unmet needs that often are overlooked and prevent them from equitable, gender-affirming health care. For example, in a prospective study following 20 transgender men starting hormone replacement therapy, the percentage of patients with facial acne increased from 35% to 82% after 6 months of therapy.⁵ In addition, the increased psychosocial burden of acne may be especially difficult in these patients, as they already report higher rates of depression and suicidal ideation compared with their heterosexual cisgender peers.⁴ Further, the primary patient populations receiving isotretinoin typically are adolescents and young adults who are undergoing major physical, mental, and hormonal changes. Self-discovery and self-actualization develop over time, and our role as physicians is to advocate for all aspects of our patients’ health and eliminate barriers to optimal care.

Inclusive Language in iPLEDGE Categories

It is important to streamline access to care for all patients, and gender-affirming, culturally sensitive language is essential to building trust and understanding between patients and providers. Howa Yeung, MD, MSc, a dermatologist at Emory University (Atlanta, Georgia) who advocated for gender-neutral iPLEDGE registration, welcomes the change and stated it “will make my job easier. I no longer have to struggle between respecting the patient’s gender identity and providing medically necessary care for patients with severe acne.”³

Sanchez et al⁶ provided a list of structured questions providers can ask their patients to assess their risk regarding pregnancy: (1) Do you have a uterus and/or ovaries?, (2) Are you engaging in sexual intercourse with a person who has a penis?, and (3) If yes to these questions, what form(s) of birth control are you using? Providers should preface these questions with the following statement: “It is important that I ask these questions to assess your risk for becoming pregnant on this medication because isotretinoin can cause very serious birth defects.” It is important to review these questions and practice asking them so residents can operate from the same place of openness and understanding when caring for their patients.

Final Thoughts

The landscape of isotretinoin prescribing currently is changing on a day-to-day basis. As residents, it is important we stay up to date with the changes regarding our regularly dispensed medications. The main modification made to the iPLEDGE REMS system was switching the risk categories from 3 (females who can get pregnant, females who cannot get pregnant, males) to 2 (people who can get pregnant, people who cannot get pregnant). This change will make registration for iPLEDGE less complex and more inclusive for all patients. It is important for residents to stay at the forefront of these patient health issues and barriers to equal care, and this change represents a step in the right direction.

Isotretinoin is one of the most highly regulated dermatologic medications on the market. The main reason for regulation through the US Food and Drug Administration (FDA)–managed iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) is to minimize the drug’s teratogenic potential, as isotretinoin can cause profound birth defects. The program originally categorized patients into 1 of 3 categories: (1) females of reproductive potential, (2) females not of reproductive potential, and (3) males. Unless the patient commits to abstinence, the program required female patients of childbearing potential to be on 2 forms of birth control and undergo regular pregnancy testing before obtaining refills. Over the last few years, the American Academy of Dermatology Association (AADA) has been advocating for changes to the iPLEDGE system. Proposed changes have included decreasing attestation frequency for patients who cannot get pregnant, increasing contraception counseling and options, and changing enrollment guidelines to encompass all gender and sexual minorities. As of December 13, 2021, the iPLEDGE system changed enrollment categories to reflect the AADA’s wishes and rolled out gender-neutral categories for enrollment in iPLEDGE. This change will simplify and enhance patients’ experience when starting isotretinoin.

Developing Inclusive iPLEDGE Categories

In recent years, dermatologists and patients have viewed these strict gender-based categories as limiting and problematic, especially for their transgender patients and female patients of childbearing potential who exclusively engage in intercourse with cisgender females. The United States has more than 10 million LGBTQIA+ citizens and an estimated 1.4 million adults who identify as transgender individuals, rendering the previously established gender-binary iPLEDGE categories outdated.^1,2

As a result, over the last few years, dermatologists, LGBTQIA+ allies, and patients have urged the FDA to create a gender-neutral registration process for iPLEDGE. With support from the AADA, the new modifications were approved for implementation and include 2 risk categories: (1) people who can get pregnant and (2) people who cannot get pregnant.³

As exciting as these changes are for the future of dermatologic practice, the actual transition to the new iPLEDGE system was described as a “failure, chaotic, and a disaster” due to additional changes made at the same time.⁴ The iPLEDGE system was switched to a new website administered by a different vendor and required providers to confirm each patient online by December 13, 2021. In addition, the new system required pharmacists to obtain risk management authorization via the iPLEDGE REMS website or by calling the iPLEDGE REMS center before dispensing isotretinoin. This overhaul did not work as planned, as the new website was constantly down and it was nearly impossible to reach a contact over the telephone. The complications resulted in major disruptions and delayed prescriptions for thousands of patients nationwide as well as a great disruption in workflow for physicians and pharmacists. The AADA subsequently met with the Isotretinoin Products Manufacturers Group to create workable solutions for these issues.

On January 14, 2022, the FDA posted updates regarding access to the iPLEDGE system. They have worked with the Isotretinoin Products Manufacturers Group to create workable solutions for patients and physicians while transferring the patients’ information to the new database. Their solution includes allowing physicians to send patients login links through their email to access their account instead of waiting for the call center. The majority of iPLEDGE users now have access to their accounts without issues, and the gender-neutral guidelines have been in place since the original change.

Impact of iPLEDGE Categories on Transgender Patients

These changes specifically will improve the experience of transgender men and cisgender women who are at no risk for pregnancy and could be subjected to monthly pregnancy testing when it is not medically necessary.

Consider the following patient scenario. A transgender man presents to your dermatology office seeking treatment of severe nodulocystic acne. He was placed on hormonal replacement therapy with exogenous testosterone—injections, oral pills, topical gel, topical patches, or subdermal pellets—to achieve secondary sex characteristics and promote gender congruence. The patient mentions he has been amenorrheic for several months now. He has tried many topical acne treatments as well as oral antibiotics without much benefit and is now interested in enrolling in iPLEDGE to obtain isotretinoin. With the prior iPLEDGE registration packets, how would this transgender man be classified? As a female with childbearing potential due to his retained ovaries and uterus? What if he did not endorse engaging in sexual intercourse that could result in pregnancy?

Transgender patients have unique and unmet needs that often are overlooked and prevent them from equitable, gender-affirming health care. For example, in a prospective study following 20 transgender men starting hormone replacement therapy, the percentage of patients with facial acne increased from 35% to 82% after 6 months of therapy.⁵ In addition, the increased psychosocial burden of acne may be especially difficult in these patients, as they already report higher rates of depression and suicidal ideation compared with their heterosexual cisgender peers.⁴ Further, the primary patient populations receiving isotretinoin typically are adolescents and young adults who are undergoing major physical, mental, and hormonal changes. Self-discovery and self-actualization develop over time, and our role as physicians is to advocate for all aspects of our patients’ health and eliminate barriers to optimal care.

Inclusive Language in iPLEDGE Categories

It is important to streamline access to care for all patients, and gender-affirming, culturally sensitive language is essential to building trust and understanding between patients and providers. Howa Yeung, MD, MSc, a dermatologist at Emory University (Atlanta, Georgia) who advocated for gender-neutral iPLEDGE registration, welcomes the change and stated it “will make my job easier. I no longer have to struggle between respecting the patient’s gender identity and providing medically necessary care for patients with severe acne.”³

Sanchez et al⁶ provided a list of structured questions providers can ask their patients to assess their risk regarding pregnancy: (1) Do you have a uterus and/or ovaries?, (2) Are you engaging in sexual intercourse with a person who has a penis?, and (3) If yes to these questions, what form(s) of birth control are you using? Providers should preface these questions with the following statement: “It is important that I ask these questions to assess your risk for becoming pregnant on this medication because isotretinoin can cause very serious birth defects.” It is important to review these questions and practice asking them so residents can operate from the same place of openness and understanding when caring for their patients.

Final Thoughts

The landscape of isotretinoin prescribing currently is changing on a day-to-day basis. As residents, it is important we stay up to date with the changes regarding our regularly dispensed medications. The main modification made to the iPLEDGE REMS system was switching the risk categories from 3 (females who can get pregnant, females who cannot get pregnant, males) to 2 (people who can get pregnant, people who cannot get pregnant). This change will make registration for iPLEDGE less complex and more inclusive for all patients. It is important for residents to stay at the forefront of these patient health issues and barriers to equal care, and this change represents a step in the right direction.

Isotretinoin is one of the most highly regulated dermatologic medications on the market. The main reason for regulation through the US Food and Drug Administration (FDA)–managed iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) is to minimize the drug’s teratogenic potential, as isotretinoin can cause profound birth defects. The program originally categorized patients into 1 of 3 categories: (1) females of reproductive potential, (2) females not of reproductive potential, and (3) males. Unless the patient commits to abstinence, the program required female patients of childbearing potential to be on 2 forms of birth control and undergo regular pregnancy testing before obtaining refills. Over the last few years, the American Academy of Dermatology Association (AADA) has been advocating for changes to the iPLEDGE system. Proposed changes have included decreasing attestation frequency for patients who cannot get pregnant, increasing contraception counseling and options, and changing enrollment guidelines to encompass all gender and sexual minorities. As of December 13, 2021, the iPLEDGE system changed enrollment categories to reflect the AADA’s wishes and rolled out gender-neutral categories for enrollment in iPLEDGE. This change will simplify and enhance patients’ experience when starting isotretinoin.

Developing Inclusive iPLEDGE Categories

In recent years, dermatologists and patients have viewed these strict gender-based categories as limiting and problematic, especially for their transgender patients and female patients of childbearing potential who exclusively engage in intercourse with cisgender females. The United States has more than 10 million LGBTQIA+ citizens and an estimated 1.4 million adults who identify as transgender individuals, rendering the previously established gender-binary iPLEDGE categories outdated.^1,2

As a result, over the last few years, dermatologists, LGBTQIA+ allies, and patients have urged the FDA to create a gender-neutral registration process for iPLEDGE. With support from the AADA, the new modifications were approved for implementation and include 2 risk categories: (1) people who can get pregnant and (2) people who cannot get pregnant.³

As exciting as these changes are for the future of dermatologic practice, the actual transition to the new iPLEDGE system was described as a “failure, chaotic, and a disaster” due to additional changes made at the same time.⁴ The iPLEDGE system was switched to a new website administered by a different vendor and required providers to confirm each patient online by December 13, 2021. In addition, the new system required pharmacists to obtain risk management authorization via the iPLEDGE REMS website or by calling the iPLEDGE REMS center before dispensing isotretinoin. This overhaul did not work as planned, as the new website was constantly down and it was nearly impossible to reach a contact over the telephone. The complications resulted in major disruptions and delayed prescriptions for thousands of patients nationwide as well as a great disruption in workflow for physicians and pharmacists. The AADA subsequently met with the Isotretinoin Products Manufacturers Group to create workable solutions for these issues.

On January 14, 2022, the FDA posted updates regarding access to the iPLEDGE system. They have worked with the Isotretinoin Products Manufacturers Group to create workable solutions for patients and physicians while transferring the patients’ information to the new database. Their solution includes allowing physicians to send patients login links through their email to access their account instead of waiting for the call center. The majority of iPLEDGE users now have access to their accounts without issues, and the gender-neutral guidelines have been in place since the original change.

Impact of iPLEDGE Categories on Transgender Patients

These changes specifically will improve the experience of transgender men and cisgender women who are at no risk for pregnancy and could be subjected to monthly pregnancy testing when it is not medically necessary.

Consider the following patient scenario. A transgender man presents to your dermatology office seeking treatment of severe nodulocystic acne. He was placed on hormonal replacement therapy with exogenous testosterone—injections, oral pills, topical gel, topical patches, or subdermal pellets—to achieve secondary sex characteristics and promote gender congruence. The patient mentions he has been amenorrheic for several months now. He has tried many topical acne treatments as well as oral antibiotics without much benefit and is now interested in enrolling in iPLEDGE to obtain isotretinoin. With the prior iPLEDGE registration packets, how would this transgender man be classified? As a female with childbearing potential due to his retained ovaries and uterus? What if he did not endorse engaging in sexual intercourse that could result in pregnancy?

Transgender patients have unique and unmet needs that often are overlooked and prevent them from equitable, gender-affirming health care. For example, in a prospective study following 20 transgender men starting hormone replacement therapy, the percentage of patients with facial acne increased from 35% to 82% after 6 months of therapy.⁵ In addition, the increased psychosocial burden of acne may be especially difficult in these patients, as they already report higher rates of depression and suicidal ideation compared with their heterosexual cisgender peers.⁴ Further, the primary patient populations receiving isotretinoin typically are adolescents and young adults who are undergoing major physical, mental, and hormonal changes. Self-discovery and self-actualization develop over time, and our role as physicians is to advocate for all aspects of our patients’ health and eliminate barriers to optimal care.

Inclusive Language in iPLEDGE Categories

It is important to streamline access to care for all patients, and gender-affirming, culturally sensitive language is essential to building trust and understanding between patients and providers. Howa Yeung, MD, MSc, a dermatologist at Emory University (Atlanta, Georgia) who advocated for gender-neutral iPLEDGE registration, welcomes the change and stated it “will make my job easier. I no longer have to struggle between respecting the patient’s gender identity and providing medically necessary care for patients with severe acne.”³

Sanchez et al⁶ provided a list of structured questions providers can ask their patients to assess their risk regarding pregnancy: (1) Do you have a uterus and/or ovaries?, (2) Are you engaging in sexual intercourse with a person who has a penis?, and (3) If yes to these questions, what form(s) of birth control are you using? Providers should preface these questions with the following statement: “It is important that I ask these questions to assess your risk for becoming pregnant on this medication because isotretinoin can cause very serious birth defects.” It is important to review these questions and practice asking them so residents can operate from the same place of openness and understanding when caring for their patients.

Final Thoughts

The landscape of isotretinoin prescribing currently is changing on a day-to-day basis. As residents, it is important we stay up to date with the changes regarding our regularly dispensed medications. The main modification made to the iPLEDGE REMS system was switching the risk categories from 3 (females who can get pregnant, females who cannot get pregnant, males) to 2 (people who can get pregnant, people who cannot get pregnant). This change will make registration for iPLEDGE less complex and more inclusive for all patients. It is important for residents to stay at the forefront of these patient health issues and barriers to equal care, and this change represents a step in the right direction.

Before working to create standards for electronic prior authorization, the entire process itself needs some work.

That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”

According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.

In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”

AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.

Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.

Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
 

AHA: Most common prior auth means are phones, fax

The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”

The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.

To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.

In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.

The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.

Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.

In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”

The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”

The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”

In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”

A version of this article first appeared on Medscape.com.

Before working to create standards for electronic prior authorization, the entire process itself needs some work.

That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”

According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.

In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”

AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.

Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.

Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
 

AHA: Most common prior auth means are phones, fax

The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”

The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.

To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.

In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.

The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.

Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.

In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”

The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”

The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”

In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”

A version of this article first appeared on Medscape.com.

Before working to create standards for electronic prior authorization, the entire process itself needs some work.

That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”

According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.

In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”

AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.

Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.

Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
 

AHA: Most common prior auth means are phones, fax

The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”

The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.

To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.

In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.

The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.

Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.

In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”

The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”

The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”

In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”

A version of this article first appeared on Medscape.com.

Thank Goodness it’s Monday? Sincerely yours, #hustle. 

The COVID-19 pandemic has given us the opportunity to reevaluate what we believe is important and valuable in our life. For some, it’s the opportunity to perform meaningful work; for others, it’s increased financial compensation; and, for the remaining, it may be autonomy (e.g., control over their time). One example of where this mindset has manifested has been in the Great Resignation. 

The Great Resignation refers to the significant increase in resignations that was recorded in April 2021. Resignation rates tend to be higher in fields with high turnover rates (e.g., health care, tech) as a result of increased demand and burnout. Although hustle culture has been an ongoing trend for the last few years, the pandemic has given somewhat of a reality check of the future. 

Hustle culture refers to the embracing of work as a lifestyle such that it takes over other important aspects of your life – in other words, when work-life balance becomes work-work (im)balance. It has also been aptly referred to as burnout culture or grind culture. It’s a bit ironic or counterintuitive to think that stopping work means increased productivity – but it’s true. 

During my undergraduate years, I was always hustling – there wasn’t a moment where I wasn’t studying, doing research, training for my sport, or thinking about how I could do better and be better. It was all about working 24/7 – an illusion to think I was being productive. Now don’t get me wrong, I think the time and effort I invested during those years paid off. However, it also resulted in a sense of dissatisfaction; that is, dissatisfaction that I didn’t explore other potential paths, that I didn’t have the courage to try new things and to be okay with making mistakes. I had extremely narrow tunnel vision because my one and only goal was to go to medical school. 

However, after entering graduate school and actually taking the time to explore other options and career pathways in health, as well as realize that nontraditional pathways are becoming more and more conventional, there is a sense of relief that “failure” is not about changing paths or making mistakes. 

The part of hustle culture that has me hung up is being able to take the time to reflect whether this is what you truly want. I still believe in the value of hard work but I also believe in the value of meaningful and efficient work while also taking the time to reflect. 

The pandemic has shaped a lot of the way we think, what we value, and how we proceed forward. Who we are and what we value is a continuing and ever-growing process, and how we choose to live our lives will play a part. 

I’m curious to hear from you, do you believe in #hustle? Are you part of the #grind culture? Or do you believe we can achieve success, greatness, and satisfaction without the hustle culture?
 

Ms. Lui is an MSc candidate at the University of Toronto, and is with the Mood Disorders Psychopharmacology Unit, Toronto Western Hospital. She has received income from Braxia Scientific. A version of this article first appeared on Medscape.com.

Thank Goodness it’s Monday? Sincerely yours, #hustle. 

The COVID-19 pandemic has given us the opportunity to reevaluate what we believe is important and valuable in our life. For some, it’s the opportunity to perform meaningful work; for others, it’s increased financial compensation; and, for the remaining, it may be autonomy (e.g., control over their time). One example of where this mindset has manifested has been in the Great Resignation. 

The Great Resignation refers to the significant increase in resignations that was recorded in April 2021. Resignation rates tend to be higher in fields with high turnover rates (e.g., health care, tech) as a result of increased demand and burnout. Although hustle culture has been an ongoing trend for the last few years, the pandemic has given somewhat of a reality check of the future. 

Hustle culture refers to the embracing of work as a lifestyle such that it takes over other important aspects of your life – in other words, when work-life balance becomes work-work (im)balance. It has also been aptly referred to as burnout culture or grind culture. It’s a bit ironic or counterintuitive to think that stopping work means increased productivity – but it’s true. 

During my undergraduate years, I was always hustling – there wasn’t a moment where I wasn’t studying, doing research, training for my sport, or thinking about how I could do better and be better. It was all about working 24/7 – an illusion to think I was being productive. Now don’t get me wrong, I think the time and effort I invested during those years paid off. However, it also resulted in a sense of dissatisfaction; that is, dissatisfaction that I didn’t explore other potential paths, that I didn’t have the courage to try new things and to be okay with making mistakes. I had extremely narrow tunnel vision because my one and only goal was to go to medical school. 

However, after entering graduate school and actually taking the time to explore other options and career pathways in health, as well as realize that nontraditional pathways are becoming more and more conventional, there is a sense of relief that “failure” is not about changing paths or making mistakes. 

The part of hustle culture that has me hung up is being able to take the time to reflect whether this is what you truly want. I still believe in the value of hard work but I also believe in the value of meaningful and efficient work while also taking the time to reflect. 

The pandemic has shaped a lot of the way we think, what we value, and how we proceed forward. Who we are and what we value is a continuing and ever-growing process, and how we choose to live our lives will play a part. 

I’m curious to hear from you, do you believe in #hustle? Are you part of the #grind culture? Or do you believe we can achieve success, greatness, and satisfaction without the hustle culture?
 

Ms. Lui is an MSc candidate at the University of Toronto, and is with the Mood Disorders Psychopharmacology Unit, Toronto Western Hospital. She has received income from Braxia Scientific. A version of this article first appeared on Medscape.com.

Thank Goodness it’s Monday? Sincerely yours, #hustle. 

The COVID-19 pandemic has given us the opportunity to reevaluate what we believe is important and valuable in our life. For some, it’s the opportunity to perform meaningful work; for others, it’s increased financial compensation; and, for the remaining, it may be autonomy (e.g., control over their time). One example of where this mindset has manifested has been in the Great Resignation. 

The Great Resignation refers to the significant increase in resignations that was recorded in April 2021. Resignation rates tend to be higher in fields with high turnover rates (e.g., health care, tech) as a result of increased demand and burnout. Although hustle culture has been an ongoing trend for the last few years, the pandemic has given somewhat of a reality check of the future. 

Hustle culture refers to the embracing of work as a lifestyle such that it takes over other important aspects of your life – in other words, when work-life balance becomes work-work (im)balance. It has also been aptly referred to as burnout culture or grind culture. It’s a bit ironic or counterintuitive to think that stopping work means increased productivity – but it’s true. 

During my undergraduate years, I was always hustling – there wasn’t a moment where I wasn’t studying, doing research, training for my sport, or thinking about how I could do better and be better. It was all about working 24/7 – an illusion to think I was being productive. Now don’t get me wrong, I think the time and effort I invested during those years paid off. However, it also resulted in a sense of dissatisfaction; that is, dissatisfaction that I didn’t explore other potential paths, that I didn’t have the courage to try new things and to be okay with making mistakes. I had extremely narrow tunnel vision because my one and only goal was to go to medical school. 

However, after entering graduate school and actually taking the time to explore other options and career pathways in health, as well as realize that nontraditional pathways are becoming more and more conventional, there is a sense of relief that “failure” is not about changing paths or making mistakes. 

The part of hustle culture that has me hung up is being able to take the time to reflect whether this is what you truly want. I still believe in the value of hard work but I also believe in the value of meaningful and efficient work while also taking the time to reflect. 

The pandemic has shaped a lot of the way we think, what we value, and how we proceed forward. Who we are and what we value is a continuing and ever-growing process, and how we choose to live our lives will play a part. 

I’m curious to hear from you, do you believe in #hustle? Are you part of the #grind culture? Or do you believe we can achieve success, greatness, and satisfaction without the hustle culture?
 

Ms. Lui is an MSc candidate at the University of Toronto, and is with the Mood Disorders Psychopharmacology Unit, Toronto Western Hospital. She has received income from Braxia Scientific. A version of this article first appeared on Medscape.com.

During a recent virtual medical malpractice trial, the judge called a break, and the participants left their screens. When the trial resumed a short time later, one juror was missing. The court called his phone, but there was no answer.

“Everyone had to keep waiting and waiting while the bailiff kept trying to call,” recalled Elizabeth Leedom, a medical malpractice defense attorney based in Seattle. “The juror fell asleep.”

The sleeping juror caused a significant delay in the trial, Ms. Leedom said. Finally, he woke up, and the trial was able to continue.

In another instance, a potential juror showed up drunk to a virtual jury selection. The man was slurring his words as he answered questions, Ms. Leedom said, and when asked if he was okay, he admitted that he had a drinking problem. The judge asked whether he had consumed alcohol, and the man admitted that he’d been drinking that day. He was excused from jury selection.

These alarming incidents are among the mishaps that happen during virtual medical malpractice trials. Since the pandemic started, many courts have moved to virtual settings to slow the spread of COVID-19. Although some courts have now shifted back to in-person trials, some areas continue to mandate virtual malpractice trials, hearings, and depositions.

Such trials can save money and are convenient, but legal experts say virtual trials present serious challenges for physicians and raise concerns about fairness. Some jurors are not taking virtual cases seriously or do not stay focused on the subject matter, according to attorneys.

“Virtual trials are not as fair to physicians as in-person trials,” said Andrew DeSimone, a medical malpractice defense attorney based in Lexington, Ky. “It’s too easy not to pay attention in a virtual setting. And when you are dealing with complex medical topics, juror attention is a paramount issue.”
 

Casual settings, constant interruptions during jury selections

Understanding and reaching the jury have been the greatest challenges with virtual and hybrid trials, said Laura Eschleman, a medical liability defense attorney based in Atlanta. Hybrid trials are part virtual and part in person.

Ms. Eschleman has participated in jury selections via Zoom in which jurors lounge in bed during the process and spouses and children waltz into the room as they please, she said.

“With over 36 Zoom boxes of potential jurors, assessing each potential juror was difficult to say the least,” she said. “[Jury selection] has always been an opportunity to introduce the defendant physicians to the jurors as humans; doing it virtually took that away. It is difficult to humanize a box on a screen.”

Regarding one virtual jury selection, Ms. Eschleman said the court had narrowed the pool to a final 12 jurors when one juror’s wife burst into his room and started yelling in front of his computer.

The judge allowed her to speak, and the crying woman begged the judge not to select her husband for the trial because it would disrupt the couple’s child care. After a lengthy exchange, they learned that the child was 16 years old and had his own car. The husband disagreed with his wife and wanted to remain a juror.

“This would have never happened had the twelfth juror been called to an in-person jury selection,” Ms. Eschleman said.

Keeping juries focused while the trial is underway can also be a problem, DeSimone said. He describes the courtroom during malpractice trials as a theater of sorts. Jurors watch intently as witnesses testify, evidence is presented, and the judge gives instructions. During virtual trials, however, watching through a screen doesn’t always yield the same captive audiences, he said.

“During Zoom, it’s much harder to connect with the jury because they won’t be as tuned into it,” he said. “If the jury believes the physician is empathetic, conscientious, caring, and compassionate, they will give the physician the benefit of the doubt, even if something went wrong or a bad outcome occurred. Developing that connection through good eye contact, being a teacher, and showing compassion is the most important thing a physician can do when testifying.”

A related challenge is that medical experts can’t connect as well with jurors, and some may have trouble conveying their message from a screen, said Evan Lyman, a medical malpractice defense attorney based in White Plains, N.Y.

“Some experts like to get out of the witness box and kind of take over the courtroom with a laser pointer or a white board,” he said. “For some, that’s what makes them effective experts. Some experts lose their touch when they can’t do that.”

Technical difficulties during virtual trials can cause further woes, said Kari Adams, vice president of claims for Physicians Insurance – A Mutual Company. She recalled a recent case in which technical problems arose during the defense attorney’s closing arguments.

“It’s hard to see our defense attorneys who are used to using all of their advocacy skills, all of their charisma trying to convey it in a virtual format,” she said. “When it’s disrupted, it can really throw things. A lot of their advocacy and personality can play through, but it’s just a little less in that forum.”
 

Doc fights against virtual trial

When Texas cardiologist Amin Al-Ahmad’s malpractice trial was changed to a virtual format because of COVID-19 concerns, Dr. Al-Ahmad and his attorneys fought the move.

They argued that the malpractice case was too complex for a virtual format and that a video trial would deprive Dr. Al-Ahmad of his rights to due process, including the right to trial by jury.

Dr. Al-Ahmad’s case involved allegations that he had failed to promptly diagnose and treat an atrial esophageal fistula, resulting in a patient’s stroke and ongoing neurologic problems. The trial was expected to last up to 10 days. Nine witnesses were expected to testify, and $1 million in damages were at stake, according to court documents.

“The length of trial anticipated, complexity of the medical issues, the confidential medical information at issue, and the number of anticipated medical records exhibits lead to a real risk of juror ‘Zoom fatigue,’ even if the trial is not interrupted with technology glitches, such as jurors dropping off the link or sound loss,” Dr. Al-Ahmad’s attorneys wrote in a petition to the Texas Supreme Court. “The risks of forcing [the defendants] to trial through the procedure of a remote or virtual jury trial are numerous. Not least of these is the risk that [defendants’] relators will be prevented from presenting an adequate defense or being able to fully preserve error during a virtual trial.”

Another concern regards the lack of uniformity from county to county in conducting a virtual trial, said David A. Wright, an attorney for Dr. Al-Ahmad. Some counties don’t permit them, while others permit parties to opt out of virtual trials, he noted.

“Even those that hold virtual trials seem to have different procedures and rules,” he said. “Travis County, where I have tried my virtual cases, has iPads that they provide to each juror so that they are limited to using just the county iPad for the trial. Others, I have heard, permit jurors to use their own devices. There are simply no uniform rules.”

Despite requests to the trial court and petitions to the appellate and Texas Supreme Court, Dr. Al-Ahmad lost his bid to have his trial delayed until in-person trials resumed. The Texas Supreme Court in late 2021 refused to halt the virtual trial.

Dr. Al-Ahmad, based in Austin, declined to comment through his attorney. Mr. Wright said the court’s denial “was not unexpected.”

Dr. Al-Ahmad’s virtual trial went forward in October 2021, and the jury ruled in his favor.

“We were very pleased with the jury’s verdict,” Mr. Wright said.
 

Are virtual trials ending in higher awards?

In addition to jurors’ not taking their roles as seriously, the casual vibe of virtual trials may also be diminishing how jurors view the verdict’s magnitude.

“Virtual trials don’t have the gravity or the seriousness of a real trial,” Ms. Leedom said. “I don’t think the importance of the jury’s decision weighs on them as much during a Zoom trial as it does an in-person trial.”

Alarmingly, Ms. Leedom said that, in her experience, damages in virtual trials have been higher in comparison with damages awarded during in-person trials.

Ms. Adams agreed with this observation.

“We’ll still win cases, but we’re concerned that, in the cases we lose, the damages can be slightly higher because there hasn’t been that interpersonal connection with the defendant,” she said. “It almost becomes like monopoly money to jurors.”
 

Remember these tips during virtual trials

Physicians undergoing virtual trials may have better experiences if they keep a few tips in mind.

Mr. DeSimone emphasized the importance of eye contact with jurors, which can be tricky during virtual settings. It helps if physicians look at the camera, rather than the screen, while talking.

Physicians should be cognizant of their facial expressions as they watch others speak.

“Don’t roll your eyes like: ‘Oh my gosh, he’s an idiot,’ ” Mr. DeSimone said. “Keep a poker face. Be respectful of what’s going on. Don’t be lulled into letting your guard down.”

Before the virtual trial, practice the cross examination and direct examination with your attorney and record it, Ms. Leedom said. That way, doctors can watch how they present on video and make necessary changes before the real trial. Lighting is also important, she noted. Her firm provides special lamps to clients and witnesses for virtual trials and proceedings.

“The lighting makes a huge difference,” she said.

Its also a good idea for physicians to have a paper copy of the records or exhibits that are going to be used so it’s easy for them to flip through them while on the screen. Physicians should also be mindful of how they come across during video depositions, which are sometimes played during virtual trials, Ms. Adams said.

“If you’re not looking professional during the video deposition – you’re eating, you’re not dressed well – the plaintiff’s attorney will take the most inopportune segment of the deposition and portray the physician as: ‘Look, here’s someone who was careless in the medical care, and look, they don’t even look professional when they’re testifying about this horrifying experience,’ ” she said. “They’ll use the clips to make a very careful provider appear distracted.”
 

Are virtual trials and hearings here to stay?

Whether virtual malpractice trials continue will largely depend on the location in which physicians practice. Some insurance carriers are opting to continue virtual trials, but in some areas, trials are being delayed until in-person proceedings can resume, Ms. Adams said. Some areas never adopted video trials and never ceased in-person trials.

“I think it’s going to be very regionally based,” she said. “Some of the smaller, rural counties just don’t have the capacity or the resources to continue, so they’ll probably just go back to in person.”

Not all virtual proceedings are problematic for physicians, say legal experts. Virtual depositions can be beneficial for doctors because they are less intimidating and confrontational than in-person depositions, Mr. Lyman said.

Additionally, virtual mediations can take much less time than in-person mediations, Ms. Adams said. Video depositions and mediations also save travel costs and reduce time missed from work for physicians.

“But I hope we all go back to in-person trials,” Ms. Leedom said. “Even here in King County, [Washington,] where we’ve done federal and state court trials by Zoom, I’m hopeful that it will go back to in-person trials.”

A version of this article first appeared on Medscape.com.

During a recent virtual medical malpractice trial, the judge called a break, and the participants left their screens. When the trial resumed a short time later, one juror was missing. The court called his phone, but there was no answer.

“Everyone had to keep waiting and waiting while the bailiff kept trying to call,” recalled Elizabeth Leedom, a medical malpractice defense attorney based in Seattle. “The juror fell asleep.”

The sleeping juror caused a significant delay in the trial, Ms. Leedom said. Finally, he woke up, and the trial was able to continue.

In another instance, a potential juror showed up drunk to a virtual jury selection. The man was slurring his words as he answered questions, Ms. Leedom said, and when asked if he was okay, he admitted that he had a drinking problem. The judge asked whether he had consumed alcohol, and the man admitted that he’d been drinking that day. He was excused from jury selection.

These alarming incidents are among the mishaps that happen during virtual medical malpractice trials. Since the pandemic started, many courts have moved to virtual settings to slow the spread of COVID-19. Although some courts have now shifted back to in-person trials, some areas continue to mandate virtual malpractice trials, hearings, and depositions.

Such trials can save money and are convenient, but legal experts say virtual trials present serious challenges for physicians and raise concerns about fairness. Some jurors are not taking virtual cases seriously or do not stay focused on the subject matter, according to attorneys.

“Virtual trials are not as fair to physicians as in-person trials,” said Andrew DeSimone, a medical malpractice defense attorney based in Lexington, Ky. “It’s too easy not to pay attention in a virtual setting. And when you are dealing with complex medical topics, juror attention is a paramount issue.”
 

Casual settings, constant interruptions during jury selections

Understanding and reaching the jury have been the greatest challenges with virtual and hybrid trials, said Laura Eschleman, a medical liability defense attorney based in Atlanta. Hybrid trials are part virtual and part in person.

Ms. Eschleman has participated in jury selections via Zoom in which jurors lounge in bed during the process and spouses and children waltz into the room as they please, she said.

“With over 36 Zoom boxes of potential jurors, assessing each potential juror was difficult to say the least,” she said. “[Jury selection] has always been an opportunity to introduce the defendant physicians to the jurors as humans; doing it virtually took that away. It is difficult to humanize a box on a screen.”

Regarding one virtual jury selection, Ms. Eschleman said the court had narrowed the pool to a final 12 jurors when one juror’s wife burst into his room and started yelling in front of his computer.

The judge allowed her to speak, and the crying woman begged the judge not to select her husband for the trial because it would disrupt the couple’s child care. After a lengthy exchange, they learned that the child was 16 years old and had his own car. The husband disagreed with his wife and wanted to remain a juror.

“This would have never happened had the twelfth juror been called to an in-person jury selection,” Ms. Eschleman said.

Keeping juries focused while the trial is underway can also be a problem, DeSimone said. He describes the courtroom during malpractice trials as a theater of sorts. Jurors watch intently as witnesses testify, evidence is presented, and the judge gives instructions. During virtual trials, however, watching through a screen doesn’t always yield the same captive audiences, he said.

“During Zoom, it’s much harder to connect with the jury because they won’t be as tuned into it,” he said. “If the jury believes the physician is empathetic, conscientious, caring, and compassionate, they will give the physician the benefit of the doubt, even if something went wrong or a bad outcome occurred. Developing that connection through good eye contact, being a teacher, and showing compassion is the most important thing a physician can do when testifying.”

A related challenge is that medical experts can’t connect as well with jurors, and some may have trouble conveying their message from a screen, said Evan Lyman, a medical malpractice defense attorney based in White Plains, N.Y.

“Some experts like to get out of the witness box and kind of take over the courtroom with a laser pointer or a white board,” he said. “For some, that’s what makes them effective experts. Some experts lose their touch when they can’t do that.”

Technical difficulties during virtual trials can cause further woes, said Kari Adams, vice president of claims for Physicians Insurance – A Mutual Company. She recalled a recent case in which technical problems arose during the defense attorney’s closing arguments.

“It’s hard to see our defense attorneys who are used to using all of their advocacy skills, all of their charisma trying to convey it in a virtual format,” she said. “When it’s disrupted, it can really throw things. A lot of their advocacy and personality can play through, but it’s just a little less in that forum.”
 

Doc fights against virtual trial

When Texas cardiologist Amin Al-Ahmad’s malpractice trial was changed to a virtual format because of COVID-19 concerns, Dr. Al-Ahmad and his attorneys fought the move.

They argued that the malpractice case was too complex for a virtual format and that a video trial would deprive Dr. Al-Ahmad of his rights to due process, including the right to trial by jury.

Dr. Al-Ahmad’s case involved allegations that he had failed to promptly diagnose and treat an atrial esophageal fistula, resulting in a patient’s stroke and ongoing neurologic problems. The trial was expected to last up to 10 days. Nine witnesses were expected to testify, and $1 million in damages were at stake, according to court documents.

“The length of trial anticipated, complexity of the medical issues, the confidential medical information at issue, and the number of anticipated medical records exhibits lead to a real risk of juror ‘Zoom fatigue,’ even if the trial is not interrupted with technology glitches, such as jurors dropping off the link or sound loss,” Dr. Al-Ahmad’s attorneys wrote in a petition to the Texas Supreme Court. “The risks of forcing [the defendants] to trial through the procedure of a remote or virtual jury trial are numerous. Not least of these is the risk that [defendants’] relators will be prevented from presenting an adequate defense or being able to fully preserve error during a virtual trial.”

Another concern regards the lack of uniformity from county to county in conducting a virtual trial, said David A. Wright, an attorney for Dr. Al-Ahmad. Some counties don’t permit them, while others permit parties to opt out of virtual trials, he noted.

“Even those that hold virtual trials seem to have different procedures and rules,” he said. “Travis County, where I have tried my virtual cases, has iPads that they provide to each juror so that they are limited to using just the county iPad for the trial. Others, I have heard, permit jurors to use their own devices. There are simply no uniform rules.”

Despite requests to the trial court and petitions to the appellate and Texas Supreme Court, Dr. Al-Ahmad lost his bid to have his trial delayed until in-person trials resumed. The Texas Supreme Court in late 2021 refused to halt the virtual trial.

Dr. Al-Ahmad, based in Austin, declined to comment through his attorney. Mr. Wright said the court’s denial “was not unexpected.”

Dr. Al-Ahmad’s virtual trial went forward in October 2021, and the jury ruled in his favor.

“We were very pleased with the jury’s verdict,” Mr. Wright said.
 

Are virtual trials ending in higher awards?

In addition to jurors’ not taking their roles as seriously, the casual vibe of virtual trials may also be diminishing how jurors view the verdict’s magnitude.

“Virtual trials don’t have the gravity or the seriousness of a real trial,” Ms. Leedom said. “I don’t think the importance of the jury’s decision weighs on them as much during a Zoom trial as it does an in-person trial.”

Alarmingly, Ms. Leedom said that, in her experience, damages in virtual trials have been higher in comparison with damages awarded during in-person trials.

Ms. Adams agreed with this observation.

“We’ll still win cases, but we’re concerned that, in the cases we lose, the damages can be slightly higher because there hasn’t been that interpersonal connection with the defendant,” she said. “It almost becomes like monopoly money to jurors.”
 

Remember these tips during virtual trials

Physicians undergoing virtual trials may have better experiences if they keep a few tips in mind.

Mr. DeSimone emphasized the importance of eye contact with jurors, which can be tricky during virtual settings. It helps if physicians look at the camera, rather than the screen, while talking.

Physicians should be cognizant of their facial expressions as they watch others speak.

“Don’t roll your eyes like: ‘Oh my gosh, he’s an idiot,’ ” Mr. DeSimone said. “Keep a poker face. Be respectful of what’s going on. Don’t be lulled into letting your guard down.”

Before the virtual trial, practice the cross examination and direct examination with your attorney and record it, Ms. Leedom said. That way, doctors can watch how they present on video and make necessary changes before the real trial. Lighting is also important, she noted. Her firm provides special lamps to clients and witnesses for virtual trials and proceedings.

“The lighting makes a huge difference,” she said.

Its also a good idea for physicians to have a paper copy of the records or exhibits that are going to be used so it’s easy for them to flip through them while on the screen. Physicians should also be mindful of how they come across during video depositions, which are sometimes played during virtual trials, Ms. Adams said.

“If you’re not looking professional during the video deposition – you’re eating, you’re not dressed well – the plaintiff’s attorney will take the most inopportune segment of the deposition and portray the physician as: ‘Look, here’s someone who was careless in the medical care, and look, they don’t even look professional when they’re testifying about this horrifying experience,’ ” she said. “They’ll use the clips to make a very careful provider appear distracted.”
 

Are virtual trials and hearings here to stay?

Whether virtual malpractice trials continue will largely depend on the location in which physicians practice. Some insurance carriers are opting to continue virtual trials, but in some areas, trials are being delayed until in-person proceedings can resume, Ms. Adams said. Some areas never adopted video trials and never ceased in-person trials.

“I think it’s going to be very regionally based,” she said. “Some of the smaller, rural counties just don’t have the capacity or the resources to continue, so they’ll probably just go back to in person.”

Not all virtual proceedings are problematic for physicians, say legal experts. Virtual depositions can be beneficial for doctors because they are less intimidating and confrontational than in-person depositions, Mr. Lyman said.

Additionally, virtual mediations can take much less time than in-person mediations, Ms. Adams said. Video depositions and mediations also save travel costs and reduce time missed from work for physicians.

“But I hope we all go back to in-person trials,” Ms. Leedom said. “Even here in King County, [Washington,] where we’ve done federal and state court trials by Zoom, I’m hopeful that it will go back to in-person trials.”

A version of this article first appeared on Medscape.com.

During a recent virtual medical malpractice trial, the judge called a break, and the participants left their screens. When the trial resumed a short time later, one juror was missing. The court called his phone, but there was no answer.

“Everyone had to keep waiting and waiting while the bailiff kept trying to call,” recalled Elizabeth Leedom, a medical malpractice defense attorney based in Seattle. “The juror fell asleep.”

The sleeping juror caused a significant delay in the trial, Ms. Leedom said. Finally, he woke up, and the trial was able to continue.

In another instance, a potential juror showed up drunk to a virtual jury selection. The man was slurring his words as he answered questions, Ms. Leedom said, and when asked if he was okay, he admitted that he had a drinking problem. The judge asked whether he had consumed alcohol, and the man admitted that he’d been drinking that day. He was excused from jury selection.

These alarming incidents are among the mishaps that happen during virtual medical malpractice trials. Since the pandemic started, many courts have moved to virtual settings to slow the spread of COVID-19. Although some courts have now shifted back to in-person trials, some areas continue to mandate virtual malpractice trials, hearings, and depositions.

Such trials can save money and are convenient, but legal experts say virtual trials present serious challenges for physicians and raise concerns about fairness. Some jurors are not taking virtual cases seriously or do not stay focused on the subject matter, according to attorneys.

“Virtual trials are not as fair to physicians as in-person trials,” said Andrew DeSimone, a medical malpractice defense attorney based in Lexington, Ky. “It’s too easy not to pay attention in a virtual setting. And when you are dealing with complex medical topics, juror attention is a paramount issue.”
 

Casual settings, constant interruptions during jury selections

Understanding and reaching the jury have been the greatest challenges with virtual and hybrid trials, said Laura Eschleman, a medical liability defense attorney based in Atlanta. Hybrid trials are part virtual and part in person.

Ms. Eschleman has participated in jury selections via Zoom in which jurors lounge in bed during the process and spouses and children waltz into the room as they please, she said.

“With over 36 Zoom boxes of potential jurors, assessing each potential juror was difficult to say the least,” she said. “[Jury selection] has always been an opportunity to introduce the defendant physicians to the jurors as humans; doing it virtually took that away. It is difficult to humanize a box on a screen.”

Regarding one virtual jury selection, Ms. Eschleman said the court had narrowed the pool to a final 12 jurors when one juror’s wife burst into his room and started yelling in front of his computer.

The judge allowed her to speak, and the crying woman begged the judge not to select her husband for the trial because it would disrupt the couple’s child care. After a lengthy exchange, they learned that the child was 16 years old and had his own car. The husband disagreed with his wife and wanted to remain a juror.

“This would have never happened had the twelfth juror been called to an in-person jury selection,” Ms. Eschleman said.

Keeping juries focused while the trial is underway can also be a problem, DeSimone said. He describes the courtroom during malpractice trials as a theater of sorts. Jurors watch intently as witnesses testify, evidence is presented, and the judge gives instructions. During virtual trials, however, watching through a screen doesn’t always yield the same captive audiences, he said.

“During Zoom, it’s much harder to connect with the jury because they won’t be as tuned into it,” he said. “If the jury believes the physician is empathetic, conscientious, caring, and compassionate, they will give the physician the benefit of the doubt, even if something went wrong or a bad outcome occurred. Developing that connection through good eye contact, being a teacher, and showing compassion is the most important thing a physician can do when testifying.”

A related challenge is that medical experts can’t connect as well with jurors, and some may have trouble conveying their message from a screen, said Evan Lyman, a medical malpractice defense attorney based in White Plains, N.Y.

“Some experts like to get out of the witness box and kind of take over the courtroom with a laser pointer or a white board,” he said. “For some, that’s what makes them effective experts. Some experts lose their touch when they can’t do that.”

Technical difficulties during virtual trials can cause further woes, said Kari Adams, vice president of claims for Physicians Insurance – A Mutual Company. She recalled a recent case in which technical problems arose during the defense attorney’s closing arguments.

“It’s hard to see our defense attorneys who are used to using all of their advocacy skills, all of their charisma trying to convey it in a virtual format,” she said. “When it’s disrupted, it can really throw things. A lot of their advocacy and personality can play through, but it’s just a little less in that forum.”
 

Doc fights against virtual trial

When Texas cardiologist Amin Al-Ahmad’s malpractice trial was changed to a virtual format because of COVID-19 concerns, Dr. Al-Ahmad and his attorneys fought the move.

They argued that the malpractice case was too complex for a virtual format and that a video trial would deprive Dr. Al-Ahmad of his rights to due process, including the right to trial by jury.

Dr. Al-Ahmad’s case involved allegations that he had failed to promptly diagnose and treat an atrial esophageal fistula, resulting in a patient’s stroke and ongoing neurologic problems. The trial was expected to last up to 10 days. Nine witnesses were expected to testify, and $1 million in damages were at stake, according to court documents.

“The length of trial anticipated, complexity of the medical issues, the confidential medical information at issue, and the number of anticipated medical records exhibits lead to a real risk of juror ‘Zoom fatigue,’ even if the trial is not interrupted with technology glitches, such as jurors dropping off the link or sound loss,” Dr. Al-Ahmad’s attorneys wrote in a petition to the Texas Supreme Court. “The risks of forcing [the defendants] to trial through the procedure of a remote or virtual jury trial are numerous. Not least of these is the risk that [defendants’] relators will be prevented from presenting an adequate defense or being able to fully preserve error during a virtual trial.”

Another concern regards the lack of uniformity from county to county in conducting a virtual trial, said David A. Wright, an attorney for Dr. Al-Ahmad. Some counties don’t permit them, while others permit parties to opt out of virtual trials, he noted.

“Even those that hold virtual trials seem to have different procedures and rules,” he said. “Travis County, where I have tried my virtual cases, has iPads that they provide to each juror so that they are limited to using just the county iPad for the trial. Others, I have heard, permit jurors to use their own devices. There are simply no uniform rules.”

Despite requests to the trial court and petitions to the appellate and Texas Supreme Court, Dr. Al-Ahmad lost his bid to have his trial delayed until in-person trials resumed. The Texas Supreme Court in late 2021 refused to halt the virtual trial.

Dr. Al-Ahmad, based in Austin, declined to comment through his attorney. Mr. Wright said the court’s denial “was not unexpected.”

Dr. Al-Ahmad’s virtual trial went forward in October 2021, and the jury ruled in his favor.

“We were very pleased with the jury’s verdict,” Mr. Wright said.
 

Are virtual trials ending in higher awards?

In addition to jurors’ not taking their roles as seriously, the casual vibe of virtual trials may also be diminishing how jurors view the verdict’s magnitude.

“Virtual trials don’t have the gravity or the seriousness of a real trial,” Ms. Leedom said. “I don’t think the importance of the jury’s decision weighs on them as much during a Zoom trial as it does an in-person trial.”

Alarmingly, Ms. Leedom said that, in her experience, damages in virtual trials have been higher in comparison with damages awarded during in-person trials.

Ms. Adams agreed with this observation.

“We’ll still win cases, but we’re concerned that, in the cases we lose, the damages can be slightly higher because there hasn’t been that interpersonal connection with the defendant,” she said. “It almost becomes like monopoly money to jurors.”
 

Remember these tips during virtual trials

Physicians undergoing virtual trials may have better experiences if they keep a few tips in mind.

Mr. DeSimone emphasized the importance of eye contact with jurors, which can be tricky during virtual settings. It helps if physicians look at the camera, rather than the screen, while talking.

Physicians should be cognizant of their facial expressions as they watch others speak.

“Don’t roll your eyes like: ‘Oh my gosh, he’s an idiot,’ ” Mr. DeSimone said. “Keep a poker face. Be respectful of what’s going on. Don’t be lulled into letting your guard down.”

Before the virtual trial, practice the cross examination and direct examination with your attorney and record it, Ms. Leedom said. That way, doctors can watch how they present on video and make necessary changes before the real trial. Lighting is also important, she noted. Her firm provides special lamps to clients and witnesses for virtual trials and proceedings.

“The lighting makes a huge difference,” she said.

Its also a good idea for physicians to have a paper copy of the records or exhibits that are going to be used so it’s easy for them to flip through them while on the screen. Physicians should also be mindful of how they come across during video depositions, which are sometimes played during virtual trials, Ms. Adams said.

“If you’re not looking professional during the video deposition – you’re eating, you’re not dressed well – the plaintiff’s attorney will take the most inopportune segment of the deposition and portray the physician as: ‘Look, here’s someone who was careless in the medical care, and look, they don’t even look professional when they’re testifying about this horrifying experience,’ ” she said. “They’ll use the clips to make a very careful provider appear distracted.”
 

Are virtual trials and hearings here to stay?

Whether virtual malpractice trials continue will largely depend on the location in which physicians practice. Some insurance carriers are opting to continue virtual trials, but in some areas, trials are being delayed until in-person proceedings can resume, Ms. Adams said. Some areas never adopted video trials and never ceased in-person trials.

“I think it’s going to be very regionally based,” she said. “Some of the smaller, rural counties just don’t have the capacity or the resources to continue, so they’ll probably just go back to in person.”

Not all virtual proceedings are problematic for physicians, say legal experts. Virtual depositions can be beneficial for doctors because they are less intimidating and confrontational than in-person depositions, Mr. Lyman said.

Additionally, virtual mediations can take much less time than in-person mediations, Ms. Adams said. Video depositions and mediations also save travel costs and reduce time missed from work for physicians.

“But I hope we all go back to in-person trials,” Ms. Leedom said. “Even here in King County, [Washington,] where we’ve done federal and state court trials by Zoom, I’m hopeful that it will go back to in-person trials.”

A version of this article first appeared on Medscape.com.

Morton J, MD, a 68-year-old cardiologist based in the Midwest, saw things become dramatically worse when his nine-physician practice was taken over by a large health system.

“Everything changed. My partners and I lost a lot of autonomy. We had a say – but not the final say-so in who we hired as medical assistants or receptionists. We had to change how long we spent with patients and justify procedures or tests – not just to the insurance companies, which is an old story, but to our new employer,” said Dr. J, who asked to remain anonymous.

Worst of all, “I had to report to a kid – a doctor in his 30s, someone young enough to be my son, someone with a fraction of the clinical training and experience I had but who now got to tell me what to do and how to run my practice.”

The “final straw” for Dr. J came when the practice had to change to a new electronic health record (EHR) system. “Learning this new system was like pulling teeth,” he said. His youthful supervisor was “obviously impatient and irritated – his whole attitude and demeanor reflected a sense that he was saddled with a dinosaur.”

After much anguishing and soul-searching, Dr. J decided to retire. “I was already close to retirement age, and I thought it would be nice to spend more time with my grandchildren. Feeling so disrespected was simply the catalyst that brought the decision to a head a couple of years sooner than I had planned.”
 

Getting through a delicate discussion

This unfortunate situation could have been avoided had the younger supervisor shown more sensitivity, says otolaryngologist Mark Wallace, DO.

Dr. Wallace is speaking from personal experience. Early in his career, he was a younger physician who was forced to discuss a practice management issue with an older physician.

Dr. Wallace was a member of a committee that was responsible for “maximizing the efficiency of good care, while still being aware of cost issues.” When the committee “wanted one of the physicians in the group to change their behavior to improve cost savings, it was my job to discuss that with them.”

Dr. Wallace, who today is a locum tenens physician and a medical practice consultant to Physicians Thrive – an advisory group that helps physicians with financial and practice management problems – recalls feeling uncomfortable about broaching the subject to his supervisee. In this case, the older physician was prescribing name brand medications, and the committee that appointed Dr. Wallace wanted him to encourage the physician to prescribe a generic medication first and reserve brand prescriptions only for cases in which the generic was ineffective.

He acknowledges that he thought the generic was equivalent to the branded product in safety and efficacy.

“I always felt this to be a delicate discussion, whatever the age of the physician, because I didn’t like the idea of telling a doctor that they have to change how they practice so as to save money. I would never want anyone to feel they’re providing a lower level of care.”

The fact that this was an older physician – in his 60s – compounded his hesitancy. “Older physicians have a lot more experience than what I had in my 30s,” Dr. Wallace said. “I could talk to them about studies and outcomes and things like that, but a large part of medicine is the experience you gain over time.

“I presented it simply as a cost issue raised by the committee and asked him to consider experimenting with changing his prescribing behavior, while emphasizing that ultimately, it was his decision,” says Dr. Wallace.

The supervisee understood the concern and agreed to the experiment. He ended up prescribing the generic more frequently, although perhaps not as frequently as the committee would have liked.

Respectful, authentic, honest communication is important in any leadership situation but especially in those in which younger physicians are supervising physicians who are old enough to be their parents, says Ted Epperly, MD, a family physician in Boise, Idaho, and president and CEO of Family Medicine Residency of Idaho.

Dr. Wallace said that older physicians, on coming out of training, felt more respected, were better paid, and didn’t have to continually adjust to new regulations and new complicated insurance requirements. Today’s young physicians coming out of training may not find the practice of medicine as enjoyable as their older counterparts did, but they are accustomed to increasingly complex rules and regulations, so it’s less of an adjustment. But many may not feel they want to work 80 hours per week, as their older counterparts did.
 

Challenges of technology

Technology is one of the most central areas where intergenerational differences play out, says Tracy Clarke, chief human resources officer at Kitsap Mental Health Services, a large nonprofit organization in Bremerton, Wash., that employs roughly 500 individuals. “The younger physicians in our practice are really prepared, already engaged in technology, and used to using technology for documentation, and it is already integrated into the way they do business in general and practice,” she said.

Dr. Epperly noted that Gen X-ers are typically comfortable with digital technology, although not quite as much as the following generation, the millennials, who have grown up with smartphones and computers quite literally at their fingertips from earliest childhood.

Dr. Epperly, now 67, described the experience of having his organization convert to a new EHR system. “Although the younger physicians were not my supervisors, the dynamic that occurred when we were switching to the new system is typical of what might happen in a more formal reporting structure of older ‘supervisee’ and younger supervisor,” he said. In fact, his experience was similar to that of Dr. J.

“Some of the millennials were so quick to learn the new system that they forgot to check in with the older ones about how they were doing, or they were frustrated with our slow pace of learning the new technology,” said Dr. Epperly. “In fact, I was struggling to master it, and so were many others of my generation, and I felt very dumb, slow, and vulnerable, even though I usually regard myself as a pretty bright guy.”

Dr. Epperly encourages younger physicians not to think, “He’s asked me five times how to do this – what’s his problem?” This impatience can be intuited by the older physician, who may take it personally and feel devalued and disrespected.

Joy Engblade, an internal medicine physician and CMO of Northern Inyo Hospital, Bishop, Calif., said that when her institution was transitioning to a new EHR system this past May, she was worried that the older physicians would have the most difficulty.

Ironically, that turned out not to be the case. In fact, the younger physicians struggled more because the older physicians recognized their limitations and “were willing to do whatever we asked them to do. They watched the tutorials about how to use the new EHR. They went to every class that was offered and did all the practice sessions.” By contrast, many of the younger ones thought, “I know how to work an EHR, I’ve been doing it for years, so how hard could it be?” By the time they needed to actually use it, the instructional resources and tutorials were no longer available.

Dr. Epperly’s experience is different. He noted that some older physicians may be embarrassed to acknowledge that they are technologically challenged and may say, “I got it, I understand,” when they are still struggling to master the new technology.

Ms. Clarke notes that the leadership in her organization is younger than many of the physicians who report to them. “For the leadership, the biggest challenge is that many older physicians are set in their ways, and they haven’t really seen a reason to change their practice or ways of doing things.” For example, some still prefer paper charting or making voice recordings of patient visits for other people to transcribe.

Ms. Clarke has some advice for younger leaders: “Really explore what the pain points are of these older physicians. Beyond their saying, ‘because I’ve always done it this way,’ what really is the advantage of, for example, paper charting when using the EHR is more efficient?”

Daniel DeBehnke, MD, is an emergency medicine physician and vice president and chief physician executive for Premier Inc., where he helps hospitals improve quality, safety, and financial performance. Before joining Premier, he was both a practicing physician and CEO of a health system consisting of more than 1,500 physicians.

“Having been on both sides of the spectrum as manager/leader within a physician group, some of whom are senior to me and some of whom are junior, I can tell you that I have never had any issues related to the age gap.” In fact, it is less about age per se and more about “the expertise that you, as a manager, bring to the table in understanding the nuances of the medical practice and for the individual being ‘managed.’ It is about trusting the expertise of the manager.”
 

Before and after hourly caps

Dr. Engblade regards “generational” issues to be less about age and birth year and more about the cap on hours worked during residency.

Dr. Engblade, who is 45 years old, said she did her internship year with no hourly restrictions. Such restrictions only went into effect during her second year of residency. “This created a paradigm shift in how much people wanted to work and created a consciousness of work-life balance that hadn’t been part of the conversation before,” she said.

When she interviews an older physician, a typical response is, “Of course I’ll be available any time,” whereas younger physicians, who went through residency after hourly restrictions had been established, are more likely to ask how many hours they will be on and how many they’ll be off.

Matt Lambert, MD, an independent emergency medicine physician and CMO of Curation Health, Washington, agreed, noting that differences in the cap on hours during training “can create a bit of an undertow, a tension between younger managers who are better adjusted in terms of work-life balance and older physicians being managed, who have a different work ethic and also might regard their managers as being less trained because they put in fewer hours during training.”

It is also important to be cognizant of differences in style and priorities that each generation brings to the table. Jaciel Keltgen, PhD, assistant professor of business administration, Augustana University, Sioux Falls, S.D., has heard older physicians say, “We did this the hard way, we sacrificed for our organization, and we expect the same values of younger physicians.” The younger ones tend to say, “We need to use all the tools at our disposal, and medicine doesn’t have to be practiced the way it’s always been.”

Dr. Keltgen, whose PhD is in political science and who has studied public administration, said that younger physicians may also question the mores and protocols that older physicians take for granted. For example, when her physician son was beginning his career, he was told by his senior supervisors that although he was “performing beautifully as a physician, he needed to shave more frequently, wear his white coat more often, and introduce himself as ‘Doctor’ rather than by his first name. Although he did wear his white coat more often, he didn’t change how he introduced himself to patients.”

Flexibility and mutual understanding of each generation’s needs, the type, structure, and amount of training they underwent, and the prevailing values will smooth supervisory interactions and optimize outcomes, experts agree.
 

Every generation’s No. 1 concern

For her dissertation, Dr. Keltgen used a large dataset of physicians and sought to draw a predictive model by generation and gender as to what physicians were seeking in order to be satisfied in their careers. One “overwhelming finding” of her research into generational differences in physicians is that “every single generation and gender is there to promote the health of their patients, and providing excellent care is their No. 1 concern. That is the common focus and the foundation that everyone can build on.”

Dr. J agreed. “Had I felt like a valued collaborator, I might have made a different decision.” He has begun to consider reentering clinical practice, perhaps as locum tenens or on a part-time basis. “I don’t want to feel that I’ve been driven out of a field that I love. I will see if I can find some type of context where my experience will be valued and learn to bring myself up to speed with technology if necessary. I believe I still have much to offer patients, and I would like to find a context to do so.”

A version of this article first appeared on Medscape.com.

Morton J, MD, a 68-year-old cardiologist based in the Midwest, saw things become dramatically worse when his nine-physician practice was taken over by a large health system.

“Everything changed. My partners and I lost a lot of autonomy. We had a say – but not the final say-so in who we hired as medical assistants or receptionists. We had to change how long we spent with patients and justify procedures or tests – not just to the insurance companies, which is an old story, but to our new employer,” said Dr. J, who asked to remain anonymous.

Worst of all, “I had to report to a kid – a doctor in his 30s, someone young enough to be my son, someone with a fraction of the clinical training and experience I had but who now got to tell me what to do and how to run my practice.”

The “final straw” for Dr. J came when the practice had to change to a new electronic health record (EHR) system. “Learning this new system was like pulling teeth,” he said. His youthful supervisor was “obviously impatient and irritated – his whole attitude and demeanor reflected a sense that he was saddled with a dinosaur.”

After much anguishing and soul-searching, Dr. J decided to retire. “I was already close to retirement age, and I thought it would be nice to spend more time with my grandchildren. Feeling so disrespected was simply the catalyst that brought the decision to a head a couple of years sooner than I had planned.”
 

Getting through a delicate discussion

This unfortunate situation could have been avoided had the younger supervisor shown more sensitivity, says otolaryngologist Mark Wallace, DO.

Dr. Wallace is speaking from personal experience. Early in his career, he was a younger physician who was forced to discuss a practice management issue with an older physician.

Dr. Wallace was a member of a committee that was responsible for “maximizing the efficiency of good care, while still being aware of cost issues.” When the committee “wanted one of the physicians in the group to change their behavior to improve cost savings, it was my job to discuss that with them.”

Dr. Wallace, who today is a locum tenens physician and a medical practice consultant to Physicians Thrive – an advisory group that helps physicians with financial and practice management problems – recalls feeling uncomfortable about broaching the subject to his supervisee. In this case, the older physician was prescribing name brand medications, and the committee that appointed Dr. Wallace wanted him to encourage the physician to prescribe a generic medication first and reserve brand prescriptions only for cases in which the generic was ineffective.

He acknowledges that he thought the generic was equivalent to the branded product in safety and efficacy.

“I always felt this to be a delicate discussion, whatever the age of the physician, because I didn’t like the idea of telling a doctor that they have to change how they practice so as to save money. I would never want anyone to feel they’re providing a lower level of care.”

The fact that this was an older physician – in his 60s – compounded his hesitancy. “Older physicians have a lot more experience than what I had in my 30s,” Dr. Wallace said. “I could talk to them about studies and outcomes and things like that, but a large part of medicine is the experience you gain over time.

“I presented it simply as a cost issue raised by the committee and asked him to consider experimenting with changing his prescribing behavior, while emphasizing that ultimately, it was his decision,” says Dr. Wallace.

The supervisee understood the concern and agreed to the experiment. He ended up prescribing the generic more frequently, although perhaps not as frequently as the committee would have liked.

Respectful, authentic, honest communication is important in any leadership situation but especially in those in which younger physicians are supervising physicians who are old enough to be their parents, says Ted Epperly, MD, a family physician in Boise, Idaho, and president and CEO of Family Medicine Residency of Idaho.

Dr. Wallace said that older physicians, on coming out of training, felt more respected, were better paid, and didn’t have to continually adjust to new regulations and new complicated insurance requirements. Today’s young physicians coming out of training may not find the practice of medicine as enjoyable as their older counterparts did, but they are accustomed to increasingly complex rules and regulations, so it’s less of an adjustment. But many may not feel they want to work 80 hours per week, as their older counterparts did.
 

Challenges of technology

Technology is one of the most central areas where intergenerational differences play out, says Tracy Clarke, chief human resources officer at Kitsap Mental Health Services, a large nonprofit organization in Bremerton, Wash., that employs roughly 500 individuals. “The younger physicians in our practice are really prepared, already engaged in technology, and used to using technology for documentation, and it is already integrated into the way they do business in general and practice,” she said.

Dr. Epperly noted that Gen X-ers are typically comfortable with digital technology, although not quite as much as the following generation, the millennials, who have grown up with smartphones and computers quite literally at their fingertips from earliest childhood.

Dr. Epperly, now 67, described the experience of having his organization convert to a new EHR system. “Although the younger physicians were not my supervisors, the dynamic that occurred when we were switching to the new system is typical of what might happen in a more formal reporting structure of older ‘supervisee’ and younger supervisor,” he said. In fact, his experience was similar to that of Dr. J.

“Some of the millennials were so quick to learn the new system that they forgot to check in with the older ones about how they were doing, or they were frustrated with our slow pace of learning the new technology,” said Dr. Epperly. “In fact, I was struggling to master it, and so were many others of my generation, and I felt very dumb, slow, and vulnerable, even though I usually regard myself as a pretty bright guy.”

Dr. Epperly encourages younger physicians not to think, “He’s asked me five times how to do this – what’s his problem?” This impatience can be intuited by the older physician, who may take it personally and feel devalued and disrespected.

Joy Engblade, an internal medicine physician and CMO of Northern Inyo Hospital, Bishop, Calif., said that when her institution was transitioning to a new EHR system this past May, she was worried that the older physicians would have the most difficulty.

Ironically, that turned out not to be the case. In fact, the younger physicians struggled more because the older physicians recognized their limitations and “were willing to do whatever we asked them to do. They watched the tutorials about how to use the new EHR. They went to every class that was offered and did all the practice sessions.” By contrast, many of the younger ones thought, “I know how to work an EHR, I’ve been doing it for years, so how hard could it be?” By the time they needed to actually use it, the instructional resources and tutorials were no longer available.

Dr. Epperly’s experience is different. He noted that some older physicians may be embarrassed to acknowledge that they are technologically challenged and may say, “I got it, I understand,” when they are still struggling to master the new technology.

Ms. Clarke notes that the leadership in her organization is younger than many of the physicians who report to them. “For the leadership, the biggest challenge is that many older physicians are set in their ways, and they haven’t really seen a reason to change their practice or ways of doing things.” For example, some still prefer paper charting or making voice recordings of patient visits for other people to transcribe.

Ms. Clarke has some advice for younger leaders: “Really explore what the pain points are of these older physicians. Beyond their saying, ‘because I’ve always done it this way,’ what really is the advantage of, for example, paper charting when using the EHR is more efficient?”

Daniel DeBehnke, MD, is an emergency medicine physician and vice president and chief physician executive for Premier Inc., where he helps hospitals improve quality, safety, and financial performance. Before joining Premier, he was both a practicing physician and CEO of a health system consisting of more than 1,500 physicians.

“Having been on both sides of the spectrum as manager/leader within a physician group, some of whom are senior to me and some of whom are junior, I can tell you that I have never had any issues related to the age gap.” In fact, it is less about age per se and more about “the expertise that you, as a manager, bring to the table in understanding the nuances of the medical practice and for the individual being ‘managed.’ It is about trusting the expertise of the manager.”
 

Before and after hourly caps

Dr. Engblade regards “generational” issues to be less about age and birth year and more about the cap on hours worked during residency.

Dr. Engblade, who is 45 years old, said she did her internship year with no hourly restrictions. Such restrictions only went into effect during her second year of residency. “This created a paradigm shift in how much people wanted to work and created a consciousness of work-life balance that hadn’t been part of the conversation before,” she said.

When she interviews an older physician, a typical response is, “Of course I’ll be available any time,” whereas younger physicians, who went through residency after hourly restrictions had been established, are more likely to ask how many hours they will be on and how many they’ll be off.

Matt Lambert, MD, an independent emergency medicine physician and CMO of Curation Health, Washington, agreed, noting that differences in the cap on hours during training “can create a bit of an undertow, a tension between younger managers who are better adjusted in terms of work-life balance and older physicians being managed, who have a different work ethic and also might regard their managers as being less trained because they put in fewer hours during training.”

It is also important to be cognizant of differences in style and priorities that each generation brings to the table. Jaciel Keltgen, PhD, assistant professor of business administration, Augustana University, Sioux Falls, S.D., has heard older physicians say, “We did this the hard way, we sacrificed for our organization, and we expect the same values of younger physicians.” The younger ones tend to say, “We need to use all the tools at our disposal, and medicine doesn’t have to be practiced the way it’s always been.”

Dr. Keltgen, whose PhD is in political science and who has studied public administration, said that younger physicians may also question the mores and protocols that older physicians take for granted. For example, when her physician son was beginning his career, he was told by his senior supervisors that although he was “performing beautifully as a physician, he needed to shave more frequently, wear his white coat more often, and introduce himself as ‘Doctor’ rather than by his first name. Although he did wear his white coat more often, he didn’t change how he introduced himself to patients.”

Flexibility and mutual understanding of each generation’s needs, the type, structure, and amount of training they underwent, and the prevailing values will smooth supervisory interactions and optimize outcomes, experts agree.
 

Every generation’s No. 1 concern

For her dissertation, Dr. Keltgen used a large dataset of physicians and sought to draw a predictive model by generation and gender as to what physicians were seeking in order to be satisfied in their careers. One “overwhelming finding” of her research into generational differences in physicians is that “every single generation and gender is there to promote the health of their patients, and providing excellent care is their No. 1 concern. That is the common focus and the foundation that everyone can build on.”

Dr. J agreed. “Had I felt like a valued collaborator, I might have made a different decision.” He has begun to consider reentering clinical practice, perhaps as locum tenens or on a part-time basis. “I don’t want to feel that I’ve been driven out of a field that I love. I will see if I can find some type of context where my experience will be valued and learn to bring myself up to speed with technology if necessary. I believe I still have much to offer patients, and I would like to find a context to do so.”

A version of this article first appeared on Medscape.com.

Morton J, MD, a 68-year-old cardiologist based in the Midwest, saw things become dramatically worse when his nine-physician practice was taken over by a large health system.

“Everything changed. My partners and I lost a lot of autonomy. We had a say – but not the final say-so in who we hired as medical assistants or receptionists. We had to change how long we spent with patients and justify procedures or tests – not just to the insurance companies, which is an old story, but to our new employer,” said Dr. J, who asked to remain anonymous.

Worst of all, “I had to report to a kid – a doctor in his 30s, someone young enough to be my son, someone with a fraction of the clinical training and experience I had but who now got to tell me what to do and how to run my practice.”

The “final straw” for Dr. J came when the practice had to change to a new electronic health record (EHR) system. “Learning this new system was like pulling teeth,” he said. His youthful supervisor was “obviously impatient and irritated – his whole attitude and demeanor reflected a sense that he was saddled with a dinosaur.”

After much anguishing and soul-searching, Dr. J decided to retire. “I was already close to retirement age, and I thought it would be nice to spend more time with my grandchildren. Feeling so disrespected was simply the catalyst that brought the decision to a head a couple of years sooner than I had planned.”
 

Getting through a delicate discussion

This unfortunate situation could have been avoided had the younger supervisor shown more sensitivity, says otolaryngologist Mark Wallace, DO.

Dr. Wallace is speaking from personal experience. Early in his career, he was a younger physician who was forced to discuss a practice management issue with an older physician.

Dr. Wallace was a member of a committee that was responsible for “maximizing the efficiency of good care, while still being aware of cost issues.” When the committee “wanted one of the physicians in the group to change their behavior to improve cost savings, it was my job to discuss that with them.”

Dr. Wallace, who today is a locum tenens physician and a medical practice consultant to Physicians Thrive – an advisory group that helps physicians with financial and practice management problems – recalls feeling uncomfortable about broaching the subject to his supervisee. In this case, the older physician was prescribing name brand medications, and the committee that appointed Dr. Wallace wanted him to encourage the physician to prescribe a generic medication first and reserve brand prescriptions only for cases in which the generic was ineffective.

He acknowledges that he thought the generic was equivalent to the branded product in safety and efficacy.

“I always felt this to be a delicate discussion, whatever the age of the physician, because I didn’t like the idea of telling a doctor that they have to change how they practice so as to save money. I would never want anyone to feel they’re providing a lower level of care.”

The fact that this was an older physician – in his 60s – compounded his hesitancy. “Older physicians have a lot more experience than what I had in my 30s,” Dr. Wallace said. “I could talk to them about studies and outcomes and things like that, but a large part of medicine is the experience you gain over time.

“I presented it simply as a cost issue raised by the committee and asked him to consider experimenting with changing his prescribing behavior, while emphasizing that ultimately, it was his decision,” says Dr. Wallace.

The supervisee understood the concern and agreed to the experiment. He ended up prescribing the generic more frequently, although perhaps not as frequently as the committee would have liked.

Respectful, authentic, honest communication is important in any leadership situation but especially in those in which younger physicians are supervising physicians who are old enough to be their parents, says Ted Epperly, MD, a family physician in Boise, Idaho, and president and CEO of Family Medicine Residency of Idaho.

Dr. Wallace said that older physicians, on coming out of training, felt more respected, were better paid, and didn’t have to continually adjust to new regulations and new complicated insurance requirements. Today’s young physicians coming out of training may not find the practice of medicine as enjoyable as their older counterparts did, but they are accustomed to increasingly complex rules and regulations, so it’s less of an adjustment. But many may not feel they want to work 80 hours per week, as their older counterparts did.
 

Challenges of technology

Technology is one of the most central areas where intergenerational differences play out, says Tracy Clarke, chief human resources officer at Kitsap Mental Health Services, a large nonprofit organization in Bremerton, Wash., that employs roughly 500 individuals. “The younger physicians in our practice are really prepared, already engaged in technology, and used to using technology for documentation, and it is already integrated into the way they do business in general and practice,” she said.

Dr. Epperly noted that Gen X-ers are typically comfortable with digital technology, although not quite as much as the following generation, the millennials, who have grown up with smartphones and computers quite literally at their fingertips from earliest childhood.

Dr. Epperly, now 67, described the experience of having his organization convert to a new EHR system. “Although the younger physicians were not my supervisors, the dynamic that occurred when we were switching to the new system is typical of what might happen in a more formal reporting structure of older ‘supervisee’ and younger supervisor,” he said. In fact, his experience was similar to that of Dr. J.

“Some of the millennials were so quick to learn the new system that they forgot to check in with the older ones about how they were doing, or they were frustrated with our slow pace of learning the new technology,” said Dr. Epperly. “In fact, I was struggling to master it, and so were many others of my generation, and I felt very dumb, slow, and vulnerable, even though I usually regard myself as a pretty bright guy.”

Dr. Epperly encourages younger physicians not to think, “He’s asked me five times how to do this – what’s his problem?” This impatience can be intuited by the older physician, who may take it personally and feel devalued and disrespected.

Joy Engblade, an internal medicine physician and CMO of Northern Inyo Hospital, Bishop, Calif., said that when her institution was transitioning to a new EHR system this past May, she was worried that the older physicians would have the most difficulty.

Ironically, that turned out not to be the case. In fact, the younger physicians struggled more because the older physicians recognized their limitations and “were willing to do whatever we asked them to do. They watched the tutorials about how to use the new EHR. They went to every class that was offered and did all the practice sessions.” By contrast, many of the younger ones thought, “I know how to work an EHR, I’ve been doing it for years, so how hard could it be?” By the time they needed to actually use it, the instructional resources and tutorials were no longer available.

Dr. Epperly’s experience is different. He noted that some older physicians may be embarrassed to acknowledge that they are technologically challenged and may say, “I got it, I understand,” when they are still struggling to master the new technology.

Ms. Clarke notes that the leadership in her organization is younger than many of the physicians who report to them. “For the leadership, the biggest challenge is that many older physicians are set in their ways, and they haven’t really seen a reason to change their practice or ways of doing things.” For example, some still prefer paper charting or making voice recordings of patient visits for other people to transcribe.

Ms. Clarke has some advice for younger leaders: “Really explore what the pain points are of these older physicians. Beyond their saying, ‘because I’ve always done it this way,’ what really is the advantage of, for example, paper charting when using the EHR is more efficient?”

Daniel DeBehnke, MD, is an emergency medicine physician and vice president and chief physician executive for Premier Inc., where he helps hospitals improve quality, safety, and financial performance. Before joining Premier, he was both a practicing physician and CEO of a health system consisting of more than 1,500 physicians.

“Having been on both sides of the spectrum as manager/leader within a physician group, some of whom are senior to me and some of whom are junior, I can tell you that I have never had any issues related to the age gap.” In fact, it is less about age per se and more about “the expertise that you, as a manager, bring to the table in understanding the nuances of the medical practice and for the individual being ‘managed.’ It is about trusting the expertise of the manager.”
 

Before and after hourly caps

Dr. Engblade regards “generational” issues to be less about age and birth year and more about the cap on hours worked during residency.

Dr. Engblade, who is 45 years old, said she did her internship year with no hourly restrictions. Such restrictions only went into effect during her second year of residency. “This created a paradigm shift in how much people wanted to work and created a consciousness of work-life balance that hadn’t been part of the conversation before,” she said.

When she interviews an older physician, a typical response is, “Of course I’ll be available any time,” whereas younger physicians, who went through residency after hourly restrictions had been established, are more likely to ask how many hours they will be on and how many they’ll be off.

Matt Lambert, MD, an independent emergency medicine physician and CMO of Curation Health, Washington, agreed, noting that differences in the cap on hours during training “can create a bit of an undertow, a tension between younger managers who are better adjusted in terms of work-life balance and older physicians being managed, who have a different work ethic and also might regard their managers as being less trained because they put in fewer hours during training.”

It is also important to be cognizant of differences in style and priorities that each generation brings to the table. Jaciel Keltgen, PhD, assistant professor of business administration, Augustana University, Sioux Falls, S.D., has heard older physicians say, “We did this the hard way, we sacrificed for our organization, and we expect the same values of younger physicians.” The younger ones tend to say, “We need to use all the tools at our disposal, and medicine doesn’t have to be practiced the way it’s always been.”

Dr. Keltgen, whose PhD is in political science and who has studied public administration, said that younger physicians may also question the mores and protocols that older physicians take for granted. For example, when her physician son was beginning his career, he was told by his senior supervisors that although he was “performing beautifully as a physician, he needed to shave more frequently, wear his white coat more often, and introduce himself as ‘Doctor’ rather than by his first name. Although he did wear his white coat more often, he didn’t change how he introduced himself to patients.”

Flexibility and mutual understanding of each generation’s needs, the type, structure, and amount of training they underwent, and the prevailing values will smooth supervisory interactions and optimize outcomes, experts agree.
 

Every generation’s No. 1 concern

For her dissertation, Dr. Keltgen used a large dataset of physicians and sought to draw a predictive model by generation and gender as to what physicians were seeking in order to be satisfied in their careers. One “overwhelming finding” of her research into generational differences in physicians is that “every single generation and gender is there to promote the health of their patients, and providing excellent care is their No. 1 concern. That is the common focus and the foundation that everyone can build on.”

Dr. J agreed. “Had I felt like a valued collaborator, I might have made a different decision.” He has begun to consider reentering clinical practice, perhaps as locum tenens or on a part-time basis. “I don’t want to feel that I’ve been driven out of a field that I love. I will see if I can find some type of context where my experience will be valued and learn to bring myself up to speed with technology if necessary. I believe I still have much to offer patients, and I would like to find a context to do so.”

A version of this article first appeared on Medscape.com.

While several health care professionals can perform some of the same functions as physicians, at the end of the day, they are not MDs or DOs, nor do they have the education and training to earn the right to present themselves to patients as such. That’s the reasoning behind Senate Bill 239, recently signed into law by Indiana Gov. Eric J. Holcomb.

“It’s about transparency. Health care professionals at every level should be proud of their profession and want to help patients make an informed choice when seeking out options for treatment,” Carrie Davis, MD, a Bloomington, Ind.–based dermatologist and member of the Indiana State Medical Association’s commission on legislation, told this news organization. “When this law goes into effect, a patient will be able to seek that treatment with confidence knowing they can trust the education, training, and license of the health care expert they’ve chosen to see.”

The patient safety measure, which will take effect on July 1, specifically prohibits the misappropriation of medical specialty titles such as anesthesiologist, cardiologist, dermatologist, and others by professionals who have not graduated from medical school and completed the necessary training to adopt the physician title. It also prohibits health care professionals from using deceptive or misleading advertising that misrepresents or falsely describes their profession, education, or skills.

“Using the medical term ‘anesthesiologist’ for nurse anesthetists, confuses patients who deserve to be fully informed of their health care provider’s qualifications,” Randall M. Clark, MD, president of the American Society of Anesthesiologists (ASA), said in a statement. “This new law affirms the most fundamental right of patients to know the qualifications of their health care professional.”
 

What’s in a title?

The problem stretches far beyond professional turf battles, as patients are often confused about the differences between various types of health care providers, according to the American Medical Association’s Truth in Advertising Campaign. Often, patients mistakenly believe they are meeting with medical doctors or doctors of osteopathic medicine when they are not.

Seung Sim, MD, an Indiana anesthesiologist and the immediate past president of the Indiana Society of Anesthesiologists, said in an interview that every member of the medical team plays an important role in high-quality patient care, but among that team, education and training differs.

“The threat to patient safety comes by nonphysicians marketing themselves in a way that is confusing to patients, and misleading, making the patient believe they’re seeing a physician when they’re not,” said Dr. Sim. “That patient deserves to know who is providing their health care and what level of education and training they have, so the patient can make the best decision for their treatment.”
 

Medical groups speak out

Several professional medical groups have voiced their opposition to medical title misappropriation.

Perhaps most notably, the ASA has been spearheading efforts that prohibit medical professionals to identify as physicians for several years. In 2019, the ASA authored Resolution 228, which calls on the AMA to oppose and work with state medical societies to prevent the misappropriation of medical specialties’ titles.

The resolution, which was adopted by the AMA in June 2019, also reaffirms support of the Scope of Practice Partnership’s Truth in Advertising Campaign to ensure patients receive accurate information about who is providing their care.

In addition, in 2021, the ASA condemned the decision by the American Association of Nurse Anesthetists to change its name to the American Association of Nurse Anesthesiology (AANA) – pointing out that the term “nurse anesthesiologist” could confuse patients and create discord in the care setting, ultimately risking patient safety.

While the ASA and other professional groups support team-based models of care, they are quick to point out that health care professionals need to know their place in the lineup.

A statement from the American Osteopathic Association (AOA), for instance, points out that only DOs and MDs can be licensed to practice medicine – and, therefore, “physician-led” should not mean “physician-optional.” In fact, only professionals who have earned the right to practice medicine through completion of medical school and accredited residency/fellowship training and who have achieved board certification in their chosen specialty/subspecialty should take the helm of these multidisciplinary teams, according to the AOA.

The AANA cast the controversy in a completely different light, characterizing its name change as part of a rebranding effort to advance the science of nurse anesthesiology and advocate for certified registered nurse anesthetists. In 2021, the AANA asserted: “The notion of being pushed by the American Society of Anesthesiologists that rebranding and changing the name of the AANA will somehow mislead or harm patients or create discord among providers is absurd at best and false and inflammatory fearmongering at worst.”

A version of this article first appeared on Medscape.com.

While several health care professionals can perform some of the same functions as physicians, at the end of the day, they are not MDs or DOs, nor do they have the education and training to earn the right to present themselves to patients as such. That’s the reasoning behind Senate Bill 239, recently signed into law by Indiana Gov. Eric J. Holcomb.

“It’s about transparency. Health care professionals at every level should be proud of their profession and want to help patients make an informed choice when seeking out options for treatment,” Carrie Davis, MD, a Bloomington, Ind.–based dermatologist and member of the Indiana State Medical Association’s commission on legislation, told this news organization. “When this law goes into effect, a patient will be able to seek that treatment with confidence knowing they can trust the education, training, and license of the health care expert they’ve chosen to see.”

The patient safety measure, which will take effect on July 1, specifically prohibits the misappropriation of medical specialty titles such as anesthesiologist, cardiologist, dermatologist, and others by professionals who have not graduated from medical school and completed the necessary training to adopt the physician title. It also prohibits health care professionals from using deceptive or misleading advertising that misrepresents or falsely describes their profession, education, or skills.

“Using the medical term ‘anesthesiologist’ for nurse anesthetists, confuses patients who deserve to be fully informed of their health care provider’s qualifications,” Randall M. Clark, MD, president of the American Society of Anesthesiologists (ASA), said in a statement. “This new law affirms the most fundamental right of patients to know the qualifications of their health care professional.”
 

What’s in a title?

The problem stretches far beyond professional turf battles, as patients are often confused about the differences between various types of health care providers, according to the American Medical Association’s Truth in Advertising Campaign. Often, patients mistakenly believe they are meeting with medical doctors or doctors of osteopathic medicine when they are not.

Seung Sim, MD, an Indiana anesthesiologist and the immediate past president of the Indiana Society of Anesthesiologists, said in an interview that every member of the medical team plays an important role in high-quality patient care, but among that team, education and training differs.

“The threat to patient safety comes by nonphysicians marketing themselves in a way that is confusing to patients, and misleading, making the patient believe they’re seeing a physician when they’re not,” said Dr. Sim. “That patient deserves to know who is providing their health care and what level of education and training they have, so the patient can make the best decision for their treatment.”
 

Medical groups speak out

Several professional medical groups have voiced their opposition to medical title misappropriation.

Perhaps most notably, the ASA has been spearheading efforts that prohibit medical professionals to identify as physicians for several years. In 2019, the ASA authored Resolution 228, which calls on the AMA to oppose and work with state medical societies to prevent the misappropriation of medical specialties’ titles.

The resolution, which was adopted by the AMA in June 2019, also reaffirms support of the Scope of Practice Partnership’s Truth in Advertising Campaign to ensure patients receive accurate information about who is providing their care.

In addition, in 2021, the ASA condemned the decision by the American Association of Nurse Anesthetists to change its name to the American Association of Nurse Anesthesiology (AANA) – pointing out that the term “nurse anesthesiologist” could confuse patients and create discord in the care setting, ultimately risking patient safety.

While the ASA and other professional groups support team-based models of care, they are quick to point out that health care professionals need to know their place in the lineup.

A statement from the American Osteopathic Association (AOA), for instance, points out that only DOs and MDs can be licensed to practice medicine – and, therefore, “physician-led” should not mean “physician-optional.” In fact, only professionals who have earned the right to practice medicine through completion of medical school and accredited residency/fellowship training and who have achieved board certification in their chosen specialty/subspecialty should take the helm of these multidisciplinary teams, according to the AOA.

The AANA cast the controversy in a completely different light, characterizing its name change as part of a rebranding effort to advance the science of nurse anesthesiology and advocate for certified registered nurse anesthetists. In 2021, the AANA asserted: “The notion of being pushed by the American Society of Anesthesiologists that rebranding and changing the name of the AANA will somehow mislead or harm patients or create discord among providers is absurd at best and false and inflammatory fearmongering at worst.”

A version of this article first appeared on Medscape.com.

While several health care professionals can perform some of the same functions as physicians, at the end of the day, they are not MDs or DOs, nor do they have the education and training to earn the right to present themselves to patients as such. That’s the reasoning behind Senate Bill 239, recently signed into law by Indiana Gov. Eric J. Holcomb.

“It’s about transparency. Health care professionals at every level should be proud of their profession and want to help patients make an informed choice when seeking out options for treatment,” Carrie Davis, MD, a Bloomington, Ind.–based dermatologist and member of the Indiana State Medical Association’s commission on legislation, told this news organization. “When this law goes into effect, a patient will be able to seek that treatment with confidence knowing they can trust the education, training, and license of the health care expert they’ve chosen to see.”

The patient safety measure, which will take effect on July 1, specifically prohibits the misappropriation of medical specialty titles such as anesthesiologist, cardiologist, dermatologist, and others by professionals who have not graduated from medical school and completed the necessary training to adopt the physician title. It also prohibits health care professionals from using deceptive or misleading advertising that misrepresents or falsely describes their profession, education, or skills.

“Using the medical term ‘anesthesiologist’ for nurse anesthetists, confuses patients who deserve to be fully informed of their health care provider’s qualifications,” Randall M. Clark, MD, president of the American Society of Anesthesiologists (ASA), said in a statement. “This new law affirms the most fundamental right of patients to know the qualifications of their health care professional.”
 

What’s in a title?

The problem stretches far beyond professional turf battles, as patients are often confused about the differences between various types of health care providers, according to the American Medical Association’s Truth in Advertising Campaign. Often, patients mistakenly believe they are meeting with medical doctors or doctors of osteopathic medicine when they are not.

Seung Sim, MD, an Indiana anesthesiologist and the immediate past president of the Indiana Society of Anesthesiologists, said in an interview that every member of the medical team plays an important role in high-quality patient care, but among that team, education and training differs.

“The threat to patient safety comes by nonphysicians marketing themselves in a way that is confusing to patients, and misleading, making the patient believe they’re seeing a physician when they’re not,” said Dr. Sim. “That patient deserves to know who is providing their health care and what level of education and training they have, so the patient can make the best decision for their treatment.”
 

Medical groups speak out

Several professional medical groups have voiced their opposition to medical title misappropriation.

Perhaps most notably, the ASA has been spearheading efforts that prohibit medical professionals to identify as physicians for several years. In 2019, the ASA authored Resolution 228, which calls on the AMA to oppose and work with state medical societies to prevent the misappropriation of medical specialties’ titles.

The resolution, which was adopted by the AMA in June 2019, also reaffirms support of the Scope of Practice Partnership’s Truth in Advertising Campaign to ensure patients receive accurate information about who is providing their care.

In addition, in 2021, the ASA condemned the decision by the American Association of Nurse Anesthetists to change its name to the American Association of Nurse Anesthesiology (AANA) – pointing out that the term “nurse anesthesiologist” could confuse patients and create discord in the care setting, ultimately risking patient safety.

While the ASA and other professional groups support team-based models of care, they are quick to point out that health care professionals need to know their place in the lineup.

A statement from the American Osteopathic Association (AOA), for instance, points out that only DOs and MDs can be licensed to practice medicine – and, therefore, “physician-led” should not mean “physician-optional.” In fact, only professionals who have earned the right to practice medicine through completion of medical school and accredited residency/fellowship training and who have achieved board certification in their chosen specialty/subspecialty should take the helm of these multidisciplinary teams, according to the AOA.

The AANA cast the controversy in a completely different light, characterizing its name change as part of a rebranding effort to advance the science of nurse anesthesiology and advocate for certified registered nurse anesthetists. In 2021, the AANA asserted: “The notion of being pushed by the American Society of Anesthesiologists that rebranding and changing the name of the AANA will somehow mislead or harm patients or create discord among providers is absurd at best and false and inflammatory fearmongering at worst.”

A version of this article first appeared on Medscape.com.

As we transition out of the Omicron surge, the lessons we’ve learned from the prior surges carry forward and add to our knowledge foundation. Medical journals have published numerous research and perspectives manuscripts on all aspects of COVID-19 over the past 2 years, adding much-needed knowledge to our clinical practice during the pandemic. However, the story does not stop there, as the pandemic has impacted the usual, non-COVID-19 clinical care we provide. The value-based health care delivery model accounts for both COVID-19 clinical care and the usual care we provide our patients every day. Clinicians, administrators, and health care workers will need to know how to balance both worlds in the years to come.

In this issue of JCOM, the work of balancing the demands of COVID-19 care with those of system improvement continues. Two original research articles address the former, with Liesching et al¹ reporting data on improving clinical outcomes of patients with COVID-19 through acute care oxygen therapies, and Ali et al² explaining the impact of COVID-19 on STEMI care delivery models. Liesching et al’s study showed that patients admitted for COVID-19 after the first surge were more likely to receive high-flow nasal cannula and had better outcomes, while Ali et al showed that patients with STEMI yet again experienced worse outcomes during the first wave.

On the system improvement front, Cusick et al³ report on a quality improvement (QI) project that addressed acute disease management of heparin-induced thrombocytopenia (HIT) during hospitalization, Sosa et al⁴ discuss efforts to improve comorbidity capture at their institution, and Uche et al⁵ present the results of a nonpharmacologic initiative to improve management of chronic pain among veterans. Cusick et al’s QI project showed that a HIT testing strategy could be safely implemented through an evidence-based process to nudge resource utilization using specific management pathways. While capturing and measuring the complexity of diseases and comorbidities can be challenging, accurate capture is essential, as patient acuity has implications for reimbursement and quality comparisons for hospitals and physicians; Sosa et al describe a series of initiatives implemented at their institution that improved comorbidity capture. Furthermore, Uche et al report on a 10-week complementary and integrative health program for veterans with noncancer chronic pain that reduced pain intensity and improved quality of life for its participants. These QI reports show that, though the health care landscape has changed over the past 2 years, the aim remains the same: to provide the best care for patients regardless of the diagnosis, location, or time.

Conducting QI projects during the COVID-19 pandemic has been difficult, especially in terms of implementing consistent processes and management pathways while contending with staff and supply shortages. The pandemic, however, has highlighted the importance of continuing QI efforts, specifically around infectious disease prevention and good clinical practices. Moreover, the recent continuous learning and implementation around COVID-19 patient care has been a significant achievement, as clinicians and administrators worked continuously to understand and improve processes, create a supporting culture, and redesign care delivery on the fly. The management of both COVID-19 care and our usual care QI efforts should incorporate the lessons learned from the pandemic and leverage system redesign for future steps. As we’ve seen, survival in COVID-19 improved dramatically since the beginning of the pandemic, as clinical trials became more adaptive and efficient and system upgrades like telemedicine and digital technologies in the public health response led to major advancements. The work to improve the care provided in the clinic and at the bedside will continue through one collective approach in the new normal.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine Brigham and Women’s Hospital, Boston, MA; [email protected]

As we transition out of the Omicron surge, the lessons we’ve learned from the prior surges carry forward and add to our knowledge foundation. Medical journals have published numerous research and perspectives manuscripts on all aspects of COVID-19 over the past 2 years, adding much-needed knowledge to our clinical practice during the pandemic. However, the story does not stop there, as the pandemic has impacted the usual, non-COVID-19 clinical care we provide. The value-based health care delivery model accounts for both COVID-19 clinical care and the usual care we provide our patients every day. Clinicians, administrators, and health care workers will need to know how to balance both worlds in the years to come.

In this issue of JCOM, the work of balancing the demands of COVID-19 care with those of system improvement continues. Two original research articles address the former, with Liesching et al¹ reporting data on improving clinical outcomes of patients with COVID-19 through acute care oxygen therapies, and Ali et al² explaining the impact of COVID-19 on STEMI care delivery models. Liesching et al’s study showed that patients admitted for COVID-19 after the first surge were more likely to receive high-flow nasal cannula and had better outcomes, while Ali et al showed that patients with STEMI yet again experienced worse outcomes during the first wave.

On the system improvement front, Cusick et al³ report on a quality improvement (QI) project that addressed acute disease management of heparin-induced thrombocytopenia (HIT) during hospitalization, Sosa et al⁴ discuss efforts to improve comorbidity capture at their institution, and Uche et al⁵ present the results of a nonpharmacologic initiative to improve management of chronic pain among veterans. Cusick et al’s QI project showed that a HIT testing strategy could be safely implemented through an evidence-based process to nudge resource utilization using specific management pathways. While capturing and measuring the complexity of diseases and comorbidities can be challenging, accurate capture is essential, as patient acuity has implications for reimbursement and quality comparisons for hospitals and physicians; Sosa et al describe a series of initiatives implemented at their institution that improved comorbidity capture. Furthermore, Uche et al report on a 10-week complementary and integrative health program for veterans with noncancer chronic pain that reduced pain intensity and improved quality of life for its participants. These QI reports show that, though the health care landscape has changed over the past 2 years, the aim remains the same: to provide the best care for patients regardless of the diagnosis, location, or time.

Conducting QI projects during the COVID-19 pandemic has been difficult, especially in terms of implementing consistent processes and management pathways while contending with staff and supply shortages. The pandemic, however, has highlighted the importance of continuing QI efforts, specifically around infectious disease prevention and good clinical practices. Moreover, the recent continuous learning and implementation around COVID-19 patient care has been a significant achievement, as clinicians and administrators worked continuously to understand and improve processes, create a supporting culture, and redesign care delivery on the fly. The management of both COVID-19 care and our usual care QI efforts should incorporate the lessons learned from the pandemic and leverage system redesign for future steps. As we’ve seen, survival in COVID-19 improved dramatically since the beginning of the pandemic, as clinical trials became more adaptive and efficient and system upgrades like telemedicine and digital technologies in the public health response led to major advancements. The work to improve the care provided in the clinic and at the bedside will continue through one collective approach in the new normal.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine Brigham and Women’s Hospital, Boston, MA; [email protected]

As we transition out of the Omicron surge, the lessons we’ve learned from the prior surges carry forward and add to our knowledge foundation. Medical journals have published numerous research and perspectives manuscripts on all aspects of COVID-19 over the past 2 years, adding much-needed knowledge to our clinical practice during the pandemic. However, the story does not stop there, as the pandemic has impacted the usual, non-COVID-19 clinical care we provide. The value-based health care delivery model accounts for both COVID-19 clinical care and the usual care we provide our patients every day. Clinicians, administrators, and health care workers will need to know how to balance both worlds in the years to come.

In this issue of JCOM, the work of balancing the demands of COVID-19 care with those of system improvement continues. Two original research articles address the former, with Liesching et al¹ reporting data on improving clinical outcomes of patients with COVID-19 through acute care oxygen therapies, and Ali et al² explaining the impact of COVID-19 on STEMI care delivery models. Liesching et al’s study showed that patients admitted for COVID-19 after the first surge were more likely to receive high-flow nasal cannula and had better outcomes, while Ali et al showed that patients with STEMI yet again experienced worse outcomes during the first wave.

On the system improvement front, Cusick et al³ report on a quality improvement (QI) project that addressed acute disease management of heparin-induced thrombocytopenia (HIT) during hospitalization, Sosa et al⁴ discuss efforts to improve comorbidity capture at their institution, and Uche et al⁵ present the results of a nonpharmacologic initiative to improve management of chronic pain among veterans. Cusick et al’s QI project showed that a HIT testing strategy could be safely implemented through an evidence-based process to nudge resource utilization using specific management pathways. While capturing and measuring the complexity of diseases and comorbidities can be challenging, accurate capture is essential, as patient acuity has implications for reimbursement and quality comparisons for hospitals and physicians; Sosa et al describe a series of initiatives implemented at their institution that improved comorbidity capture. Furthermore, Uche et al report on a 10-week complementary and integrative health program for veterans with noncancer chronic pain that reduced pain intensity and improved quality of life for its participants. These QI reports show that, though the health care landscape has changed over the past 2 years, the aim remains the same: to provide the best care for patients regardless of the diagnosis, location, or time.

Conducting QI projects during the COVID-19 pandemic has been difficult, especially in terms of implementing consistent processes and management pathways while contending with staff and supply shortages. The pandemic, however, has highlighted the importance of continuing QI efforts, specifically around infectious disease prevention and good clinical practices. Moreover, the recent continuous learning and implementation around COVID-19 patient care has been a significant achievement, as clinicians and administrators worked continuously to understand and improve processes, create a supporting culture, and redesign care delivery on the fly. The management of both COVID-19 care and our usual care QI efforts should incorporate the lessons learned from the pandemic and leverage system redesign for future steps. As we’ve seen, survival in COVID-19 improved dramatically since the beginning of the pandemic, as clinical trials became more adaptive and efficient and system upgrades like telemedicine and digital technologies in the public health response led to major advancements. The work to improve the care provided in the clinic and at the bedside will continue through one collective approach in the new normal.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine Brigham and Women’s Hospital, Boston, MA; [email protected]

From Neurology/Chronic Pain Management Services, Department of Veterans Affairs (VA) Maryland Health Care System, Baltimore VA Medical Center, Baltimore, MD (Dr. Uche), and School of Nursing, Washburn University, Topeka, KS (Drs. Jamison and Waugh).

Abstract

Objective: The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the Empower Veterans Program (EVP) offered by a Veterans Administration facility in the northeastern United States.

Methods: This quality improvement project used data collected from veterans with chronic pain who completed the veterans health care facility’s EVP between August 2017 and August 2019. Pre- and post-intervention data on pain intensity, pain interference, quality of life, and pain catastrophizing were compared using paired t-tests.

Results: Although data were abstracted from 115 patients, the final sample included 67 patients who completed both pre-and postintervention questionnaires. Baseline measures of completers and noncompleters were similar. Comparison of pre and post mean scores on completers showed statistically significant findings (P = .004) based on the Bonferroni correction. The medium and large effect sizes (Cohen’s d) indicated clinically significant improvements for veterans who completed the program. Veterans reported high levels of satisfaction with the program.

Conclusion: Veterans with chronic high-impact noncancer pain who completed the EVP had reduced pain intensity, pain interference, pain catastrophizing as well as improved quality of life and satisfaction with their health.

Keywords: musculoskeletal pain, Veterans Affairs, complementary and integrative health, acceptance and commitment therapy, mind-body therapies, whole health, multidisciplinary pain management.

More than 100 million American adults suffer from chronic pain; costs associated with managing chronic pain are approximately $635 billion each year.¹ Chronic pain is prevalent among military veterans, affecting one-third of the 9 million veterans who receive care from Veterans Health Administration (VHA) facilities.² The biopsychosocial impact of chronic pain on the general population, and specifically on veterans, has been compounded by the opioid crisis. The effects of chronic pain and the opioid crisis have fueled interest in the use of complementary and integrative health (CIH) modalities in the management of chronic noncancer pain. Providers are increasingly developing treatment programs that incorporate CIH in their management of chronic noncancer pain.

One such program is the Empower Veterans Program (EVP). Originally developed at the Atlanta Veterans Affairs Health Care System, the EVP is a CIH modality based on the biopsychosocial model of pain developed by psychiatrist George Engel in 1977.³ The biopsychosocial model of pain recognizes that pain is a complex, multidimensional, biopsychosocial experience. Under this model, the mind and body work in unison as interconnected entities. Because the model acknowledges biological, psychological, and social components of pain and illness,⁴ treatment focuses on all aspects of a person’s health, life, and relationships.

The EVP fits into the VHA Pain Management Stepped Care Model and is an adjunctive complement for that model.^5-7 The EVP complements care at the first step, where patient/family provide self-care and where care is provided by patient-aligned primary care teams, at the second step, which includes secondary consultation with multidisciplinary pain medicine specialty teams and other specialists, and at the third step, with the addition of tertiary interdisciplinary pain centers.

The VA Maryland Health Care System (VAMHCS) implemented the EVP as part of a quality improvement project for the management of chronic pain. The objectives of the program were to reduce pain intensity, pain catastrophizing, and pain interference, as well as improve functionality and quality of life among veterans with chronic high-impact noncancer pain. More than 2 years after the program was implemented, collected data had not been analyzed. The purpose of this quality improvement project was to abstract and analyze the previously collected data from veterans with high-impact chronic pain who attended an EVP offered by the VAMHCS. The results of the data analysis were used to inform decisions regarding the future of the program.

Methods

This quality improvement project used the Plan-Do-Study-Act (PDSA) process.⁸ The first 2 phases of the PDSA cycle (Plan and Do) were completed by a team of VA employees from the VAMHCS, who donated their time to establish and implement the program at the project site. This team consisted of psychologists, a physical therapist, a social worker, and a chaplain, and included support from medical administrative staff. This team planned and implemented the EVP at the VA facility based on the model developed at the Atlanta VA Health Care System. During the “Do” phase, the team collected data on pain intensity, pain interference, quality of life, and pain negative cognition (catastrophizing) before the intervention and post intervention. They also collected data on program outcome (patient treatment satisfaction) post intervention. Because these employees did not have time to retrieve and analyze the data, they welcomed the opportunity to have the data analyzed by the investigators during the Study phase of the PDSA cycle. Based on the results of the analysis, recommendations for program changes were made during the Act phase of the cycle.

Intervention

The EVP was developed as a 10-week (30 hours) interdisciplinary CIH approach that coached veterans with chronic pain to live fuller lives based on their individual values and what matters to them. EVP is the “What Else” management modality for the 5% of veterans with high-impact chronic pain.⁹ The EVP provided functional restoration through its components of whole health, mindfulness training, coaching calls, acceptance and commitment therapy, and mindful movement. It used the Wheel of Health with the 4 key components of me, self-care, professional care, and community.^10,11

Veterans who had a diagnosis of chronic nonmalignant pain for 3 months or more and who agreed to participate in the EVP at this facility attended 3-hour classes every Tuesday with a cohort of 8 to 12 peers and engaged in one-on-one coaching with interdisciplinary team members. During the class sessions, veterans were coached to understand and accept their pain and commit to maintaining function despite their pain. Mindful movement by the physical therapist emphasized the pivotal place of exercise in pain management. The therapist used the mantra “Motion is Lotion.”⁹ The guiding principle of the EVP was that small incremental changes can have a big impact on the individual’s whole life. Emphasis was placed on increasing self-efficacy and mindful awareness for veterans with high-impact pain by giving them “Skills before Pills.”⁹

Outcome Measures

Outcome measures included the Numerical Pain Rating Scale (NPRS), the Multidimensional Pain Inventory (MPI), the World Health Organization Quality of Life assessment (WHOQOL-BREF), the Pain Catastrophizing Scale (PCS), and the Pain Treatment Satisfaction Scale (PTSS). Cronbach alpha coefficients were calculated to assess internal consistency reliability of these measures in the sample of veterans who completed the EVP.

NPRS. The NPRS is ubiquitous as a screening tool in many health care environments and its use is mandated by the VA health care system.¹² The choice of the NPRS as the tool for pain screening in the VA health care system was based on a large body of research that supports the reliability and validity of the NPRS as a single index of pain intensity or severity. Studies suggest that the NPRS is valid for use in the assessment of acute, cancer, or chronic nonmalignant pain and in varied clinical settings.¹³ The NPRS has 4 items, each on a scale of 0 to 10. For the purpose of this project, only 3 items were used. The 3 items assessed the worst pain, usual pain, and the current pain (right now). The higher the score, the higher the pain intensity. Cronbach alpha coefficients on the NPRS obtained from the current sample of veterans were 0.85 on both pre- and postintervention assessments.

MPI. The MPI is an easily accessible, reliable, and valid self-report questionnaire that measures the impact of pain on an individual’s life, quality of social support, and general activity.¹⁴ This instrument is a short version of the West Haven-Yale MPI.¹⁵ The MPI contains 9 items rated on a scale from 0 to 6. The higher the score, the greater pain interference a person is experiencing. The MPI produces reliable, valid information for diagnostic purposes and for therapy outcome studies.¹⁶ The MPI had a Cronbach alpha of 0.90 on pre-intervention and 0.92 on postintervention assessments in the current sample.

WHOQOL-BREF. The WHOQOL-BREF is a measure of quality of life and is an abbreviated version of the WHOQOL-100. Quality of life is defined by the World Health Organization¹⁷ “as an individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.” The WHOQOL-BREF contains 26 items. The first 2 items were examined separately; the first item asks individuals to rate their overall quality of life and the second asks individuals how satisfied they are with their health. The remaining 24 items were used to calculate the following 4 domain scores: physical health, psychological health, social relationship, and environment.¹⁸ Each item is measured on a scale of 1 to 5. Higher scores denote higher or better quality of life. Domain scores have demonstrated good reliability and validity.^19-21 Cronbach alpha coefficients for the domain subscales ranged from 0.63 to 0.84 in the current sample, with the lowest alphas for the 3-item Social Relationships Domain.

PCS. The PCS is a widely used measure of catastrophic thinking related to pain. Catastrophizing has been conceived by Sullivan and colleagues as “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.”²² The PCS provides a total score and scores for the following subscales: rumination, magnification, and helplessness.²³ It has been used in a variety of chronic pain populations and has demonstrated good reliability and validity in clinical as well as nonclinical samples.^24-26 The PCS has 13 items rated on a scale of 0 to 4. Higher scores mean greater negative pain cognition (catastrophizing). In the current sample, the PCS total scale had a Cronbach alpha coefficient of 0.95 and 0.94 on the 2 assessments. The coefficients for the subscales ranged from 0.81 to 0.90.

PTSS. The PTSS is a 5-item tool that measures patient satisfaction with pain treatment. It includes items that address overall satisfaction, staff warmth, staff skill level, ease of scheduling appointments, and recommendation of the program to other veterans. It was derived from the post-treatment version of The Pain Outcome Questionnaire-VA and has demonstrated reliability and validity.²⁷ The questions are scaled from 0 to 10. High scores on the PTSS denote high patient satisfaction with the EVP. The Cronbach alpha coefficient on the PTSS obtained from the current sample was 0.80.

Data Gathering and Analysis

Prior to starting the Study phase, Washburn University’s Institutional Review Board (IRB) and the VA IRB approved the project. The VA IRB, through its affiliate, gave a Not Human Research Determination and granted a waiver of informed consent and the Health Insurance Portability and Accountability Act authorization. The VA facility’s Research and Development department also approved the quality improvement project.

Once these approvals were obtained, the Study phase began with the abstraction of retrospective data obtained from veterans who participated in the VA health care facility’s EVP between August 2017 and August 2019. Most of the measurement tools changed in August 2019, and for this reason data abstraction was limited to the time period August 2017 to August 2019. The first author (JUU) abstracted data for both program completers and noncompleters. The second (MJ) and third (SW) authors analyzed the data in SPSS 24 and calculated effect sizes.

Veterans who completed the program were compared to veterans who did not complete the program on age, gender, and baseline measures. The investigators used independent samples t-tests to compare completers and noncompleters on age, pain intensity, pain interference, quality of life, and pain catastrophizing. They used the chi-square test of independence to analyze the association between gender and program completion.

Data were included in the pre- and postintervention analysis if the veteran completed the NPRS, MPI, WHOQOL-BREF, and PCS pre and post intervention. This became an important eligibility requirement as some of the tools/measures were changed towards the end of the review period in 2019. Pre- and postintervention data on pain intensity, pain interference, quality of life, pain catastrophizing, and patient satisfaction were compared using paired samples t-test at .004 level of significance based on the Bonferroni correction.²⁸ Data on patient satisfaction with pain treatment were collected at program completion (week 8 or 10) and were analyzed using descriptive statistics.

Effect sizes (Cohen’s d) were calculated to determine the substantive significance or magnitude of the mean differences in scores. Effect sizes (expressed as absolute values of Cohen’s d) were calculated as the mean difference divided by the standard deviation. Values of 0.2 were considered a small effect size, 0.5 a medium effect size, and 0.8 a large effect size.²⁹

Data were abstracted for 115 veterans who started the EVP. Of these, 48 left the program, leaving 67 veterans (58%) who completed the program. Completers and noncompleters were similar in age, gender, and baseline measures (Table 1). Fifty-three (79%) completers and 35 (73%) noncompleters were male. A chi-square test of independence showed no significant association between gender and program completion (χ^2₁ [N = 115] = .595, P = .440).

Comparison of pre-and postintervention mean scale scores resulted in statistically significant differences for all comparisons (Table 2). These comparisons yielded improvements in the desired direction. For example, the scores on the NPRS, the MPI, and the PCS (along with its subscales) decreased, revealing reductions in pain severity, the impact of pain on the veterans’ lives, and pain catastrophizing. The 2 individual item scores on the WHOQOL-BREF increased, indicating improvements in perceived quality of life and satisfaction with health. The domain scores on the WHOQOL-BREF increased, revealing improvements in pain-related quality of life. The moderate to large effect sizes indicated clinically significant improvements for veterans with chronic high-impact pain who completed the EVP.

Analysis of data obtained using the PTSS yielded high mean scores for items that focused on patient satisfaction with treatment (Table 3). Scaled statistics yielded a mean (SD) of 46.95 (4.40). These results denoted overall patient satisfaction with the EVP.

Discussion

The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the EVP. Comparison of pre-intervention and postintervention data obtained from 67 veterans who completed the program revealed improvements in pain intensity, pain interference, negative cognition (catastrophizing), and quality of life. The differences were statistically significant and clinically meaningful, with medium and large effect sizes. In addition, veterans reported high satisfaction with the EVP.

The EVP includes CIH approaches that have demonstrated effectiveness among veterans and other populations with chronic pain. A wealth of studies, for example, support the effectiveness of CIH approaches among veterans.^30-34 Other studies focus on specific CIH approaches that are components of the EVP. Evidence supports, for example, the efficacy of mindfulness-based stress reduction,^35-39 acceptance and commitment therapy,^40-43 brief peer support intervention,⁴⁴ and interdisciplinary biopsychosocial rehabilitation.^45,46

While empirical evidence supports components of the EVP, only one study focused on the outcomes of the Atlanta VA EVP among veterans with chronic pain. Results of a qualitative study conducted by Penney and Haro⁴⁷ described the experience of veterans with the EVP. Those veterans reported adopting new self-care or lifestyle practices for pain management and health, accepting pain, being better able to adjust and set boundaries, feeling more in control, participating in life, and changing their medication use.

The mean baseline scores from the current sample were similar to samples of patients with chronic pain in other studies (NPRS,⁴⁸ MPI,⁴⁸ and PCS^48-51). After converting scores on the WHOQOL-BREF from those that ranged from 4 to 20 to those that ranged from 0 to 100,¹⁸ the scores from the current sample were similar to those of other studies of patients with chronic pain.^48,52,53Several strengths of the project should be noted. Data were collected using well established measurement tools that had previously demonstrated reliability and validity. All the tools used in data collection demonstrated good internal consistency reliabilities in the current sample of veterans. Weaknesses of the project include the use of a convenience sample of veterans and small sample size. Data were not available on the number of veterans who were offered participation or on how many veterans declined enrollment. The sample of veterans who chose to participate in the EVP may or may not have been representative of the population of veterans with high-impact chronic pain. As a pre- and postintervention design with no comparison group, the results are subject to multiple threats to internal validity, including the Hawthorne effect, maturation in the form of healing, and attrition. Reasons for leaving the program had not been recorded, so the investigators had no way of knowing factors that may have contributed to attrition. Also, data on when veterans left the program were unavailable. Research is needed with a control group to reduce the effect of confounding variables on the outcome measures. This project used data collected at a single VA facility, which limits its generalizability.

While completers and noncompleters of the EVP were similar on age, gender, and baseline measures, there may have been unidentified characteristics that influenced program completion. The investigators noticed the presence of more missing data among noncompleters compared to completers on the pre-intervention PCS; thus, noncompleters may have scored lower than completers on this instrument simply because there were more individual items that were unanswered/missing among this group of noncompleters.

Data were analyzed using a limited number of outcome measures that had previously been collected. Other outcome measures might include whether EVP participants reduced their use of medications, clinical resources, and personnel. Future projects, for example, could determine whether the EVP is effective in reducing opioid analgesic medication use and decreasing primary care and emergency department visits. Cost-benefit analyses could be completed to determine whether EVP is associated with financial savings.

Because no follow-up assessments were made to determine whether improvements were maintained over time, the project focus was limited to an evaluation of the short-term changes in the outcome measures. Future projects could include a follow-up assessment of the veterans 1- or 2-years post completion of the EVP.

Data for the project were collected prior to the COVID-19 pandemic, when the EVP was implemented through face-to-face meetings with participants and their peers. It is not clear how changes to the delivery of the program (such as offering it through telehealth) might impact veterans’ satisfaction with the program, willingness to complete it, and other variables of interest.

The results of this project were made available to stakeholders with recommendations for program expansion both at the current location and at other VA facilities, including the recommendation to hire additional personnel that would implement the program. As the VA network of facilities expand the EVP program and adapt it for telehealth delivery, the investigators recommended a similar analysis of data be performed following telehealth delivery. If delivery through telehealth is shown to improve outcome measures, the EVP could provide pain management treatment options for patients challenged by transportation barriers, including rural veterans.

Conclusion

This quality improvement project provided evidence of improvement in measures of pain severity, pain interference, negative cognition (catastrophizing), quality of life, and patient treatment satisfaction among veterans with chronic high-impact pain. Findings have been well received by the northeastern VA as well as the Veterans Integrated Systems Network 5. The results of the analyses were used to inform decisions regarding the future of the program.

Disclaimer: This material is the result of work supported with resources and the use of facilities at the VA Maryland Health Care System, Baltimore, Maryland. The views expressed are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

Acknowledgments: The authors thank Dr. Arianna Perra, the recent past coordinator of the Empower Veterans Program (EVP), who provided initial insights and support that motivated the decision to evaluate the program. We also thank the veterans and VA EVP clinicians who contributed data for the evaluation, and Dr. Michael Saenger (Director, TelePain-EVP: EVP) and Dr. Robert Lavin for their ongoing support, care, and concern for veteran patients. We also thank Dr. Beverly Bradley and the neurology service administrative team for their guidance in the process of obtaining necessary VA approvals for this project.

Corresponding author: Jessica U. Uche, DNP, CRNP-Family; [email protected]

doi:10.12788/jcom.0089

From Neurology/Chronic Pain Management Services, Department of Veterans Affairs (VA) Maryland Health Care System, Baltimore VA Medical Center, Baltimore, MD (Dr. Uche), and School of Nursing, Washburn University, Topeka, KS (Drs. Jamison and Waugh).

Abstract

Objective: The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the Empower Veterans Program (EVP) offered by a Veterans Administration facility in the northeastern United States.

Methods: This quality improvement project used data collected from veterans with chronic pain who completed the veterans health care facility’s EVP between August 2017 and August 2019. Pre- and post-intervention data on pain intensity, pain interference, quality of life, and pain catastrophizing were compared using paired t-tests.

Results: Although data were abstracted from 115 patients, the final sample included 67 patients who completed both pre-and postintervention questionnaires. Baseline measures of completers and noncompleters were similar. Comparison of pre and post mean scores on completers showed statistically significant findings (P = .004) based on the Bonferroni correction. The medium and large effect sizes (Cohen’s d) indicated clinically significant improvements for veterans who completed the program. Veterans reported high levels of satisfaction with the program.

Conclusion: Veterans with chronic high-impact noncancer pain who completed the EVP had reduced pain intensity, pain interference, pain catastrophizing as well as improved quality of life and satisfaction with their health.

Keywords: musculoskeletal pain, Veterans Affairs, complementary and integrative health, acceptance and commitment therapy, mind-body therapies, whole health, multidisciplinary pain management.

More than 100 million American adults suffer from chronic pain; costs associated with managing chronic pain are approximately $635 billion each year.¹ Chronic pain is prevalent among military veterans, affecting one-third of the 9 million veterans who receive care from Veterans Health Administration (VHA) facilities.² The biopsychosocial impact of chronic pain on the general population, and specifically on veterans, has been compounded by the opioid crisis. The effects of chronic pain and the opioid crisis have fueled interest in the use of complementary and integrative health (CIH) modalities in the management of chronic noncancer pain. Providers are increasingly developing treatment programs that incorporate CIH in their management of chronic noncancer pain.

One such program is the Empower Veterans Program (EVP). Originally developed at the Atlanta Veterans Affairs Health Care System, the EVP is a CIH modality based on the biopsychosocial model of pain developed by psychiatrist George Engel in 1977.³ The biopsychosocial model of pain recognizes that pain is a complex, multidimensional, biopsychosocial experience. Under this model, the mind and body work in unison as interconnected entities. Because the model acknowledges biological, psychological, and social components of pain and illness,⁴ treatment focuses on all aspects of a person’s health, life, and relationships.

The EVP fits into the VHA Pain Management Stepped Care Model and is an adjunctive complement for that model.^5-7 The EVP complements care at the first step, where patient/family provide self-care and where care is provided by patient-aligned primary care teams, at the second step, which includes secondary consultation with multidisciplinary pain medicine specialty teams and other specialists, and at the third step, with the addition of tertiary interdisciplinary pain centers.

The VA Maryland Health Care System (VAMHCS) implemented the EVP as part of a quality improvement project for the management of chronic pain. The objectives of the program were to reduce pain intensity, pain catastrophizing, and pain interference, as well as improve functionality and quality of life among veterans with chronic high-impact noncancer pain. More than 2 years after the program was implemented, collected data had not been analyzed. The purpose of this quality improvement project was to abstract and analyze the previously collected data from veterans with high-impact chronic pain who attended an EVP offered by the VAMHCS. The results of the data analysis were used to inform decisions regarding the future of the program.

Methods

This quality improvement project used the Plan-Do-Study-Act (PDSA) process.⁸ The first 2 phases of the PDSA cycle (Plan and Do) were completed by a team of VA employees from the VAMHCS, who donated their time to establish and implement the program at the project site. This team consisted of psychologists, a physical therapist, a social worker, and a chaplain, and included support from medical administrative staff. This team planned and implemented the EVP at the VA facility based on the model developed at the Atlanta VA Health Care System. During the “Do” phase, the team collected data on pain intensity, pain interference, quality of life, and pain negative cognition (catastrophizing) before the intervention and post intervention. They also collected data on program outcome (patient treatment satisfaction) post intervention. Because these employees did not have time to retrieve and analyze the data, they welcomed the opportunity to have the data analyzed by the investigators during the Study phase of the PDSA cycle. Based on the results of the analysis, recommendations for program changes were made during the Act phase of the cycle.

Intervention

The EVP was developed as a 10-week (30 hours) interdisciplinary CIH approach that coached veterans with chronic pain to live fuller lives based on their individual values and what matters to them. EVP is the “What Else” management modality for the 5% of veterans with high-impact chronic pain.⁹ The EVP provided functional restoration through its components of whole health, mindfulness training, coaching calls, acceptance and commitment therapy, and mindful movement. It used the Wheel of Health with the 4 key components of me, self-care, professional care, and community.^10,11

Veterans who had a diagnosis of chronic nonmalignant pain for 3 months or more and who agreed to participate in the EVP at this facility attended 3-hour classes every Tuesday with a cohort of 8 to 12 peers and engaged in one-on-one coaching with interdisciplinary team members. During the class sessions, veterans were coached to understand and accept their pain and commit to maintaining function despite their pain. Mindful movement by the physical therapist emphasized the pivotal place of exercise in pain management. The therapist used the mantra “Motion is Lotion.”⁹ The guiding principle of the EVP was that small incremental changes can have a big impact on the individual’s whole life. Emphasis was placed on increasing self-efficacy and mindful awareness for veterans with high-impact pain by giving them “Skills before Pills.”⁹

Outcome Measures

Outcome measures included the Numerical Pain Rating Scale (NPRS), the Multidimensional Pain Inventory (MPI), the World Health Organization Quality of Life assessment (WHOQOL-BREF), the Pain Catastrophizing Scale (PCS), and the Pain Treatment Satisfaction Scale (PTSS). Cronbach alpha coefficients were calculated to assess internal consistency reliability of these measures in the sample of veterans who completed the EVP.

NPRS. The NPRS is ubiquitous as a screening tool in many health care environments and its use is mandated by the VA health care system.¹² The choice of the NPRS as the tool for pain screening in the VA health care system was based on a large body of research that supports the reliability and validity of the NPRS as a single index of pain intensity or severity. Studies suggest that the NPRS is valid for use in the assessment of acute, cancer, or chronic nonmalignant pain and in varied clinical settings.¹³ The NPRS has 4 items, each on a scale of 0 to 10. For the purpose of this project, only 3 items were used. The 3 items assessed the worst pain, usual pain, and the current pain (right now). The higher the score, the higher the pain intensity. Cronbach alpha coefficients on the NPRS obtained from the current sample of veterans were 0.85 on both pre- and postintervention assessments.

MPI. The MPI is an easily accessible, reliable, and valid self-report questionnaire that measures the impact of pain on an individual’s life, quality of social support, and general activity.¹⁴ This instrument is a short version of the West Haven-Yale MPI.¹⁵ The MPI contains 9 items rated on a scale from 0 to 6. The higher the score, the greater pain interference a person is experiencing. The MPI produces reliable, valid information for diagnostic purposes and for therapy outcome studies.¹⁶ The MPI had a Cronbach alpha of 0.90 on pre-intervention and 0.92 on postintervention assessments in the current sample.

WHOQOL-BREF. The WHOQOL-BREF is a measure of quality of life and is an abbreviated version of the WHOQOL-100. Quality of life is defined by the World Health Organization¹⁷ “as an individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.” The WHOQOL-BREF contains 26 items. The first 2 items were examined separately; the first item asks individuals to rate their overall quality of life and the second asks individuals how satisfied they are with their health. The remaining 24 items were used to calculate the following 4 domain scores: physical health, psychological health, social relationship, and environment.¹⁸ Each item is measured on a scale of 1 to 5. Higher scores denote higher or better quality of life. Domain scores have demonstrated good reliability and validity.^19-21 Cronbach alpha coefficients for the domain subscales ranged from 0.63 to 0.84 in the current sample, with the lowest alphas for the 3-item Social Relationships Domain.

PCS. The PCS is a widely used measure of catastrophic thinking related to pain. Catastrophizing has been conceived by Sullivan and colleagues as “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.”²² The PCS provides a total score and scores for the following subscales: rumination, magnification, and helplessness.²³ It has been used in a variety of chronic pain populations and has demonstrated good reliability and validity in clinical as well as nonclinical samples.^24-26 The PCS has 13 items rated on a scale of 0 to 4. Higher scores mean greater negative pain cognition (catastrophizing). In the current sample, the PCS total scale had a Cronbach alpha coefficient of 0.95 and 0.94 on the 2 assessments. The coefficients for the subscales ranged from 0.81 to 0.90.

PTSS. The PTSS is a 5-item tool that measures patient satisfaction with pain treatment. It includes items that address overall satisfaction, staff warmth, staff skill level, ease of scheduling appointments, and recommendation of the program to other veterans. It was derived from the post-treatment version of The Pain Outcome Questionnaire-VA and has demonstrated reliability and validity.²⁷ The questions are scaled from 0 to 10. High scores on the PTSS denote high patient satisfaction with the EVP. The Cronbach alpha coefficient on the PTSS obtained from the current sample was 0.80.

Data Gathering and Analysis

Prior to starting the Study phase, Washburn University’s Institutional Review Board (IRB) and the VA IRB approved the project. The VA IRB, through its affiliate, gave a Not Human Research Determination and granted a waiver of informed consent and the Health Insurance Portability and Accountability Act authorization. The VA facility’s Research and Development department also approved the quality improvement project.

Once these approvals were obtained, the Study phase began with the abstraction of retrospective data obtained from veterans who participated in the VA health care facility’s EVP between August 2017 and August 2019. Most of the measurement tools changed in August 2019, and for this reason data abstraction was limited to the time period August 2017 to August 2019. The first author (JUU) abstracted data for both program completers and noncompleters. The second (MJ) and third (SW) authors analyzed the data in SPSS 24 and calculated effect sizes.

Veterans who completed the program were compared to veterans who did not complete the program on age, gender, and baseline measures. The investigators used independent samples t-tests to compare completers and noncompleters on age, pain intensity, pain interference, quality of life, and pain catastrophizing. They used the chi-square test of independence to analyze the association between gender and program completion.

Data were included in the pre- and postintervention analysis if the veteran completed the NPRS, MPI, WHOQOL-BREF, and PCS pre and post intervention. This became an important eligibility requirement as some of the tools/measures were changed towards the end of the review period in 2019. Pre- and postintervention data on pain intensity, pain interference, quality of life, pain catastrophizing, and patient satisfaction were compared using paired samples t-test at .004 level of significance based on the Bonferroni correction.²⁸ Data on patient satisfaction with pain treatment were collected at program completion (week 8 or 10) and were analyzed using descriptive statistics.

Effect sizes (Cohen’s d) were calculated to determine the substantive significance or magnitude of the mean differences in scores. Effect sizes (expressed as absolute values of Cohen’s d) were calculated as the mean difference divided by the standard deviation. Values of 0.2 were considered a small effect size, 0.5 a medium effect size, and 0.8 a large effect size.²⁹

Data were abstracted for 115 veterans who started the EVP. Of these, 48 left the program, leaving 67 veterans (58%) who completed the program. Completers and noncompleters were similar in age, gender, and baseline measures (Table 1). Fifty-three (79%) completers and 35 (73%) noncompleters were male. A chi-square test of independence showed no significant association between gender and program completion (χ^2₁ [N = 115] = .595, P = .440).

Comparison of pre-and postintervention mean scale scores resulted in statistically significant differences for all comparisons (Table 2). These comparisons yielded improvements in the desired direction. For example, the scores on the NPRS, the MPI, and the PCS (along with its subscales) decreased, revealing reductions in pain severity, the impact of pain on the veterans’ lives, and pain catastrophizing. The 2 individual item scores on the WHOQOL-BREF increased, indicating improvements in perceived quality of life and satisfaction with health. The domain scores on the WHOQOL-BREF increased, revealing improvements in pain-related quality of life. The moderate to large effect sizes indicated clinically significant improvements for veterans with chronic high-impact pain who completed the EVP.

Analysis of data obtained using the PTSS yielded high mean scores for items that focused on patient satisfaction with treatment (Table 3). Scaled statistics yielded a mean (SD) of 46.95 (4.40). These results denoted overall patient satisfaction with the EVP.

Discussion

The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the EVP. Comparison of pre-intervention and postintervention data obtained from 67 veterans who completed the program revealed improvements in pain intensity, pain interference, negative cognition (catastrophizing), and quality of life. The differences were statistically significant and clinically meaningful, with medium and large effect sizes. In addition, veterans reported high satisfaction with the EVP.

The EVP includes CIH approaches that have demonstrated effectiveness among veterans and other populations with chronic pain. A wealth of studies, for example, support the effectiveness of CIH approaches among veterans.^30-34 Other studies focus on specific CIH approaches that are components of the EVP. Evidence supports, for example, the efficacy of mindfulness-based stress reduction,^35-39 acceptance and commitment therapy,^40-43 brief peer support intervention,⁴⁴ and interdisciplinary biopsychosocial rehabilitation.^45,46

While empirical evidence supports components of the EVP, only one study focused on the outcomes of the Atlanta VA EVP among veterans with chronic pain. Results of a qualitative study conducted by Penney and Haro⁴⁷ described the experience of veterans with the EVP. Those veterans reported adopting new self-care or lifestyle practices for pain management and health, accepting pain, being better able to adjust and set boundaries, feeling more in control, participating in life, and changing their medication use.

The mean baseline scores from the current sample were similar to samples of patients with chronic pain in other studies (NPRS,⁴⁸ MPI,⁴⁸ and PCS^48-51). After converting scores on the WHOQOL-BREF from those that ranged from 4 to 20 to those that ranged from 0 to 100,¹⁸ the scores from the current sample were similar to those of other studies of patients with chronic pain.^48,52,53Several strengths of the project should be noted. Data were collected using well established measurement tools that had previously demonstrated reliability and validity. All the tools used in data collection demonstrated good internal consistency reliabilities in the current sample of veterans. Weaknesses of the project include the use of a convenience sample of veterans and small sample size. Data were not available on the number of veterans who were offered participation or on how many veterans declined enrollment. The sample of veterans who chose to participate in the EVP may or may not have been representative of the population of veterans with high-impact chronic pain. As a pre- and postintervention design with no comparison group, the results are subject to multiple threats to internal validity, including the Hawthorne effect, maturation in the form of healing, and attrition. Reasons for leaving the program had not been recorded, so the investigators had no way of knowing factors that may have contributed to attrition. Also, data on when veterans left the program were unavailable. Research is needed with a control group to reduce the effect of confounding variables on the outcome measures. This project used data collected at a single VA facility, which limits its generalizability.

While completers and noncompleters of the EVP were similar on age, gender, and baseline measures, there may have been unidentified characteristics that influenced program completion. The investigators noticed the presence of more missing data among noncompleters compared to completers on the pre-intervention PCS; thus, noncompleters may have scored lower than completers on this instrument simply because there were more individual items that were unanswered/missing among this group of noncompleters.

Data were analyzed using a limited number of outcome measures that had previously been collected. Other outcome measures might include whether EVP participants reduced their use of medications, clinical resources, and personnel. Future projects, for example, could determine whether the EVP is effective in reducing opioid analgesic medication use and decreasing primary care and emergency department visits. Cost-benefit analyses could be completed to determine whether EVP is associated with financial savings.

Because no follow-up assessments were made to determine whether improvements were maintained over time, the project focus was limited to an evaluation of the short-term changes in the outcome measures. Future projects could include a follow-up assessment of the veterans 1- or 2-years post completion of the EVP.

Data for the project were collected prior to the COVID-19 pandemic, when the EVP was implemented through face-to-face meetings with participants and their peers. It is not clear how changes to the delivery of the program (such as offering it through telehealth) might impact veterans’ satisfaction with the program, willingness to complete it, and other variables of interest.

The results of this project were made available to stakeholders with recommendations for program expansion both at the current location and at other VA facilities, including the recommendation to hire additional personnel that would implement the program. As the VA network of facilities expand the EVP program and adapt it for telehealth delivery, the investigators recommended a similar analysis of data be performed following telehealth delivery. If delivery through telehealth is shown to improve outcome measures, the EVP could provide pain management treatment options for patients challenged by transportation barriers, including rural veterans.

Conclusion

This quality improvement project provided evidence of improvement in measures of pain severity, pain interference, negative cognition (catastrophizing), quality of life, and patient treatment satisfaction among veterans with chronic high-impact pain. Findings have been well received by the northeastern VA as well as the Veterans Integrated Systems Network 5. The results of the analyses were used to inform decisions regarding the future of the program.

Disclaimer: This material is the result of work supported with resources and the use of facilities at the VA Maryland Health Care System, Baltimore, Maryland. The views expressed are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

Acknowledgments: The authors thank Dr. Arianna Perra, the recent past coordinator of the Empower Veterans Program (EVP), who provided initial insights and support that motivated the decision to evaluate the program. We also thank the veterans and VA EVP clinicians who contributed data for the evaluation, and Dr. Michael Saenger (Director, TelePain-EVP: EVP) and Dr. Robert Lavin for their ongoing support, care, and concern for veteran patients. We also thank Dr. Beverly Bradley and the neurology service administrative team for their guidance in the process of obtaining necessary VA approvals for this project.

Corresponding author: Jessica U. Uche, DNP, CRNP-Family; [email protected]

doi:10.12788/jcom.0089

From Neurology/Chronic Pain Management Services, Department of Veterans Affairs (VA) Maryland Health Care System, Baltimore VA Medical Center, Baltimore, MD (Dr. Uche), and School of Nursing, Washburn University, Topeka, KS (Drs. Jamison and Waugh).

Abstract

Objective: The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the Empower Veterans Program (EVP) offered by a Veterans Administration facility in the northeastern United States.

Methods: This quality improvement project used data collected from veterans with chronic pain who completed the veterans health care facility’s EVP between August 2017 and August 2019. Pre- and post-intervention data on pain intensity, pain interference, quality of life, and pain catastrophizing were compared using paired t-tests.

Results: Although data were abstracted from 115 patients, the final sample included 67 patients who completed both pre-and postintervention questionnaires. Baseline measures of completers and noncompleters were similar. Comparison of pre and post mean scores on completers showed statistically significant findings (P = .004) based on the Bonferroni correction. The medium and large effect sizes (Cohen’s d) indicated clinically significant improvements for veterans who completed the program. Veterans reported high levels of satisfaction with the program.

Conclusion: Veterans with chronic high-impact noncancer pain who completed the EVP had reduced pain intensity, pain interference, pain catastrophizing as well as improved quality of life and satisfaction with their health.

Keywords: musculoskeletal pain, Veterans Affairs, complementary and integrative health, acceptance and commitment therapy, mind-body therapies, whole health, multidisciplinary pain management.

More than 100 million American adults suffer from chronic pain; costs associated with managing chronic pain are approximately $635 billion each year.¹ Chronic pain is prevalent among military veterans, affecting one-third of the 9 million veterans who receive care from Veterans Health Administration (VHA) facilities.² The biopsychosocial impact of chronic pain on the general population, and specifically on veterans, has been compounded by the opioid crisis. The effects of chronic pain and the opioid crisis have fueled interest in the use of complementary and integrative health (CIH) modalities in the management of chronic noncancer pain. Providers are increasingly developing treatment programs that incorporate CIH in their management of chronic noncancer pain.

One such program is the Empower Veterans Program (EVP). Originally developed at the Atlanta Veterans Affairs Health Care System, the EVP is a CIH modality based on the biopsychosocial model of pain developed by psychiatrist George Engel in 1977.³ The biopsychosocial model of pain recognizes that pain is a complex, multidimensional, biopsychosocial experience. Under this model, the mind and body work in unison as interconnected entities. Because the model acknowledges biological, psychological, and social components of pain and illness,⁴ treatment focuses on all aspects of a person’s health, life, and relationships.

The EVP fits into the VHA Pain Management Stepped Care Model and is an adjunctive complement for that model.^5-7 The EVP complements care at the first step, where patient/family provide self-care and where care is provided by patient-aligned primary care teams, at the second step, which includes secondary consultation with multidisciplinary pain medicine specialty teams and other specialists, and at the third step, with the addition of tertiary interdisciplinary pain centers.

The VA Maryland Health Care System (VAMHCS) implemented the EVP as part of a quality improvement project for the management of chronic pain. The objectives of the program were to reduce pain intensity, pain catastrophizing, and pain interference, as well as improve functionality and quality of life among veterans with chronic high-impact noncancer pain. More than 2 years after the program was implemented, collected data had not been analyzed. The purpose of this quality improvement project was to abstract and analyze the previously collected data from veterans with high-impact chronic pain who attended an EVP offered by the VAMHCS. The results of the data analysis were used to inform decisions regarding the future of the program.

Methods

This quality improvement project used the Plan-Do-Study-Act (PDSA) process.⁸ The first 2 phases of the PDSA cycle (Plan and Do) were completed by a team of VA employees from the VAMHCS, who donated their time to establish and implement the program at the project site. This team consisted of psychologists, a physical therapist, a social worker, and a chaplain, and included support from medical administrative staff. This team planned and implemented the EVP at the VA facility based on the model developed at the Atlanta VA Health Care System. During the “Do” phase, the team collected data on pain intensity, pain interference, quality of life, and pain negative cognition (catastrophizing) before the intervention and post intervention. They also collected data on program outcome (patient treatment satisfaction) post intervention. Because these employees did not have time to retrieve and analyze the data, they welcomed the opportunity to have the data analyzed by the investigators during the Study phase of the PDSA cycle. Based on the results of the analysis, recommendations for program changes were made during the Act phase of the cycle.

Intervention

The EVP was developed as a 10-week (30 hours) interdisciplinary CIH approach that coached veterans with chronic pain to live fuller lives based on their individual values and what matters to them. EVP is the “What Else” management modality for the 5% of veterans with high-impact chronic pain.⁹ The EVP provided functional restoration through its components of whole health, mindfulness training, coaching calls, acceptance and commitment therapy, and mindful movement. It used the Wheel of Health with the 4 key components of me, self-care, professional care, and community.^10,11

Veterans who had a diagnosis of chronic nonmalignant pain for 3 months or more and who agreed to participate in the EVP at this facility attended 3-hour classes every Tuesday with a cohort of 8 to 12 peers and engaged in one-on-one coaching with interdisciplinary team members. During the class sessions, veterans were coached to understand and accept their pain and commit to maintaining function despite their pain. Mindful movement by the physical therapist emphasized the pivotal place of exercise in pain management. The therapist used the mantra “Motion is Lotion.”⁹ The guiding principle of the EVP was that small incremental changes can have a big impact on the individual’s whole life. Emphasis was placed on increasing self-efficacy and mindful awareness for veterans with high-impact pain by giving them “Skills before Pills.”⁹

Outcome Measures

Outcome measures included the Numerical Pain Rating Scale (NPRS), the Multidimensional Pain Inventory (MPI), the World Health Organization Quality of Life assessment (WHOQOL-BREF), the Pain Catastrophizing Scale (PCS), and the Pain Treatment Satisfaction Scale (PTSS). Cronbach alpha coefficients were calculated to assess internal consistency reliability of these measures in the sample of veterans who completed the EVP.

NPRS. The NPRS is ubiquitous as a screening tool in many health care environments and its use is mandated by the VA health care system.¹² The choice of the NPRS as the tool for pain screening in the VA health care system was based on a large body of research that supports the reliability and validity of the NPRS as a single index of pain intensity or severity. Studies suggest that the NPRS is valid for use in the assessment of acute, cancer, or chronic nonmalignant pain and in varied clinical settings.¹³ The NPRS has 4 items, each on a scale of 0 to 10. For the purpose of this project, only 3 items were used. The 3 items assessed the worst pain, usual pain, and the current pain (right now). The higher the score, the higher the pain intensity. Cronbach alpha coefficients on the NPRS obtained from the current sample of veterans were 0.85 on both pre- and postintervention assessments.

MPI. The MPI is an easily accessible, reliable, and valid self-report questionnaire that measures the impact of pain on an individual’s life, quality of social support, and general activity.¹⁴ This instrument is a short version of the West Haven-Yale MPI.¹⁵ The MPI contains 9 items rated on a scale from 0 to 6. The higher the score, the greater pain interference a person is experiencing. The MPI produces reliable, valid information for diagnostic purposes and for therapy outcome studies.¹⁶ The MPI had a Cronbach alpha of 0.90 on pre-intervention and 0.92 on postintervention assessments in the current sample.

WHOQOL-BREF. The WHOQOL-BREF is a measure of quality of life and is an abbreviated version of the WHOQOL-100. Quality of life is defined by the World Health Organization¹⁷ “as an individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.” The WHOQOL-BREF contains 26 items. The first 2 items were examined separately; the first item asks individuals to rate their overall quality of life and the second asks individuals how satisfied they are with their health. The remaining 24 items were used to calculate the following 4 domain scores: physical health, psychological health, social relationship, and environment.¹⁸ Each item is measured on a scale of 1 to 5. Higher scores denote higher or better quality of life. Domain scores have demonstrated good reliability and validity.^19-21 Cronbach alpha coefficients for the domain subscales ranged from 0.63 to 0.84 in the current sample, with the lowest alphas for the 3-item Social Relationships Domain.

PCS. The PCS is a widely used measure of catastrophic thinking related to pain. Catastrophizing has been conceived by Sullivan and colleagues as “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.”²² The PCS provides a total score and scores for the following subscales: rumination, magnification, and helplessness.²³ It has been used in a variety of chronic pain populations and has demonstrated good reliability and validity in clinical as well as nonclinical samples.^24-26 The PCS has 13 items rated on a scale of 0 to 4. Higher scores mean greater negative pain cognition (catastrophizing). In the current sample, the PCS total scale had a Cronbach alpha coefficient of 0.95 and 0.94 on the 2 assessments. The coefficients for the subscales ranged from 0.81 to 0.90.

PTSS. The PTSS is a 5-item tool that measures patient satisfaction with pain treatment. It includes items that address overall satisfaction, staff warmth, staff skill level, ease of scheduling appointments, and recommendation of the program to other veterans. It was derived from the post-treatment version of The Pain Outcome Questionnaire-VA and has demonstrated reliability and validity.²⁷ The questions are scaled from 0 to 10. High scores on the PTSS denote high patient satisfaction with the EVP. The Cronbach alpha coefficient on the PTSS obtained from the current sample was 0.80.

Data Gathering and Analysis

Prior to starting the Study phase, Washburn University’s Institutional Review Board (IRB) and the VA IRB approved the project. The VA IRB, through its affiliate, gave a Not Human Research Determination and granted a waiver of informed consent and the Health Insurance Portability and Accountability Act authorization. The VA facility’s Research and Development department also approved the quality improvement project.

Once these approvals were obtained, the Study phase began with the abstraction of retrospective data obtained from veterans who participated in the VA health care facility’s EVP between August 2017 and August 2019. Most of the measurement tools changed in August 2019, and for this reason data abstraction was limited to the time period August 2017 to August 2019. The first author (JUU) abstracted data for both program completers and noncompleters. The second (MJ) and third (SW) authors analyzed the data in SPSS 24 and calculated effect sizes.

Veterans who completed the program were compared to veterans who did not complete the program on age, gender, and baseline measures. The investigators used independent samples t-tests to compare completers and noncompleters on age, pain intensity, pain interference, quality of life, and pain catastrophizing. They used the chi-square test of independence to analyze the association between gender and program completion.

Data were included in the pre- and postintervention analysis if the veteran completed the NPRS, MPI, WHOQOL-BREF, and PCS pre and post intervention. This became an important eligibility requirement as some of the tools/measures were changed towards the end of the review period in 2019. Pre- and postintervention data on pain intensity, pain interference, quality of life, pain catastrophizing, and patient satisfaction were compared using paired samples t-test at .004 level of significance based on the Bonferroni correction.²⁸ Data on patient satisfaction with pain treatment were collected at program completion (week 8 or 10) and were analyzed using descriptive statistics.

Effect sizes (Cohen’s d) were calculated to determine the substantive significance or magnitude of the mean differences in scores. Effect sizes (expressed as absolute values of Cohen’s d) were calculated as the mean difference divided by the standard deviation. Values of 0.2 were considered a small effect size, 0.5 a medium effect size, and 0.8 a large effect size.²⁹

Data were abstracted for 115 veterans who started the EVP. Of these, 48 left the program, leaving 67 veterans (58%) who completed the program. Completers and noncompleters were similar in age, gender, and baseline measures (Table 1). Fifty-three (79%) completers and 35 (73%) noncompleters were male. A chi-square test of independence showed no significant association between gender and program completion (χ^2₁ [N = 115] = .595, P = .440).

Comparison of pre-and postintervention mean scale scores resulted in statistically significant differences for all comparisons (Table 2). These comparisons yielded improvements in the desired direction. For example, the scores on the NPRS, the MPI, and the PCS (along with its subscales) decreased, revealing reductions in pain severity, the impact of pain on the veterans’ lives, and pain catastrophizing. The 2 individual item scores on the WHOQOL-BREF increased, indicating improvements in perceived quality of life and satisfaction with health. The domain scores on the WHOQOL-BREF increased, revealing improvements in pain-related quality of life. The moderate to large effect sizes indicated clinically significant improvements for veterans with chronic high-impact pain who completed the EVP.

Analysis of data obtained using the PTSS yielded high mean scores for items that focused on patient satisfaction with treatment (Table 3). Scaled statistics yielded a mean (SD) of 46.95 (4.40). These results denoted overall patient satisfaction with the EVP.

Discussion

The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the EVP. Comparison of pre-intervention and postintervention data obtained from 67 veterans who completed the program revealed improvements in pain intensity, pain interference, negative cognition (catastrophizing), and quality of life. The differences were statistically significant and clinically meaningful, with medium and large effect sizes. In addition, veterans reported high satisfaction with the EVP.

The EVP includes CIH approaches that have demonstrated effectiveness among veterans and other populations with chronic pain. A wealth of studies, for example, support the effectiveness of CIH approaches among veterans.^30-34 Other studies focus on specific CIH approaches that are components of the EVP. Evidence supports, for example, the efficacy of mindfulness-based stress reduction,^35-39 acceptance and commitment therapy,^40-43 brief peer support intervention,⁴⁴ and interdisciplinary biopsychosocial rehabilitation.^45,46

While empirical evidence supports components of the EVP, only one study focused on the outcomes of the Atlanta VA EVP among veterans with chronic pain. Results of a qualitative study conducted by Penney and Haro⁴⁷ described the experience of veterans with the EVP. Those veterans reported adopting new self-care or lifestyle practices for pain management and health, accepting pain, being better able to adjust and set boundaries, feeling more in control, participating in life, and changing their medication use.

The mean baseline scores from the current sample were similar to samples of patients with chronic pain in other studies (NPRS,⁴⁸ MPI,⁴⁸ and PCS^48-51). After converting scores on the WHOQOL-BREF from those that ranged from 4 to 20 to those that ranged from 0 to 100,¹⁸ the scores from the current sample were similar to those of other studies of patients with chronic pain.^48,52,53Several strengths of the project should be noted. Data were collected using well established measurement tools that had previously demonstrated reliability and validity. All the tools used in data collection demonstrated good internal consistency reliabilities in the current sample of veterans. Weaknesses of the project include the use of a convenience sample of veterans and small sample size. Data were not available on the number of veterans who were offered participation or on how many veterans declined enrollment. The sample of veterans who chose to participate in the EVP may or may not have been representative of the population of veterans with high-impact chronic pain. As a pre- and postintervention design with no comparison group, the results are subject to multiple threats to internal validity, including the Hawthorne effect, maturation in the form of healing, and attrition. Reasons for leaving the program had not been recorded, so the investigators had no way of knowing factors that may have contributed to attrition. Also, data on when veterans left the program were unavailable. Research is needed with a control group to reduce the effect of confounding variables on the outcome measures. This project used data collected at a single VA facility, which limits its generalizability.

While completers and noncompleters of the EVP were similar on age, gender, and baseline measures, there may have been unidentified characteristics that influenced program completion. The investigators noticed the presence of more missing data among noncompleters compared to completers on the pre-intervention PCS; thus, noncompleters may have scored lower than completers on this instrument simply because there were more individual items that were unanswered/missing among this group of noncompleters.

Data were analyzed using a limited number of outcome measures that had previously been collected. Other outcome measures might include whether EVP participants reduced their use of medications, clinical resources, and personnel. Future projects, for example, could determine whether the EVP is effective in reducing opioid analgesic medication use and decreasing primary care and emergency department visits. Cost-benefit analyses could be completed to determine whether EVP is associated with financial savings.

Because no follow-up assessments were made to determine whether improvements were maintained over time, the project focus was limited to an evaluation of the short-term changes in the outcome measures. Future projects could include a follow-up assessment of the veterans 1- or 2-years post completion of the EVP.

Data for the project were collected prior to the COVID-19 pandemic, when the EVP was implemented through face-to-face meetings with participants and their peers. It is not clear how changes to the delivery of the program (such as offering it through telehealth) might impact veterans’ satisfaction with the program, willingness to complete it, and other variables of interest.

The results of this project were made available to stakeholders with recommendations for program expansion both at the current location and at other VA facilities, including the recommendation to hire additional personnel that would implement the program. As the VA network of facilities expand the EVP program and adapt it for telehealth delivery, the investigators recommended a similar analysis of data be performed following telehealth delivery. If delivery through telehealth is shown to improve outcome measures, the EVP could provide pain management treatment options for patients challenged by transportation barriers, including rural veterans.

Conclusion

This quality improvement project provided evidence of improvement in measures of pain severity, pain interference, negative cognition (catastrophizing), quality of life, and patient treatment satisfaction among veterans with chronic high-impact pain. Findings have been well received by the northeastern VA as well as the Veterans Integrated Systems Network 5. The results of the analyses were used to inform decisions regarding the future of the program.

Disclaimer: This material is the result of work supported with resources and the use of facilities at the VA Maryland Health Care System, Baltimore, Maryland. The views expressed are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

Acknowledgments: The authors thank Dr. Arianna Perra, the recent past coordinator of the Empower Veterans Program (EVP), who provided initial insights and support that motivated the decision to evaluate the program. We also thank the veterans and VA EVP clinicians who contributed data for the evaluation, and Dr. Michael Saenger (Director, TelePain-EVP: EVP) and Dr. Robert Lavin for their ongoing support, care, and concern for veteran patients. We also thank Dr. Beverly Bradley and the neurology service administrative team for their guidance in the process of obtaining necessary VA approvals for this project.

Corresponding author: Jessica U. Uche, DNP, CRNP-Family; [email protected]

doi:10.12788/jcom.0089

From the University of Miami Miller School of Medicine (Drs. Sosa, Ferreira, Gershengorn, Soto, Parekh, and Suarez), and the Quality Department of the University of Miami Hospital and Clinics (Estin Kelly, Ameena Shrestha, Julianne Burgos, and Sandeep Devabhaktuni), Miami, FL.

Abstract

Background: Case mix index (CMI) and expected mortality are determined based on comorbidities. Improving documentation and coding can impact performance indicators. During and prior to 2018, our patient acuity was under-represented, with low expected mortality and CMI. Those metrics motivated our quality team to develop the quality initiatives reported here.

Objectives: We sought to assess the impact of quality initiatives on number of comorbidities, diagnoses, CMI, and expected mortality at the University of Miami Health System.

Design: We conducted an observational study of a series of quality initiatives: (1) education of clinical documentation specialists (CDS) to capture comorbidities (10/2019); (2) facilitating the process for physician query response (2/2020); (3) implementation of computer logic to capture electrolyte disturbances and renal dysfunction (8/2020); (4) development of a tool to capture Elixhauser comorbidities (11/2020); and (5) provider education and electronic health record reviews by the quality team.

Setting and participants: All admissions during 2019 and 2020 at University of Miami Health System. The health system includes 2 academic inpatient facilities, a 560-bed tertiary hospital, and a 40-bed cancer facility. Our hospital is 1 of the 11 PPS-Exempt Cancer Hospitals and is the South Florida’s only NCI-Designated Cancer Center.

Measures: Number of coded diagnoses and Elixhauser comorbidities; CMI and expected mortality were compared between the pre-intervention and the intervention periods using t-tests and Chi-square test.

Results: There were 33 066 admissions during the study period—13 689 before the intervention and 19 377 during the intervention period. From pre-intervention to intervention, the mean (SD) number of comorbidities increased from 2.5 (1.7) to 3.1 (2.0) (P < .0001), diagnoses increased from 11.3 (7.3) to 18.5 (10.4) (P < .0001), CMI increased from 2.1 (1.9) to 2.4 (2.2) (P < .0001), and expected mortality increased from 1.8% (6.1) to 3.1% (9.2) (P < .0001).

Conclusion: The number of comorbidities, diagnoses, and CMI all improved, and expected mortality increased in the year of implementation of the quality initiatives.

Keywords: PS/QI, coding, case mix index, comorbidities, mortality.

Accurate documentation of the patient’s clinical course during hospitalization is essential for patient care. To date, Diagnosis Related Groups (DRG) remain the standard for calculating health care system–level risk-adjusted outcomes data and are essential for institutional reputation (eg, US News & World Report rankings).^1,2 With an ever-increasing emphasis on pay-for-performance and value-based purchasing within the US health care system, there is a pressing need for institutions to accurately capture the complexity and acuity of the patients they care for.

Adoption of comprehensive electronic health record (EHR) systems by US hospitals, defined as an EHR capable of meeting all core meaningful-use metrics including evaluation and tracking of quality metrics, has been steadily increasing.^3,4 Many institutions have looked to EHR system transitions as an inflection point to expand clinical documentation improvement (CDI) efforts. Over the past several years, our institution, an academic medical center, has endeavored to fully transition to a comprehensive EHR system (Epic from Epic Systems Corporation). Part of the purpose of this transition was to help study and improve outcomes, reduce readmissions, improve quality of care, and meet performance indicators.

Prior to 2019, our hospital’s patient acuity was low, with a CMI consistently below 2, ranging from 1.81 to 1.99, and an expected mortality consistently below 1.9%, ranging from 1.65% to 1.85%. Our concern that these values underestimated the real severity of illness of our patient population prompted the development of a quality improvement plan. In this report, we describe the processes we undertook to improve documentation and coding of comorbid illness, and report on the impact of these initiatives on performance indicators. We hypothesized that our initiatives would have a significant impact on our ability to capture patient complexity, and thus impact our CMI and expected mortality.

Methods

In the fall of 2019, we embarked on a multifaceted quality improvement project aimed at improving comorbidity capture for patients hospitalized at our institution. The health system includes 2 academic inpatient facilities, a 560-bed tertiary hospital and a 40-bed cancer facility. Since September 2017, we have used Epic as our EHR. In August 2019, we started working with Vizient Clinical Data Base⁵ to allow benchmarking with peer institutions. We assessed the impact of this initiative with a pre/post study design.

Quality Initiatives

This quality improvement project consisted of a series of 5 targeted interventions coupled with continuous monitoring and education.

1. Comorbidity coding. In October 2019, we met with the clinical documentation specialists (CDS) and the coding team to educate them on the value of coding all comorbidities that have an impact on CMI and expected mortality, not only those that optimize the DRG.

2. Physician query. In October 2019, we modified the process for physician query response, allowing physicians to answer queries in the EHR through a reply tool incorporated into the query and accept answers in the body of the Epic message as an active part of the EHR.

3. EHR logic. In August 2020, we developed an EHR smart logic to automatically capture fluid and electrolyte disturbances and renal dysfunction, based on the most recent laboratory values. The logic automatically populated potentially appropriate diagnoses in the assessment and plan of provider notes, which require provider acknowledgment and which providers are able to modify (eFigure 1).

Assessment of Quality Initiatives’ Impact

Data on the number of comorbidities and performance indicators were obtained retrospectively. The data included all hospital admissions from 2019 and 2020 divided into 2 periods: pre-intervention from January 1, 2019 through September 30, 2019, and intervention from October 1, 2019 through December 31, 2020. The primary outcome of this observational study was the rate of comorbidity capture during the intervention period. Comorbidity capture was assessed using the Vizient Clinical Data Base (CDB) health care performance tool.⁵ Vizient CDB uses the Agency for Healthcare Research and Quality Elixhauser index, which includes 29 of the initial 31 comorbidities described by Elixhauser,⁶ as it combines hypertension with and without complications into one. We secondarily aimed to examine the impact of the quality improvement initiatives on several institutional-level performance indicators, including total number of diagnoses, comorbidities or complications (CC), major comorbidities or complications (MCC), CMI, and expected mortality.

Case mix index is the average Medicare Severity-DRG (MS-DRG) weighted across all hospital discharges (appropriate to their discharge date). The expected mortality represents the average expected number of deaths based on diagnosed conditions, age, and gender within the same time frame, and it is based on coded diagnosis; we obtained the mortality index by dividing the observed mortality by the expected mortality. The Vizient CDB Mortality Risk Adjustment Model was used to assign an expected mortality (0%-100%) to each case based on factors such as demographics, admission type, diagnoses, and procedures.

Standard statistics were used to measure the outcomes. We used Excel to compare pre-intervention and intervention period characteristics and outcomes, using t-testing for continuous variables and Chi-square testing for categorial outcomes. P values <0.05 were considered statistically significant.

The study was reviewed by the institutional review board (IRB) of our institution (IRB ID: 20210070). The IRB determined that the proposed activity was not research involving human subjects, as defined by the Department of Health and Human Services and US Food and Drug Administration regulations, and that IRB review and approval by the organization were not required.

Results

The health system had a total of 33 066 admissions during the study period—13 689 pre-intervention (January 1, 2019 through September 30, 2019) and 19,377 during the intervention period (October 1, 2019 to December 31, 2020). Demographics were similar among the pre-intervention and intervention periods: mean age was 60 years and 61 years, 52% and 51% of patients were male, 72% and 71% were White, and 20% and 19% were Black, respectively (Table 1).

The multifaceted intervention resulted in a significant improvement in the primary outcome: mean comorbidity capture increased from 2.5 (SD, 1.7) before the intervention to 3.1 (SD, 2.0) during the intervention (P < .00001). Secondary outcomes also improved. The mean number of secondary diagnoses for admissions increased from 11.3 (SD, 7.3) prior to the intervention to 18.5 (SD, 10.4) (P < .00001) during the intervention period. The mean CMI increased from 2.1 (SD, 1.9) to 2.4 (SD, 2.2) post intervention (P < .00001), an increase during the intervention period of 14%. The expected mortality increased from 1.8% (SD, 6.1%) to 3.1% (SD, 9.2%) after the intervention (P < .00001) (Table 2).

Discussion

The need for accurate documentation by physicians has been recognized for many years.⁷Patient acuity at our institution during 2018 and prior was under-represented, with low expected mortality and CMI. Those metrics motivated our quality team to develop the initiatives described here. We had previously sought to improve documentation and performance indicators at our institution through educational initiatives. These unpublished interventions included quarterly data review by departments and divisions with physician educational didactics. These educational initiatives are necessary but require considerable workforce time and are limited to the targeted subgroup. While education and engagement of providers are essential to enhance documentation and were an important part of our interventions, we felt that additional, more sustainable interventions were needed. Leveraging the EHR to facilitate physician documentation was key. All our interventions, including our tool to help capture fluid and electrolyte abnormalities and renal dysfunction, together with our Elixhauser comorbidities tool, had a substantial impact on performance metrics.

With the growing complexity of the documentation and coding process, it is difficult for clinicians to keep up with the terminology required by the Centers for Medicare and Medicaid Services (CMS). Several different methods to improve documentation have been proposed. Prior interventions to standardize documentation templates in the trauma service have shown improvement in CMI.⁸ An educational program on coding for internal medicine that included a lecture series and creation of a laminated pocket card listing common CMS diagnoses, CC, and MCC has been implemented, with an improvement in the capture rate of CC and MCC from 42% to 48% and an impact on expected mortality.⁹ This program resulted in a 30% decrease in the median quarterly mortality index and an increase in CMI from 1.27 to 1.36.

Our results show that there was an increase in comorbidities documentation of admitted patients after all interventions were implemented, more accurately reflecting the complexity of our patient population in a tertiary care academic medical center. Our CMI increased by 14% during the intervention period. The estimated CMI dollar impact increased by 75% from the pre-intervention period (adjusted for PPS-exempt hospital). The hospital-expected mortality increased from 1.77 to 3.07 (peak at 4.74 during third quarter of 2020) during the implementation period, which is a key driver of quality rankings for national outcomes reporting services such as US News & World Report.

There was increased physician satisfaction as a result of the change of functionality of the query response system, and no additional monetary provider incentive for complete documentation was allocated, apart from education and 1:1 support that improved physician engagement. Our next steps include the implementation of an advanced program to concurrently and automatically capture and nudge providers to respond and complete their documentation in real time.

Limitations

The limitations of our study include those inherent to a retrospective review and are associative and observational in nature. Although we used expected mortality and CMI as a surrogate for patient acuity for comparison, there was no way to control for actual changes in patient acuity that contributed to the increase in CMI, although we believe that the population we served and the services provided and their structure did not change significantly during the intervention period. Additionally, the observed increase in CMI during the implementation period may be a result of described variabilities in CMI and would be better studied over a longer period. Also, during the year of our interventions, 2020, we were affected by the COVID-19 pandemic. Patients with COVID-19 are known to carry a lower-than-expected mortality, and that could have had a negative impact on our results. In fact, we did observe a decrease in our expected mortality during the last quarter of 2020, which correlated with one of our regional peaks for COVID-19, and that could be a confounding factor. While the described intervention process is potentially applicable to multiple EHR systems, the exact form to capture the Elixhauser comorbidities was built into the Epic EHR, limiting external applicability of this tool to other EHR software.

Conclusion

A continuous comprehensive series of interventions substantially increased our patient acuity scores. The increased scores have implications for reimbursement and quality comparisons for hospitals and physicians. Our institution can now be stratified more accurately with our peers and other hospitals. Accurate medical record documentation has become increasingly important, but also increasingly complex. Leveraging the EHR through quality initiatives that facilitate the workflow for providers can have an impact on documentation, coding, and ultimately risk-adjusted outcomes data that influence institutional reputation.

Corresponding author: Marie Anne Sosa, MD; 1120 NW 14th St., Suite 809, Miami, FL, 33134; [email protected]

Disclosures: None reported.

doi:10.12788/jcom.0088

From the University of Miami Miller School of Medicine (Drs. Sosa, Ferreira, Gershengorn, Soto, Parekh, and Suarez), and the Quality Department of the University of Miami Hospital and Clinics (Estin Kelly, Ameena Shrestha, Julianne Burgos, and Sandeep Devabhaktuni), Miami, FL.

Abstract

Background: Case mix index (CMI) and expected mortality are determined based on comorbidities. Improving documentation and coding can impact performance indicators. During and prior to 2018, our patient acuity was under-represented, with low expected mortality and CMI. Those metrics motivated our quality team to develop the quality initiatives reported here.

Objectives: We sought to assess the impact of quality initiatives on number of comorbidities, diagnoses, CMI, and expected mortality at the University of Miami Health System.

Design: We conducted an observational study of a series of quality initiatives: (1) education of clinical documentation specialists (CDS) to capture comorbidities (10/2019); (2) facilitating the process for physician query response (2/2020); (3) implementation of computer logic to capture electrolyte disturbances and renal dysfunction (8/2020); (4) development of a tool to capture Elixhauser comorbidities (11/2020); and (5) provider education and electronic health record reviews by the quality team.

Setting and participants: All admissions during 2019 and 2020 at University of Miami Health System. The health system includes 2 academic inpatient facilities, a 560-bed tertiary hospital, and a 40-bed cancer facility. Our hospital is 1 of the 11 PPS-Exempt Cancer Hospitals and is the South Florida’s only NCI-Designated Cancer Center.

Measures: Number of coded diagnoses and Elixhauser comorbidities; CMI and expected mortality were compared between the pre-intervention and the intervention periods using t-tests and Chi-square test.

Results: There were 33 066 admissions during the study period—13 689 before the intervention and 19 377 during the intervention period. From pre-intervention to intervention, the mean (SD) number of comorbidities increased from 2.5 (1.7) to 3.1 (2.0) (P < .0001), diagnoses increased from 11.3 (7.3) to 18.5 (10.4) (P < .0001), CMI increased from 2.1 (1.9) to 2.4 (2.2) (P < .0001), and expected mortality increased from 1.8% (6.1) to 3.1% (9.2) (P < .0001).

Conclusion: The number of comorbidities, diagnoses, and CMI all improved, and expected mortality increased in the year of implementation of the quality initiatives.

Keywords: PS/QI, coding, case mix index, comorbidities, mortality.

Accurate documentation of the patient’s clinical course during hospitalization is essential for patient care. To date, Diagnosis Related Groups (DRG) remain the standard for calculating health care system–level risk-adjusted outcomes data and are essential for institutional reputation (eg, US News & World Report rankings).^1,2 With an ever-increasing emphasis on pay-for-performance and value-based purchasing within the US health care system, there is a pressing need for institutions to accurately capture the complexity and acuity of the patients they care for.

Adoption of comprehensive electronic health record (EHR) systems by US hospitals, defined as an EHR capable of meeting all core meaningful-use metrics including evaluation and tracking of quality metrics, has been steadily increasing.^3,4 Many institutions have looked to EHR system transitions as an inflection point to expand clinical documentation improvement (CDI) efforts. Over the past several years, our institution, an academic medical center, has endeavored to fully transition to a comprehensive EHR system (Epic from Epic Systems Corporation). Part of the purpose of this transition was to help study and improve outcomes, reduce readmissions, improve quality of care, and meet performance indicators.

Prior to 2019, our hospital’s patient acuity was low, with a CMI consistently below 2, ranging from 1.81 to 1.99, and an expected mortality consistently below 1.9%, ranging from 1.65% to 1.85%. Our concern that these values underestimated the real severity of illness of our patient population prompted the development of a quality improvement plan. In this report, we describe the processes we undertook to improve documentation and coding of comorbid illness, and report on the impact of these initiatives on performance indicators. We hypothesized that our initiatives would have a significant impact on our ability to capture patient complexity, and thus impact our CMI and expected mortality.

Methods

In the fall of 2019, we embarked on a multifaceted quality improvement project aimed at improving comorbidity capture for patients hospitalized at our institution. The health system includes 2 academic inpatient facilities, a 560-bed tertiary hospital and a 40-bed cancer facility. Since September 2017, we have used Epic as our EHR. In August 2019, we started working with Vizient Clinical Data Base⁵ to allow benchmarking with peer institutions. We assessed the impact of this initiative with a pre/post study design.

Quality Initiatives

This quality improvement project consisted of a series of 5 targeted interventions coupled with continuous monitoring and education.

1. Comorbidity coding. In October 2019, we met with the clinical documentation specialists (CDS) and the coding team to educate them on the value of coding all comorbidities that have an impact on CMI and expected mortality, not only those that optimize the DRG.

2. Physician query. In October 2019, we modified the process for physician query response, allowing physicians to answer queries in the EHR through a reply tool incorporated into the query and accept answers in the body of the Epic message as an active part of the EHR.

3. EHR logic. In August 2020, we developed an EHR smart logic to automatically capture fluid and electrolyte disturbances and renal dysfunction, based on the most recent laboratory values. The logic automatically populated potentially appropriate diagnoses in the assessment and plan of provider notes, which require provider acknowledgment and which providers are able to modify (eFigure 1).

Assessment of Quality Initiatives’ Impact

Data on the number of comorbidities and performance indicators were obtained retrospectively. The data included all hospital admissions from 2019 and 2020 divided into 2 periods: pre-intervention from January 1, 2019 through September 30, 2019, and intervention from October 1, 2019 through December 31, 2020. The primary outcome of this observational study was the rate of comorbidity capture during the intervention period. Comorbidity capture was assessed using the Vizient Clinical Data Base (CDB) health care performance tool.⁵ Vizient CDB uses the Agency for Healthcare Research and Quality Elixhauser index, which includes 29 of the initial 31 comorbidities described by Elixhauser,⁶ as it combines hypertension with and without complications into one. We secondarily aimed to examine the impact of the quality improvement initiatives on several institutional-level performance indicators, including total number of diagnoses, comorbidities or complications (CC), major comorbidities or complications (MCC), CMI, and expected mortality.

Case mix index is the average Medicare Severity-DRG (MS-DRG) weighted across all hospital discharges (appropriate to their discharge date). The expected mortality represents the average expected number of deaths based on diagnosed conditions, age, and gender within the same time frame, and it is based on coded diagnosis; we obtained the mortality index by dividing the observed mortality by the expected mortality. The Vizient CDB Mortality Risk Adjustment Model was used to assign an expected mortality (0%-100%) to each case based on factors such as demographics, admission type, diagnoses, and procedures.

Standard statistics were used to measure the outcomes. We used Excel to compare pre-intervention and intervention period characteristics and outcomes, using t-testing for continuous variables and Chi-square testing for categorial outcomes. P values <0.05 were considered statistically significant.

The study was reviewed by the institutional review board (IRB) of our institution (IRB ID: 20210070). The IRB determined that the proposed activity was not research involving human subjects, as defined by the Department of Health and Human Services and US Food and Drug Administration regulations, and that IRB review and approval by the organization were not required.

Results

The health system had a total of 33 066 admissions during the study period—13 689 pre-intervention (January 1, 2019 through September 30, 2019) and 19,377 during the intervention period (October 1, 2019 to December 31, 2020). Demographics were similar among the pre-intervention and intervention periods: mean age was 60 years and 61 years, 52% and 51% of patients were male, 72% and 71% were White, and 20% and 19% were Black, respectively (Table 1).

The multifaceted intervention resulted in a significant improvement in the primary outcome: mean comorbidity capture increased from 2.5 (SD, 1.7) before the intervention to 3.1 (SD, 2.0) during the intervention (P < .00001). Secondary outcomes also improved. The mean number of secondary diagnoses for admissions increased from 11.3 (SD, 7.3) prior to the intervention to 18.5 (SD, 10.4) (P < .00001) during the intervention period. The mean CMI increased from 2.1 (SD, 1.9) to 2.4 (SD, 2.2) post intervention (P < .00001), an increase during the intervention period of 14%. The expected mortality increased from 1.8% (SD, 6.1%) to 3.1% (SD, 9.2%) after the intervention (P < .00001) (Table 2).

Discussion

The need for accurate documentation by physicians has been recognized for many years.⁷Patient acuity at our institution during 2018 and prior was under-represented, with low expected mortality and CMI. Those metrics motivated our quality team to develop the initiatives described here. We had previously sought to improve documentation and performance indicators at our institution through educational initiatives. These unpublished interventions included quarterly data review by departments and divisions with physician educational didactics. These educational initiatives are necessary but require considerable workforce time and are limited to the targeted subgroup. While education and engagement of providers are essential to enhance documentation and were an important part of our interventions, we felt that additional, more sustainable interventions were needed. Leveraging the EHR to facilitate physician documentation was key. All our interventions, including our tool to help capture fluid and electrolyte abnormalities and renal dysfunction, together with our Elixhauser comorbidities tool, had a substantial impact on performance metrics.

With the growing complexity of the documentation and coding process, it is difficult for clinicians to keep up with the terminology required by the Centers for Medicare and Medicaid Services (CMS). Several different methods to improve documentation have been proposed. Prior interventions to standardize documentation templates in the trauma service have shown improvement in CMI.⁸ An educational program on coding for internal medicine that included a lecture series and creation of a laminated pocket card listing common CMS diagnoses, CC, and MCC has been implemented, with an improvement in the capture rate of CC and MCC from 42% to 48% and an impact on expected mortality.⁹ This program resulted in a 30% decrease in the median quarterly mortality index and an increase in CMI from 1.27 to 1.36.

Our results show that there was an increase in comorbidities documentation of admitted patients after all interventions were implemented, more accurately reflecting the complexity of our patient population in a tertiary care academic medical center. Our CMI increased by 14% during the intervention period. The estimated CMI dollar impact increased by 75% from the pre-intervention period (adjusted for PPS-exempt hospital). The hospital-expected mortality increased from 1.77 to 3.07 (peak at 4.74 during third quarter of 2020) during the implementation period, which is a key driver of quality rankings for national outcomes reporting services such as US News & World Report.

There was increased physician satisfaction as a result of the change of functionality of the query response system, and no additional monetary provider incentive for complete documentation was allocated, apart from education and 1:1 support that improved physician engagement. Our next steps include the implementation of an advanced program to concurrently and automatically capture and nudge providers to respond and complete their documentation in real time.

Limitations

The limitations of our study include those inherent to a retrospective review and are associative and observational in nature. Although we used expected mortality and CMI as a surrogate for patient acuity for comparison, there was no way to control for actual changes in patient acuity that contributed to the increase in CMI, although we believe that the population we served and the services provided and their structure did not change significantly during the intervention period. Additionally, the observed increase in CMI during the implementation period may be a result of described variabilities in CMI and would be better studied over a longer period. Also, during the year of our interventions, 2020, we were affected by the COVID-19 pandemic. Patients with COVID-19 are known to carry a lower-than-expected mortality, and that could have had a negative impact on our results. In fact, we did observe a decrease in our expected mortality during the last quarter of 2020, which correlated with one of our regional peaks for COVID-19, and that could be a confounding factor. While the described intervention process is potentially applicable to multiple EHR systems, the exact form to capture the Elixhauser comorbidities was built into the Epic EHR, limiting external applicability of this tool to other EHR software.

Conclusion

A continuous comprehensive series of interventions substantially increased our patient acuity scores. The increased scores have implications for reimbursement and quality comparisons for hospitals and physicians. Our institution can now be stratified more accurately with our peers and other hospitals. Accurate medical record documentation has become increasingly important, but also increasingly complex. Leveraging the EHR through quality initiatives that facilitate the workflow for providers can have an impact on documentation, coding, and ultimately risk-adjusted outcomes data that influence institutional reputation.

Corresponding author: Marie Anne Sosa, MD; 1120 NW 14th St., Suite 809, Miami, FL, 33134; [email protected]

Disclosures: None reported.

doi:10.12788/jcom.0088

From the University of Miami Miller School of Medicine (Drs. Sosa, Ferreira, Gershengorn, Soto, Parekh, and Suarez), and the Quality Department of the University of Miami Hospital and Clinics (Estin Kelly, Ameena Shrestha, Julianne Burgos, and Sandeep Devabhaktuni), Miami, FL.

Abstract

Background: Case mix index (CMI) and expected mortality are determined based on comorbidities. Improving documentation and coding can impact performance indicators. During and prior to 2018, our patient acuity was under-represented, with low expected mortality and CMI. Those metrics motivated our quality team to develop the quality initiatives reported here.

Objectives: We sought to assess the impact of quality initiatives on number of comorbidities, diagnoses, CMI, and expected mortality at the University of Miami Health System.

Design: We conducted an observational study of a series of quality initiatives: (1) education of clinical documentation specialists (CDS) to capture comorbidities (10/2019); (2) facilitating the process for physician query response (2/2020); (3) implementation of computer logic to capture electrolyte disturbances and renal dysfunction (8/2020); (4) development of a tool to capture Elixhauser comorbidities (11/2020); and (5) provider education and electronic health record reviews by the quality team.

Setting and participants: All admissions during 2019 and 2020 at University of Miami Health System. The health system includes 2 academic inpatient facilities, a 560-bed tertiary hospital, and a 40-bed cancer facility. Our hospital is 1 of the 11 PPS-Exempt Cancer Hospitals and is the South Florida’s only NCI-Designated Cancer Center.

Measures: Number of coded diagnoses and Elixhauser comorbidities; CMI and expected mortality were compared between the pre-intervention and the intervention periods using t-tests and Chi-square test.

Results: There were 33 066 admissions during the study period—13 689 before the intervention and 19 377 during the intervention period. From pre-intervention to intervention, the mean (SD) number of comorbidities increased from 2.5 (1.7) to 3.1 (2.0) (P < .0001), diagnoses increased from 11.3 (7.3) to 18.5 (10.4) (P < .0001), CMI increased from 2.1 (1.9) to 2.4 (2.2) (P < .0001), and expected mortality increased from 1.8% (6.1) to 3.1% (9.2) (P < .0001).

Conclusion: The number of comorbidities, diagnoses, and CMI all improved, and expected mortality increased in the year of implementation of the quality initiatives.

Keywords: PS/QI, coding, case mix index, comorbidities, mortality.

Accurate documentation of the patient’s clinical course during hospitalization is essential for patient care. To date, Diagnosis Related Groups (DRG) remain the standard for calculating health care system–level risk-adjusted outcomes data and are essential for institutional reputation (eg, US News & World Report rankings).^1,2 With an ever-increasing emphasis on pay-for-performance and value-based purchasing within the US health care system, there is a pressing need for institutions to accurately capture the complexity and acuity of the patients they care for.

Adoption of comprehensive electronic health record (EHR) systems by US hospitals, defined as an EHR capable of meeting all core meaningful-use metrics including evaluation and tracking of quality metrics, has been steadily increasing.^3,4 Many institutions have looked to EHR system transitions as an inflection point to expand clinical documentation improvement (CDI) efforts. Over the past several years, our institution, an academic medical center, has endeavored to fully transition to a comprehensive EHR system (Epic from Epic Systems Corporation). Part of the purpose of this transition was to help study and improve outcomes, reduce readmissions, improve quality of care, and meet performance indicators.

Prior to 2019, our hospital’s patient acuity was low, with a CMI consistently below 2, ranging from 1.81 to 1.99, and an expected mortality consistently below 1.9%, ranging from 1.65% to 1.85%. Our concern that these values underestimated the real severity of illness of our patient population prompted the development of a quality improvement plan. In this report, we describe the processes we undertook to improve documentation and coding of comorbid illness, and report on the impact of these initiatives on performance indicators. We hypothesized that our initiatives would have a significant impact on our ability to capture patient complexity, and thus impact our CMI and expected mortality.

Methods

In the fall of 2019, we embarked on a multifaceted quality improvement project aimed at improving comorbidity capture for patients hospitalized at our institution. The health system includes 2 academic inpatient facilities, a 560-bed tertiary hospital and a 40-bed cancer facility. Since September 2017, we have used Epic as our EHR. In August 2019, we started working with Vizient Clinical Data Base⁵ to allow benchmarking with peer institutions. We assessed the impact of this initiative with a pre/post study design.

Quality Initiatives

This quality improvement project consisted of a series of 5 targeted interventions coupled with continuous monitoring and education.

1. Comorbidity coding. In October 2019, we met with the clinical documentation specialists (CDS) and the coding team to educate them on the value of coding all comorbidities that have an impact on CMI and expected mortality, not only those that optimize the DRG.

2. Physician query. In October 2019, we modified the process for physician query response, allowing physicians to answer queries in the EHR through a reply tool incorporated into the query and accept answers in the body of the Epic message as an active part of the EHR.

3. EHR logic. In August 2020, we developed an EHR smart logic to automatically capture fluid and electrolyte disturbances and renal dysfunction, based on the most recent laboratory values. The logic automatically populated potentially appropriate diagnoses in the assessment and plan of provider notes, which require provider acknowledgment and which providers are able to modify (eFigure 1).

Assessment of Quality Initiatives’ Impact

Data on the number of comorbidities and performance indicators were obtained retrospectively. The data included all hospital admissions from 2019 and 2020 divided into 2 periods: pre-intervention from January 1, 2019 through September 30, 2019, and intervention from October 1, 2019 through December 31, 2020. The primary outcome of this observational study was the rate of comorbidity capture during the intervention period. Comorbidity capture was assessed using the Vizient Clinical Data Base (CDB) health care performance tool.⁵ Vizient CDB uses the Agency for Healthcare Research and Quality Elixhauser index, which includes 29 of the initial 31 comorbidities described by Elixhauser,⁶ as it combines hypertension with and without complications into one. We secondarily aimed to examine the impact of the quality improvement initiatives on several institutional-level performance indicators, including total number of diagnoses, comorbidities or complications (CC), major comorbidities or complications (MCC), CMI, and expected mortality.

Case mix index is the average Medicare Severity-DRG (MS-DRG) weighted across all hospital discharges (appropriate to their discharge date). The expected mortality represents the average expected number of deaths based on diagnosed conditions, age, and gender within the same time frame, and it is based on coded diagnosis; we obtained the mortality index by dividing the observed mortality by the expected mortality. The Vizient CDB Mortality Risk Adjustment Model was used to assign an expected mortality (0%-100%) to each case based on factors such as demographics, admission type, diagnoses, and procedures.

Standard statistics were used to measure the outcomes. We used Excel to compare pre-intervention and intervention period characteristics and outcomes, using t-testing for continuous variables and Chi-square testing for categorial outcomes. P values <0.05 were considered statistically significant.

The study was reviewed by the institutional review board (IRB) of our institution (IRB ID: 20210070). The IRB determined that the proposed activity was not research involving human subjects, as defined by the Department of Health and Human Services and US Food and Drug Administration regulations, and that IRB review and approval by the organization were not required.

Results

The health system had a total of 33 066 admissions during the study period—13 689 pre-intervention (January 1, 2019 through September 30, 2019) and 19,377 during the intervention period (October 1, 2019 to December 31, 2020). Demographics were similar among the pre-intervention and intervention periods: mean age was 60 years and 61 years, 52% and 51% of patients were male, 72% and 71% were White, and 20% and 19% were Black, respectively (Table 1).

The multifaceted intervention resulted in a significant improvement in the primary outcome: mean comorbidity capture increased from 2.5 (SD, 1.7) before the intervention to 3.1 (SD, 2.0) during the intervention (P < .00001). Secondary outcomes also improved. The mean number of secondary diagnoses for admissions increased from 11.3 (SD, 7.3) prior to the intervention to 18.5 (SD, 10.4) (P < .00001) during the intervention period. The mean CMI increased from 2.1 (SD, 1.9) to 2.4 (SD, 2.2) post intervention (P < .00001), an increase during the intervention period of 14%. The expected mortality increased from 1.8% (SD, 6.1%) to 3.1% (SD, 9.2%) after the intervention (P < .00001) (Table 2).

Discussion

The need for accurate documentation by physicians has been recognized for many years.⁷Patient acuity at our institution during 2018 and prior was under-represented, with low expected mortality and CMI. Those metrics motivated our quality team to develop the initiatives described here. We had previously sought to improve documentation and performance indicators at our institution through educational initiatives. These unpublished interventions included quarterly data review by departments and divisions with physician educational didactics. These educational initiatives are necessary but require considerable workforce time and are limited to the targeted subgroup. While education and engagement of providers are essential to enhance documentation and were an important part of our interventions, we felt that additional, more sustainable interventions were needed. Leveraging the EHR to facilitate physician documentation was key. All our interventions, including our tool to help capture fluid and electrolyte abnormalities and renal dysfunction, together with our Elixhauser comorbidities tool, had a substantial impact on performance metrics.

With the growing complexity of the documentation and coding process, it is difficult for clinicians to keep up with the terminology required by the Centers for Medicare and Medicaid Services (CMS). Several different methods to improve documentation have been proposed. Prior interventions to standardize documentation templates in the trauma service have shown improvement in CMI.⁸ An educational program on coding for internal medicine that included a lecture series and creation of a laminated pocket card listing common CMS diagnoses, CC, and MCC has been implemented, with an improvement in the capture rate of CC and MCC from 42% to 48% and an impact on expected mortality.⁹ This program resulted in a 30% decrease in the median quarterly mortality index and an increase in CMI from 1.27 to 1.36.

Our results show that there was an increase in comorbidities documentation of admitted patients after all interventions were implemented, more accurately reflecting the complexity of our patient population in a tertiary care academic medical center. Our CMI increased by 14% during the intervention period. The estimated CMI dollar impact increased by 75% from the pre-intervention period (adjusted for PPS-exempt hospital). The hospital-expected mortality increased from 1.77 to 3.07 (peak at 4.74 during third quarter of 2020) during the implementation period, which is a key driver of quality rankings for national outcomes reporting services such as US News & World Report.

There was increased physician satisfaction as a result of the change of functionality of the query response system, and no additional monetary provider incentive for complete documentation was allocated, apart from education and 1:1 support that improved physician engagement. Our next steps include the implementation of an advanced program to concurrently and automatically capture and nudge providers to respond and complete their documentation in real time.

Limitations

The limitations of our study include those inherent to a retrospective review and are associative and observational in nature. Although we used expected mortality and CMI as a surrogate for patient acuity for comparison, there was no way to control for actual changes in patient acuity that contributed to the increase in CMI, although we believe that the population we served and the services provided and their structure did not change significantly during the intervention period. Additionally, the observed increase in CMI during the implementation period may be a result of described variabilities in CMI and would be better studied over a longer period. Also, during the year of our interventions, 2020, we were affected by the COVID-19 pandemic. Patients with COVID-19 are known to carry a lower-than-expected mortality, and that could have had a negative impact on our results. In fact, we did observe a decrease in our expected mortality during the last quarter of 2020, which correlated with one of our regional peaks for COVID-19, and that could be a confounding factor. While the described intervention process is potentially applicable to multiple EHR systems, the exact form to capture the Elixhauser comorbidities was built into the Epic EHR, limiting external applicability of this tool to other EHR software.

Conclusion

A continuous comprehensive series of interventions substantially increased our patient acuity scores. The increased scores have implications for reimbursement and quality comparisons for hospitals and physicians. Our institution can now be stratified more accurately with our peers and other hospitals. Accurate medical record documentation has become increasingly important, but also increasingly complex. Leveraging the EHR through quality initiatives that facilitate the workflow for providers can have an impact on documentation, coding, and ultimately risk-adjusted outcomes data that influence institutional reputation.

Corresponding author: Marie Anne Sosa, MD; 1120 NW 14th St., Suite 809, Miami, FL, 33134; [email protected]

Disclosures: None reported.

doi:10.12788/jcom.0088

From the Veterans Affairs Ann Arbor Healthcare System Medicine Service (Dr. Cusick), University of Michigan College of Pharmacy, Clinical Pharmacy Service, Michigan Medicine (Dr. Hanigan), Department of Internal Medicine Clinical Experience and Quality, Michigan Medicine (Linda Bashaw), Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI (Dr. Heidemann), and the Operational Excellence Department, Sparrow Health System, Lansing, MI (Matthew Johnson).

Abstract

Background: Diagnosis of heparin-induced thrombocytopenia (HIT) requires completion of an enzyme-linked immunosorbent assay (ELISA)–based heparin-platelet factor 4 (PF4) antibody test. If this test is negative, HIT is excluded. If positive, a serotonin-release assay (SRA) test is indicated. The SRA is expensive and sometimes inappropriately ordered despite negative PF4 results, leading to unnecessary treatment with argatroban while awaiting SRA results.

Objectives: The primary objectives of this project were to reduce unnecessary SRA testing and argatroban utilization in patients with suspected HIT.

Methods: The authors implemented an intervention at a tertiary care academic hospital in November 2017 targeting patients hospitalized with suspected HIT. The intervention was controlled at the level of the laboratory and prevented ordering of SRA tests in the absence of a positive PF4 test. The number of SRA tests performed and argatroban bags administered were identified retrospectively via chart review before the intervention (January 2016 to November 2017) and post intervention (December 2017 to March 2020). Associated costs were calculated based on institutional SRA testing cost as well as the average wholesale price of argatroban.

Results: SRA testing decreased from an average of 3.7 SRA results per 1000 admissions before the intervention to an average of 0.6 results per 1000 admissions post intervention. The number of 50-mL argatroban bags used per 1000 admissions decreased from 18.8 prior to the intervention to 14.3 post intervention. Total estimated cost savings per 1000 admissions was $2361.20.

Conclusion: An evidence-based testing strategy for HIT can be effectively implemented at the level of the laboratory. This approach led to reductions in SRA testing and argatroban utilization with resultant cost savings.

Keywords: HIT, argatroban, anticoagulation, serotonin-release assay.

Thrombocytopenia is a common finding in hospitalized patients.^1,2 Heparin-induced thrombocytopenia (HIT) is one of the many potential causes of thrombocytopenia in hospitalized patients and occurs when antibodies to the heparin-platelet factor 4 (PF4) complex develop after heparin exposure. This triggers a cascade of events, leading to platelet activation, platelet consumption, and thrombosis. While HIT is relatively rare, occurring in 0.3% to 0.5% of critically ill patients, many patients will be tested to rule out this potentially life-threatening cause of thrombocytopenia.³

The diagnosis of HIT utilizes a combination of both clinical suspicion and laboratory testing.⁴ The 4T score (Table) was developed to evaluate the clinical probability of HIT and involves assessing the degree and timing of thrombocytopenia, the presence or absence of thrombosis, and other potential causes of the thrombocytopenia.⁵ The 4T score is designed to be utilized to identify patients who require laboratory testing for HIT; however, it has low inter-rater agreement in patients undergoing evaluation for HIT,⁶ and, in our experience, completion of this scoring is time-consuming.

The enzyme-linked immunosorbent assay (ELISA) is a commonly used laboratory test to diagnose HIT that detects antibodies to the heparin-PF4 complex utilizing optical density (OD) units. When using an OD cutoff of 0.400, ELISA PF4 (PF4) tests have a sensitivity of 99.6%, but poor specificity at 69.3%.⁷ When the PF4 antibody test is positive with an OD ≥0.400, then a functional test is used to determine whether the antibodies detected will activate platelets. The serotonin-release assay (SRA) is a functional test that measures 14C-labeled serotonin release from donor platelets when mixed with patient serum or plasma containing HIT antibodies. In the correct clinical context, a positive ELISA PF4 antibody test along with a positive SRA is diagnostic of HIT.⁸

The process of diagnosing HIT in a timely and cost-effective manner is dependent on the clinician’s experience in diagnosing HIT as well as access to the laboratory testing necessary to confirm the diagnosis. PF4 antibody tests are time-consuming and not always available daily and/or are not available onsite. The SRA requires access to donor platelets and specialized radioactivity counting equipment, making it available only at particular centers.

The treatment of HIT is more straightforward and involves stopping all heparin products and starting a nonheparin anticoagulant. The direct thrombin inhibitor argatroban is one of the standard nonheparin anticoagulants used in patients with suspected HIT.⁴ While it is expensive, its short half-life and lack of renal clearance make it ideal for treatment of hospitalized patients with suspected HIT, many of whom need frequent procedures and/or have renal disease.

At our academic tertiary care center, we performed a retrospective analysis that showed inappropriate ordering of diagnostic HIT testing as well as unnecessary use of argatroban even when there was low suspicion for HIT based on laboratory findings. The aim of our project was to reduce unnecessary HIT testing and argatroban utilization without overburdening providers or interfering with established workflows.

Methods

Setting

The University of Michigan (UM) hospital is a 1000-bed tertiary care center in Ann Arbor, Michigan. The UM guidelines reflect evidence-based guidelines for the diagnosis and treatment of HIT.⁴ In 2016 the UM guidelines for laboratory testing included sending the PF4 antibody test first when there was clinical suspicion of HIT. The SRA was to be sent separately only when the PF4 returned positive (OD ≥ 0.400). Standard guidelines at UM also included switching patients with suspected HIT from heparin to a nonheparin anticoagulant and stopping all heparin products while awaiting the SRA results. The direct thrombin inhibitor argatroban is utilized at UM and monitored with anti-IIa levels. University of Michigan Hospital utilizes the Immucor PF4 IgG ELISA for detecting heparin-associated antibodies.⁹ In 2016, this PF4 test was performed in the UM onsite laboratory Monday through Friday. At UM the SRA is performed off site, with a turnaround time of 3 to 5 business days.

Baseline Data

We retrospectively reviewed PF4 and SRA testing as well as argatroban usage from December 2016 to May 2017. Despite the institutional guidelines, providers were sending PF4 and SRA simultaneously as soon as HIT was suspected; 62% of PF4 tests were ordered simultaneously with the SRA, but only 8% of these PF4 tests were positive with an OD ≥0.400. Of those patients with negative PF4 testing, argatroban was continued until the SRA returned negative, leading to many days of unnecessary argatroban usage. An informal survey of the anticoagulation pharmacists revealed that many recommended discontinuing argatroban when the PF4 test was negative, but providers routinely did not feel comfortable with this approach. This suggested many providers misunderstood the performance characteristics of the PF4 test.

Intervention

Our team consisted of hematology and internal medicine faculty, pharmacists, coagulation laboratory personnel, and quality improvement specialists. We designed and implemented an intervention in November 2017 focused on controlling the ordering of the SRA test. We chose to focus on this step due to the excellent sensitivity of the PF4 test with a cutoff of OD <0.400 and the significant expense of the SRA test. Under direction of the Coagulation Laboratory Director, a standard operating procedure was developed where the coagulation laboratory personnel did not send out the SRA until a positive PF4 test (OD ≥ 0.400) was reported. If the PF4 was negative, the SRA was canceled and the ordering provider received notification of the cancelled test via the electronic medical record, accompanied by education about HIT testing (Figure 1). In addition, the lab increased the availability of PF4 testing from 5 days to 7 days a week so there were no delays in tests ordered on Fridays or weekends.

Outcomes

Our primary goals were to decrease both SRA testing and argatroban use. Secondarily, we examined the cost-effectiveness of this intervention. We hypothesized that controlling the SRA testing at the laboratory level would decrease both SRA testing and argatroban use.

Data Collection

Pre- and postintervention data were collected retrospectively. Pre-intervention data were from January 2016 through November 2017, and postintervention data were from December 2017 through March 2020. The number of SRA tests performed were identified retrospectively via review of electronic ordering records. All patients who had a hospital admission after January 1, 2016, were included. These patients were filtered to include only those who had a result for an SRA test. In order to calculate cost-savings, we identified both the number of SRA tests ordered retrospectively as well as patients who had both an SRA resulted and had been administered argatroban. Cost-savings were calculated based on our institutional cost of $357 per SRA test.

At our institution, argatroban is supplied in 50-mL bags; therefore, we utilized the number of bags to identify argatroban usage. Savings were calculated using the average wholesale price (AWP) of $292.50 per 50-mL bag. The amounts billed or collected for the SRA testing or argatroban treatment were not collected. Costs were estimated using only direct costs to the institution. Safety data were not collected. As the intent of our project was a quality improvement activity, this project did not require institutional review board regulation per our institutional guidance.

Results

During the pre-intervention period, the average number of admissions (adults and children) at UM was 5863 per month. Post intervention there was an average of 5842 admissions per month. A total of 1192 PF4 tests were ordered before the intervention and 1148 were ordered post intervention. Prior to the intervention, 481 SRA tests were completed, while post intervention 105 were completed. Serotonin-release testing decreased from an average of 3.7 SRA results per 1000 admissions during the pre-intervention period to an average of 0.6 per 1000 admissions post intervention (Figure 2). Cost-savings were $1045 per 1000 admissions.

During the pre-intervention period, 2539 bags of argatroban were used, while 2337 bags were used post intervention. The number of 50-mL argatroban bags used per 1000 admissions decreased from 18.8 before the intervention to 14.3 post intervention. Cost-savings were $1316.20 per 1000 admissions. Figure 3 illustrates the monthly argatroban utilization per 1000 admissions during each quarter from January 2016 through March 2020.

Discussion

We designed and implemented an evidence-based strategy for HIT at our academic institution which led to a decrease in unnecessary SRA testing and argatroban utilization, with associated cost savings. By focusing on a single point of intervention at the laboratory level where SRA tests were held and canceled if the PF4 test was negative, we helped offload the decision-making from the provider while simultaneously providing just-in-time education to the provider. This intervention was designed with input from multiple stakeholders, including physicians, quality improvement specialists, pharmacists, and coagulation laboratory personnel.

Serotonin-release testing dramatically decreased post intervention even though a similar number of PF4 tests were performed before and after the intervention. This suggests that the decrease in SRA testing was a direct consequence of our intervention. Post intervention the number of completed SRA tests was 9% of the number of PF4 tests sent. This is consistent with our baseline pre-intervention data showing that only 8% of all PF4 tests sent were positive.

While the absolute number of argatroban bags utilized did not dramatically decrease after the intervention, the quarterly rate did, particularly after 2018. Given that argatroban data were only drawn from patients with a concurrent SRA test, this decrease is clearly from decreased usage in patients with suspected HIT. We suspect the decrease occurred because argatroban was not being continued while awaiting an SRA test in patients with a negative PF4 test. Decreasing the utilization of argatroban not only saved money but also reduced days of exposure to argatroban. While we do not have data regarding adverse events related to argatroban prior to the intervention, it is logical to conclude that reducing unnecessary exposure to argatroban reduces the risk of adverse events related to bleeding. Future studies would ideally address specific safety outcome metrics such as adverse events, bleeding risk, or missed diagnoses of HIT.

Our institutional guidelines for the diagnosis of HIT are evidence-based and helpful but are rarely followed by busy inpatient providers. Controlling the utilization of the SRA at the laboratory level had several advantages. First, removing SRA decision-making from providers who are not experts in the diagnosis of HIT guaranteed adherence to evidence-based guidelines. Second, pharmacists could safely recommend discontinuing argatroban when the PF4 test was negative as there was no SRA pending. Third, with cancellation at the laboratory level there was no need to further burden providers with yet another alert in the electronic health record. Fourth, just-in-time education was provided to the providers with justification for why the SRA test was canceled. Last, ruling out HIT within 24 hours with the PF4 test alone allowed providers to evaluate patients for other causes of thrombocytopenia much earlier than the 3 to 5 business days before the SRA results returned.

A limitation of this study is that it was conducted at a single center. Our approach is also limited by the lack of universal applicability. At our institution we are fortunate to have PF4 testing available in our coagulation laboratory 7 days a week. In addition, the coagulation laboratory controls sending the SRA to the reference laboratory. The specific intervention of controlling the SRA testing is therefore applicable only to institutions similar to ours; however, the concept of removing control of specialized testing from the provider is not unique. Inpatient thrombophilia testing has been a successful target of this approach.^11-13 While electronic alerts and education of individual providers can also be effective initially, the effectiveness of these interventions has been repeatedly shown to wane over time.^14-16

Conclusion

At our institution we were able to implement practical, evidence-based testing for HIT by implementing control over SRA testing at the level of the laboratory. This approach led to decreased argatroban utilization and cost savings.

Corresponding author: Alice Cusick, MD; LTC Charles S Kettles VA Medical Center, 2215 Fuller Road, Ann Arbor, MI 48105; [email protected]

Disclosures: None reported.

doi: 10.12788/jcom.0087

From the Veterans Affairs Ann Arbor Healthcare System Medicine Service (Dr. Cusick), University of Michigan College of Pharmacy, Clinical Pharmacy Service, Michigan Medicine (Dr. Hanigan), Department of Internal Medicine Clinical Experience and Quality, Michigan Medicine (Linda Bashaw), Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI (Dr. Heidemann), and the Operational Excellence Department, Sparrow Health System, Lansing, MI (Matthew Johnson).

Abstract

Background: Diagnosis of heparin-induced thrombocytopenia (HIT) requires completion of an enzyme-linked immunosorbent assay (ELISA)–based heparin-platelet factor 4 (PF4) antibody test. If this test is negative, HIT is excluded. If positive, a serotonin-release assay (SRA) test is indicated. The SRA is expensive and sometimes inappropriately ordered despite negative PF4 results, leading to unnecessary treatment with argatroban while awaiting SRA results.

Objectives: The primary objectives of this project were to reduce unnecessary SRA testing and argatroban utilization in patients with suspected HIT.

Methods: The authors implemented an intervention at a tertiary care academic hospital in November 2017 targeting patients hospitalized with suspected HIT. The intervention was controlled at the level of the laboratory and prevented ordering of SRA tests in the absence of a positive PF4 test. The number of SRA tests performed and argatroban bags administered were identified retrospectively via chart review before the intervention (January 2016 to November 2017) and post intervention (December 2017 to March 2020). Associated costs were calculated based on institutional SRA testing cost as well as the average wholesale price of argatroban.

Results: SRA testing decreased from an average of 3.7 SRA results per 1000 admissions before the intervention to an average of 0.6 results per 1000 admissions post intervention. The number of 50-mL argatroban bags used per 1000 admissions decreased from 18.8 prior to the intervention to 14.3 post intervention. Total estimated cost savings per 1000 admissions was $2361.20.

Conclusion: An evidence-based testing strategy for HIT can be effectively implemented at the level of the laboratory. This approach led to reductions in SRA testing and argatroban utilization with resultant cost savings.

Keywords: HIT, argatroban, anticoagulation, serotonin-release assay.

Thrombocytopenia is a common finding in hospitalized patients.^1,2 Heparin-induced thrombocytopenia (HIT) is one of the many potential causes of thrombocytopenia in hospitalized patients and occurs when antibodies to the heparin-platelet factor 4 (PF4) complex develop after heparin exposure. This triggers a cascade of events, leading to platelet activation, platelet consumption, and thrombosis. While HIT is relatively rare, occurring in 0.3% to 0.5% of critically ill patients, many patients will be tested to rule out this potentially life-threatening cause of thrombocytopenia.³

The diagnosis of HIT utilizes a combination of both clinical suspicion and laboratory testing.⁴ The 4T score (Table) was developed to evaluate the clinical probability of HIT and involves assessing the degree and timing of thrombocytopenia, the presence or absence of thrombosis, and other potential causes of the thrombocytopenia.⁵ The 4T score is designed to be utilized to identify patients who require laboratory testing for HIT; however, it has low inter-rater agreement in patients undergoing evaluation for HIT,⁶ and, in our experience, completion of this scoring is time-consuming.

The enzyme-linked immunosorbent assay (ELISA) is a commonly used laboratory test to diagnose HIT that detects antibodies to the heparin-PF4 complex utilizing optical density (OD) units. When using an OD cutoff of 0.400, ELISA PF4 (PF4) tests have a sensitivity of 99.6%, but poor specificity at 69.3%.⁷ When the PF4 antibody test is positive with an OD ≥0.400, then a functional test is used to determine whether the antibodies detected will activate platelets. The serotonin-release assay (SRA) is a functional test that measures 14C-labeled serotonin release from donor platelets when mixed with patient serum or plasma containing HIT antibodies. In the correct clinical context, a positive ELISA PF4 antibody test along with a positive SRA is diagnostic of HIT.⁸

The process of diagnosing HIT in a timely and cost-effective manner is dependent on the clinician’s experience in diagnosing HIT as well as access to the laboratory testing necessary to confirm the diagnosis. PF4 antibody tests are time-consuming and not always available daily and/or are not available onsite. The SRA requires access to donor platelets and specialized radioactivity counting equipment, making it available only at particular centers.

The treatment of HIT is more straightforward and involves stopping all heparin products and starting a nonheparin anticoagulant. The direct thrombin inhibitor argatroban is one of the standard nonheparin anticoagulants used in patients with suspected HIT.⁴ While it is expensive, its short half-life and lack of renal clearance make it ideal for treatment of hospitalized patients with suspected HIT, many of whom need frequent procedures and/or have renal disease.

At our academic tertiary care center, we performed a retrospective analysis that showed inappropriate ordering of diagnostic HIT testing as well as unnecessary use of argatroban even when there was low suspicion for HIT based on laboratory findings. The aim of our project was to reduce unnecessary HIT testing and argatroban utilization without overburdening providers or interfering with established workflows.

Methods

Setting

The University of Michigan (UM) hospital is a 1000-bed tertiary care center in Ann Arbor, Michigan. The UM guidelines reflect evidence-based guidelines for the diagnosis and treatment of HIT.⁴ In 2016 the UM guidelines for laboratory testing included sending the PF4 antibody test first when there was clinical suspicion of HIT. The SRA was to be sent separately only when the PF4 returned positive (OD ≥ 0.400). Standard guidelines at UM also included switching patients with suspected HIT from heparin to a nonheparin anticoagulant and stopping all heparin products while awaiting the SRA results. The direct thrombin inhibitor argatroban is utilized at UM and monitored with anti-IIa levels. University of Michigan Hospital utilizes the Immucor PF4 IgG ELISA for detecting heparin-associated antibodies.⁹ In 2016, this PF4 test was performed in the UM onsite laboratory Monday through Friday. At UM the SRA is performed off site, with a turnaround time of 3 to 5 business days.

Baseline Data

We retrospectively reviewed PF4 and SRA testing as well as argatroban usage from December 2016 to May 2017. Despite the institutional guidelines, providers were sending PF4 and SRA simultaneously as soon as HIT was suspected; 62% of PF4 tests were ordered simultaneously with the SRA, but only 8% of these PF4 tests were positive with an OD ≥0.400. Of those patients with negative PF4 testing, argatroban was continued until the SRA returned negative, leading to many days of unnecessary argatroban usage. An informal survey of the anticoagulation pharmacists revealed that many recommended discontinuing argatroban when the PF4 test was negative, but providers routinely did not feel comfortable with this approach. This suggested many providers misunderstood the performance characteristics of the PF4 test.

Intervention

Our team consisted of hematology and internal medicine faculty, pharmacists, coagulation laboratory personnel, and quality improvement specialists. We designed and implemented an intervention in November 2017 focused on controlling the ordering of the SRA test. We chose to focus on this step due to the excellent sensitivity of the PF4 test with a cutoff of OD <0.400 and the significant expense of the SRA test. Under direction of the Coagulation Laboratory Director, a standard operating procedure was developed where the coagulation laboratory personnel did not send out the SRA until a positive PF4 test (OD ≥ 0.400) was reported. If the PF4 was negative, the SRA was canceled and the ordering provider received notification of the cancelled test via the electronic medical record, accompanied by education about HIT testing (Figure 1). In addition, the lab increased the availability of PF4 testing from 5 days to 7 days a week so there were no delays in tests ordered on Fridays or weekends.

Outcomes

Our primary goals were to decrease both SRA testing and argatroban use. Secondarily, we examined the cost-effectiveness of this intervention. We hypothesized that controlling the SRA testing at the laboratory level would decrease both SRA testing and argatroban use.

Data Collection

Pre- and postintervention data were collected retrospectively. Pre-intervention data were from January 2016 through November 2017, and postintervention data were from December 2017 through March 2020. The number of SRA tests performed were identified retrospectively via review of electronic ordering records. All patients who had a hospital admission after January 1, 2016, were included. These patients were filtered to include only those who had a result for an SRA test. In order to calculate cost-savings, we identified both the number of SRA tests ordered retrospectively as well as patients who had both an SRA resulted and had been administered argatroban. Cost-savings were calculated based on our institutional cost of $357 per SRA test.

At our institution, argatroban is supplied in 50-mL bags; therefore, we utilized the number of bags to identify argatroban usage. Savings were calculated using the average wholesale price (AWP) of $292.50 per 50-mL bag. The amounts billed or collected for the SRA testing or argatroban treatment were not collected. Costs were estimated using only direct costs to the institution. Safety data were not collected. As the intent of our project was a quality improvement activity, this project did not require institutional review board regulation per our institutional guidance.

Results

During the pre-intervention period, the average number of admissions (adults and children) at UM was 5863 per month. Post intervention there was an average of 5842 admissions per month. A total of 1192 PF4 tests were ordered before the intervention and 1148 were ordered post intervention. Prior to the intervention, 481 SRA tests were completed, while post intervention 105 were completed. Serotonin-release testing decreased from an average of 3.7 SRA results per 1000 admissions during the pre-intervention period to an average of 0.6 per 1000 admissions post intervention (Figure 2). Cost-savings were $1045 per 1000 admissions.

During the pre-intervention period, 2539 bags of argatroban were used, while 2337 bags were used post intervention. The number of 50-mL argatroban bags used per 1000 admissions decreased from 18.8 before the intervention to 14.3 post intervention. Cost-savings were $1316.20 per 1000 admissions. Figure 3 illustrates the monthly argatroban utilization per 1000 admissions during each quarter from January 2016 through March 2020.

Discussion

We designed and implemented an evidence-based strategy for HIT at our academic institution which led to a decrease in unnecessary SRA testing and argatroban utilization, with associated cost savings. By focusing on a single point of intervention at the laboratory level where SRA tests were held and canceled if the PF4 test was negative, we helped offload the decision-making from the provider while simultaneously providing just-in-time education to the provider. This intervention was designed with input from multiple stakeholders, including physicians, quality improvement specialists, pharmacists, and coagulation laboratory personnel.

Serotonin-release testing dramatically decreased post intervention even though a similar number of PF4 tests were performed before and after the intervention. This suggests that the decrease in SRA testing was a direct consequence of our intervention. Post intervention the number of completed SRA tests was 9% of the number of PF4 tests sent. This is consistent with our baseline pre-intervention data showing that only 8% of all PF4 tests sent were positive.

While the absolute number of argatroban bags utilized did not dramatically decrease after the intervention, the quarterly rate did, particularly after 2018. Given that argatroban data were only drawn from patients with a concurrent SRA test, this decrease is clearly from decreased usage in patients with suspected HIT. We suspect the decrease occurred because argatroban was not being continued while awaiting an SRA test in patients with a negative PF4 test. Decreasing the utilization of argatroban not only saved money but also reduced days of exposure to argatroban. While we do not have data regarding adverse events related to argatroban prior to the intervention, it is logical to conclude that reducing unnecessary exposure to argatroban reduces the risk of adverse events related to bleeding. Future studies would ideally address specific safety outcome metrics such as adverse events, bleeding risk, or missed diagnoses of HIT.

Our institutional guidelines for the diagnosis of HIT are evidence-based and helpful but are rarely followed by busy inpatient providers. Controlling the utilization of the SRA at the laboratory level had several advantages. First, removing SRA decision-making from providers who are not experts in the diagnosis of HIT guaranteed adherence to evidence-based guidelines. Second, pharmacists could safely recommend discontinuing argatroban when the PF4 test was negative as there was no SRA pending. Third, with cancellation at the laboratory level there was no need to further burden providers with yet another alert in the electronic health record. Fourth, just-in-time education was provided to the providers with justification for why the SRA test was canceled. Last, ruling out HIT within 24 hours with the PF4 test alone allowed providers to evaluate patients for other causes of thrombocytopenia much earlier than the 3 to 5 business days before the SRA results returned.

A limitation of this study is that it was conducted at a single center. Our approach is also limited by the lack of universal applicability. At our institution we are fortunate to have PF4 testing available in our coagulation laboratory 7 days a week. In addition, the coagulation laboratory controls sending the SRA to the reference laboratory. The specific intervention of controlling the SRA testing is therefore applicable only to institutions similar to ours; however, the concept of removing control of specialized testing from the provider is not unique. Inpatient thrombophilia testing has been a successful target of this approach.^11-13 While electronic alerts and education of individual providers can also be effective initially, the effectiveness of these interventions has been repeatedly shown to wane over time.^14-16

Conclusion

At our institution we were able to implement practical, evidence-based testing for HIT by implementing control over SRA testing at the level of the laboratory. This approach led to decreased argatroban utilization and cost savings.

Corresponding author: Alice Cusick, MD; LTC Charles S Kettles VA Medical Center, 2215 Fuller Road, Ann Arbor, MI 48105; [email protected]

Disclosures: None reported.

doi: 10.12788/jcom.0087

From the Veterans Affairs Ann Arbor Healthcare System Medicine Service (Dr. Cusick), University of Michigan College of Pharmacy, Clinical Pharmacy Service, Michigan Medicine (Dr. Hanigan), Department of Internal Medicine Clinical Experience and Quality, Michigan Medicine (Linda Bashaw), Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI (Dr. Heidemann), and the Operational Excellence Department, Sparrow Health System, Lansing, MI (Matthew Johnson).

Abstract

Background: Diagnosis of heparin-induced thrombocytopenia (HIT) requires completion of an enzyme-linked immunosorbent assay (ELISA)–based heparin-platelet factor 4 (PF4) antibody test. If this test is negative, HIT is excluded. If positive, a serotonin-release assay (SRA) test is indicated. The SRA is expensive and sometimes inappropriately ordered despite negative PF4 results, leading to unnecessary treatment with argatroban while awaiting SRA results.

Objectives: The primary objectives of this project were to reduce unnecessary SRA testing and argatroban utilization in patients with suspected HIT.

Methods: The authors implemented an intervention at a tertiary care academic hospital in November 2017 targeting patients hospitalized with suspected HIT. The intervention was controlled at the level of the laboratory and prevented ordering of SRA tests in the absence of a positive PF4 test. The number of SRA tests performed and argatroban bags administered were identified retrospectively via chart review before the intervention (January 2016 to November 2017) and post intervention (December 2017 to March 2020). Associated costs were calculated based on institutional SRA testing cost as well as the average wholesale price of argatroban.

Results: SRA testing decreased from an average of 3.7 SRA results per 1000 admissions before the intervention to an average of 0.6 results per 1000 admissions post intervention. The number of 50-mL argatroban bags used per 1000 admissions decreased from 18.8 prior to the intervention to 14.3 post intervention. Total estimated cost savings per 1000 admissions was $2361.20.

Conclusion: An evidence-based testing strategy for HIT can be effectively implemented at the level of the laboratory. This approach led to reductions in SRA testing and argatroban utilization with resultant cost savings.

Keywords: HIT, argatroban, anticoagulation, serotonin-release assay.

Thrombocytopenia is a common finding in hospitalized patients.^1,2 Heparin-induced thrombocytopenia (HIT) is one of the many potential causes of thrombocytopenia in hospitalized patients and occurs when antibodies to the heparin-platelet factor 4 (PF4) complex develop after heparin exposure. This triggers a cascade of events, leading to platelet activation, platelet consumption, and thrombosis. While HIT is relatively rare, occurring in 0.3% to 0.5% of critically ill patients, many patients will be tested to rule out this potentially life-threatening cause of thrombocytopenia.³

The diagnosis of HIT utilizes a combination of both clinical suspicion and laboratory testing.⁴ The 4T score (Table) was developed to evaluate the clinical probability of HIT and involves assessing the degree and timing of thrombocytopenia, the presence or absence of thrombosis, and other potential causes of the thrombocytopenia.⁵ The 4T score is designed to be utilized to identify patients who require laboratory testing for HIT; however, it has low inter-rater agreement in patients undergoing evaluation for HIT,⁶ and, in our experience, completion of this scoring is time-consuming.

The enzyme-linked immunosorbent assay (ELISA) is a commonly used laboratory test to diagnose HIT that detects antibodies to the heparin-PF4 complex utilizing optical density (OD) units. When using an OD cutoff of 0.400, ELISA PF4 (PF4) tests have a sensitivity of 99.6%, but poor specificity at 69.3%.⁷ When the PF4 antibody test is positive with an OD ≥0.400, then a functional test is used to determine whether the antibodies detected will activate platelets. The serotonin-release assay (SRA) is a functional test that measures 14C-labeled serotonin release from donor platelets when mixed with patient serum or plasma containing HIT antibodies. In the correct clinical context, a positive ELISA PF4 antibody test along with a positive SRA is diagnostic of HIT.⁸

The process of diagnosing HIT in a timely and cost-effective manner is dependent on the clinician’s experience in diagnosing HIT as well as access to the laboratory testing necessary to confirm the diagnosis. PF4 antibody tests are time-consuming and not always available daily and/or are not available onsite. The SRA requires access to donor platelets and specialized radioactivity counting equipment, making it available only at particular centers.

The treatment of HIT is more straightforward and involves stopping all heparin products and starting a nonheparin anticoagulant. The direct thrombin inhibitor argatroban is one of the standard nonheparin anticoagulants used in patients with suspected HIT.⁴ While it is expensive, its short half-life and lack of renal clearance make it ideal for treatment of hospitalized patients with suspected HIT, many of whom need frequent procedures and/or have renal disease.

At our academic tertiary care center, we performed a retrospective analysis that showed inappropriate ordering of diagnostic HIT testing as well as unnecessary use of argatroban even when there was low suspicion for HIT based on laboratory findings. The aim of our project was to reduce unnecessary HIT testing and argatroban utilization without overburdening providers or interfering with established workflows.

Methods

Setting

The University of Michigan (UM) hospital is a 1000-bed tertiary care center in Ann Arbor, Michigan. The UM guidelines reflect evidence-based guidelines for the diagnosis and treatment of HIT.⁴ In 2016 the UM guidelines for laboratory testing included sending the PF4 antibody test first when there was clinical suspicion of HIT. The SRA was to be sent separately only when the PF4 returned positive (OD ≥ 0.400). Standard guidelines at UM also included switching patients with suspected HIT from heparin to a nonheparin anticoagulant and stopping all heparin products while awaiting the SRA results. The direct thrombin inhibitor argatroban is utilized at UM and monitored with anti-IIa levels. University of Michigan Hospital utilizes the Immucor PF4 IgG ELISA for detecting heparin-associated antibodies.⁹ In 2016, this PF4 test was performed in the UM onsite laboratory Monday through Friday. At UM the SRA is performed off site, with a turnaround time of 3 to 5 business days.

Baseline Data

We retrospectively reviewed PF4 and SRA testing as well as argatroban usage from December 2016 to May 2017. Despite the institutional guidelines, providers were sending PF4 and SRA simultaneously as soon as HIT was suspected; 62% of PF4 tests were ordered simultaneously with the SRA, but only 8% of these PF4 tests were positive with an OD ≥0.400. Of those patients with negative PF4 testing, argatroban was continued until the SRA returned negative, leading to many days of unnecessary argatroban usage. An informal survey of the anticoagulation pharmacists revealed that many recommended discontinuing argatroban when the PF4 test was negative, but providers routinely did not feel comfortable with this approach. This suggested many providers misunderstood the performance characteristics of the PF4 test.

Intervention

Our team consisted of hematology and internal medicine faculty, pharmacists, coagulation laboratory personnel, and quality improvement specialists. We designed and implemented an intervention in November 2017 focused on controlling the ordering of the SRA test. We chose to focus on this step due to the excellent sensitivity of the PF4 test with a cutoff of OD <0.400 and the significant expense of the SRA test. Under direction of the Coagulation Laboratory Director, a standard operating procedure was developed where the coagulation laboratory personnel did not send out the SRA until a positive PF4 test (OD ≥ 0.400) was reported. If the PF4 was negative, the SRA was canceled and the ordering provider received notification of the cancelled test via the electronic medical record, accompanied by education about HIT testing (Figure 1). In addition, the lab increased the availability of PF4 testing from 5 days to 7 days a week so there were no delays in tests ordered on Fridays or weekends.

Outcomes

Our primary goals were to decrease both SRA testing and argatroban use. Secondarily, we examined the cost-effectiveness of this intervention. We hypothesized that controlling the SRA testing at the laboratory level would decrease both SRA testing and argatroban use.

Data Collection

Pre- and postintervention data were collected retrospectively. Pre-intervention data were from January 2016 through November 2017, and postintervention data were from December 2017 through March 2020. The number of SRA tests performed were identified retrospectively via review of electronic ordering records. All patients who had a hospital admission after January 1, 2016, were included. These patients were filtered to include only those who had a result for an SRA test. In order to calculate cost-savings, we identified both the number of SRA tests ordered retrospectively as well as patients who had both an SRA resulted and had been administered argatroban. Cost-savings were calculated based on our institutional cost of $357 per SRA test.

At our institution, argatroban is supplied in 50-mL bags; therefore, we utilized the number of bags to identify argatroban usage. Savings were calculated using the average wholesale price (AWP) of $292.50 per 50-mL bag. The amounts billed or collected for the SRA testing or argatroban treatment were not collected. Costs were estimated using only direct costs to the institution. Safety data were not collected. As the intent of our project was a quality improvement activity, this project did not require institutional review board regulation per our institutional guidance.

Results

During the pre-intervention period, the average number of admissions (adults and children) at UM was 5863 per month. Post intervention there was an average of 5842 admissions per month. A total of 1192 PF4 tests were ordered before the intervention and 1148 were ordered post intervention. Prior to the intervention, 481 SRA tests were completed, while post intervention 105 were completed. Serotonin-release testing decreased from an average of 3.7 SRA results per 1000 admissions during the pre-intervention period to an average of 0.6 per 1000 admissions post intervention (Figure 2). Cost-savings were $1045 per 1000 admissions.

During the pre-intervention period, 2539 bags of argatroban were used, while 2337 bags were used post intervention. The number of 50-mL argatroban bags used per 1000 admissions decreased from 18.8 before the intervention to 14.3 post intervention. Cost-savings were $1316.20 per 1000 admissions. Figure 3 illustrates the monthly argatroban utilization per 1000 admissions during each quarter from January 2016 through March 2020.

Discussion

We designed and implemented an evidence-based strategy for HIT at our academic institution which led to a decrease in unnecessary SRA testing and argatroban utilization, with associated cost savings. By focusing on a single point of intervention at the laboratory level where SRA tests were held and canceled if the PF4 test was negative, we helped offload the decision-making from the provider while simultaneously providing just-in-time education to the provider. This intervention was designed with input from multiple stakeholders, including physicians, quality improvement specialists, pharmacists, and coagulation laboratory personnel.

Serotonin-release testing dramatically decreased post intervention even though a similar number of PF4 tests were performed before and after the intervention. This suggests that the decrease in SRA testing was a direct consequence of our intervention. Post intervention the number of completed SRA tests was 9% of the number of PF4 tests sent. This is consistent with our baseline pre-intervention data showing that only 8% of all PF4 tests sent were positive.

While the absolute number of argatroban bags utilized did not dramatically decrease after the intervention, the quarterly rate did, particularly after 2018. Given that argatroban data were only drawn from patients with a concurrent SRA test, this decrease is clearly from decreased usage in patients with suspected HIT. We suspect the decrease occurred because argatroban was not being continued while awaiting an SRA test in patients with a negative PF4 test. Decreasing the utilization of argatroban not only saved money but also reduced days of exposure to argatroban. While we do not have data regarding adverse events related to argatroban prior to the intervention, it is logical to conclude that reducing unnecessary exposure to argatroban reduces the risk of adverse events related to bleeding. Future studies would ideally address specific safety outcome metrics such as adverse events, bleeding risk, or missed diagnoses of HIT.

Our institutional guidelines for the diagnosis of HIT are evidence-based and helpful but are rarely followed by busy inpatient providers. Controlling the utilization of the SRA at the laboratory level had several advantages. First, removing SRA decision-making from providers who are not experts in the diagnosis of HIT guaranteed adherence to evidence-based guidelines. Second, pharmacists could safely recommend discontinuing argatroban when the PF4 test was negative as there was no SRA pending. Third, with cancellation at the laboratory level there was no need to further burden providers with yet another alert in the electronic health record. Fourth, just-in-time education was provided to the providers with justification for why the SRA test was canceled. Last, ruling out HIT within 24 hours with the PF4 test alone allowed providers to evaluate patients for other causes of thrombocytopenia much earlier than the 3 to 5 business days before the SRA results returned.

A limitation of this study is that it was conducted at a single center. Our approach is also limited by the lack of universal applicability. At our institution we are fortunate to have PF4 testing available in our coagulation laboratory 7 days a week. In addition, the coagulation laboratory controls sending the SRA to the reference laboratory. The specific intervention of controlling the SRA testing is therefore applicable only to institutions similar to ours; however, the concept of removing control of specialized testing from the provider is not unique. Inpatient thrombophilia testing has been a successful target of this approach.^11-13 While electronic alerts and education of individual providers can also be effective initially, the effectiveness of these interventions has been repeatedly shown to wane over time.^14-16

Conclusion

At our institution we were able to implement practical, evidence-based testing for HIT by implementing control over SRA testing at the level of the laboratory. This approach led to decreased argatroban utilization and cost savings.

Corresponding author: Alice Cusick, MD; LTC Charles S Kettles VA Medical Center, 2215 Fuller Road, Ann Arbor, MI 48105; [email protected]

Disclosures: None reported.

doi: 10.12788/jcom.0087