BCPS

In the U.S., 2.7 to 3.9 million people are chronically infected with the hepatitis C virus (HCV).¹ Survey data suggest that HCV infection is more prevalent in patients enrolled in the VA health care system than it is in civilian health care systems.² Studies have shown that Vietnam veterans, veterans with mental health and substance abuse disorders, and veterans without stable housing are more likely to be infected with HCV.³ Data from the VA HCV Clinical Case Registry (CCR) for 2015 showed that 174,842 veterans with chronic HCV infection receieved care within the VHA, which makes the VA the single largest HCV care provider in the nation.⁴

The VA is dedicated to providing treatment to veterans with HCV infection. For fiscal year (FY) 2016, the VA allocated $1 billion to HCV care,and in February 2016 it began offering treatment to all veterans with HCV, regardless of degree of fibrosis or severity of underlying liver disease.^3,5 Each VAMC was tasked with improving veterans’ access to HCV treatment.

In an effort to engage patients in HCV care, the multidisciplinary HCV team at the Richard L. Roudebush VAMC (RLRVAMC) in Indianapolis, Indiana, launched a 2-phase improvement process in 2016. The goal in phase 1 was to increase patient access to HCV clinics, and the goal in phase 2 was to recruit patients for direct-acting antiviral (DAA) therapy for HCV. These efforts were designed to increase screening, identification, and linkage to care for HCV and to expand clinic access for the treatment and cure of all identified veterans who pursued treatment.

Patients with HCV infection, referred from primary care clinics, initially were evaluated by HCV clinic providers (hepatologists, infectious disease specialists, gastroenterology fellows, or nurse practitioners) for eligibility to receive DAA therapy for HCV. Eligible patients then were referred to a pharmacist-run HCV clinic, which had been established at RLRVAMC in 2011. At the start of FY 2016, the clinic, staffed by 3 pharmacists, operated 5 half-days per week and accommodated up to 35 weekly patient appointments.

In this clinic, patients received initial education and medication reconciliation for potential drug interactions with DAAs. Once the HCV treatment was initiated, patients were evaluated in the clinic every 2 weeks for medication refills and assessment for tolerability, adherence, and laboratory abnormalities until end of treatment (8-24 weeks, depending on HCV genotype, experiences with prior HCV treatment, and presence/absence of cirrhosis). Twelve weeks after completion of treatment, viral load was obtained to determine sustained virologic response (SVR12).

Methods

Phase 1: Improve Clinic Access

During FY 2016, methods for expanding clinic access to accommodate a large influx of treatment-eligible patients were reviewed and implemented.

In the first intervention, unneeded follow-up visits were eliminated to make room for additional new patient appointments. In general, patients treated with ribavirin require close monitoring, given the risk for anemia.⁶ With the release of newer DAAs, however, more patients became eligible for treatment with ribavirin-free regimens.⁷ As a result, follow-up appointments for these patients were extended to 4-week intervals instead of every 2 weeks. A patient with a history of nonadherence to medication use or clinic visits was still maintained on a 2-week schedule of follow-up for close monitoring.

In the second intervention, opportunities for switching those who completed treatment from face-to-face clinic visits to telephone were identified. These patients historically were seen in clinic for a brief interview and for a blood test used to determine end-of-treatment viral load. Improving access for new patients in the clinic involved moving more existing patients from in-clinic visits to telephone. At the end of the treatment plan, existing patients received an order for laboratory tests that included viral load. When all laboratory results were ready, patients were contacted by telephone. Recruiting a registered nurse to the treatment team who assisted with telephone visits further improved clinic efficiency.

The third intervention was inspired by successful results at other VA sites and launched a group treatment clinic for patients who were starting ribavirin-free DAA regimens^.7 Group visits were run by 2 pharmacists and accommodated up to 10 veterans. Patients underwent testing for HCV genotype and viral load before the initial group visit. At check-in, patients received a short questionnaire and consent form for group participation. The questionnaire reviewed patient history of drug and alcohol use and potential barriers to medication adherence. Patients also were encouraged to write down any questions they had about the treatment. During the initial group visit, pharmacists provided general education about the medications, potential adverse effects, treatment expectations, and the monitoring plan. Follow-up visits were conducted in a group setting as well.

Phase 2: Increase Recruitment

The records of 534 patients with advanced liver disease (F3-F4 fibrosis on the Fibrosis-4 Index for Liver Fibrosis) and HCV infection were identified in the CCR database for the period August 2015 to December 2015 (Figure 1).⁸ Patients were excluded if they were deceased, were receiving palliative care (n = 45), or if they had transferred their care to another VA facility (n = 69). Of the 420 patients in the study reviewed, 234 (56%) had not previously been referred to an HCV clinic or been started on treatment because of a variety of social issues, including active substance use (Figure 2).

Many of the patients were difficult to engage because the clinic could not effectively assist them in achieving sobriety and lacked support personnel who could address their complex social issues. Given the availability of all-oral HCV treatments, the VA Public Health Department issued guidance allowing all HCV-infected patients to receive DAA treatment regardless of ongoing drug or alcohol use disorders.⁹ Substance use was not to be considered a contraindication to therapy. It was suggested that health care providers determine these patients’ treatment eligibility on a case-by-case basis. An official VA memorandum supporting this initiative was released in September 2016.¹⁰

Interventions

In an effort to engage all HCV-infected patients, the CCR review was expanded to include patients without advanced liver disease. All patients were contacted by mail. Any patient registered for secure messaging through MyHealtheVet also received a secure message. Patients were informed about the newly approved DAA therapies and were connected directly with specialized HCV clinic schedulers at RLRVAMC. Patients who responded were scheduled for a group education class facilitated by 2 members of the HCV treatment team.

Unlike patients in the group treatment clinic, patients in the education class had not completed the necessary workup for treatment initiation. In the class, patients received education on new HCV treatments and were linked to social work care if needed to streamline the referral process. All baseline laboratory test results also were obtained.

Another intervention implemented to recruit patients in this difficult-to-treat population was the addition of a social worker to the treatment team. Beginning in late June 2016, high-risk patients were referred to the social worker by HCV providers or pharmacists. For each referred patient, the social worker performed a psychosocial assessment to identify potential barriers to successful treatment and then connected the patient with either VA or community resources for support.

The social worker linked patients to mental health or substance use-related services, empowered them to access transportation resources for clinic appointments, orchestrated assistance with medication adherence from a home health nurse, and reached out to patients in person or by telephone to address specific needs that might limit their ability to attend appointments. The social worker also provided harm reduction planning and goal setting support to help patients with substance use disorders achieve sobriety or reduce substance use while on HCV treatment. All efforts were made to ensure that patients adhered to their clinic visits and medication use. In addition, during social work assessment, factors such as housing concerns, travel barriers, and loss and grief were identified and promptly addressed.

Results

After the phase 1 intervention, 730 additional appointments were added in FY 2016 (Figure 3). As a result, 409 patients with HCV infection were started on treatment in FY 2016 compared with 192 in FY 2015. More important, the rapid increase in capacity and treatment initiation did not sacrifice the quality of care provided. Ninety-eight percent of patients who started treatment in FY 2016 successfully completed their treatment course. The overall SVR12 rate was 96% for all genotype 1 patients treated with ledipasvir/sofosbuvir, ombitasvir/paritaprevir/ritonavir plus dasabuvir, or elbasvir/grazoprevir with or without ribavirin. In addition, the SVR12 rate was 82% for genotype 2 patients (almost all cirrhotic) treated with sofosbuvir plus ribavirin and 93% for genotype 3 patients treated with daclatasvir, sofosbuvir, and ribavirin.

Phase 2: Increase Recruitment

The expanded CCR review identified 234 patients with advanced liver disease and 546 patients without advanced disease. As this was a rolling review, 58 patients were linked to care before being contacted. Of the 722 patients in the cohort, 528 were contacted by mail and 194 both by mail and by MyHealtheVet messaging. One hundred forty-one patients responded: 129 by mail and 12 by MyHealtheVet messaging (eFigure 1).

Of the 101 patients scheduled for group education, 43 attended education in FY 2016 (eFigure 2).

In June 2016, a social worker was added to the treatment team in an effort to improve recruitment in this difficult to treat population (Figure 2). Between June 2016 and end of FY 2016, 48 patients were referred to the social worker for evaluation. The primary reasons for referral were ongoing substance/alcohol use or high risk for relapse (n = 22); appointment adherence barriers, including problems with transportation (n = 16); underlying mental health disorders (n = 4); barriers to medication adherence (n = 3); and unstable housing (n = 3). Of these 48 patients, 31 received a single social worker intervention to connect with resources; the other 17 were recommended for intensive case management for ongoing support during preparation for HCV treatment and during therapy. As a result of social work involvement, 31 out of 48 referred patients were successfully started on treatment in FY 2016.

Discussion

The VA continues focusing its efforts and resources on treating HCV infection in FY 2017. To further expand outreach, RLRVAMC is working on several additional process improvements. One reason for the lower than expected number of patients who did not see a provider after attending the group education class is that these patients were difficult to reach for scheduling. A medical support assistant is now attending these classes; immediately after a class ends and before leaving the facility, this assistant schedules patients for appointments with HCV providers. The team social worker continues to help prepare patients for treatment and targets interventions for patients early in their HCV workup so that resources are allocated before treatment initiation. In the first 2 months of FY 2017, about 10 more patients who were referred to the social worker for assessment and support started treatment.

Outreach letter responses identified almost 600 potential candidates for treatment. Pharmacists telephoned these patients in another effort to connect them with VA services. Interested patients were scheduled for a group education visit. Also, pharmacists reached out to all primary care clinics and community-based outpatient clinics connected with the facility to provide education on VA policies regarding HCV treatment eligibility and to encourage providers to refer all patients with HCV infection to the HCV clinic. This education was provided at primary care team meetings, and providers not in attendance receive individual outreach by pharmacists. Primary care providers also received a pocket card that summarized recommendations for HCV screening and referrals. These efforts and initiatives are expected to increase veterans’ access to care for HCV infection within the catchment area.

Conclusion

Treatment team interventions in FY 2016 significantly increased veterans’ access to RLRVAMC HCV care. The number of patients who started treatment more than doubled since the previous year. Many of these patients had complex social issues or treatment barriers but successfully started therapy with the help of additional support staff.

Click here to read the digital edition.

In the U.S., 2.7 to 3.9 million people are chronically infected with the hepatitis C virus (HCV).¹ Survey data suggest that HCV infection is more prevalent in patients enrolled in the VA health care system than it is in civilian health care systems.² Studies have shown that Vietnam veterans, veterans with mental health and substance abuse disorders, and veterans without stable housing are more likely to be infected with HCV.³ Data from the VA HCV Clinical Case Registry (CCR) for 2015 showed that 174,842 veterans with chronic HCV infection receieved care within the VHA, which makes the VA the single largest HCV care provider in the nation.⁴

The VA is dedicated to providing treatment to veterans with HCV infection. For fiscal year (FY) 2016, the VA allocated $1 billion to HCV care,and in February 2016 it began offering treatment to all veterans with HCV, regardless of degree of fibrosis or severity of underlying liver disease.^3,5 Each VAMC was tasked with improving veterans’ access to HCV treatment.

In an effort to engage patients in HCV care, the multidisciplinary HCV team at the Richard L. Roudebush VAMC (RLRVAMC) in Indianapolis, Indiana, launched a 2-phase improvement process in 2016. The goal in phase 1 was to increase patient access to HCV clinics, and the goal in phase 2 was to recruit patients for direct-acting antiviral (DAA) therapy for HCV. These efforts were designed to increase screening, identification, and linkage to care for HCV and to expand clinic access for the treatment and cure of all identified veterans who pursued treatment.

Patients with HCV infection, referred from primary care clinics, initially were evaluated by HCV clinic providers (hepatologists, infectious disease specialists, gastroenterology fellows, or nurse practitioners) for eligibility to receive DAA therapy for HCV. Eligible patients then were referred to a pharmacist-run HCV clinic, which had been established at RLRVAMC in 2011. At the start of FY 2016, the clinic, staffed by 3 pharmacists, operated 5 half-days per week and accommodated up to 35 weekly patient appointments.

In this clinic, patients received initial education and medication reconciliation for potential drug interactions with DAAs. Once the HCV treatment was initiated, patients were evaluated in the clinic every 2 weeks for medication refills and assessment for tolerability, adherence, and laboratory abnormalities until end of treatment (8-24 weeks, depending on HCV genotype, experiences with prior HCV treatment, and presence/absence of cirrhosis). Twelve weeks after completion of treatment, viral load was obtained to determine sustained virologic response (SVR12).

Methods

Phase 1: Improve Clinic Access

During FY 2016, methods for expanding clinic access to accommodate a large influx of treatment-eligible patients were reviewed and implemented.

In the first intervention, unneeded follow-up visits were eliminated to make room for additional new patient appointments. In general, patients treated with ribavirin require close monitoring, given the risk for anemia.⁶ With the release of newer DAAs, however, more patients became eligible for treatment with ribavirin-free regimens.⁷ As a result, follow-up appointments for these patients were extended to 4-week intervals instead of every 2 weeks. A patient with a history of nonadherence to medication use or clinic visits was still maintained on a 2-week schedule of follow-up for close monitoring.

In the second intervention, opportunities for switching those who completed treatment from face-to-face clinic visits to telephone were identified. These patients historically were seen in clinic for a brief interview and for a blood test used to determine end-of-treatment viral load. Improving access for new patients in the clinic involved moving more existing patients from in-clinic visits to telephone. At the end of the treatment plan, existing patients received an order for laboratory tests that included viral load. When all laboratory results were ready, patients were contacted by telephone. Recruiting a registered nurse to the treatment team who assisted with telephone visits further improved clinic efficiency.

The third intervention was inspired by successful results at other VA sites and launched a group treatment clinic for patients who were starting ribavirin-free DAA regimens^.7 Group visits were run by 2 pharmacists and accommodated up to 10 veterans. Patients underwent testing for HCV genotype and viral load before the initial group visit. At check-in, patients received a short questionnaire and consent form for group participation. The questionnaire reviewed patient history of drug and alcohol use and potential barriers to medication adherence. Patients also were encouraged to write down any questions they had about the treatment. During the initial group visit, pharmacists provided general education about the medications, potential adverse effects, treatment expectations, and the monitoring plan. Follow-up visits were conducted in a group setting as well.

Phase 2: Increase Recruitment

The records of 534 patients with advanced liver disease (F3-F4 fibrosis on the Fibrosis-4 Index for Liver Fibrosis) and HCV infection were identified in the CCR database for the period August 2015 to December 2015 (Figure 1).⁸ Patients were excluded if they were deceased, were receiving palliative care (n = 45), or if they had transferred their care to another VA facility (n = 69). Of the 420 patients in the study reviewed, 234 (56%) had not previously been referred to an HCV clinic or been started on treatment because of a variety of social issues, including active substance use (Figure 2).

Many of the patients were difficult to engage because the clinic could not effectively assist them in achieving sobriety and lacked support personnel who could address their complex social issues. Given the availability of all-oral HCV treatments, the VA Public Health Department issued guidance allowing all HCV-infected patients to receive DAA treatment regardless of ongoing drug or alcohol use disorders.⁹ Substance use was not to be considered a contraindication to therapy. It was suggested that health care providers determine these patients’ treatment eligibility on a case-by-case basis. An official VA memorandum supporting this initiative was released in September 2016.¹⁰

Interventions

In an effort to engage all HCV-infected patients, the CCR review was expanded to include patients without advanced liver disease. All patients were contacted by mail. Any patient registered for secure messaging through MyHealtheVet also received a secure message. Patients were informed about the newly approved DAA therapies and were connected directly with specialized HCV clinic schedulers at RLRVAMC. Patients who responded were scheduled for a group education class facilitated by 2 members of the HCV treatment team.

Unlike patients in the group treatment clinic, patients in the education class had not completed the necessary workup for treatment initiation. In the class, patients received education on new HCV treatments and were linked to social work care if needed to streamline the referral process. All baseline laboratory test results also were obtained.

Another intervention implemented to recruit patients in this difficult-to-treat population was the addition of a social worker to the treatment team. Beginning in late June 2016, high-risk patients were referred to the social worker by HCV providers or pharmacists. For each referred patient, the social worker performed a psychosocial assessment to identify potential barriers to successful treatment and then connected the patient with either VA or community resources for support.

The social worker linked patients to mental health or substance use-related services, empowered them to access transportation resources for clinic appointments, orchestrated assistance with medication adherence from a home health nurse, and reached out to patients in person or by telephone to address specific needs that might limit their ability to attend appointments. The social worker also provided harm reduction planning and goal setting support to help patients with substance use disorders achieve sobriety or reduce substance use while on HCV treatment. All efforts were made to ensure that patients adhered to their clinic visits and medication use. In addition, during social work assessment, factors such as housing concerns, travel barriers, and loss and grief were identified and promptly addressed.

Results

After the phase 1 intervention, 730 additional appointments were added in FY 2016 (Figure 3). As a result, 409 patients with HCV infection were started on treatment in FY 2016 compared with 192 in FY 2015. More important, the rapid increase in capacity and treatment initiation did not sacrifice the quality of care provided. Ninety-eight percent of patients who started treatment in FY 2016 successfully completed their treatment course. The overall SVR12 rate was 96% for all genotype 1 patients treated with ledipasvir/sofosbuvir, ombitasvir/paritaprevir/ritonavir plus dasabuvir, or elbasvir/grazoprevir with or without ribavirin. In addition, the SVR12 rate was 82% for genotype 2 patients (almost all cirrhotic) treated with sofosbuvir plus ribavirin and 93% for genotype 3 patients treated with daclatasvir, sofosbuvir, and ribavirin.

Phase 2: Increase Recruitment

The expanded CCR review identified 234 patients with advanced liver disease and 546 patients without advanced disease. As this was a rolling review, 58 patients were linked to care before being contacted. Of the 722 patients in the cohort, 528 were contacted by mail and 194 both by mail and by MyHealtheVet messaging. One hundred forty-one patients responded: 129 by mail and 12 by MyHealtheVet messaging (eFigure 1).

Of the 101 patients scheduled for group education, 43 attended education in FY 2016 (eFigure 2).

In June 2016, a social worker was added to the treatment team in an effort to improve recruitment in this difficult to treat population (Figure 2). Between June 2016 and end of FY 2016, 48 patients were referred to the social worker for evaluation. The primary reasons for referral were ongoing substance/alcohol use or high risk for relapse (n = 22); appointment adherence barriers, including problems with transportation (n = 16); underlying mental health disorders (n = 4); barriers to medication adherence (n = 3); and unstable housing (n = 3). Of these 48 patients, 31 received a single social worker intervention to connect with resources; the other 17 were recommended for intensive case management for ongoing support during preparation for HCV treatment and during therapy. As a result of social work involvement, 31 out of 48 referred patients were successfully started on treatment in FY 2016.

Discussion

The VA continues focusing its efforts and resources on treating HCV infection in FY 2017. To further expand outreach, RLRVAMC is working on several additional process improvements. One reason for the lower than expected number of patients who did not see a provider after attending the group education class is that these patients were difficult to reach for scheduling. A medical support assistant is now attending these classes; immediately after a class ends and before leaving the facility, this assistant schedules patients for appointments with HCV providers. The team social worker continues to help prepare patients for treatment and targets interventions for patients early in their HCV workup so that resources are allocated before treatment initiation. In the first 2 months of FY 2017, about 10 more patients who were referred to the social worker for assessment and support started treatment.

Outreach letter responses identified almost 600 potential candidates for treatment. Pharmacists telephoned these patients in another effort to connect them with VA services. Interested patients were scheduled for a group education visit. Also, pharmacists reached out to all primary care clinics and community-based outpatient clinics connected with the facility to provide education on VA policies regarding HCV treatment eligibility and to encourage providers to refer all patients with HCV infection to the HCV clinic. This education was provided at primary care team meetings, and providers not in attendance receive individual outreach by pharmacists. Primary care providers also received a pocket card that summarized recommendations for HCV screening and referrals. These efforts and initiatives are expected to increase veterans’ access to care for HCV infection within the catchment area.

Conclusion

Treatment team interventions in FY 2016 significantly increased veterans’ access to RLRVAMC HCV care. The number of patients who started treatment more than doubled since the previous year. Many of these patients had complex social issues or treatment barriers but successfully started therapy with the help of additional support staff.

Click here to read the digital edition.

In the U.S., 2.7 to 3.9 million people are chronically infected with the hepatitis C virus (HCV).¹ Survey data suggest that HCV infection is more prevalent in patients enrolled in the VA health care system than it is in civilian health care systems.² Studies have shown that Vietnam veterans, veterans with mental health and substance abuse disorders, and veterans without stable housing are more likely to be infected with HCV.³ Data from the VA HCV Clinical Case Registry (CCR) for 2015 showed that 174,842 veterans with chronic HCV infection receieved care within the VHA, which makes the VA the single largest HCV care provider in the nation.⁴

The VA is dedicated to providing treatment to veterans with HCV infection. For fiscal year (FY) 2016, the VA allocated $1 billion to HCV care,and in February 2016 it began offering treatment to all veterans with HCV, regardless of degree of fibrosis or severity of underlying liver disease.^3,5 Each VAMC was tasked with improving veterans’ access to HCV treatment.

In an effort to engage patients in HCV care, the multidisciplinary HCV team at the Richard L. Roudebush VAMC (RLRVAMC) in Indianapolis, Indiana, launched a 2-phase improvement process in 2016. The goal in phase 1 was to increase patient access to HCV clinics, and the goal in phase 2 was to recruit patients for direct-acting antiviral (DAA) therapy for HCV. These efforts were designed to increase screening, identification, and linkage to care for HCV and to expand clinic access for the treatment and cure of all identified veterans who pursued treatment.

Patients with HCV infection, referred from primary care clinics, initially were evaluated by HCV clinic providers (hepatologists, infectious disease specialists, gastroenterology fellows, or nurse practitioners) for eligibility to receive DAA therapy for HCV. Eligible patients then were referred to a pharmacist-run HCV clinic, which had been established at RLRVAMC in 2011. At the start of FY 2016, the clinic, staffed by 3 pharmacists, operated 5 half-days per week and accommodated up to 35 weekly patient appointments.

In this clinic, patients received initial education and medication reconciliation for potential drug interactions with DAAs. Once the HCV treatment was initiated, patients were evaluated in the clinic every 2 weeks for medication refills and assessment for tolerability, adherence, and laboratory abnormalities until end of treatment (8-24 weeks, depending on HCV genotype, experiences with prior HCV treatment, and presence/absence of cirrhosis). Twelve weeks after completion of treatment, viral load was obtained to determine sustained virologic response (SVR12).

Methods

Phase 1: Improve Clinic Access

During FY 2016, methods for expanding clinic access to accommodate a large influx of treatment-eligible patients were reviewed and implemented.

In the first intervention, unneeded follow-up visits were eliminated to make room for additional new patient appointments. In general, patients treated with ribavirin require close monitoring, given the risk for anemia.⁶ With the release of newer DAAs, however, more patients became eligible for treatment with ribavirin-free regimens.⁷ As a result, follow-up appointments for these patients were extended to 4-week intervals instead of every 2 weeks. A patient with a history of nonadherence to medication use or clinic visits was still maintained on a 2-week schedule of follow-up for close monitoring.

In the second intervention, opportunities for switching those who completed treatment from face-to-face clinic visits to telephone were identified. These patients historically were seen in clinic for a brief interview and for a blood test used to determine end-of-treatment viral load. Improving access for new patients in the clinic involved moving more existing patients from in-clinic visits to telephone. At the end of the treatment plan, existing patients received an order for laboratory tests that included viral load. When all laboratory results were ready, patients were contacted by telephone. Recruiting a registered nurse to the treatment team who assisted with telephone visits further improved clinic efficiency.

The third intervention was inspired by successful results at other VA sites and launched a group treatment clinic for patients who were starting ribavirin-free DAA regimens^.7 Group visits were run by 2 pharmacists and accommodated up to 10 veterans. Patients underwent testing for HCV genotype and viral load before the initial group visit. At check-in, patients received a short questionnaire and consent form for group participation. The questionnaire reviewed patient history of drug and alcohol use and potential barriers to medication adherence. Patients also were encouraged to write down any questions they had about the treatment. During the initial group visit, pharmacists provided general education about the medications, potential adverse effects, treatment expectations, and the monitoring plan. Follow-up visits were conducted in a group setting as well.

Phase 2: Increase Recruitment

The records of 534 patients with advanced liver disease (F3-F4 fibrosis on the Fibrosis-4 Index for Liver Fibrosis) and HCV infection were identified in the CCR database for the period August 2015 to December 2015 (Figure 1).⁸ Patients were excluded if they were deceased, were receiving palliative care (n = 45), or if they had transferred their care to another VA facility (n = 69). Of the 420 patients in the study reviewed, 234 (56%) had not previously been referred to an HCV clinic or been started on treatment because of a variety of social issues, including active substance use (Figure 2).

Many of the patients were difficult to engage because the clinic could not effectively assist them in achieving sobriety and lacked support personnel who could address their complex social issues. Given the availability of all-oral HCV treatments, the VA Public Health Department issued guidance allowing all HCV-infected patients to receive DAA treatment regardless of ongoing drug or alcohol use disorders.⁹ Substance use was not to be considered a contraindication to therapy. It was suggested that health care providers determine these patients’ treatment eligibility on a case-by-case basis. An official VA memorandum supporting this initiative was released in September 2016.¹⁰

Interventions

In an effort to engage all HCV-infected patients, the CCR review was expanded to include patients without advanced liver disease. All patients were contacted by mail. Any patient registered for secure messaging through MyHealtheVet also received a secure message. Patients were informed about the newly approved DAA therapies and were connected directly with specialized HCV clinic schedulers at RLRVAMC. Patients who responded were scheduled for a group education class facilitated by 2 members of the HCV treatment team.

Unlike patients in the group treatment clinic, patients in the education class had not completed the necessary workup for treatment initiation. In the class, patients received education on new HCV treatments and were linked to social work care if needed to streamline the referral process. All baseline laboratory test results also were obtained.

Another intervention implemented to recruit patients in this difficult-to-treat population was the addition of a social worker to the treatment team. Beginning in late June 2016, high-risk patients were referred to the social worker by HCV providers or pharmacists. For each referred patient, the social worker performed a psychosocial assessment to identify potential barriers to successful treatment and then connected the patient with either VA or community resources for support.

The social worker linked patients to mental health or substance use-related services, empowered them to access transportation resources for clinic appointments, orchestrated assistance with medication adherence from a home health nurse, and reached out to patients in person or by telephone to address specific needs that might limit their ability to attend appointments. The social worker also provided harm reduction planning and goal setting support to help patients with substance use disorders achieve sobriety or reduce substance use while on HCV treatment. All efforts were made to ensure that patients adhered to their clinic visits and medication use. In addition, during social work assessment, factors such as housing concerns, travel barriers, and loss and grief were identified and promptly addressed.

Results

After the phase 1 intervention, 730 additional appointments were added in FY 2016 (Figure 3). As a result, 409 patients with HCV infection were started on treatment in FY 2016 compared with 192 in FY 2015. More important, the rapid increase in capacity and treatment initiation did not sacrifice the quality of care provided. Ninety-eight percent of patients who started treatment in FY 2016 successfully completed their treatment course. The overall SVR12 rate was 96% for all genotype 1 patients treated with ledipasvir/sofosbuvir, ombitasvir/paritaprevir/ritonavir plus dasabuvir, or elbasvir/grazoprevir with or without ribavirin. In addition, the SVR12 rate was 82% for genotype 2 patients (almost all cirrhotic) treated with sofosbuvir plus ribavirin and 93% for genotype 3 patients treated with daclatasvir, sofosbuvir, and ribavirin.

Phase 2: Increase Recruitment

The expanded CCR review identified 234 patients with advanced liver disease and 546 patients without advanced disease. As this was a rolling review, 58 patients were linked to care before being contacted. Of the 722 patients in the cohort, 528 were contacted by mail and 194 both by mail and by MyHealtheVet messaging. One hundred forty-one patients responded: 129 by mail and 12 by MyHealtheVet messaging (eFigure 1).

Of the 101 patients scheduled for group education, 43 attended education in FY 2016 (eFigure 2).

In June 2016, a social worker was added to the treatment team in an effort to improve recruitment in this difficult to treat population (Figure 2). Between June 2016 and end of FY 2016, 48 patients were referred to the social worker for evaluation. The primary reasons for referral were ongoing substance/alcohol use or high risk for relapse (n = 22); appointment adherence barriers, including problems with transportation (n = 16); underlying mental health disorders (n = 4); barriers to medication adherence (n = 3); and unstable housing (n = 3). Of these 48 patients, 31 received a single social worker intervention to connect with resources; the other 17 were recommended for intensive case management for ongoing support during preparation for HCV treatment and during therapy. As a result of social work involvement, 31 out of 48 referred patients were successfully started on treatment in FY 2016.

Discussion

The VA continues focusing its efforts and resources on treating HCV infection in FY 2017. To further expand outreach, RLRVAMC is working on several additional process improvements. One reason for the lower than expected number of patients who did not see a provider after attending the group education class is that these patients were difficult to reach for scheduling. A medical support assistant is now attending these classes; immediately after a class ends and before leaving the facility, this assistant schedules patients for appointments with HCV providers. The team social worker continues to help prepare patients for treatment and targets interventions for patients early in their HCV workup so that resources are allocated before treatment initiation. In the first 2 months of FY 2017, about 10 more patients who were referred to the social worker for assessment and support started treatment.

Outreach letter responses identified almost 600 potential candidates for treatment. Pharmacists telephoned these patients in another effort to connect them with VA services. Interested patients were scheduled for a group education visit. Also, pharmacists reached out to all primary care clinics and community-based outpatient clinics connected with the facility to provide education on VA policies regarding HCV treatment eligibility and to encourage providers to refer all patients with HCV infection to the HCV clinic. This education was provided at primary care team meetings, and providers not in attendance receive individual outreach by pharmacists. Primary care providers also received a pocket card that summarized recommendations for HCV screening and referrals. These efforts and initiatives are expected to increase veterans’ access to care for HCV infection within the catchment area.

Conclusion

Treatment team interventions in FY 2016 significantly increased veterans’ access to RLRVAMC HCV care. The number of patients who started treatment more than doubled since the previous year. Many of these patients had complex social issues or treatment barriers but successfully started therapy with the help of additional support staff.

Click here to read the digital edition.

Procalcitonin (PCT) is a precursor to the hormone calcitonin and is a serum biomarker of interest in infectious diseases. Many studies have analyzed its utility and role in assisting clinical decision making, especially in conditions that result in inflammation due to a bacterial infection. A systemic inflammatory response from a bacterial infection begins with the release of endotoxins/exotoxins and a response from immune system mediators that release cytokines, such as interleukin-1β and tumor necrosis factor-α. These cytokines contribute to the development of a fever, the release of stress hormones, such as cortisone and epinephrine, and interleukin-6, which stimulates acute phase reactants, such as C-reactive protein (CRP) and PCT.^1,2

C-reactive protein and white blood cell count (WBC) are commonly used clinically as biomarkers that assist in the recognition of the infectious process and may be indicators of disease prognosis, but both lack specificity for bacterial infections. Consequentially, using CRP and WBC as clinical decision aids may result in unnecessary antibiotic therapy, which may result in an increase in drug-related adverse events and antibiotic resistance. A major distinction of PCT is that it has greater specificity than does CRP, because it tends to be elevated primarily as a result of inflammation due to bacterial infections. Procalcitonin can be used to distinguish bacterial from viral infections because its up-regulation is attenuated by interferon-gamma, a cytokine released in response to viral infections.² Thus, PCT may be a more effective clinical marker for optimizing the diagnosis, monitoring, and treatment in patients with systemic bacterial infections.

Procalcitonin as a Marker

A study evaluating infectious markers compared the use of PCT, lactate, and CRP as diagnostic tools in patients with septic shock. The results of this study indicated that PCT was the only marker significantly elevated in patients with septic shock that was also normal in patients not in septic shock (14 µg/mL vs 1 µg/mL, P = .0003).³ This and other studies led the FDA to approve PCT use in 2005 as an aid to clinical decision making in the assessment of critically ill patients with sepsis.⁴ Overall, the literature supports the use of PCT as a diagnostic tool in infections requiring antimicrobial therapy within appropriate clinical settings.

Strong evidence exists confirming PCT’s role as an aid to clinical decision making in bronchitis, chronic obstructive pulmonary disease exacerbations, pneumonia, and severe sepsis/shock management.² Procalcitonin’s kinetic profile makes it a good monitoring tool, because its levels promptly increase within 3 to 6 hours of infection, peak at 12 to 48 hours, and rapidly decline during recovery. Additionally, its levels closely parallel the extent and severity of present inflammation, making it a useful prognostic marker of disease progression and response to antibiotic therapy.^2,4,5

Related: Mass Transit for Viruses

Christ-Crain and colleagues studied the outcome of PCT-guided antibiotic algorithms for patients with lower respiratory tract infections (RTIs) presenting to the emergency department. A serum PCT level of 0.25 to 0.5 µg/L suggested a likely bacterial infection, and physicians were advised to initiate antimicrobial therapy. Serum levels above 0.5 µg/L were suggestive of a bacterial infection, and initiation of antimicrobial therapy was strongly recommended. The results showed that PCT-guided algorithms significantly reduced the number of antibiotic-treated patients (n = 99 [83%] vs n = 55 [44%]; P < .0001), reduced the duration of antibiotic treatment (12.8 days vs 10.9 days; P = .03), and decreased the antibiotic cost per patient ($202.5 vs $96.3; P < .0001) compared with the standard group (n = 119) without a significant difference in mortality.⁶

Sepsis/septic shock is another area in which PCT has been studied. Use of a PCT-guided algorithm in critically ill patients with suspected or documented severe sepsis or septic shock to guide discontinuation of antimicrobial therapy resulted in reduced duration of antibiotic therapy (10 days vs 6 days; P = .003) in the PCT group (n = 31) compared with the standard of care group (n = 37) while maintaining similar mortality and infection recurrence rates between the 2 groups. The PCT algorithm in this study recommended discontinuing antimicrobial therapy when PCT levels had decreased by > 90% from identification of sepsis/septic shock but not prior to 3 or 5 days of therapy, depending on the baseline PCT level.⁷

Systematic reviews of multiple trials have confirmed these representative results. Using a PCT algorithm to withhold or de-escalate antibiotics in patients with suspected bacterial infection leads to a significant reduction in antimicrobial utilization without adversely affecting patient outcome.⁸

Related: Health Care Use Among Iraq and Afghanistan Veterans With Infectious Diseases

Procalcitonin levels should be rechecked 48 to 72 hours after beginning antimicrobial therapy in clinically stable patients with RTIs in order to reevaluate patient need for continued therapy. In patients whose antibiotics are withheld due to low PCT levels, it is recommended to obtain a repeat level 12 to 48 hours after the decision if clinical improvement is not seen.^6,9-12 Literature suggests that it is reasonable to check PCT levels every 48 to 72 hours in patients with sepsis for considering discontinuation of antibiotic therapy as well as in patients who are not clinically improving and may need to broaden antibiotic therapy.^7,12

Limitations of the use of PCT as a clinical biomarker include its inability to be used in immunocompromised patients. In addition, PCT levels are increased in severe, noninfectious inflammatory conditions, such as inhalation injury, pulmonary aspiration, severe burns, pancreatitis, heat stroke, mesenteric infarction, trauma, surgery, and pneumonitis.¹² The presence of low-grade inflammation from a bacterial infection can lead to slightly elevated PCT levels that are difficult to quantify due to the low sensitivity of current PCT assays.¹³

The level of PCT up-regulation may depend on the infecting pathogen. One study showed that PCT was highly elevated in patients with pneumococcal community-acquired pneumonia (CAP), and another study demonstrated that PCT levels did not increase in CAP due to atypical organisms.^14,15 Thus, atypical antimicrobial coverage should be continued per current guidelines in patients in whom there is high suspicion of atypical organism-involvement in CAP.

Related: The Importance of an Antimicrobial Stewardship Program

Conclusion

Many studies have analyzed the use of PCT as a biomarker for infectious disease diagnosis, monitoring, and treatment. Current evidence supports its use in RTIs and sepsis, although it may be useful in other conditions as well, such as bacteremia and postoperative infections.² Due to its limitations and controversy, PCT should not be used as a sole marker but as an adjunct to a patient’s clinical presentation, overall clinical picture, and other biomarkers. 

Additional Note
An earlier version of this article appeared in the Pharmacy Related Newsletter: The Capsule, of the William S. Middleton Memorial Veterans Hospital.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Procalcitonin (PCT) is a precursor to the hormone calcitonin and is a serum biomarker of interest in infectious diseases. Many studies have analyzed its utility and role in assisting clinical decision making, especially in conditions that result in inflammation due to a bacterial infection. A systemic inflammatory response from a bacterial infection begins with the release of endotoxins/exotoxins and a response from immune system mediators that release cytokines, such as interleukin-1β and tumor necrosis factor-α. These cytokines contribute to the development of a fever, the release of stress hormones, such as cortisone and epinephrine, and interleukin-6, which stimulates acute phase reactants, such as C-reactive protein (CRP) and PCT.^1,2

C-reactive protein and white blood cell count (WBC) are commonly used clinically as biomarkers that assist in the recognition of the infectious process and may be indicators of disease prognosis, but both lack specificity for bacterial infections. Consequentially, using CRP and WBC as clinical decision aids may result in unnecessary antibiotic therapy, which may result in an increase in drug-related adverse events and antibiotic resistance. A major distinction of PCT is that it has greater specificity than does CRP, because it tends to be elevated primarily as a result of inflammation due to bacterial infections. Procalcitonin can be used to distinguish bacterial from viral infections because its up-regulation is attenuated by interferon-gamma, a cytokine released in response to viral infections.² Thus, PCT may be a more effective clinical marker for optimizing the diagnosis, monitoring, and treatment in patients with systemic bacterial infections.

Procalcitonin as a Marker

A study evaluating infectious markers compared the use of PCT, lactate, and CRP as diagnostic tools in patients with septic shock. The results of this study indicated that PCT was the only marker significantly elevated in patients with septic shock that was also normal in patients not in septic shock (14 µg/mL vs 1 µg/mL, P = .0003).³ This and other studies led the FDA to approve PCT use in 2005 as an aid to clinical decision making in the assessment of critically ill patients with sepsis.⁴ Overall, the literature supports the use of PCT as a diagnostic tool in infections requiring antimicrobial therapy within appropriate clinical settings.

Strong evidence exists confirming PCT’s role as an aid to clinical decision making in bronchitis, chronic obstructive pulmonary disease exacerbations, pneumonia, and severe sepsis/shock management.² Procalcitonin’s kinetic profile makes it a good monitoring tool, because its levels promptly increase within 3 to 6 hours of infection, peak at 12 to 48 hours, and rapidly decline during recovery. Additionally, its levels closely parallel the extent and severity of present inflammation, making it a useful prognostic marker of disease progression and response to antibiotic therapy.^2,4,5

Related: Mass Transit for Viruses

Christ-Crain and colleagues studied the outcome of PCT-guided antibiotic algorithms for patients with lower respiratory tract infections (RTIs) presenting to the emergency department. A serum PCT level of 0.25 to 0.5 µg/L suggested a likely bacterial infection, and physicians were advised to initiate antimicrobial therapy. Serum levels above 0.5 µg/L were suggestive of a bacterial infection, and initiation of antimicrobial therapy was strongly recommended. The results showed that PCT-guided algorithms significantly reduced the number of antibiotic-treated patients (n = 99 [83%] vs n = 55 [44%]; P < .0001), reduced the duration of antibiotic treatment (12.8 days vs 10.9 days; P = .03), and decreased the antibiotic cost per patient ($202.5 vs $96.3; P < .0001) compared with the standard group (n = 119) without a significant difference in mortality.⁶

Sepsis/septic shock is another area in which PCT has been studied. Use of a PCT-guided algorithm in critically ill patients with suspected or documented severe sepsis or septic shock to guide discontinuation of antimicrobial therapy resulted in reduced duration of antibiotic therapy (10 days vs 6 days; P = .003) in the PCT group (n = 31) compared with the standard of care group (n = 37) while maintaining similar mortality and infection recurrence rates between the 2 groups. The PCT algorithm in this study recommended discontinuing antimicrobial therapy when PCT levels had decreased by > 90% from identification of sepsis/septic shock but not prior to 3 or 5 days of therapy, depending on the baseline PCT level.⁷

Systematic reviews of multiple trials have confirmed these representative results. Using a PCT algorithm to withhold or de-escalate antibiotics in patients with suspected bacterial infection leads to a significant reduction in antimicrobial utilization without adversely affecting patient outcome.⁸

Related: Health Care Use Among Iraq and Afghanistan Veterans With Infectious Diseases

Procalcitonin levels should be rechecked 48 to 72 hours after beginning antimicrobial therapy in clinically stable patients with RTIs in order to reevaluate patient need for continued therapy. In patients whose antibiotics are withheld due to low PCT levels, it is recommended to obtain a repeat level 12 to 48 hours after the decision if clinical improvement is not seen.^6,9-12 Literature suggests that it is reasonable to check PCT levels every 48 to 72 hours in patients with sepsis for considering discontinuation of antibiotic therapy as well as in patients who are not clinically improving and may need to broaden antibiotic therapy.^7,12

Limitations of the use of PCT as a clinical biomarker include its inability to be used in immunocompromised patients. In addition, PCT levels are increased in severe, noninfectious inflammatory conditions, such as inhalation injury, pulmonary aspiration, severe burns, pancreatitis, heat stroke, mesenteric infarction, trauma, surgery, and pneumonitis.¹² The presence of low-grade inflammation from a bacterial infection can lead to slightly elevated PCT levels that are difficult to quantify due to the low sensitivity of current PCT assays.¹³

The level of PCT up-regulation may depend on the infecting pathogen. One study showed that PCT was highly elevated in patients with pneumococcal community-acquired pneumonia (CAP), and another study demonstrated that PCT levels did not increase in CAP due to atypical organisms.^14,15 Thus, atypical antimicrobial coverage should be continued per current guidelines in patients in whom there is high suspicion of atypical organism-involvement in CAP.

Related: The Importance of an Antimicrobial Stewardship Program

Conclusion

Many studies have analyzed the use of PCT as a biomarker for infectious disease diagnosis, monitoring, and treatment. Current evidence supports its use in RTIs and sepsis, although it may be useful in other conditions as well, such as bacteremia and postoperative infections.² Due to its limitations and controversy, PCT should not be used as a sole marker but as an adjunct to a patient’s clinical presentation, overall clinical picture, and other biomarkers. 

Additional Note
An earlier version of this article appeared in the Pharmacy Related Newsletter: The Capsule, of the William S. Middleton Memorial Veterans Hospital.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Procalcitonin (PCT) is a precursor to the hormone calcitonin and is a serum biomarker of interest in infectious diseases. Many studies have analyzed its utility and role in assisting clinical decision making, especially in conditions that result in inflammation due to a bacterial infection. A systemic inflammatory response from a bacterial infection begins with the release of endotoxins/exotoxins and a response from immune system mediators that release cytokines, such as interleukin-1β and tumor necrosis factor-α. These cytokines contribute to the development of a fever, the release of stress hormones, such as cortisone and epinephrine, and interleukin-6, which stimulates acute phase reactants, such as C-reactive protein (CRP) and PCT.^1,2

C-reactive protein and white blood cell count (WBC) are commonly used clinically as biomarkers that assist in the recognition of the infectious process and may be indicators of disease prognosis, but both lack specificity for bacterial infections. Consequentially, using CRP and WBC as clinical decision aids may result in unnecessary antibiotic therapy, which may result in an increase in drug-related adverse events and antibiotic resistance. A major distinction of PCT is that it has greater specificity than does CRP, because it tends to be elevated primarily as a result of inflammation due to bacterial infections. Procalcitonin can be used to distinguish bacterial from viral infections because its up-regulation is attenuated by interferon-gamma, a cytokine released in response to viral infections.² Thus, PCT may be a more effective clinical marker for optimizing the diagnosis, monitoring, and treatment in patients with systemic bacterial infections.

Procalcitonin as a Marker

A study evaluating infectious markers compared the use of PCT, lactate, and CRP as diagnostic tools in patients with septic shock. The results of this study indicated that PCT was the only marker significantly elevated in patients with septic shock that was also normal in patients not in septic shock (14 µg/mL vs 1 µg/mL, P = .0003).³ This and other studies led the FDA to approve PCT use in 2005 as an aid to clinical decision making in the assessment of critically ill patients with sepsis.⁴ Overall, the literature supports the use of PCT as a diagnostic tool in infections requiring antimicrobial therapy within appropriate clinical settings.

Strong evidence exists confirming PCT’s role as an aid to clinical decision making in bronchitis, chronic obstructive pulmonary disease exacerbations, pneumonia, and severe sepsis/shock management.² Procalcitonin’s kinetic profile makes it a good monitoring tool, because its levels promptly increase within 3 to 6 hours of infection, peak at 12 to 48 hours, and rapidly decline during recovery. Additionally, its levels closely parallel the extent and severity of present inflammation, making it a useful prognostic marker of disease progression and response to antibiotic therapy.^2,4,5

Related: Mass Transit for Viruses

Christ-Crain and colleagues studied the outcome of PCT-guided antibiotic algorithms for patients with lower respiratory tract infections (RTIs) presenting to the emergency department. A serum PCT level of 0.25 to 0.5 µg/L suggested a likely bacterial infection, and physicians were advised to initiate antimicrobial therapy. Serum levels above 0.5 µg/L were suggestive of a bacterial infection, and initiation of antimicrobial therapy was strongly recommended. The results showed that PCT-guided algorithms significantly reduced the number of antibiotic-treated patients (n = 99 [83%] vs n = 55 [44%]; P < .0001), reduced the duration of antibiotic treatment (12.8 days vs 10.9 days; P = .03), and decreased the antibiotic cost per patient ($202.5 vs $96.3; P < .0001) compared with the standard group (n = 119) without a significant difference in mortality.⁶

Sepsis/septic shock is another area in which PCT has been studied. Use of a PCT-guided algorithm in critically ill patients with suspected or documented severe sepsis or septic shock to guide discontinuation of antimicrobial therapy resulted in reduced duration of antibiotic therapy (10 days vs 6 days; P = .003) in the PCT group (n = 31) compared with the standard of care group (n = 37) while maintaining similar mortality and infection recurrence rates between the 2 groups. The PCT algorithm in this study recommended discontinuing antimicrobial therapy when PCT levels had decreased by > 90% from identification of sepsis/septic shock but not prior to 3 or 5 days of therapy, depending on the baseline PCT level.⁷

Systematic reviews of multiple trials have confirmed these representative results. Using a PCT algorithm to withhold or de-escalate antibiotics in patients with suspected bacterial infection leads to a significant reduction in antimicrobial utilization without adversely affecting patient outcome.⁸

Related: Health Care Use Among Iraq and Afghanistan Veterans With Infectious Diseases

Procalcitonin levels should be rechecked 48 to 72 hours after beginning antimicrobial therapy in clinically stable patients with RTIs in order to reevaluate patient need for continued therapy. In patients whose antibiotics are withheld due to low PCT levels, it is recommended to obtain a repeat level 12 to 48 hours after the decision if clinical improvement is not seen.^6,9-12 Literature suggests that it is reasonable to check PCT levels every 48 to 72 hours in patients with sepsis for considering discontinuation of antibiotic therapy as well as in patients who are not clinically improving and may need to broaden antibiotic therapy.^7,12

Limitations of the use of PCT as a clinical biomarker include its inability to be used in immunocompromised patients. In addition, PCT levels are increased in severe, noninfectious inflammatory conditions, such as inhalation injury, pulmonary aspiration, severe burns, pancreatitis, heat stroke, mesenteric infarction, trauma, surgery, and pneumonitis.¹² The presence of low-grade inflammation from a bacterial infection can lead to slightly elevated PCT levels that are difficult to quantify due to the low sensitivity of current PCT assays.¹³

The level of PCT up-regulation may depend on the infecting pathogen. One study showed that PCT was highly elevated in patients with pneumococcal community-acquired pneumonia (CAP), and another study demonstrated that PCT levels did not increase in CAP due to atypical organisms.^14,15 Thus, atypical antimicrobial coverage should be continued per current guidelines in patients in whom there is high suspicion of atypical organism-involvement in CAP.

Related: The Importance of an Antimicrobial Stewardship Program

Conclusion

Many studies have analyzed the use of PCT as a biomarker for infectious disease diagnosis, monitoring, and treatment. Current evidence supports its use in RTIs and sepsis, although it may be useful in other conditions as well, such as bacteremia and postoperative infections.² Due to its limitations and controversy, PCT should not be used as a sole marker but as an adjunct to a patient’s clinical presentation, overall clinical picture, and other biomarkers. 

Additional Note
An earlier version of this article appeared in the Pharmacy Related Newsletter: The Capsule, of the William S. Middleton Memorial Veterans Hospital.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

According to the Centers for Disease Control and Prevention, asthma prevalence in the U.S. increased between 2001 and 2010 and is now at its highest level. In 2010, about 25.7 million people had asthma: 18.7 million adults (8%) and 7 million children (9%). Despite well-known treatment options, asthma continues to be poorly controlled. In 2009 there were 1.6 million emergency department (ED) visits, 497,300 hospitalizations, and 3,404 deaths related to asthma. Additionally, in 2008 the disease affected attendance at school and work with 10.5 million and 14.2 million missed school days and workdays, respectively.^1-5

The American Indian and Alaska Native (AIAN) populations have not escaped the realities of asthma. According to a 2010 report of the National Center for Health Statistics, AIAN populations also have a high prevalence of asthma at 14.2%. This percentage is much higher than that of the general population.¹

Over the past decade, pharmacists have expanded their roles from educators to clinicians with prescriptive authority in various settings. The greatest success has been seen with anticoagulation clinics, both clinically and financially.^6-10 Pharmacists have also demonstrated positive outcomes when involved in cardiovascular clinics.^11-13

Additionally, pharmacists have been involved with asthma clinics as both educators and prescribers with favorable results clinically and economically.^14-16 A study from Taiwan done by Chan and Wang indicated that pharmacist asthma interventions in an outpatient setting improved the quality of care, reduced cost, and relieved stress on general medical resources.¹⁷ Another study indicated that education by a community pharmacist can improve asthma control in a self-managed program.¹⁸

In 2007, an asthma medication use evaluation (MUE) was completed at the Northern Navajo Medical Center (NNMC) in Shiprock, New Mexico. The results of the MUE concluded that asthma statistics for the local population differed from that of the national data (Table 1). Overall, the Navajo population served by the NNMC had a lower incidence of asthma but a higher rate of hospital admissions and ED visits.

One of the primary focus points for the MUE was short-acting beta agonist (SABA) refills. According to national guidelines, using a SABA 2 or more times per week (not for exercise-induced bronchospasms) would indicate a patient was not well controlled.¹⁹ This use equates to 2 refills of SABA per year. The MUE found that 51% of patients had ≥ 3 refills per year, and 38% of patients had 4 or more refills per year. Based on asthma prevalence and SABA history, it was determined that a specialty clinic could have a positive impact on asthma care.

This study addresses how a specialized adult asthma clinic managed by pharmacists with physician oversight can improve asthma outcomes. Since January 2010, the NNMC has had a program in place and has experienced a concurrent substantial drop in asthma-related ED visits and admissions, an improved level of control, and a decreased cost burden to the facility.

Methods

A retrospective chart review was completed on all patients currently enrolled in the clinic. The Resource and Patient Management System Visit General Retrieval (RPMS VGEN), Electronic Health Record, and the asthma clinic database were used to evaluate patients. The evaluation period began January 1, 2010, and ended December 31, 2011.

Performance improvement inclusion criteria for clinic patients were based on active status in the clinic. Active patients were defined as patients with at least 2 clinic visits and a clinic visit within 3 months of an ED visit or admission. The 3-month cutoff was chosen based on several criteria. First, most patients referred to the clinic were categorized as either not well controlled (NWC) or very poorly controlled (VPC) and required at least a 2- to 4-week follow-up based on guidelines. Second, patients who were categorized as well controlled (WC) were scheduled for clinic visits every 3 months for regular follow-up.

Using all ICD-9 codes for asthma, RPMS VGEN was used to find the number of ED visits and admissions that occurred with asthma as the primary diagnosis from both clinic and nonclinic patients. The inclusion criteria were then applied to the clinic patients, and those not meeting these criteria were returned to the nonclinic pool of patients.

Cost analysis was evaluated based on the results of a random selection of 20 patients from 2009 and 2010 ED and hospital visits at the NNMC. These numbers were averaged to determine ED and admission costs. Length of admission stay was determined from a RPMS VGEN search for each clinic and nonclinic patient admission.

Determination of the level of control was based on the 2007 national asthma guidelines. The guidelines state that the level of control can be determined by either asthma symptoms or by peak flow evaluation.¹⁹ Because of the language barrier that sometimes arises with the treated population, the use of symptom-based evaluation has been observationally superior to providing peak flow meters for home use. At each visit, patients were interviewed using tables from the asthma guidelines. Table 2 is an abbreviated portion of the guidelines representing the assessment tool used by the clinic. The level of control was determined by selecting the column with the highest severity of impairment.¹⁹

All patients seen at the clinic were tracked in a database, and their current level of control was documented at each visit. To determine the level of control, the database was reviewed, and those patients with > 1 visit were included in the analysis. The levels of control from the first visit to the most recent visit were compared.

Patient surveys were completed at each visit. These surveys included questions to assist the pharmacy provider in classifying the level of control, patient satisfaction with asthma care, and patient perception of asthma control. Approval from the Navajo Area Institutional Review Board was obtained for data publication. Odds ratios were used to determine the impact of the clinic, using a 95% confidence interval.

Results

For the review period, 2,997 patients were coded as having some form of asthma, resulting in 12,739 asthma visits within the medical center.

ED Visits and Hospital Admissions
Of these 2,997 patients, 301 visited the ED between 2010 and 2011 with 22 being active asthma clinic patients. These 22 active clinic patients accounted for 31 ED visits. The remaining 279 patients had 428 visits with a total of 459 ED visits from clinic and nonclinic patients. Sixty patients were hospitalized for asthma with 7 of them active asthma clinic patients. The 7 clinic patients admitted accounted for 8 admissions. There is a statistical significance in total ED visits and admissions as well as for individual patients (Table 3).

To determine the clinic impact, a 2-year analysis of patient pre- and postclinic enrollment was done. Search criteria for RPMS VGEN were identical to the study period search except for dates. Those patients enrolled in the clinic during the study period (2010-2011) were evaluated for the 2 years before the clinic startup (2008-2009). The results indicated a decrease in both ED visits and hospital admissions related to asthma for clinic patients (Table 4).

Cost Data and Length of Stay
Emergency department and hospital admissions costs were determined from an earlier performance improvement review of the clinic. The median cost of an ED visit was $373 with a range from $228 to $910. The cost range represented the severity of the asthma exacerbation being treated. This cost range was similar to published data that reported a cost range from $234 to $400 with an average of $339 per visit.^20,21 Hospital costs (including ED visit) per day ranged from $528 to $2,470 with a median of $1,199 per day. Table 5 shows the calculated actual annual cost savings for patients pre- and postenrollment. The cost difference between clinic and nonclinic patients from 2010 to 2011 was calculated to be $111,000 annually (data not shown). The median length of the hospital stay for clinic and nonclinic patients was 2 days (range, 1-10 and 1-7 days, respectively). The national average was 4.3 days.

From 2008 to 2009, there were 123 ED visits and 20 hospital admissions related to asthma of patients who would later be enrolled in the asthma clinic study. From 2010 to 2011 there were 31 ED visits and 8 hospital asthma admissions
(Table 4). These data were used to determine the potential cost savings for the clinic (Table 5). Based on current reductions, the potential annual cost savings was $85,405 if all adult asthma patients were seen in the pharmacy managed clinic (Table 6).

Level of Control
A total of 66 patients had 3 or more visits to the asthma clinic. Of these patients, 30% had no change in control, 60% showed some measure of improvement, and 11% had a decrease in control based on the national guidelines (Table 7).

Patient Perception
At each visit, the patient’s current perception of asthma control, satisfaction with control, and clinic grade related to asthma care was determined. Of the 66 patients with 3 or more visits, a large portion of the questionnaires were missing when the data were collected. Table 8 shows the results of the data for patients with 3 more visits and 2 completed forms from different visits. These data points may not have been from the first or most recent visits.

From earliest to most recent visit, patient perception of asthma control compared with clinical guidelines improved moderately. Sixteen patients had a clinical improvement from VPC to NWC with 13 (81%) believing their symptoms were now WC.

Discussion

The results of this performance improvement evaluation are encouraging. However, not all positive data may be directly attributed to the asthma clinic. The statistical analysis for this study does not seek to remove confounding variables. Without removing potential confounding variables, questions remain about the accuracy of the outcome. However, combining the statistical data in Table 3 and the 2-year comparative data in Table 4, strong evidence exists that a positive impact from the clinic had occurred even in the presence of potential confounding variables.

The financial impact of asthma was evident with the 2010 to 2011 cost for ED visits and hospital admissions at $265,928. Asthma clinic patients made up only 8% ($21,155) of this cost and yielded an annual cost savings of $24,352. Obviously, the 8% was a direct result of the number of nonclinic vs clinic patients. However, the cost savings of $24,352 was independent of patient numbers and was calculated directly from patients pre- and postenrollment. The potential savings if all current nonclinic patients were enrolled in the clinic was $85,405 annually.

The savings was only direct cost and did not include indirect costs related to asthma, such as lost work/school days, impact on employer productivity, and so forth. This was calculated after applying the 75% and 60% reduction in ED and hospital costs. As more patients are enrolled in the clinic, the potential cost could become an actual cost savings, based on the assumption that the 75% and 60% reduction stays constant (Figure). Over 1 year, the actual savings of the clinic makes up for 31% of the current ED visits from nonclinic patients. With the addition of the potential savings, the clinic could almost negate the money that is currently spent on asthma care.

Clinic data indicated a positive impact on level of control. Of those patients with 3 or more visits to the asthma clinic, 59% had some form of improvement. Fifteen of those patients (23%) had the biggest improvement: from VPC to WC. While any form of improvement is beneficial, a jump of this magnitude in so many patients is extremely encouraging. Thirty percent of the patients had no change in level of control. Of these, 14% were WC, so it would be hoped that no change would occur. Eleven patients remained at suboptimal control. The most concerning control data were those patients who lost control of their asthma during the 2-year period.

Chronic nonadherence from a select number of clinic patients seemed to be a major problem. Thirty-one ED visits were from 22 patients, and the 8 admissions were from 7 patients. Of the 22 ED patients, 82% had poor adherence to asthma medications. The hospital data were similar with 6 out of the total 7 (86%) clinic patients reporting poor medication adherence. Additionally, the majority of patients with a decrease in level of control since enrolling in the clinic had a history of poor medication adherence (4 of 7 patients).

In rating the level of asthma care, patients indicated they received the same level of care after enrollment as they did before enrollment. Most of the care given before the clinic was by primary care providers (PCPs), the ED, and urgent care providers. Since the patients rated the level of care equal, it would suggest that pharmacists were providing the same level of care as were these providers, at least from a patient standpoint. Overall, patients were satisfied with their level of control. Most patients were satisfied at enrollment and did not have a change of opinion throughout the study period, and a large number showed increased satisfaction. The patients who showed a decrease in satisfaction of asthma control were those patients who also had no improvement in actual control. Most of these patients stayed at the VPC level. About half these same patients had a history of noncompliance.

There is significant concern regarding those patients who continue to believe they are better controlled than what the guidelines indicate. Sixteen patients moved from VPC to NWC per the guidelines. Thirteen of these patients now believe that their asthma is WC. This belief places the patients at risk for a severe asthma exacerbation. Patients who believe they are WC may be less likely to self-medicate with albuterol or seek medical help during the initial stages of an exacerbation. These patients will need further education to bring their personal perceptions and actual asthma control together.

Conclusions

Based on clinical results it seems that the NNMC Adult Asthma Clinic has made a positive impact on asthma care. Additionally, significant reduction in the financial burden to the facility is achievable. The results, both clinically and statistically significant, indicate the impact a specialty clinic can provide. Specialty clinics, pharmacy or otherwise, have a history of providing positive outcomes.

As previously noted, no confounding variables were included in the data analysis, which could bias the results, even though data for the same time frame from separate years will reduce some errors. However, there will always be a difference in pollen counts, outbreaks (ie, influenza), temperature changes, and so forth. Such variables should be reduced but not removed completely, based on this performance improvement design. If any of these variables were significantly different, it could alter the results, so a potential weakness is present in this study.

Probably the most important mechanism for the success of the clinic is education. Each visit is set at 30-minute appointments (1 hour for new patients), allowing for a significant amount of time that can be spent on education topics, including pathophysiology, trigger avoidances, and medication use. Patients are asked to bring their medications to the clinic and demonstrate inhaler technique at every visit. Patients who do not bring their inhalers to the clinic will have them filled at the clinic and given to them for demonstration. This type of show-and-tell education allows clinic providers to correct improper inhaler technique immediately. Having patients actually use their medication seems to influence the patient’s inhaler mechanics to a greater extent than does demonstration with a placebo.

In the eyes of the clinic provider, it is important for patients to understand the basic pathophysiology of the disease. The better understanding patients have of a disease, the better they can take part in the treatment. Since the clinic actively engages patients in education topics, it brings patients into an active role in the treatment. As mentioned, the inhaler technique seems to be the most effective first step. However, as patients gain trust in clinic providers due to significant improvement in symptoms secondary to inhaler technique, this trust leads to a dialogue about pathophysiology and triggers.

Another key component in the clinic success is the nature of the clinic itself. Providers in the clinic focus on only 1 disease and the guidelines to treat that disease. Therefore, providers in the clinic are trained to be extremely familiar with the treatment of asthma. This is not to imply that a patient’s PCP or usual care provider is unfamiliar with the guidelines. It simply means that specialty care involves an extra time commitment to a specific disease. Each clinic provider must attain a high level of asthma knowledge before consideration as a full-time provider. Pharmacists are encouraged to sit for the Certified Asthma Educators examination, Board Certified Pharmacotherapy Specialist examination, and/or obtain the Indian Health Service National Clinical Pharmacy Specialist certification.

Although the clinic has moved in the right direction, there are still several patients who have not had any improvement since being referred to the clinic. These patients have refractory asthma (ie, step 6) and are not able to be treated at this facility, continued poor medication adherence, or do not have asthma at all. These patients will be flagged and will be evaluated on a case-by-case basis.

In conclusion, the clinic has begun to achieve what it was intended to do: improve asthma control, reduce patient burden on ED staff, and decrease financial burden to the facility. Additionally, there is improvement in the satisfaction of the asthma care and a trend toward the patients’ perception of asthma control agreeing with medical guidelines. These findings further support the use of pharmacists in the role as provider for the management of chronic diseases.

Acknowledgements
Shail Mehta, MD, is an internal medicine provider at the NNMC. He attended the University of Pittsburgh School of Medicine in Pennsylvania and completed a residency in internal medicine at the University of Michigan in Ann Arbor. Dr. Mehta is certified with the American Board of Internal Medicine.

Erica Markovitz, MD, is an internal medicine provider at the NNMC. She attended the University of Miami School of Medicine in Florida and completed a residency at the University of Michigan. Dr. Markovitz is certified with the American Board of Internal Medicine and the American Board of Pediatrics.

Thad Koppenhafer, PharmD, is the director of pharmacy at the NNMC and the area pharmacy consultant for the Navajo Area of the IHS. He is a member of the American Society of Health-Systems Pharmacists.

CAPT Mark Strong, PharmD, MT (ASCP) is a senior supervisory pharmacist with the U.S. Public Health Commissioned Corps and is assigned to the IHS. He is currently the chief of outpatient pharmacy services at the NNMC.

CDR Clint Krestel, PharmD, is the assistant chief of pharmacy responsible for Inpatient Pharmacy Services. His professional memberships currently include the American College of Clinical Pharmacy, the American Society of Health-System Pharmacists, and the Commissioned Officers Association.

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

According to the Centers for Disease Control and Prevention, asthma prevalence in the U.S. increased between 2001 and 2010 and is now at its highest level. In 2010, about 25.7 million people had asthma: 18.7 million adults (8%) and 7 million children (9%). Despite well-known treatment options, asthma continues to be poorly controlled. In 2009 there were 1.6 million emergency department (ED) visits, 497,300 hospitalizations, and 3,404 deaths related to asthma. Additionally, in 2008 the disease affected attendance at school and work with 10.5 million and 14.2 million missed school days and workdays, respectively.^1-5

The American Indian and Alaska Native (AIAN) populations have not escaped the realities of asthma. According to a 2010 report of the National Center for Health Statistics, AIAN populations also have a high prevalence of asthma at 14.2%. This percentage is much higher than that of the general population.¹

Over the past decade, pharmacists have expanded their roles from educators to clinicians with prescriptive authority in various settings. The greatest success has been seen with anticoagulation clinics, both clinically and financially.^6-10 Pharmacists have also demonstrated positive outcomes when involved in cardiovascular clinics.^11-13

Additionally, pharmacists have been involved with asthma clinics as both educators and prescribers with favorable results clinically and economically.^14-16 A study from Taiwan done by Chan and Wang indicated that pharmacist asthma interventions in an outpatient setting improved the quality of care, reduced cost, and relieved stress on general medical resources.¹⁷ Another study indicated that education by a community pharmacist can improve asthma control in a self-managed program.¹⁸

In 2007, an asthma medication use evaluation (MUE) was completed at the Northern Navajo Medical Center (NNMC) in Shiprock, New Mexico. The results of the MUE concluded that asthma statistics for the local population differed from that of the national data (Table 1). Overall, the Navajo population served by the NNMC had a lower incidence of asthma but a higher rate of hospital admissions and ED visits.

One of the primary focus points for the MUE was short-acting beta agonist (SABA) refills. According to national guidelines, using a SABA 2 or more times per week (not for exercise-induced bronchospasms) would indicate a patient was not well controlled.¹⁹ This use equates to 2 refills of SABA per year. The MUE found that 51% of patients had ≥ 3 refills per year, and 38% of patients had 4 or more refills per year. Based on asthma prevalence and SABA history, it was determined that a specialty clinic could have a positive impact on asthma care.

This study addresses how a specialized adult asthma clinic managed by pharmacists with physician oversight can improve asthma outcomes. Since January 2010, the NNMC has had a program in place and has experienced a concurrent substantial drop in asthma-related ED visits and admissions, an improved level of control, and a decreased cost burden to the facility.

Methods

A retrospective chart review was completed on all patients currently enrolled in the clinic. The Resource and Patient Management System Visit General Retrieval (RPMS VGEN), Electronic Health Record, and the asthma clinic database were used to evaluate patients. The evaluation period began January 1, 2010, and ended December 31, 2011.

Performance improvement inclusion criteria for clinic patients were based on active status in the clinic. Active patients were defined as patients with at least 2 clinic visits and a clinic visit within 3 months of an ED visit or admission. The 3-month cutoff was chosen based on several criteria. First, most patients referred to the clinic were categorized as either not well controlled (NWC) or very poorly controlled (VPC) and required at least a 2- to 4-week follow-up based on guidelines. Second, patients who were categorized as well controlled (WC) were scheduled for clinic visits every 3 months for regular follow-up.

Using all ICD-9 codes for asthma, RPMS VGEN was used to find the number of ED visits and admissions that occurred with asthma as the primary diagnosis from both clinic and nonclinic patients. The inclusion criteria were then applied to the clinic patients, and those not meeting these criteria were returned to the nonclinic pool of patients.

Cost analysis was evaluated based on the results of a random selection of 20 patients from 2009 and 2010 ED and hospital visits at the NNMC. These numbers were averaged to determine ED and admission costs. Length of admission stay was determined from a RPMS VGEN search for each clinic and nonclinic patient admission.

Determination of the level of control was based on the 2007 national asthma guidelines. The guidelines state that the level of control can be determined by either asthma symptoms or by peak flow evaluation.¹⁹ Because of the language barrier that sometimes arises with the treated population, the use of symptom-based evaluation has been observationally superior to providing peak flow meters for home use. At each visit, patients were interviewed using tables from the asthma guidelines. Table 2 is an abbreviated portion of the guidelines representing the assessment tool used by the clinic. The level of control was determined by selecting the column with the highest severity of impairment.¹⁹

All patients seen at the clinic were tracked in a database, and their current level of control was documented at each visit. To determine the level of control, the database was reviewed, and those patients with > 1 visit were included in the analysis. The levels of control from the first visit to the most recent visit were compared.

Patient surveys were completed at each visit. These surveys included questions to assist the pharmacy provider in classifying the level of control, patient satisfaction with asthma care, and patient perception of asthma control. Approval from the Navajo Area Institutional Review Board was obtained for data publication. Odds ratios were used to determine the impact of the clinic, using a 95% confidence interval.

Results

For the review period, 2,997 patients were coded as having some form of asthma, resulting in 12,739 asthma visits within the medical center.

ED Visits and Hospital Admissions
Of these 2,997 patients, 301 visited the ED between 2010 and 2011 with 22 being active asthma clinic patients. These 22 active clinic patients accounted for 31 ED visits. The remaining 279 patients had 428 visits with a total of 459 ED visits from clinic and nonclinic patients. Sixty patients were hospitalized for asthma with 7 of them active asthma clinic patients. The 7 clinic patients admitted accounted for 8 admissions. There is a statistical significance in total ED visits and admissions as well as for individual patients (Table 3).

To determine the clinic impact, a 2-year analysis of patient pre- and postclinic enrollment was done. Search criteria for RPMS VGEN were identical to the study period search except for dates. Those patients enrolled in the clinic during the study period (2010-2011) were evaluated for the 2 years before the clinic startup (2008-2009). The results indicated a decrease in both ED visits and hospital admissions related to asthma for clinic patients (Table 4).

Cost Data and Length of Stay
Emergency department and hospital admissions costs were determined from an earlier performance improvement review of the clinic. The median cost of an ED visit was $373 with a range from $228 to $910. The cost range represented the severity of the asthma exacerbation being treated. This cost range was similar to published data that reported a cost range from $234 to $400 with an average of $339 per visit.^20,21 Hospital costs (including ED visit) per day ranged from $528 to $2,470 with a median of $1,199 per day. Table 5 shows the calculated actual annual cost savings for patients pre- and postenrollment. The cost difference between clinic and nonclinic patients from 2010 to 2011 was calculated to be $111,000 annually (data not shown). The median length of the hospital stay for clinic and nonclinic patients was 2 days (range, 1-10 and 1-7 days, respectively). The national average was 4.3 days.

From 2008 to 2009, there were 123 ED visits and 20 hospital admissions related to asthma of patients who would later be enrolled in the asthma clinic study. From 2010 to 2011 there were 31 ED visits and 8 hospital asthma admissions
(Table 4). These data were used to determine the potential cost savings for the clinic (Table 5). Based on current reductions, the potential annual cost savings was $85,405 if all adult asthma patients were seen in the pharmacy managed clinic (Table 6).

Level of Control
A total of 66 patients had 3 or more visits to the asthma clinic. Of these patients, 30% had no change in control, 60% showed some measure of improvement, and 11% had a decrease in control based on the national guidelines (Table 7).

Patient Perception
At each visit, the patient’s current perception of asthma control, satisfaction with control, and clinic grade related to asthma care was determined. Of the 66 patients with 3 or more visits, a large portion of the questionnaires were missing when the data were collected. Table 8 shows the results of the data for patients with 3 more visits and 2 completed forms from different visits. These data points may not have been from the first or most recent visits.

From earliest to most recent visit, patient perception of asthma control compared with clinical guidelines improved moderately. Sixteen patients had a clinical improvement from VPC to NWC with 13 (81%) believing their symptoms were now WC.

Discussion

The results of this performance improvement evaluation are encouraging. However, not all positive data may be directly attributed to the asthma clinic. The statistical analysis for this study does not seek to remove confounding variables. Without removing potential confounding variables, questions remain about the accuracy of the outcome. However, combining the statistical data in Table 3 and the 2-year comparative data in Table 4, strong evidence exists that a positive impact from the clinic had occurred even in the presence of potential confounding variables.

The financial impact of asthma was evident with the 2010 to 2011 cost for ED visits and hospital admissions at $265,928. Asthma clinic patients made up only 8% ($21,155) of this cost and yielded an annual cost savings of $24,352. Obviously, the 8% was a direct result of the number of nonclinic vs clinic patients. However, the cost savings of $24,352 was independent of patient numbers and was calculated directly from patients pre- and postenrollment. The potential savings if all current nonclinic patients were enrolled in the clinic was $85,405 annually.

The savings was only direct cost and did not include indirect costs related to asthma, such as lost work/school days, impact on employer productivity, and so forth. This was calculated after applying the 75% and 60% reduction in ED and hospital costs. As more patients are enrolled in the clinic, the potential cost could become an actual cost savings, based on the assumption that the 75% and 60% reduction stays constant (Figure). Over 1 year, the actual savings of the clinic makes up for 31% of the current ED visits from nonclinic patients. With the addition of the potential savings, the clinic could almost negate the money that is currently spent on asthma care.

Clinic data indicated a positive impact on level of control. Of those patients with 3 or more visits to the asthma clinic, 59% had some form of improvement. Fifteen of those patients (23%) had the biggest improvement: from VPC to WC. While any form of improvement is beneficial, a jump of this magnitude in so many patients is extremely encouraging. Thirty percent of the patients had no change in level of control. Of these, 14% were WC, so it would be hoped that no change would occur. Eleven patients remained at suboptimal control. The most concerning control data were those patients who lost control of their asthma during the 2-year period.

Chronic nonadherence from a select number of clinic patients seemed to be a major problem. Thirty-one ED visits were from 22 patients, and the 8 admissions were from 7 patients. Of the 22 ED patients, 82% had poor adherence to asthma medications. The hospital data were similar with 6 out of the total 7 (86%) clinic patients reporting poor medication adherence. Additionally, the majority of patients with a decrease in level of control since enrolling in the clinic had a history of poor medication adherence (4 of 7 patients).

In rating the level of asthma care, patients indicated they received the same level of care after enrollment as they did before enrollment. Most of the care given before the clinic was by primary care providers (PCPs), the ED, and urgent care providers. Since the patients rated the level of care equal, it would suggest that pharmacists were providing the same level of care as were these providers, at least from a patient standpoint. Overall, patients were satisfied with their level of control. Most patients were satisfied at enrollment and did not have a change of opinion throughout the study period, and a large number showed increased satisfaction. The patients who showed a decrease in satisfaction of asthma control were those patients who also had no improvement in actual control. Most of these patients stayed at the VPC level. About half these same patients had a history of noncompliance.

There is significant concern regarding those patients who continue to believe they are better controlled than what the guidelines indicate. Sixteen patients moved from VPC to NWC per the guidelines. Thirteen of these patients now believe that their asthma is WC. This belief places the patients at risk for a severe asthma exacerbation. Patients who believe they are WC may be less likely to self-medicate with albuterol or seek medical help during the initial stages of an exacerbation. These patients will need further education to bring their personal perceptions and actual asthma control together.

Conclusions

Based on clinical results it seems that the NNMC Adult Asthma Clinic has made a positive impact on asthma care. Additionally, significant reduction in the financial burden to the facility is achievable. The results, both clinically and statistically significant, indicate the impact a specialty clinic can provide. Specialty clinics, pharmacy or otherwise, have a history of providing positive outcomes.

As previously noted, no confounding variables were included in the data analysis, which could bias the results, even though data for the same time frame from separate years will reduce some errors. However, there will always be a difference in pollen counts, outbreaks (ie, influenza), temperature changes, and so forth. Such variables should be reduced but not removed completely, based on this performance improvement design. If any of these variables were significantly different, it could alter the results, so a potential weakness is present in this study.

Probably the most important mechanism for the success of the clinic is education. Each visit is set at 30-minute appointments (1 hour for new patients), allowing for a significant amount of time that can be spent on education topics, including pathophysiology, trigger avoidances, and medication use. Patients are asked to bring their medications to the clinic and demonstrate inhaler technique at every visit. Patients who do not bring their inhalers to the clinic will have them filled at the clinic and given to them for demonstration. This type of show-and-tell education allows clinic providers to correct improper inhaler technique immediately. Having patients actually use their medication seems to influence the patient’s inhaler mechanics to a greater extent than does demonstration with a placebo.

In the eyes of the clinic provider, it is important for patients to understand the basic pathophysiology of the disease. The better understanding patients have of a disease, the better they can take part in the treatment. Since the clinic actively engages patients in education topics, it brings patients into an active role in the treatment. As mentioned, the inhaler technique seems to be the most effective first step. However, as patients gain trust in clinic providers due to significant improvement in symptoms secondary to inhaler technique, this trust leads to a dialogue about pathophysiology and triggers.

Another key component in the clinic success is the nature of the clinic itself. Providers in the clinic focus on only 1 disease and the guidelines to treat that disease. Therefore, providers in the clinic are trained to be extremely familiar with the treatment of asthma. This is not to imply that a patient’s PCP or usual care provider is unfamiliar with the guidelines. It simply means that specialty care involves an extra time commitment to a specific disease. Each clinic provider must attain a high level of asthma knowledge before consideration as a full-time provider. Pharmacists are encouraged to sit for the Certified Asthma Educators examination, Board Certified Pharmacotherapy Specialist examination, and/or obtain the Indian Health Service National Clinical Pharmacy Specialist certification.

Although the clinic has moved in the right direction, there are still several patients who have not had any improvement since being referred to the clinic. These patients have refractory asthma (ie, step 6) and are not able to be treated at this facility, continued poor medication adherence, or do not have asthma at all. These patients will be flagged and will be evaluated on a case-by-case basis.

In conclusion, the clinic has begun to achieve what it was intended to do: improve asthma control, reduce patient burden on ED staff, and decrease financial burden to the facility. Additionally, there is improvement in the satisfaction of the asthma care and a trend toward the patients’ perception of asthma control agreeing with medical guidelines. These findings further support the use of pharmacists in the role as provider for the management of chronic diseases.

Acknowledgements
Shail Mehta, MD, is an internal medicine provider at the NNMC. He attended the University of Pittsburgh School of Medicine in Pennsylvania and completed a residency in internal medicine at the University of Michigan in Ann Arbor. Dr. Mehta is certified with the American Board of Internal Medicine.

Erica Markovitz, MD, is an internal medicine provider at the NNMC. She attended the University of Miami School of Medicine in Florida and completed a residency at the University of Michigan. Dr. Markovitz is certified with the American Board of Internal Medicine and the American Board of Pediatrics.

Thad Koppenhafer, PharmD, is the director of pharmacy at the NNMC and the area pharmacy consultant for the Navajo Area of the IHS. He is a member of the American Society of Health-Systems Pharmacists.

CAPT Mark Strong, PharmD, MT (ASCP) is a senior supervisory pharmacist with the U.S. Public Health Commissioned Corps and is assigned to the IHS. He is currently the chief of outpatient pharmacy services at the NNMC.

CDR Clint Krestel, PharmD, is the assistant chief of pharmacy responsible for Inpatient Pharmacy Services. His professional memberships currently include the American College of Clinical Pharmacy, the American Society of Health-System Pharmacists, and the Commissioned Officers Association.

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

According to the Centers for Disease Control and Prevention, asthma prevalence in the U.S. increased between 2001 and 2010 and is now at its highest level. In 2010, about 25.7 million people had asthma: 18.7 million adults (8%) and 7 million children (9%). Despite well-known treatment options, asthma continues to be poorly controlled. In 2009 there were 1.6 million emergency department (ED) visits, 497,300 hospitalizations, and 3,404 deaths related to asthma. Additionally, in 2008 the disease affected attendance at school and work with 10.5 million and 14.2 million missed school days and workdays, respectively.^1-5

The American Indian and Alaska Native (AIAN) populations have not escaped the realities of asthma. According to a 2010 report of the National Center for Health Statistics, AIAN populations also have a high prevalence of asthma at 14.2%. This percentage is much higher than that of the general population.¹

Over the past decade, pharmacists have expanded their roles from educators to clinicians with prescriptive authority in various settings. The greatest success has been seen with anticoagulation clinics, both clinically and financially.^6-10 Pharmacists have also demonstrated positive outcomes when involved in cardiovascular clinics.^11-13

Additionally, pharmacists have been involved with asthma clinics as both educators and prescribers with favorable results clinically and economically.^14-16 A study from Taiwan done by Chan and Wang indicated that pharmacist asthma interventions in an outpatient setting improved the quality of care, reduced cost, and relieved stress on general medical resources.¹⁷ Another study indicated that education by a community pharmacist can improve asthma control in a self-managed program.¹⁸

In 2007, an asthma medication use evaluation (MUE) was completed at the Northern Navajo Medical Center (NNMC) in Shiprock, New Mexico. The results of the MUE concluded that asthma statistics for the local population differed from that of the national data (Table 1). Overall, the Navajo population served by the NNMC had a lower incidence of asthma but a higher rate of hospital admissions and ED visits.

One of the primary focus points for the MUE was short-acting beta agonist (SABA) refills. According to national guidelines, using a SABA 2 or more times per week (not for exercise-induced bronchospasms) would indicate a patient was not well controlled.¹⁹ This use equates to 2 refills of SABA per year. The MUE found that 51% of patients had ≥ 3 refills per year, and 38% of patients had 4 or more refills per year. Based on asthma prevalence and SABA history, it was determined that a specialty clinic could have a positive impact on asthma care.

This study addresses how a specialized adult asthma clinic managed by pharmacists with physician oversight can improve asthma outcomes. Since January 2010, the NNMC has had a program in place and has experienced a concurrent substantial drop in asthma-related ED visits and admissions, an improved level of control, and a decreased cost burden to the facility.

Methods

A retrospective chart review was completed on all patients currently enrolled in the clinic. The Resource and Patient Management System Visit General Retrieval (RPMS VGEN), Electronic Health Record, and the asthma clinic database were used to evaluate patients. The evaluation period began January 1, 2010, and ended December 31, 2011.

Performance improvement inclusion criteria for clinic patients were based on active status in the clinic. Active patients were defined as patients with at least 2 clinic visits and a clinic visit within 3 months of an ED visit or admission. The 3-month cutoff was chosen based on several criteria. First, most patients referred to the clinic were categorized as either not well controlled (NWC) or very poorly controlled (VPC) and required at least a 2- to 4-week follow-up based on guidelines. Second, patients who were categorized as well controlled (WC) were scheduled for clinic visits every 3 months for regular follow-up.

Using all ICD-9 codes for asthma, RPMS VGEN was used to find the number of ED visits and admissions that occurred with asthma as the primary diagnosis from both clinic and nonclinic patients. The inclusion criteria were then applied to the clinic patients, and those not meeting these criteria were returned to the nonclinic pool of patients.

Cost analysis was evaluated based on the results of a random selection of 20 patients from 2009 and 2010 ED and hospital visits at the NNMC. These numbers were averaged to determine ED and admission costs. Length of admission stay was determined from a RPMS VGEN search for each clinic and nonclinic patient admission.

Determination of the level of control was based on the 2007 national asthma guidelines. The guidelines state that the level of control can be determined by either asthma symptoms or by peak flow evaluation.¹⁹ Because of the language barrier that sometimes arises with the treated population, the use of symptom-based evaluation has been observationally superior to providing peak flow meters for home use. At each visit, patients were interviewed using tables from the asthma guidelines. Table 2 is an abbreviated portion of the guidelines representing the assessment tool used by the clinic. The level of control was determined by selecting the column with the highest severity of impairment.¹⁹

All patients seen at the clinic were tracked in a database, and their current level of control was documented at each visit. To determine the level of control, the database was reviewed, and those patients with > 1 visit were included in the analysis. The levels of control from the first visit to the most recent visit were compared.

Patient surveys were completed at each visit. These surveys included questions to assist the pharmacy provider in classifying the level of control, patient satisfaction with asthma care, and patient perception of asthma control. Approval from the Navajo Area Institutional Review Board was obtained for data publication. Odds ratios were used to determine the impact of the clinic, using a 95% confidence interval.

Results

For the review period, 2,997 patients were coded as having some form of asthma, resulting in 12,739 asthma visits within the medical center.

ED Visits and Hospital Admissions
Of these 2,997 patients, 301 visited the ED between 2010 and 2011 with 22 being active asthma clinic patients. These 22 active clinic patients accounted for 31 ED visits. The remaining 279 patients had 428 visits with a total of 459 ED visits from clinic and nonclinic patients. Sixty patients were hospitalized for asthma with 7 of them active asthma clinic patients. The 7 clinic patients admitted accounted for 8 admissions. There is a statistical significance in total ED visits and admissions as well as for individual patients (Table 3).

To determine the clinic impact, a 2-year analysis of patient pre- and postclinic enrollment was done. Search criteria for RPMS VGEN were identical to the study period search except for dates. Those patients enrolled in the clinic during the study period (2010-2011) were evaluated for the 2 years before the clinic startup (2008-2009). The results indicated a decrease in both ED visits and hospital admissions related to asthma for clinic patients (Table 4).

Cost Data and Length of Stay
Emergency department and hospital admissions costs were determined from an earlier performance improvement review of the clinic. The median cost of an ED visit was $373 with a range from $228 to $910. The cost range represented the severity of the asthma exacerbation being treated. This cost range was similar to published data that reported a cost range from $234 to $400 with an average of $339 per visit.^20,21 Hospital costs (including ED visit) per day ranged from $528 to $2,470 with a median of $1,199 per day. Table 5 shows the calculated actual annual cost savings for patients pre- and postenrollment. The cost difference between clinic and nonclinic patients from 2010 to 2011 was calculated to be $111,000 annually (data not shown). The median length of the hospital stay for clinic and nonclinic patients was 2 days (range, 1-10 and 1-7 days, respectively). The national average was 4.3 days.

From 2008 to 2009, there were 123 ED visits and 20 hospital admissions related to asthma of patients who would later be enrolled in the asthma clinic study. From 2010 to 2011 there were 31 ED visits and 8 hospital asthma admissions
(Table 4). These data were used to determine the potential cost savings for the clinic (Table 5). Based on current reductions, the potential annual cost savings was $85,405 if all adult asthma patients were seen in the pharmacy managed clinic (Table 6).

Level of Control
A total of 66 patients had 3 or more visits to the asthma clinic. Of these patients, 30% had no change in control, 60% showed some measure of improvement, and 11% had a decrease in control based on the national guidelines (Table 7).

Patient Perception
At each visit, the patient’s current perception of asthma control, satisfaction with control, and clinic grade related to asthma care was determined. Of the 66 patients with 3 or more visits, a large portion of the questionnaires were missing when the data were collected. Table 8 shows the results of the data for patients with 3 more visits and 2 completed forms from different visits. These data points may not have been from the first or most recent visits.

From earliest to most recent visit, patient perception of asthma control compared with clinical guidelines improved moderately. Sixteen patients had a clinical improvement from VPC to NWC with 13 (81%) believing their symptoms were now WC.

Discussion

The results of this performance improvement evaluation are encouraging. However, not all positive data may be directly attributed to the asthma clinic. The statistical analysis for this study does not seek to remove confounding variables. Without removing potential confounding variables, questions remain about the accuracy of the outcome. However, combining the statistical data in Table 3 and the 2-year comparative data in Table 4, strong evidence exists that a positive impact from the clinic had occurred even in the presence of potential confounding variables.

The financial impact of asthma was evident with the 2010 to 2011 cost for ED visits and hospital admissions at $265,928. Asthma clinic patients made up only 8% ($21,155) of this cost and yielded an annual cost savings of $24,352. Obviously, the 8% was a direct result of the number of nonclinic vs clinic patients. However, the cost savings of $24,352 was independent of patient numbers and was calculated directly from patients pre- and postenrollment. The potential savings if all current nonclinic patients were enrolled in the clinic was $85,405 annually.

The savings was only direct cost and did not include indirect costs related to asthma, such as lost work/school days, impact on employer productivity, and so forth. This was calculated after applying the 75% and 60% reduction in ED and hospital costs. As more patients are enrolled in the clinic, the potential cost could become an actual cost savings, based on the assumption that the 75% and 60% reduction stays constant (Figure). Over 1 year, the actual savings of the clinic makes up for 31% of the current ED visits from nonclinic patients. With the addition of the potential savings, the clinic could almost negate the money that is currently spent on asthma care.

Clinic data indicated a positive impact on level of control. Of those patients with 3 or more visits to the asthma clinic, 59% had some form of improvement. Fifteen of those patients (23%) had the biggest improvement: from VPC to WC. While any form of improvement is beneficial, a jump of this magnitude in so many patients is extremely encouraging. Thirty percent of the patients had no change in level of control. Of these, 14% were WC, so it would be hoped that no change would occur. Eleven patients remained at suboptimal control. The most concerning control data were those patients who lost control of their asthma during the 2-year period.

Chronic nonadherence from a select number of clinic patients seemed to be a major problem. Thirty-one ED visits were from 22 patients, and the 8 admissions were from 7 patients. Of the 22 ED patients, 82% had poor adherence to asthma medications. The hospital data were similar with 6 out of the total 7 (86%) clinic patients reporting poor medication adherence. Additionally, the majority of patients with a decrease in level of control since enrolling in the clinic had a history of poor medication adherence (4 of 7 patients).

In rating the level of asthma care, patients indicated they received the same level of care after enrollment as they did before enrollment. Most of the care given before the clinic was by primary care providers (PCPs), the ED, and urgent care providers. Since the patients rated the level of care equal, it would suggest that pharmacists were providing the same level of care as were these providers, at least from a patient standpoint. Overall, patients were satisfied with their level of control. Most patients were satisfied at enrollment and did not have a change of opinion throughout the study period, and a large number showed increased satisfaction. The patients who showed a decrease in satisfaction of asthma control were those patients who also had no improvement in actual control. Most of these patients stayed at the VPC level. About half these same patients had a history of noncompliance.

There is significant concern regarding those patients who continue to believe they are better controlled than what the guidelines indicate. Sixteen patients moved from VPC to NWC per the guidelines. Thirteen of these patients now believe that their asthma is WC. This belief places the patients at risk for a severe asthma exacerbation. Patients who believe they are WC may be less likely to self-medicate with albuterol or seek medical help during the initial stages of an exacerbation. These patients will need further education to bring their personal perceptions and actual asthma control together.

Conclusions

Based on clinical results it seems that the NNMC Adult Asthma Clinic has made a positive impact on asthma care. Additionally, significant reduction in the financial burden to the facility is achievable. The results, both clinically and statistically significant, indicate the impact a specialty clinic can provide. Specialty clinics, pharmacy or otherwise, have a history of providing positive outcomes.

As previously noted, no confounding variables were included in the data analysis, which could bias the results, even though data for the same time frame from separate years will reduce some errors. However, there will always be a difference in pollen counts, outbreaks (ie, influenza), temperature changes, and so forth. Such variables should be reduced but not removed completely, based on this performance improvement design. If any of these variables were significantly different, it could alter the results, so a potential weakness is present in this study.

Probably the most important mechanism for the success of the clinic is education. Each visit is set at 30-minute appointments (1 hour for new patients), allowing for a significant amount of time that can be spent on education topics, including pathophysiology, trigger avoidances, and medication use. Patients are asked to bring their medications to the clinic and demonstrate inhaler technique at every visit. Patients who do not bring their inhalers to the clinic will have them filled at the clinic and given to them for demonstration. This type of show-and-tell education allows clinic providers to correct improper inhaler technique immediately. Having patients actually use their medication seems to influence the patient’s inhaler mechanics to a greater extent than does demonstration with a placebo.

In the eyes of the clinic provider, it is important for patients to understand the basic pathophysiology of the disease. The better understanding patients have of a disease, the better they can take part in the treatment. Since the clinic actively engages patients in education topics, it brings patients into an active role in the treatment. As mentioned, the inhaler technique seems to be the most effective first step. However, as patients gain trust in clinic providers due to significant improvement in symptoms secondary to inhaler technique, this trust leads to a dialogue about pathophysiology and triggers.

Another key component in the clinic success is the nature of the clinic itself. Providers in the clinic focus on only 1 disease and the guidelines to treat that disease. Therefore, providers in the clinic are trained to be extremely familiar with the treatment of asthma. This is not to imply that a patient’s PCP or usual care provider is unfamiliar with the guidelines. It simply means that specialty care involves an extra time commitment to a specific disease. Each clinic provider must attain a high level of asthma knowledge before consideration as a full-time provider. Pharmacists are encouraged to sit for the Certified Asthma Educators examination, Board Certified Pharmacotherapy Specialist examination, and/or obtain the Indian Health Service National Clinical Pharmacy Specialist certification.

Although the clinic has moved in the right direction, there are still several patients who have not had any improvement since being referred to the clinic. These patients have refractory asthma (ie, step 6) and are not able to be treated at this facility, continued poor medication adherence, or do not have asthma at all. These patients will be flagged and will be evaluated on a case-by-case basis.

In conclusion, the clinic has begun to achieve what it was intended to do: improve asthma control, reduce patient burden on ED staff, and decrease financial burden to the facility. Additionally, there is improvement in the satisfaction of the asthma care and a trend toward the patients’ perception of asthma control agreeing with medical guidelines. These findings further support the use of pharmacists in the role as provider for the management of chronic diseases.

Acknowledgements
Shail Mehta, MD, is an internal medicine provider at the NNMC. He attended the University of Pittsburgh School of Medicine in Pennsylvania and completed a residency in internal medicine at the University of Michigan in Ann Arbor. Dr. Mehta is certified with the American Board of Internal Medicine.

Erica Markovitz, MD, is an internal medicine provider at the NNMC. She attended the University of Miami School of Medicine in Florida and completed a residency at the University of Michigan. Dr. Markovitz is certified with the American Board of Internal Medicine and the American Board of Pediatrics.

Thad Koppenhafer, PharmD, is the director of pharmacy at the NNMC and the area pharmacy consultant for the Navajo Area of the IHS. He is a member of the American Society of Health-Systems Pharmacists.

CAPT Mark Strong, PharmD, MT (ASCP) is a senior supervisory pharmacist with the U.S. Public Health Commissioned Corps and is assigned to the IHS. He is currently the chief of outpatient pharmacy services at the NNMC.

CDR Clint Krestel, PharmD, is the assistant chief of pharmacy responsible for Inpatient Pharmacy Services. His professional memberships currently include the American College of Clinical Pharmacy, the American Society of Health-System Pharmacists, and the Commissioned Officers Association.

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.