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Evaluation of a Diabetes Care Coordination Program for African-American Women Living in Public Housing
From the University of Kansas Work Group for Community Health and Development, Lawrence, KS (Hassaballa, Schultz, Hunter-Skidmore, Fawcett, Watson-Thompson) and Whittier Street Health Center, Boston, MA (Ebekozien, Ogungbadero, Williams)
Abstract
- Objective: To examine the implementation of the Diabetes Care Coordination Program (DCCP) and its effects on diabetes-related clinical health outcomes.
- Methods: Program participants were African American women (n = 148) with type 2 diabetes who lived in public housing in Boston’s Roxbury neighborhood. Through the DCCP, Whittier Street Health Center’s clinical team provided diabetes self-management education, support, and comprehensive diabetes care using the patient-centered medical home model and Diabetes Health Ambassadors as mediators for program delivery. Core intervention components of the DCCP included: 1) diabetes self-management education, 2) support for managing diabetes and distress, 3) enhancing access and linkage to care, 4) improving quality of care, 5) community organization, mobilization, and advocacy, and 6) health system and community transformation. A participatory monitoring and evaluation system was used to document and systematically reflect on program implementation.
- Results: DCCP implementation was associated with modest improvements in diabetes-related clinical health outcomes for program participants. Results showed statistically significant improvements in HbA1c (P = 0.016), weight (P = 0.021) and diastolic blood pressure (P = 0.027).
- Conclusion: Using neighborhood Diabetes Health Ambassadors for program delivery has implications for assuring access to quality diabetes care for populations experiencing health disparities.
The growing prevalence of type 2 diabetes, with its high morbidity and excess mortality, is imposing a heavy burden on the U.S. health care system [1–3]. It has been recognized that adoption of self-management skills by the person with diabetes is necessary in order to manage their diabetes. Diabetes self-management education and support (DSME/S) provides the foundation to help people with diabetes to navigate these decisions and activities and has been shown to improve health outcomes.
Compared to the general population, African Americans are disproportionately affected by diabetes. African Americans are also less likely to seek diabetes care and have routine diabetes-related visits with a health care professional [4,5]. African Americans have higher HbA1c levels, which contribute to the increased mortality and morbidity rates among this population [6]. Furthermore, African-American women have the poorest HbA1c control as compared to other groups [4]. Concentrated poverty and lower socioeconomic status are social determinants associated with higher prevalence of diabetes [7]. Economic barriers, living conditions, and the built environment play a significant role in contributing to this health disparity [8].
In 2010, the Bristol-Myers Squibb (BMS) Foundation launched the Together on Diabetes initiative to improve the health outcomes of adult populations disproportionately affected by type 2 diabetes. In November 2010, Together on Diabetes issued a request for proposals to encourage, identify, and promote new and evidence-based approaches to empower African-American women to control their diabetes [9–11], taking into account the opportunity these women have to influence the health of their families and communities. Whittier Street Health Center in Boston received a grant to implement a program that would connect African-American women living in public housing in the Roxbury neighborhood with comprehensive diabetes management, including health education by a certified diabetes educator, nutritional counseling by a dietitian, and a tailored program of physical activity.
In this article, we describe the project and effects on diabetes-related clinical health outcomes.
Methods
Setting
Whittier Street Health Center (WSHC) is a federally qualified community health center that serves over 25,000 patients annually. The WSHC is situated in the heart of Boston’s Roxbury neighborhood, close to 5 public housing developments; 83% of WSHC patients live in public housing units. Roxbury is an underserved neighborhood with high rates of poverty, violence, and disease [12]. African Americans comprise the majority of residents living in Roxbury, making up 55.6% of the total population [13].
Diabetes Care Coordination Program
Ambassadors
Diabetes Health Ambassadors, a key component of the program, were hired to engage community members in managing their own health. Five Ambassadors were recruited and retained throughout the project period. Ambassadors were referred by their primary care provider at WSHC and interviewed for the job by the patient navigator. Ambassadors were required to be African-American women with type 2 diabetes living in a public housing unit within the Roxbury neighborhood. In addition, they were required to have their diabetes under control as defined by the WSHC clinical team (HbA1c of 8.0 or below). They also had to want to help other women control their diabetes and be able to deliver motivational presentations as well as have knowledge of available community resources.
Ambassadors received 30 hours of paid training from the certified diabetes educator. During training, they learned the definition, risk factors, and causes of diabetes, how it is controlled, and how to explain this information at a fifth-grade level. Modeling and feedback was used to assure that the information each Ambassador presented was accurate. Ambassadors were also trained on how to measure blood pressure and blood glucose levels and how to respectfully deliver the results. Additionally, Ambassadors received training on cultural competence. Ambassadors were engaged in community outreach and patient support for 20 hours per week and were compensated for their time with stipends.
Participant Recruitment and Outreach
A rolling enrollment for the DCCP began January 2012. The outreach team from the WSHC attended coffee hours at the public housing units and other community events where they conducted onsite blood pressure and glucose screenings as well as educated community members on healthy eating and active lifestyle to reduce the risks for diabetes. Mobile kits were used for testing, so participants received the test results immediately. Two Ambassadors, the outreach nurse, and the patient navigator conducted the outreach events. The set up included two tables, 6 chairs, education materials, and blood pressure and blood sugar screening materials.
Screenings were offered in the public housing units 3 times a week (twice during the week and once during the weekend). Posters in the neighborhood notifed women of the time and location of the screenings. Other settings for services such as screenings and referrals to primary care and health insurance applications included churches, mosques, community festivals, farmers markets, parks, and hair salons.
Women who had elevated glucose readings were invited to enroll in the DCCP program and an appointment at the WSHC was made for those who signed up.
During the period January 2012 to June 2013, 980 African-American women were screened for diabetes. Most screenings took place in the public housing units. Among those screened, 340 had an elevated blood glucose and were referred to WSHC for services. Of those, 175 women were recruited and enrolled into the DCCP. At the WSHC, a standardized protocol was used to measure HbA1c to confirm a diagnosis of diabetes once patients attended their first appointment. Age of participants ranged from 40 to 49. Most women were unemployed and had many competing responsibilities and stressors. Completed preassessment questionaires indicated that participants did not engage in healthy eating or physical activity as part of their daily routines prior to enrollment.
Program Components
At the Center, Ambassadors spoke with program participants and inquired about their barriers to diabetes care (eg, access to food [15], health insurance, etc.) using a standardized list. Ambassadors linked program participants to community support services as needed, including health insurance enrollment, financial support, and housing support. Services were also provided in collaboration with community organizations. For example, subsidized gym memberships were available at the local YMCA and a local fitness studio, and there was an instructor at the YMCA to guide the women through physical activity routines.
Participants could attend DSME group sessions provided by the certified diabetes educator. The course met twice a week for 2 hours for a period of 6 weeks. The course was interactive and included hands-on training in blood glucose measurement and food preparation. Healthy food was offered after each session, which provided a further opportunity for participants to engage in peer-to-peer support. After the completion of the DSME course, bi-weekly support group sessions were held until program completion (June 2013). All clinical team members were present at the support group sessions, with patients rotating to speak to them to ask questions or discuss concerns related to self-management.
A part of DSME, the registered dietitian provided nutrition information and healthy cooking demonstrations for program participants within group sessions. The primary care physician met the patient once a month and kept track of clinical changes over time. Patients with HbA1c ≥ 9% were referred to the high-risk nurse case manager who worked one-on-one with program participants to help them avoid serious diabetes complications.
Ambassadors were a part of all the course and support group sessions, and when needed they attended indivdual sessions, such as doctor visits and meetings with the high-risk nurse case manager. Ambassadors accompanied program participants during visits with clinical staff to provide additional support when requested.
The manager of quality assurance assured the safety of intervention procedures and employed performance improvement methods. Program participants provided informed consent, and had the right to withdraw at any time. The Quality Assurance Committee at WSHC protected the rights of participants, assured the safety of intervention procedures, and assured the quality of care received by each participant.
Evaluation
The Work Group for Community Health and Development at the University of Kansas was selected by the BMS Foundation to evaluate the implementation and related clinical outcomes of the program using a participatory evaluation framework [16–18]. A similarly funded study used the same study approach [19]. Clinical health outcomes were analyzed through a pre-post test comparison using STATA Version 12. Paired t tests were used to examine within-patient health outcome changes. The mean interval between the pre and post measurements was 16 months. A 0.05 level of significance was used. Using a one-sided t test, Cohen’s d was computed to measure effect size.
Results
Services
Clinical Outcomes
Discussion
This empirical case study examined the implementation of the Diabetes Care Coordination Program (DCCP) and its effects on diabetes-related clinical health outcomes for program participants. The program’ glucose screenings and educational workshops at public housing units provided enhanced access to diabetes care services for community members. Referrals to WSHC allowed for the provision of clinical health services through a comprehensive care model. Modest improvements in diabetes-related clinical health indicators were seen.
Some challenges were noted during implementation of the DCCP and addressed as part of a quality improvement process. First, Diabetes Health Ambassadors originally went door to door and had difficulty recruiting participants. Holding screening events in public spaces within housing units addressed this problem. Second, the WSHC team found that women needed more behavioral health support than was being provided, with some of the women reporting to their case managers that it was difficult for them to handle the stresses of life and at the same time manage their diabetes. In response, an integrated behavioral health specialist was hired to provide guidance on how to manage life stressors and how to increase health behaviors despite physical, social, and financial barriers.
Third, women reported a lack of access to fresh fruits and vegetables. In response, WSHC implemented a formal collaboration with a mobile food truck (June 2012) that sold subsidized fresh food 3 days a week to public housing residents. Fourth, participants reported some barriers related to transportation for scheduled appointments at the WSHC. The team addressed this issue by providing taxi vouchers for those who lacked adequate access to transportation. Finally, the coordinated team noticed that medication adherence was a barrier to care for many program participants. Consequently, they developed a medication management support group led by the clinical pharmacist to address barriers related to medication adherence.
There were several methodological challenges confronted in carrying out this study. First, the dose of services that were provided for each individual participant was difficult to ascertain. For example, some of those enrolled in the DCCP earlier may not have had the full set of services that were available towards the end of the program. Second, although group data were available, data on individual level outcomes were not; this made it difficult to assess whether there was change in behavior on the part of particular individuals. Third, a case study design, without a comparison group, does not control for threats to internal validity (eg, history, maturation, and attrition) that might have accounted for improvements in clinical outcomes. Finally, despite the comprehensive documentation, there could have been program elements that were implemented but not documented. Despite these methodological limitations, the case study design facilitated learning about associations between program implementation and changes in clinical health outcomes in a context of health disparities [20].
A particular strength of the program was use of Diabetes Health Ambassadors as mediators for DCCP service delivery. Ambassadors increased diabetes awareness within the community and also played a key role in building rapport and trust in the diabetes program among community members.
Lessons Learned
As part of a qualitative component, key informant interviews with WSHC staff were used to examine lessons learned during project implementation. First, an identified positive outcome was that the Ambassadors gained new insights into the management of their own diabetes and adopted additional lifestyle changes along with program participants. Second, the WSHC team affirmed that African-American women act as gatekeepers for their families, and that teaching and serving one woman allowed for teaching and serving the entire family. Program participants reported that their own lifestyle changes had an impact on other family members. For example, one participant reported she stopped purchasing soda beverages for her family. Another participant began using healthier cooking strategies, such as using olive oil instead of butter. Third, consistent with another study, the coordinated care model helped to assure comprehensive diabetes care [21]. Staff noted that “it takes a village” (a coordinated team) to address the diverse array of clinical issues needed for diabetes control. Fourth, self-management education was helpful, especially when coupled with social support from peers and family members. Fifth, working collaboratively with partners in non-health sectors was helpful in achieving the conditions needed for improved diabetes care [22].
Recommendations for Future Research and Practice
There are several recommendations for future research and practice. First, to achieve stronger clinical health outcomes, the DCCP would need to be enhanced by assuring lower caseloads for the WSHC clinical team. Second, to expand the evidence base, stronger experimental designs are needed to draw firmer conclusions about causal relationships. For instance, a multiple-baseline design across similar federally qualified heath centers could enable a better understanding of the effects of this community-based DCCP intervention in urban contexts. Third, research and practice would benefit from further testing of the model using community health workers for delivery of DSME and DSMS services. Fourth, implementation science can aid in enhancing the role of Ambassadors by providing tools/frameworks for improved delivery of services such as the core implementation components of selection and training [23]. Finally, the use of behavioral science methods can help extend the evidence base for the effects of the DCCP intervention on behavior change at the individual and the community levels [24,25].
Conclusion
This empirical case study adds to our understanding of delivering community-based diabetes care in a public housing context. This study examined the implementation and effects of a diabetes program for African-American women experiencing health disparities. The delivery of diabetes services by Diabetes Health Ambassadors was effective in engaging women with diabetes who lived in low-income housing. This study provided further evidence that coordinated diabetes care, with a focus on culturally and contextually appropriate service delivery, can have positive health outcomes. Further research is needed to examine effects of the DCCP intervention at the individual, clinic, family, and community levels.
Addressing the rapidly increasing prevalence of diabetes is a huge challenge, especially among vulnerable populations at disproportionate risk for adverse health outcomes. These patients face physical, emotional, and financial burdens. We need to assure that community health workers and coordinated clinical teams are prepared to support patients’ acquisition and maintenance of self-care behaviors. Eliminating diabetes-related disparities requires modifying the health system and the broader community environment [26]. Addressing the barriers to medical and self-care that vulnerable populations with type 2 diabetes face will provide them with greater opportunities for health and well-being.
Acknowledgments: The authors thank the many community partners throughout Boston that made this project possible.
Corresponding author: Ithar Hassaballa, KU Work Group for Community Health and Development, University of Kansas, 1000 Sunnyside Ave, 4082 Dole Center, Lawrence, KS 66045, [email protected].
Funding/support: Funding for the Whittier Street Health Center’s Diabetes Care Coordination Program and for the evaluation of the Together on Diabetes initiative was provided by the Bristol-Myers Squibb Foundation.
Financial disclosures: None.
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From the University of Kansas Work Group for Community Health and Development, Lawrence, KS (Hassaballa, Schultz, Hunter-Skidmore, Fawcett, Watson-Thompson) and Whittier Street Health Center, Boston, MA (Ebekozien, Ogungbadero, Williams)
Abstract
- Objective: To examine the implementation of the Diabetes Care Coordination Program (DCCP) and its effects on diabetes-related clinical health outcomes.
- Methods: Program participants were African American women (n = 148) with type 2 diabetes who lived in public housing in Boston’s Roxbury neighborhood. Through the DCCP, Whittier Street Health Center’s clinical team provided diabetes self-management education, support, and comprehensive diabetes care using the patient-centered medical home model and Diabetes Health Ambassadors as mediators for program delivery. Core intervention components of the DCCP included: 1) diabetes self-management education, 2) support for managing diabetes and distress, 3) enhancing access and linkage to care, 4) improving quality of care, 5) community organization, mobilization, and advocacy, and 6) health system and community transformation. A participatory monitoring and evaluation system was used to document and systematically reflect on program implementation.
- Results: DCCP implementation was associated with modest improvements in diabetes-related clinical health outcomes for program participants. Results showed statistically significant improvements in HbA1c (P = 0.016), weight (P = 0.021) and diastolic blood pressure (P = 0.027).
- Conclusion: Using neighborhood Diabetes Health Ambassadors for program delivery has implications for assuring access to quality diabetes care for populations experiencing health disparities.
The growing prevalence of type 2 diabetes, with its high morbidity and excess mortality, is imposing a heavy burden on the U.S. health care system [1–3]. It has been recognized that adoption of self-management skills by the person with diabetes is necessary in order to manage their diabetes. Diabetes self-management education and support (DSME/S) provides the foundation to help people with diabetes to navigate these decisions and activities and has been shown to improve health outcomes.
Compared to the general population, African Americans are disproportionately affected by diabetes. African Americans are also less likely to seek diabetes care and have routine diabetes-related visits with a health care professional [4,5]. African Americans have higher HbA1c levels, which contribute to the increased mortality and morbidity rates among this population [6]. Furthermore, African-American women have the poorest HbA1c control as compared to other groups [4]. Concentrated poverty and lower socioeconomic status are social determinants associated with higher prevalence of diabetes [7]. Economic barriers, living conditions, and the built environment play a significant role in contributing to this health disparity [8].
In 2010, the Bristol-Myers Squibb (BMS) Foundation launched the Together on Diabetes initiative to improve the health outcomes of adult populations disproportionately affected by type 2 diabetes. In November 2010, Together on Diabetes issued a request for proposals to encourage, identify, and promote new and evidence-based approaches to empower African-American women to control their diabetes [9–11], taking into account the opportunity these women have to influence the health of their families and communities. Whittier Street Health Center in Boston received a grant to implement a program that would connect African-American women living in public housing in the Roxbury neighborhood with comprehensive diabetes management, including health education by a certified diabetes educator, nutritional counseling by a dietitian, and a tailored program of physical activity.
In this article, we describe the project and effects on diabetes-related clinical health outcomes.
Methods
Setting
Whittier Street Health Center (WSHC) is a federally qualified community health center that serves over 25,000 patients annually. The WSHC is situated in the heart of Boston’s Roxbury neighborhood, close to 5 public housing developments; 83% of WSHC patients live in public housing units. Roxbury is an underserved neighborhood with high rates of poverty, violence, and disease [12]. African Americans comprise the majority of residents living in Roxbury, making up 55.6% of the total population [13].
Diabetes Care Coordination Program
Ambassadors
Diabetes Health Ambassadors, a key component of the program, were hired to engage community members in managing their own health. Five Ambassadors were recruited and retained throughout the project period. Ambassadors were referred by their primary care provider at WSHC and interviewed for the job by the patient navigator. Ambassadors were required to be African-American women with type 2 diabetes living in a public housing unit within the Roxbury neighborhood. In addition, they were required to have their diabetes under control as defined by the WSHC clinical team (HbA1c of 8.0 or below). They also had to want to help other women control their diabetes and be able to deliver motivational presentations as well as have knowledge of available community resources.
Ambassadors received 30 hours of paid training from the certified diabetes educator. During training, they learned the definition, risk factors, and causes of diabetes, how it is controlled, and how to explain this information at a fifth-grade level. Modeling and feedback was used to assure that the information each Ambassador presented was accurate. Ambassadors were also trained on how to measure blood pressure and blood glucose levels and how to respectfully deliver the results. Additionally, Ambassadors received training on cultural competence. Ambassadors were engaged in community outreach and patient support for 20 hours per week and were compensated for their time with stipends.
Participant Recruitment and Outreach
A rolling enrollment for the DCCP began January 2012. The outreach team from the WSHC attended coffee hours at the public housing units and other community events where they conducted onsite blood pressure and glucose screenings as well as educated community members on healthy eating and active lifestyle to reduce the risks for diabetes. Mobile kits were used for testing, so participants received the test results immediately. Two Ambassadors, the outreach nurse, and the patient navigator conducted the outreach events. The set up included two tables, 6 chairs, education materials, and blood pressure and blood sugar screening materials.
Screenings were offered in the public housing units 3 times a week (twice during the week and once during the weekend). Posters in the neighborhood notifed women of the time and location of the screenings. Other settings for services such as screenings and referrals to primary care and health insurance applications included churches, mosques, community festivals, farmers markets, parks, and hair salons.
Women who had elevated glucose readings were invited to enroll in the DCCP program and an appointment at the WSHC was made for those who signed up.
During the period January 2012 to June 2013, 980 African-American women were screened for diabetes. Most screenings took place in the public housing units. Among those screened, 340 had an elevated blood glucose and were referred to WSHC for services. Of those, 175 women were recruited and enrolled into the DCCP. At the WSHC, a standardized protocol was used to measure HbA1c to confirm a diagnosis of diabetes once patients attended their first appointment. Age of participants ranged from 40 to 49. Most women were unemployed and had many competing responsibilities and stressors. Completed preassessment questionaires indicated that participants did not engage in healthy eating or physical activity as part of their daily routines prior to enrollment.
Program Components
At the Center, Ambassadors spoke with program participants and inquired about their barriers to diabetes care (eg, access to food [15], health insurance, etc.) using a standardized list. Ambassadors linked program participants to community support services as needed, including health insurance enrollment, financial support, and housing support. Services were also provided in collaboration with community organizations. For example, subsidized gym memberships were available at the local YMCA and a local fitness studio, and there was an instructor at the YMCA to guide the women through physical activity routines.
Participants could attend DSME group sessions provided by the certified diabetes educator. The course met twice a week for 2 hours for a period of 6 weeks. The course was interactive and included hands-on training in blood glucose measurement and food preparation. Healthy food was offered after each session, which provided a further opportunity for participants to engage in peer-to-peer support. After the completion of the DSME course, bi-weekly support group sessions were held until program completion (June 2013). All clinical team members were present at the support group sessions, with patients rotating to speak to them to ask questions or discuss concerns related to self-management.
A part of DSME, the registered dietitian provided nutrition information and healthy cooking demonstrations for program participants within group sessions. The primary care physician met the patient once a month and kept track of clinical changes over time. Patients with HbA1c ≥ 9% were referred to the high-risk nurse case manager who worked one-on-one with program participants to help them avoid serious diabetes complications.
Ambassadors were a part of all the course and support group sessions, and when needed they attended indivdual sessions, such as doctor visits and meetings with the high-risk nurse case manager. Ambassadors accompanied program participants during visits with clinical staff to provide additional support when requested.
The manager of quality assurance assured the safety of intervention procedures and employed performance improvement methods. Program participants provided informed consent, and had the right to withdraw at any time. The Quality Assurance Committee at WSHC protected the rights of participants, assured the safety of intervention procedures, and assured the quality of care received by each participant.
Evaluation
The Work Group for Community Health and Development at the University of Kansas was selected by the BMS Foundation to evaluate the implementation and related clinical outcomes of the program using a participatory evaluation framework [16–18]. A similarly funded study used the same study approach [19]. Clinical health outcomes were analyzed through a pre-post test comparison using STATA Version 12. Paired t tests were used to examine within-patient health outcome changes. The mean interval between the pre and post measurements was 16 months. A 0.05 level of significance was used. Using a one-sided t test, Cohen’s d was computed to measure effect size.
Results
Services
Clinical Outcomes
Discussion
This empirical case study examined the implementation of the Diabetes Care Coordination Program (DCCP) and its effects on diabetes-related clinical health outcomes for program participants. The program’ glucose screenings and educational workshops at public housing units provided enhanced access to diabetes care services for community members. Referrals to WSHC allowed for the provision of clinical health services through a comprehensive care model. Modest improvements in diabetes-related clinical health indicators were seen.
Some challenges were noted during implementation of the DCCP and addressed as part of a quality improvement process. First, Diabetes Health Ambassadors originally went door to door and had difficulty recruiting participants. Holding screening events in public spaces within housing units addressed this problem. Second, the WSHC team found that women needed more behavioral health support than was being provided, with some of the women reporting to their case managers that it was difficult for them to handle the stresses of life and at the same time manage their diabetes. In response, an integrated behavioral health specialist was hired to provide guidance on how to manage life stressors and how to increase health behaviors despite physical, social, and financial barriers.
Third, women reported a lack of access to fresh fruits and vegetables. In response, WSHC implemented a formal collaboration with a mobile food truck (June 2012) that sold subsidized fresh food 3 days a week to public housing residents. Fourth, participants reported some barriers related to transportation for scheduled appointments at the WSHC. The team addressed this issue by providing taxi vouchers for those who lacked adequate access to transportation. Finally, the coordinated team noticed that medication adherence was a barrier to care for many program participants. Consequently, they developed a medication management support group led by the clinical pharmacist to address barriers related to medication adherence.
There were several methodological challenges confronted in carrying out this study. First, the dose of services that were provided for each individual participant was difficult to ascertain. For example, some of those enrolled in the DCCP earlier may not have had the full set of services that were available towards the end of the program. Second, although group data were available, data on individual level outcomes were not; this made it difficult to assess whether there was change in behavior on the part of particular individuals. Third, a case study design, without a comparison group, does not control for threats to internal validity (eg, history, maturation, and attrition) that might have accounted for improvements in clinical outcomes. Finally, despite the comprehensive documentation, there could have been program elements that were implemented but not documented. Despite these methodological limitations, the case study design facilitated learning about associations between program implementation and changes in clinical health outcomes in a context of health disparities [20].
A particular strength of the program was use of Diabetes Health Ambassadors as mediators for DCCP service delivery. Ambassadors increased diabetes awareness within the community and also played a key role in building rapport and trust in the diabetes program among community members.
Lessons Learned
As part of a qualitative component, key informant interviews with WSHC staff were used to examine lessons learned during project implementation. First, an identified positive outcome was that the Ambassadors gained new insights into the management of their own diabetes and adopted additional lifestyle changes along with program participants. Second, the WSHC team affirmed that African-American women act as gatekeepers for their families, and that teaching and serving one woman allowed for teaching and serving the entire family. Program participants reported that their own lifestyle changes had an impact on other family members. For example, one participant reported she stopped purchasing soda beverages for her family. Another participant began using healthier cooking strategies, such as using olive oil instead of butter. Third, consistent with another study, the coordinated care model helped to assure comprehensive diabetes care [21]. Staff noted that “it takes a village” (a coordinated team) to address the diverse array of clinical issues needed for diabetes control. Fourth, self-management education was helpful, especially when coupled with social support from peers and family members. Fifth, working collaboratively with partners in non-health sectors was helpful in achieving the conditions needed for improved diabetes care [22].
Recommendations for Future Research and Practice
There are several recommendations for future research and practice. First, to achieve stronger clinical health outcomes, the DCCP would need to be enhanced by assuring lower caseloads for the WSHC clinical team. Second, to expand the evidence base, stronger experimental designs are needed to draw firmer conclusions about causal relationships. For instance, a multiple-baseline design across similar federally qualified heath centers could enable a better understanding of the effects of this community-based DCCP intervention in urban contexts. Third, research and practice would benefit from further testing of the model using community health workers for delivery of DSME and DSMS services. Fourth, implementation science can aid in enhancing the role of Ambassadors by providing tools/frameworks for improved delivery of services such as the core implementation components of selection and training [23]. Finally, the use of behavioral science methods can help extend the evidence base for the effects of the DCCP intervention on behavior change at the individual and the community levels [24,25].
Conclusion
This empirical case study adds to our understanding of delivering community-based diabetes care in a public housing context. This study examined the implementation and effects of a diabetes program for African-American women experiencing health disparities. The delivery of diabetes services by Diabetes Health Ambassadors was effective in engaging women with diabetes who lived in low-income housing. This study provided further evidence that coordinated diabetes care, with a focus on culturally and contextually appropriate service delivery, can have positive health outcomes. Further research is needed to examine effects of the DCCP intervention at the individual, clinic, family, and community levels.
Addressing the rapidly increasing prevalence of diabetes is a huge challenge, especially among vulnerable populations at disproportionate risk for adverse health outcomes. These patients face physical, emotional, and financial burdens. We need to assure that community health workers and coordinated clinical teams are prepared to support patients’ acquisition and maintenance of self-care behaviors. Eliminating diabetes-related disparities requires modifying the health system and the broader community environment [26]. Addressing the barriers to medical and self-care that vulnerable populations with type 2 diabetes face will provide them with greater opportunities for health and well-being.
Acknowledgments: The authors thank the many community partners throughout Boston that made this project possible.
Corresponding author: Ithar Hassaballa, KU Work Group for Community Health and Development, University of Kansas, 1000 Sunnyside Ave, 4082 Dole Center, Lawrence, KS 66045, [email protected].
Funding/support: Funding for the Whittier Street Health Center’s Diabetes Care Coordination Program and for the evaluation of the Together on Diabetes initiative was provided by the Bristol-Myers Squibb Foundation.
Financial disclosures: None.
From the University of Kansas Work Group for Community Health and Development, Lawrence, KS (Hassaballa, Schultz, Hunter-Skidmore, Fawcett, Watson-Thompson) and Whittier Street Health Center, Boston, MA (Ebekozien, Ogungbadero, Williams)
Abstract
- Objective: To examine the implementation of the Diabetes Care Coordination Program (DCCP) and its effects on diabetes-related clinical health outcomes.
- Methods: Program participants were African American women (n = 148) with type 2 diabetes who lived in public housing in Boston’s Roxbury neighborhood. Through the DCCP, Whittier Street Health Center’s clinical team provided diabetes self-management education, support, and comprehensive diabetes care using the patient-centered medical home model and Diabetes Health Ambassadors as mediators for program delivery. Core intervention components of the DCCP included: 1) diabetes self-management education, 2) support for managing diabetes and distress, 3) enhancing access and linkage to care, 4) improving quality of care, 5) community organization, mobilization, and advocacy, and 6) health system and community transformation. A participatory monitoring and evaluation system was used to document and systematically reflect on program implementation.
- Results: DCCP implementation was associated with modest improvements in diabetes-related clinical health outcomes for program participants. Results showed statistically significant improvements in HbA1c (P = 0.016), weight (P = 0.021) and diastolic blood pressure (P = 0.027).
- Conclusion: Using neighborhood Diabetes Health Ambassadors for program delivery has implications for assuring access to quality diabetes care for populations experiencing health disparities.
The growing prevalence of type 2 diabetes, with its high morbidity and excess mortality, is imposing a heavy burden on the U.S. health care system [1–3]. It has been recognized that adoption of self-management skills by the person with diabetes is necessary in order to manage their diabetes. Diabetes self-management education and support (DSME/S) provides the foundation to help people with diabetes to navigate these decisions and activities and has been shown to improve health outcomes.
Compared to the general population, African Americans are disproportionately affected by diabetes. African Americans are also less likely to seek diabetes care and have routine diabetes-related visits with a health care professional [4,5]. African Americans have higher HbA1c levels, which contribute to the increased mortality and morbidity rates among this population [6]. Furthermore, African-American women have the poorest HbA1c control as compared to other groups [4]. Concentrated poverty and lower socioeconomic status are social determinants associated with higher prevalence of diabetes [7]. Economic barriers, living conditions, and the built environment play a significant role in contributing to this health disparity [8].
In 2010, the Bristol-Myers Squibb (BMS) Foundation launched the Together on Diabetes initiative to improve the health outcomes of adult populations disproportionately affected by type 2 diabetes. In November 2010, Together on Diabetes issued a request for proposals to encourage, identify, and promote new and evidence-based approaches to empower African-American women to control their diabetes [9–11], taking into account the opportunity these women have to influence the health of their families and communities. Whittier Street Health Center in Boston received a grant to implement a program that would connect African-American women living in public housing in the Roxbury neighborhood with comprehensive diabetes management, including health education by a certified diabetes educator, nutritional counseling by a dietitian, and a tailored program of physical activity.
In this article, we describe the project and effects on diabetes-related clinical health outcomes.
Methods
Setting
Whittier Street Health Center (WSHC) is a federally qualified community health center that serves over 25,000 patients annually. The WSHC is situated in the heart of Boston’s Roxbury neighborhood, close to 5 public housing developments; 83% of WSHC patients live in public housing units. Roxbury is an underserved neighborhood with high rates of poverty, violence, and disease [12]. African Americans comprise the majority of residents living in Roxbury, making up 55.6% of the total population [13].
Diabetes Care Coordination Program
Ambassadors
Diabetes Health Ambassadors, a key component of the program, were hired to engage community members in managing their own health. Five Ambassadors were recruited and retained throughout the project period. Ambassadors were referred by their primary care provider at WSHC and interviewed for the job by the patient navigator. Ambassadors were required to be African-American women with type 2 diabetes living in a public housing unit within the Roxbury neighborhood. In addition, they were required to have their diabetes under control as defined by the WSHC clinical team (HbA1c of 8.0 or below). They also had to want to help other women control their diabetes and be able to deliver motivational presentations as well as have knowledge of available community resources.
Ambassadors received 30 hours of paid training from the certified diabetes educator. During training, they learned the definition, risk factors, and causes of diabetes, how it is controlled, and how to explain this information at a fifth-grade level. Modeling and feedback was used to assure that the information each Ambassador presented was accurate. Ambassadors were also trained on how to measure blood pressure and blood glucose levels and how to respectfully deliver the results. Additionally, Ambassadors received training on cultural competence. Ambassadors were engaged in community outreach and patient support for 20 hours per week and were compensated for their time with stipends.
Participant Recruitment and Outreach
A rolling enrollment for the DCCP began January 2012. The outreach team from the WSHC attended coffee hours at the public housing units and other community events where they conducted onsite blood pressure and glucose screenings as well as educated community members on healthy eating and active lifestyle to reduce the risks for diabetes. Mobile kits were used for testing, so participants received the test results immediately. Two Ambassadors, the outreach nurse, and the patient navigator conducted the outreach events. The set up included two tables, 6 chairs, education materials, and blood pressure and blood sugar screening materials.
Screenings were offered in the public housing units 3 times a week (twice during the week and once during the weekend). Posters in the neighborhood notifed women of the time and location of the screenings. Other settings for services such as screenings and referrals to primary care and health insurance applications included churches, mosques, community festivals, farmers markets, parks, and hair salons.
Women who had elevated glucose readings were invited to enroll in the DCCP program and an appointment at the WSHC was made for those who signed up.
During the period January 2012 to June 2013, 980 African-American women were screened for diabetes. Most screenings took place in the public housing units. Among those screened, 340 had an elevated blood glucose and were referred to WSHC for services. Of those, 175 women were recruited and enrolled into the DCCP. At the WSHC, a standardized protocol was used to measure HbA1c to confirm a diagnosis of diabetes once patients attended their first appointment. Age of participants ranged from 40 to 49. Most women were unemployed and had many competing responsibilities and stressors. Completed preassessment questionaires indicated that participants did not engage in healthy eating or physical activity as part of their daily routines prior to enrollment.
Program Components
At the Center, Ambassadors spoke with program participants and inquired about their barriers to diabetes care (eg, access to food [15], health insurance, etc.) using a standardized list. Ambassadors linked program participants to community support services as needed, including health insurance enrollment, financial support, and housing support. Services were also provided in collaboration with community organizations. For example, subsidized gym memberships were available at the local YMCA and a local fitness studio, and there was an instructor at the YMCA to guide the women through physical activity routines.
Participants could attend DSME group sessions provided by the certified diabetes educator. The course met twice a week for 2 hours for a period of 6 weeks. The course was interactive and included hands-on training in blood glucose measurement and food preparation. Healthy food was offered after each session, which provided a further opportunity for participants to engage in peer-to-peer support. After the completion of the DSME course, bi-weekly support group sessions were held until program completion (June 2013). All clinical team members were present at the support group sessions, with patients rotating to speak to them to ask questions or discuss concerns related to self-management.
A part of DSME, the registered dietitian provided nutrition information and healthy cooking demonstrations for program participants within group sessions. The primary care physician met the patient once a month and kept track of clinical changes over time. Patients with HbA1c ≥ 9% were referred to the high-risk nurse case manager who worked one-on-one with program participants to help them avoid serious diabetes complications.
Ambassadors were a part of all the course and support group sessions, and when needed they attended indivdual sessions, such as doctor visits and meetings with the high-risk nurse case manager. Ambassadors accompanied program participants during visits with clinical staff to provide additional support when requested.
The manager of quality assurance assured the safety of intervention procedures and employed performance improvement methods. Program participants provided informed consent, and had the right to withdraw at any time. The Quality Assurance Committee at WSHC protected the rights of participants, assured the safety of intervention procedures, and assured the quality of care received by each participant.
Evaluation
The Work Group for Community Health and Development at the University of Kansas was selected by the BMS Foundation to evaluate the implementation and related clinical outcomes of the program using a participatory evaluation framework [16–18]. A similarly funded study used the same study approach [19]. Clinical health outcomes were analyzed through a pre-post test comparison using STATA Version 12. Paired t tests were used to examine within-patient health outcome changes. The mean interval between the pre and post measurements was 16 months. A 0.05 level of significance was used. Using a one-sided t test, Cohen’s d was computed to measure effect size.
Results
Services
Clinical Outcomes
Discussion
This empirical case study examined the implementation of the Diabetes Care Coordination Program (DCCP) and its effects on diabetes-related clinical health outcomes for program participants. The program’ glucose screenings and educational workshops at public housing units provided enhanced access to diabetes care services for community members. Referrals to WSHC allowed for the provision of clinical health services through a comprehensive care model. Modest improvements in diabetes-related clinical health indicators were seen.
Some challenges were noted during implementation of the DCCP and addressed as part of a quality improvement process. First, Diabetes Health Ambassadors originally went door to door and had difficulty recruiting participants. Holding screening events in public spaces within housing units addressed this problem. Second, the WSHC team found that women needed more behavioral health support than was being provided, with some of the women reporting to their case managers that it was difficult for them to handle the stresses of life and at the same time manage their diabetes. In response, an integrated behavioral health specialist was hired to provide guidance on how to manage life stressors and how to increase health behaviors despite physical, social, and financial barriers.
Third, women reported a lack of access to fresh fruits and vegetables. In response, WSHC implemented a formal collaboration with a mobile food truck (June 2012) that sold subsidized fresh food 3 days a week to public housing residents. Fourth, participants reported some barriers related to transportation for scheduled appointments at the WSHC. The team addressed this issue by providing taxi vouchers for those who lacked adequate access to transportation. Finally, the coordinated team noticed that medication adherence was a barrier to care for many program participants. Consequently, they developed a medication management support group led by the clinical pharmacist to address barriers related to medication adherence.
There were several methodological challenges confronted in carrying out this study. First, the dose of services that were provided for each individual participant was difficult to ascertain. For example, some of those enrolled in the DCCP earlier may not have had the full set of services that were available towards the end of the program. Second, although group data were available, data on individual level outcomes were not; this made it difficult to assess whether there was change in behavior on the part of particular individuals. Third, a case study design, without a comparison group, does not control for threats to internal validity (eg, history, maturation, and attrition) that might have accounted for improvements in clinical outcomes. Finally, despite the comprehensive documentation, there could have been program elements that were implemented but not documented. Despite these methodological limitations, the case study design facilitated learning about associations between program implementation and changes in clinical health outcomes in a context of health disparities [20].
A particular strength of the program was use of Diabetes Health Ambassadors as mediators for DCCP service delivery. Ambassadors increased diabetes awareness within the community and also played a key role in building rapport and trust in the diabetes program among community members.
Lessons Learned
As part of a qualitative component, key informant interviews with WSHC staff were used to examine lessons learned during project implementation. First, an identified positive outcome was that the Ambassadors gained new insights into the management of their own diabetes and adopted additional lifestyle changes along with program participants. Second, the WSHC team affirmed that African-American women act as gatekeepers for their families, and that teaching and serving one woman allowed for teaching and serving the entire family. Program participants reported that their own lifestyle changes had an impact on other family members. For example, one participant reported she stopped purchasing soda beverages for her family. Another participant began using healthier cooking strategies, such as using olive oil instead of butter. Third, consistent with another study, the coordinated care model helped to assure comprehensive diabetes care [21]. Staff noted that “it takes a village” (a coordinated team) to address the diverse array of clinical issues needed for diabetes control. Fourth, self-management education was helpful, especially when coupled with social support from peers and family members. Fifth, working collaboratively with partners in non-health sectors was helpful in achieving the conditions needed for improved diabetes care [22].
Recommendations for Future Research and Practice
There are several recommendations for future research and practice. First, to achieve stronger clinical health outcomes, the DCCP would need to be enhanced by assuring lower caseloads for the WSHC clinical team. Second, to expand the evidence base, stronger experimental designs are needed to draw firmer conclusions about causal relationships. For instance, a multiple-baseline design across similar federally qualified heath centers could enable a better understanding of the effects of this community-based DCCP intervention in urban contexts. Third, research and practice would benefit from further testing of the model using community health workers for delivery of DSME and DSMS services. Fourth, implementation science can aid in enhancing the role of Ambassadors by providing tools/frameworks for improved delivery of services such as the core implementation components of selection and training [23]. Finally, the use of behavioral science methods can help extend the evidence base for the effects of the DCCP intervention on behavior change at the individual and the community levels [24,25].
Conclusion
This empirical case study adds to our understanding of delivering community-based diabetes care in a public housing context. This study examined the implementation and effects of a diabetes program for African-American women experiencing health disparities. The delivery of diabetes services by Diabetes Health Ambassadors was effective in engaging women with diabetes who lived in low-income housing. This study provided further evidence that coordinated diabetes care, with a focus on culturally and contextually appropriate service delivery, can have positive health outcomes. Further research is needed to examine effects of the DCCP intervention at the individual, clinic, family, and community levels.
Addressing the rapidly increasing prevalence of diabetes is a huge challenge, especially among vulnerable populations at disproportionate risk for adverse health outcomes. These patients face physical, emotional, and financial burdens. We need to assure that community health workers and coordinated clinical teams are prepared to support patients’ acquisition and maintenance of self-care behaviors. Eliminating diabetes-related disparities requires modifying the health system and the broader community environment [26]. Addressing the barriers to medical and self-care that vulnerable populations with type 2 diabetes face will provide them with greater opportunities for health and well-being.
Acknowledgments: The authors thank the many community partners throughout Boston that made this project possible.
Corresponding author: Ithar Hassaballa, KU Work Group for Community Health and Development, University of Kansas, 1000 Sunnyside Ave, 4082 Dole Center, Lawrence, KS 66045, [email protected].
Funding/support: Funding for the Whittier Street Health Center’s Diabetes Care Coordination Program and for the evaluation of the Together on Diabetes initiative was provided by the Bristol-Myers Squibb Foundation.
Financial disclosures: None.
1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004;27:1047–53.
2. Centers for Disease Control and Prevention. National diabetes statistics report: estimates of diabetes and its burden in the United States, 2014. Atlanta: U.S. Department of Health and Human Services; 2014.
3. Narayan KM, Boyle JP, Geiss LS, Saaddine JB, Thompson TJ. Impact of recent increase in incidence on future diabetes burden: U.S., 2005-2050. Diabetes Care 2006;29:2114–6.
4. Tang TS, Brown MB, Funnell MM, Anderson RM. Social support, quality of life, and self-care behaviors among African Americans with type 2 diabetes. Diabetes Educ 2008;34:266-76.
5. Crabtree K, Sherrer N, Rushton T, Willig A, Agne A, Shelton T, Cherrington A. Diabetes connect: African American men's preferences for a community-based diabetes management program. Diabetes Educ 2015;41:118-26.
6. Kirk JK, D'Agostino RB Jr, Bell RA, Passmore LV, Bonds DE, Karter AJ, Narayan KM. Disparities in HbA1c levels between African-American and non-Hispanic white adults with diabetes: a meta-analysis. Diabetes Care 2006;29:2130–6.
7. Batts ML, Gary TL, Huss K, Hill MN, Bone L, Brancati FL. Patient priorities and needs for diabetes care among urban African American adults. Diabetes Educ 2001;27:405–12.
8. Horowitz CR, Colson KA, Hebert PL, Lancaster K. Barriers to buying healthy foods for people with diabetes: evidence of environmental disparities. Am J Public Health 2004;94:1549–54.
9. Haas L, Maryniuk M, Beck J, et al; 2012 Standards Revision Task Force. National standards for diabetes self-management education and support. Diabetes Care 2013;36 Suppl 1:S100–8.
10. Cené CW, Haymore LB, Ellis D, Whitaker S, Henderson S, Lin FC, Corbie-Smith G. Implementation of the power to prevent diabetes prevention educational curriculum into rural African American communities: a feasibility study. Diabetes Educ 2013;39:776–85.
11. Feathers JT, Kieffer EC, Palmisano G, et al. The development, implementation, and process evaluation of the REACH Detroit Partnership's Diabetes Lifestyle Intervention. Diabetes Educ 2007;33:509–20.
12. Rahman S, Hu H, McNeely E, et al. Social and environmental risk factors for hypertension in African Americans. Fla Public Health Rev 2008;5:64–72.
13. US Bureau of the Census. Available at www.cityofboston.gov/dnd/PDR/Maps_and_Neighborhood_Profiles.asp.
14. Reid RJ, Coleman K, Johnson EA, Fishman PA, Hsu C, Soman MP, Trescott CE, Erikson M, Larson EB. The Group Health medical home at year two: cost savings, higher patient satisfaction, and less burnout for providers. Health Aff (Millwood) 2010;29:835–43.
15. Fulp RS, McManus KD, Johnson PA. Barriers to purchasing foods for a high-quality, healthy diet in a low-income African American community. Fam Community Health 2009;32:206–17.
16. Fawcett SB, Schultz JA. Supporting participatory evaluation using the Community Tool Box online documentation system. Community-Based Participatory Research for Health. San Francisco: Jossey-Bass; 2008: 419–23.
17. Collie-Akers V, Schultz JA, Carson V, Fawcett SB, Ronan M. REACH 2010: Kansas City, Missouri evaluating mobilization strategies with neighborhood and faith organizations to reduce risk for health disparities. Health Prom Pract 2009;10(Suppl 2):118S–127S.
18. Fawcett SB, Boothroyd R, Schultz JA, Francisco VT, Carson V, Bremby R. Building capacity for participatory evaluation within community initiatives. J Prev Interven Comm 2003;26:21–36.
19. Sepers CE Jr, Fawcett SB, Lipman R, Schultz J, Colie-Akers V, Perez A. Measuring the implementation and effects of a coordinated care model featuring diabetes self-management education within four patient-centered medical homes. Diabetes Educ 2015;41:328–42.
20. Yin RK. Case study research: Design and methods. Sage; 2013.
21. Mead H, Andres E, Regenstein M. Underserved patients' perspectives on patient-centered primary care: does the patient-centered medical home model meet their needs? Med Care Res Rev 2014;71:61–84.
22. Fawcett S, Schultz J, Watson-Thompson J, Fox M, Bremby R. Building multisectoral partnerships for population health and health equity. Prev Chronic Disease 2010;7:A118. Epub 2010 Oct 15.
23. Fixsen DL, Blase KA, Naoom SF, Wallace F. Core implementation components. Res Soc Work Prac 2009; 19:531–540.
24. Cooper JO, Heron TE, Heward WL. Applied behavior analysis. 2nd ed. Pearson; 2007.
25. Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of public health interventions. Annu Rev Public Health 2010;31:399–418.
26. Jack L, Jack NH, Hayes SC. Social determinants of health in minority populations: a call for multidisciplinary approaches to eliminate diabetes-related health disparities. Diabetes Spectrum 2012;25:9–13.
1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004;27:1047–53.
2. Centers for Disease Control and Prevention. National diabetes statistics report: estimates of diabetes and its burden in the United States, 2014. Atlanta: U.S. Department of Health and Human Services; 2014.
3. Narayan KM, Boyle JP, Geiss LS, Saaddine JB, Thompson TJ. Impact of recent increase in incidence on future diabetes burden: U.S., 2005-2050. Diabetes Care 2006;29:2114–6.
4. Tang TS, Brown MB, Funnell MM, Anderson RM. Social support, quality of life, and self-care behaviors among African Americans with type 2 diabetes. Diabetes Educ 2008;34:266-76.
5. Crabtree K, Sherrer N, Rushton T, Willig A, Agne A, Shelton T, Cherrington A. Diabetes connect: African American men's preferences for a community-based diabetes management program. Diabetes Educ 2015;41:118-26.
6. Kirk JK, D'Agostino RB Jr, Bell RA, Passmore LV, Bonds DE, Karter AJ, Narayan KM. Disparities in HbA1c levels between African-American and non-Hispanic white adults with diabetes: a meta-analysis. Diabetes Care 2006;29:2130–6.
7. Batts ML, Gary TL, Huss K, Hill MN, Bone L, Brancati FL. Patient priorities and needs for diabetes care among urban African American adults. Diabetes Educ 2001;27:405–12.
8. Horowitz CR, Colson KA, Hebert PL, Lancaster K. Barriers to buying healthy foods for people with diabetes: evidence of environmental disparities. Am J Public Health 2004;94:1549–54.
9. Haas L, Maryniuk M, Beck J, et al; 2012 Standards Revision Task Force. National standards for diabetes self-management education and support. Diabetes Care 2013;36 Suppl 1:S100–8.
10. Cené CW, Haymore LB, Ellis D, Whitaker S, Henderson S, Lin FC, Corbie-Smith G. Implementation of the power to prevent diabetes prevention educational curriculum into rural African American communities: a feasibility study. Diabetes Educ 2013;39:776–85.
11. Feathers JT, Kieffer EC, Palmisano G, et al. The development, implementation, and process evaluation of the REACH Detroit Partnership's Diabetes Lifestyle Intervention. Diabetes Educ 2007;33:509–20.
12. Rahman S, Hu H, McNeely E, et al. Social and environmental risk factors for hypertension in African Americans. Fla Public Health Rev 2008;5:64–72.
13. US Bureau of the Census. Available at www.cityofboston.gov/dnd/PDR/Maps_and_Neighborhood_Profiles.asp.
14. Reid RJ, Coleman K, Johnson EA, Fishman PA, Hsu C, Soman MP, Trescott CE, Erikson M, Larson EB. The Group Health medical home at year two: cost savings, higher patient satisfaction, and less burnout for providers. Health Aff (Millwood) 2010;29:835–43.
15. Fulp RS, McManus KD, Johnson PA. Barriers to purchasing foods for a high-quality, healthy diet in a low-income African American community. Fam Community Health 2009;32:206–17.
16. Fawcett SB, Schultz JA. Supporting participatory evaluation using the Community Tool Box online documentation system. Community-Based Participatory Research for Health. San Francisco: Jossey-Bass; 2008: 419–23.
17. Collie-Akers V, Schultz JA, Carson V, Fawcett SB, Ronan M. REACH 2010: Kansas City, Missouri evaluating mobilization strategies with neighborhood and faith organizations to reduce risk for health disparities. Health Prom Pract 2009;10(Suppl 2):118S–127S.
18. Fawcett SB, Boothroyd R, Schultz JA, Francisco VT, Carson V, Bremby R. Building capacity for participatory evaluation within community initiatives. J Prev Interven Comm 2003;26:21–36.
19. Sepers CE Jr, Fawcett SB, Lipman R, Schultz J, Colie-Akers V, Perez A. Measuring the implementation and effects of a coordinated care model featuring diabetes self-management education within four patient-centered medical homes. Diabetes Educ 2015;41:328–42.
20. Yin RK. Case study research: Design and methods. Sage; 2013.
21. Mead H, Andres E, Regenstein M. Underserved patients' perspectives on patient-centered primary care: does the patient-centered medical home model meet their needs? Med Care Res Rev 2014;71:61–84.
22. Fawcett S, Schultz J, Watson-Thompson J, Fox M, Bremby R. Building multisectoral partnerships for population health and health equity. Prev Chronic Disease 2010;7:A118. Epub 2010 Oct 15.
23. Fixsen DL, Blase KA, Naoom SF, Wallace F. Core implementation components. Res Soc Work Prac 2009; 19:531–540.
24. Cooper JO, Heron TE, Heward WL. Applied behavior analysis. 2nd ed. Pearson; 2007.
25. Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of public health interventions. Annu Rev Public Health 2010;31:399–418.
26. Jack L, Jack NH, Hayes SC. Social determinants of health in minority populations: a call for multidisciplinary approaches to eliminate diabetes-related health disparities. Diabetes Spectrum 2012;25:9–13.
Society of Hospital Medicine Launches Med Student Scholarship Program
The Society of Hospital Medicine has launched a new scholarship program to bring the "best and brightest" medical students into the specialty.
The Student Hospitalist Scholar Grant program awards eligible students a $5,000 summer stipend for scholarly work on a project related to patient safety, quality improvement (QI), or other areas relevant to the field of hospital medicine. The program also provides up to $1,500 in travel-related reimbursement for students to attend the SHM annual meeting.
This summer's inaugural class has three students, all going into their second year of medical school: Frank Zadravecz Jr. of the University of Illinois College of Medicine at Chicago, Miriam Zander of Touro College of Osteopathic Medicine in New York City, and Monica Shah of Wayne State University School of Medicine in Detroit.
"Getting medical students involved is important for us," says hospitalist Darlene Tad-y, MD, an assistant professor of medicine at the University of Colorado in Denver and chair of SHM's Physicians in Training Committee. It means "the future of medicine will have people who know how to do this work, people who will be more skilled and effective at this work."
Dr. Tad-y says it makes sense to merge efforts to recruit the "best and brightest" medical students to HM with QI research. This year's projects include examinations of post-hospital syndrome and physiologic alarm responses.
The program drew about a dozen applicants in its first year. Over the next few years, SHM hopes to award 10 scholarships each summer.
"QI work is really only getting off the ground broadly with people who've been in the field for a really long time," Dr. Tad-y says. "To have that many students early on in their medical school career already understand some of these concepts and be aware that this is going on, for us, it's really exciting." TH
Visit our website for more information on engaging young physicians in HM.
The Society of Hospital Medicine has launched a new scholarship program to bring the "best and brightest" medical students into the specialty.
The Student Hospitalist Scholar Grant program awards eligible students a $5,000 summer stipend for scholarly work on a project related to patient safety, quality improvement (QI), or other areas relevant to the field of hospital medicine. The program also provides up to $1,500 in travel-related reimbursement for students to attend the SHM annual meeting.
This summer's inaugural class has three students, all going into their second year of medical school: Frank Zadravecz Jr. of the University of Illinois College of Medicine at Chicago, Miriam Zander of Touro College of Osteopathic Medicine in New York City, and Monica Shah of Wayne State University School of Medicine in Detroit.
"Getting medical students involved is important for us," says hospitalist Darlene Tad-y, MD, an assistant professor of medicine at the University of Colorado in Denver and chair of SHM's Physicians in Training Committee. It means "the future of medicine will have people who know how to do this work, people who will be more skilled and effective at this work."
Dr. Tad-y says it makes sense to merge efforts to recruit the "best and brightest" medical students to HM with QI research. This year's projects include examinations of post-hospital syndrome and physiologic alarm responses.
The program drew about a dozen applicants in its first year. Over the next few years, SHM hopes to award 10 scholarships each summer.
"QI work is really only getting off the ground broadly with people who've been in the field for a really long time," Dr. Tad-y says. "To have that many students early on in their medical school career already understand some of these concepts and be aware that this is going on, for us, it's really exciting." TH
Visit our website for more information on engaging young physicians in HM.
The Society of Hospital Medicine has launched a new scholarship program to bring the "best and brightest" medical students into the specialty.
The Student Hospitalist Scholar Grant program awards eligible students a $5,000 summer stipend for scholarly work on a project related to patient safety, quality improvement (QI), or other areas relevant to the field of hospital medicine. The program also provides up to $1,500 in travel-related reimbursement for students to attend the SHM annual meeting.
This summer's inaugural class has three students, all going into their second year of medical school: Frank Zadravecz Jr. of the University of Illinois College of Medicine at Chicago, Miriam Zander of Touro College of Osteopathic Medicine in New York City, and Monica Shah of Wayne State University School of Medicine in Detroit.
"Getting medical students involved is important for us," says hospitalist Darlene Tad-y, MD, an assistant professor of medicine at the University of Colorado in Denver and chair of SHM's Physicians in Training Committee. It means "the future of medicine will have people who know how to do this work, people who will be more skilled and effective at this work."
Dr. Tad-y says it makes sense to merge efforts to recruit the "best and brightest" medical students to HM with QI research. This year's projects include examinations of post-hospital syndrome and physiologic alarm responses.
The program drew about a dozen applicants in its first year. Over the next few years, SHM hopes to award 10 scholarships each summer.
"QI work is really only getting off the ground broadly with people who've been in the field for a really long time," Dr. Tad-y says. "To have that many students early on in their medical school career already understand some of these concepts and be aware that this is going on, for us, it's really exciting." TH
Visit our website for more information on engaging young physicians in HM.
Single-session psychiatry at 11,000 feet
The woman sitting across from me talked, through two translators (Quechua to Spanish to English) about how sad she had been since the death of her husband last year. “I eat alone,” she said, and my Spanish translator, a native Peruvian, explained the cultural significance of such a phrase to me. Eating alone is not a good thing; sometimes it’s how people are shunned. The woman talked about her adult children and how little contact she had with them, a continual disappointment in a poor rural area where the younger generation often flocked to the city and the hope of a better life.
She was in her 60s and dressed in the traditional attire of the indigenous people of the Andes: a high bowler hat, layers of sweaters, a long skirt, and woolen stockings. Her long black braids remained ageless in a land where somehow hair does not turn gray, but her bronze skin was leathery from generations in the sun. Her problems – grief and loneliness – are universal issues, and while she had moments where she longed for death, she felt her animals, and her cow in particular, needed her now.
Months ago, a friend – an internist – asked if my husband and I would join him, his wife, and some other families we knew on a volunteer medical mission to Peru. Hands Across the Americas is an organization founded by Jennifer Diamond and it has sent 27 medical and surgical missions to Latin America to serve those with limited access to medical treatments. I hesitated when I heard the request, and in case I wasn’t entranced by the idea of spending a week addressing the mental health needs of indigenous people in remote Andean villages, he added that another friend of ours, Patricia Poppe, a native of Peru and an expert on health communications at the Johns Hopkins School of Public Health, was eager to show our group of friends around her homeland before we all joined the mission. With this, I was sold on the whole adventure. I will spare you the details of our wonderful vacation, but will share with you, instead, what I learned about psychiatry in the Andes.
The mission orientation began in Cusco, Peru’s second-largest city and a way station for travelers headed to Machu Picchu. The tourist district of Cusco is a beautiful and fascinating city that reflects both Incan and pre-Incan Latin America and the heavy Spanish influence brought by the 16th- century conquistadors. While the city is beautiful, and the worlds have intertwined over the centuries, it remains a land where there is tension between the different cultures.
At just over 11,000 feet, the air is thin and visitors get easily winded just walking the hills. The villages we worked in were all about an hour outside of Cusco. They were impoverished and dilapidated, with some of the homes still constructed of bricks made from mud and straw. Dogs and farm animals roamed the streets. July is midwinter there, and it’s the dry season, so everything – and everyone – was covered in a layer of Andean grit. By the end of each day, we were as well.
I wish I could say that I wasn’t anxious about the work, but I was. What can a psychiatrist do in a single visit, much less a single session that requires one, and occasionally two, translators, in a population where I had no knowledge of their culture or resources? I didn’t know what types of patients I might see, if using medication would be reasonable, or if follow-up of any kind would be feasible. In the 27 missions of Hands Across the Americas, I was to be the first psychiatrist.
Four years earlier, a psychologist, Dr. David Doolittle, had gone with another psychologist, and when we spoke on the phone, he was very enthusiastic. He told me that this had been one of the best experiences of his professional life, and he was pleased to hear that mental health would continue to be a part of the agenda.
Finally, I should add that despite my hesitation about how helpful I might be as part of a medical team offering one-time services, I did have a similar experience in a different setting; In 2005, I volunteered for 2 weeks with the Substance Abuse and Mental Health Services Administration’s Katrina Assistance Project, and while I wondered then if my efforts were helpful to those I was trying to serve, I walked away feeling that I personally had gotten a great deal from the experience. I decided I would go to Peru with limited expectations and one simple agenda: I would try to be helpful.
The mission started with a brief orientation in Cusco, and it didn’t escape me when the medical director announced that patients could be seen by internal medicine, pediatrics, ENT, gynecology, and optometry. Psychiatry was strangely missing from the list, and when I pointed this out, he told me he had a special job for me: to run the pharmacy. While I was happy to help dispense medications, I had the sense that this population might have unmet mental health needs and suggested that it could be worthwhile to offer psychiatry as a specialty as well!
While the group came with an extensive supply of medications, vitamins, reading glasses, toothbrushes, and some wheelchairs, canes, and walkers, there were no psychotropic medications in the stash. I spoke with a local doctor who served as a liaison, and learned that he was familiar only with diazepam and alprazolam. Psychiatric patients were referred to doctors in Cusco, and local doctors did not prescribe antidepressants. For complex issues that required medical or surgical subspecialization, the referrals were even more complex: Patients traveled 18 hours by bus to be treated in Lima.
On the morning of our first clinic, I was given a small supply of fluoxetine (per my request) and alprazolam. Over 5 days we worked in three sites. On the first day, we were at the municipal center in Huarocondo, a little more than an hour outside of Cusco. Tents were set up inside the building, with the waiting room, triage, and pharmacy all stationed outside on the dirt. Inside, there was very little light, and like the other places we’d set up, no heat. My tent had a table and two chairs meant for primary school children, and I absconded with an adult-sized plastic chair for my interpreter. We had no access to medical records, no labs or radiographic equipment, and no clear place to send anyone for follow-up – this was true across all specialties, though the ENT who was working with us had come with suitcases full of his own equipment. Patients didn’t know what a psychiatrist or psychologist was, and some responded to questions about depression by saying that their blood pressure was just fine. Triage resorted to asking people if they felt sad and wanted to talk to a doctor about it.
The next 2 days, we worked in medical clinics in Ancahuasi and Anta, and while the conditions were more conducive to providing medical care, there was still no heat, the lighting was poor, and the buildings had not seen new coats of paint or furniture in many years. The clinics did not have psychiatrists, but they did each have a psychologist, and a couple of the people I saw had been seen. I was also told that fluoxetine could be obtained in Anta.
Hundreds of patients came each day, and all told, more than a thousand patients were seen by nine doctors in those 5 days. My official psychiatry tally was 79, but my personal count was less – I imagine some people became impatient with the long line and left without being seen – I recorded visits with 8-15 people each day.
First, let me say that I was surprised at the lack of pure psychopathology; the issues were more reactions to tremendous deprivation, violence, loneliness, medical and developmental disorders, and chronic struggles. I saw only two adult men, the rest of the patients were women and a few children. No one I saw had ever seen a psychiatrist before, and no one had taken psychotropic medications (not even the diazepam or alprazolam, which I was told could be obtained), and in fact, very few were on any medications of any kind. No one had ever been in a psychiatric hospital. Poverty was rampant, as was domestic violence: Men beat their wives, parents beat their children, and there seemed to be no societal means to interrupt this. One bruised woman said her husband had been released from jail in a day, and several women spoke of living in fear for their lives; still, their families encouraged them to stay with men who were abusive or unfaithful. I was told that the statistic for spousal abuse in Peru was 60%, in Cusco it was 75%; I suspect it was even higher in these outlying villages. Families were fractured; employment was physically very difficult; and stress was extreme. Low mood and poor sleep were pervasive, but given the fact that I was unsure if people could get follow-up or even afford to refill medications, I gave out very little in the way of medications, and used the fluoxetine only for a few people where I felt their mood and circumstances were so dire that perhaps it would help – and it seemed unlikely to hurt. I was able to hospitalize one 18-year-old mother who was suicidal and said she had tried to hang herself, though she was released early the next morning before she was ever seen by a doctor; she did note she felt much better and was grateful for the help.
Despite tremendous stresses and limited access to care, the suicide rate in Peru are quite low at 3.2 per 100,000 (as compared with nearly 14 per 100,000 in the United States), and despite the fact that some of the patients I saw had considered it, most said that their children or animals needed them, and there are religious prohibitions.
At moments, I wondered what I could possibly offer. One woman came in with a 5-year-old child with Down syndrome strapped to her, and another, older, developmentally delayed child in tow. There were other children at home, and while many women noted that their husbands beat them while they were drunk, this woman said her husband was calmer when he was drinking; he beat her when he was sober. I asked her what would help, and she said she needed money. Feeling I had nothing else to offer, I did something I have never done in my years as a psychiatrist: I gave her money. I hoped that she would spend it on something that might provide a moment of relief from her anguished life.
For the most part, it was interesting work, and often, it felt useful to make psychological interventions, to validate the distress the patients felt and to reorient them to seeing their own strengths. The people talked of holding their problems close, and of a relief and ease that came with sharing their difficulties.
In the end, I did feel helpful for at least some of the patients some of the time. At the very least, I felt appreciated – in one clinic, we were greeted by the mayor and a band – and patients expressed their thanks to both me and my cadre of interpreters, sometimes profusely. In the end, it was an adventure, from the vacation with 16 people to Lima, the Sacred Valley, and Machu Picchu, to my foray into high-volume, single-session psychiatry in a culture so vastly different from my own.
Dr. Miller is a coauthor of “Shrink Rap: Three Psychiatrists Explain Their Work” (Baltimore: Johns Hopkins University Press, 2011).
The woman sitting across from me talked, through two translators (Quechua to Spanish to English) about how sad she had been since the death of her husband last year. “I eat alone,” she said, and my Spanish translator, a native Peruvian, explained the cultural significance of such a phrase to me. Eating alone is not a good thing; sometimes it’s how people are shunned. The woman talked about her adult children and how little contact she had with them, a continual disappointment in a poor rural area where the younger generation often flocked to the city and the hope of a better life.
She was in her 60s and dressed in the traditional attire of the indigenous people of the Andes: a high bowler hat, layers of sweaters, a long skirt, and woolen stockings. Her long black braids remained ageless in a land where somehow hair does not turn gray, but her bronze skin was leathery from generations in the sun. Her problems – grief and loneliness – are universal issues, and while she had moments where she longed for death, she felt her animals, and her cow in particular, needed her now.
Months ago, a friend – an internist – asked if my husband and I would join him, his wife, and some other families we knew on a volunteer medical mission to Peru. Hands Across the Americas is an organization founded by Jennifer Diamond and it has sent 27 medical and surgical missions to Latin America to serve those with limited access to medical treatments. I hesitated when I heard the request, and in case I wasn’t entranced by the idea of spending a week addressing the mental health needs of indigenous people in remote Andean villages, he added that another friend of ours, Patricia Poppe, a native of Peru and an expert on health communications at the Johns Hopkins School of Public Health, was eager to show our group of friends around her homeland before we all joined the mission. With this, I was sold on the whole adventure. I will spare you the details of our wonderful vacation, but will share with you, instead, what I learned about psychiatry in the Andes.
The mission orientation began in Cusco, Peru’s second-largest city and a way station for travelers headed to Machu Picchu. The tourist district of Cusco is a beautiful and fascinating city that reflects both Incan and pre-Incan Latin America and the heavy Spanish influence brought by the 16th- century conquistadors. While the city is beautiful, and the worlds have intertwined over the centuries, it remains a land where there is tension between the different cultures.
At just over 11,000 feet, the air is thin and visitors get easily winded just walking the hills. The villages we worked in were all about an hour outside of Cusco. They were impoverished and dilapidated, with some of the homes still constructed of bricks made from mud and straw. Dogs and farm animals roamed the streets. July is midwinter there, and it’s the dry season, so everything – and everyone – was covered in a layer of Andean grit. By the end of each day, we were as well.
I wish I could say that I wasn’t anxious about the work, but I was. What can a psychiatrist do in a single visit, much less a single session that requires one, and occasionally two, translators, in a population where I had no knowledge of their culture or resources? I didn’t know what types of patients I might see, if using medication would be reasonable, or if follow-up of any kind would be feasible. In the 27 missions of Hands Across the Americas, I was to be the first psychiatrist.
Four years earlier, a psychologist, Dr. David Doolittle, had gone with another psychologist, and when we spoke on the phone, he was very enthusiastic. He told me that this had been one of the best experiences of his professional life, and he was pleased to hear that mental health would continue to be a part of the agenda.
Finally, I should add that despite my hesitation about how helpful I might be as part of a medical team offering one-time services, I did have a similar experience in a different setting; In 2005, I volunteered for 2 weeks with the Substance Abuse and Mental Health Services Administration’s Katrina Assistance Project, and while I wondered then if my efforts were helpful to those I was trying to serve, I walked away feeling that I personally had gotten a great deal from the experience. I decided I would go to Peru with limited expectations and one simple agenda: I would try to be helpful.
The mission started with a brief orientation in Cusco, and it didn’t escape me when the medical director announced that patients could be seen by internal medicine, pediatrics, ENT, gynecology, and optometry. Psychiatry was strangely missing from the list, and when I pointed this out, he told me he had a special job for me: to run the pharmacy. While I was happy to help dispense medications, I had the sense that this population might have unmet mental health needs and suggested that it could be worthwhile to offer psychiatry as a specialty as well!
While the group came with an extensive supply of medications, vitamins, reading glasses, toothbrushes, and some wheelchairs, canes, and walkers, there were no psychotropic medications in the stash. I spoke with a local doctor who served as a liaison, and learned that he was familiar only with diazepam and alprazolam. Psychiatric patients were referred to doctors in Cusco, and local doctors did not prescribe antidepressants. For complex issues that required medical or surgical subspecialization, the referrals were even more complex: Patients traveled 18 hours by bus to be treated in Lima.
On the morning of our first clinic, I was given a small supply of fluoxetine (per my request) and alprazolam. Over 5 days we worked in three sites. On the first day, we were at the municipal center in Huarocondo, a little more than an hour outside of Cusco. Tents were set up inside the building, with the waiting room, triage, and pharmacy all stationed outside on the dirt. Inside, there was very little light, and like the other places we’d set up, no heat. My tent had a table and two chairs meant for primary school children, and I absconded with an adult-sized plastic chair for my interpreter. We had no access to medical records, no labs or radiographic equipment, and no clear place to send anyone for follow-up – this was true across all specialties, though the ENT who was working with us had come with suitcases full of his own equipment. Patients didn’t know what a psychiatrist or psychologist was, and some responded to questions about depression by saying that their blood pressure was just fine. Triage resorted to asking people if they felt sad and wanted to talk to a doctor about it.
The next 2 days, we worked in medical clinics in Ancahuasi and Anta, and while the conditions were more conducive to providing medical care, there was still no heat, the lighting was poor, and the buildings had not seen new coats of paint or furniture in many years. The clinics did not have psychiatrists, but they did each have a psychologist, and a couple of the people I saw had been seen. I was also told that fluoxetine could be obtained in Anta.
Hundreds of patients came each day, and all told, more than a thousand patients were seen by nine doctors in those 5 days. My official psychiatry tally was 79, but my personal count was less – I imagine some people became impatient with the long line and left without being seen – I recorded visits with 8-15 people each day.
First, let me say that I was surprised at the lack of pure psychopathology; the issues were more reactions to tremendous deprivation, violence, loneliness, medical and developmental disorders, and chronic struggles. I saw only two adult men, the rest of the patients were women and a few children. No one I saw had ever seen a psychiatrist before, and no one had taken psychotropic medications (not even the diazepam or alprazolam, which I was told could be obtained), and in fact, very few were on any medications of any kind. No one had ever been in a psychiatric hospital. Poverty was rampant, as was domestic violence: Men beat their wives, parents beat their children, and there seemed to be no societal means to interrupt this. One bruised woman said her husband had been released from jail in a day, and several women spoke of living in fear for their lives; still, their families encouraged them to stay with men who were abusive or unfaithful. I was told that the statistic for spousal abuse in Peru was 60%, in Cusco it was 75%; I suspect it was even higher in these outlying villages. Families were fractured; employment was physically very difficult; and stress was extreme. Low mood and poor sleep were pervasive, but given the fact that I was unsure if people could get follow-up or even afford to refill medications, I gave out very little in the way of medications, and used the fluoxetine only for a few people where I felt their mood and circumstances were so dire that perhaps it would help – and it seemed unlikely to hurt. I was able to hospitalize one 18-year-old mother who was suicidal and said she had tried to hang herself, though she was released early the next morning before she was ever seen by a doctor; she did note she felt much better and was grateful for the help.
Despite tremendous stresses and limited access to care, the suicide rate in Peru are quite low at 3.2 per 100,000 (as compared with nearly 14 per 100,000 in the United States), and despite the fact that some of the patients I saw had considered it, most said that their children or animals needed them, and there are religious prohibitions.
At moments, I wondered what I could possibly offer. One woman came in with a 5-year-old child with Down syndrome strapped to her, and another, older, developmentally delayed child in tow. There were other children at home, and while many women noted that their husbands beat them while they were drunk, this woman said her husband was calmer when he was drinking; he beat her when he was sober. I asked her what would help, and she said she needed money. Feeling I had nothing else to offer, I did something I have never done in my years as a psychiatrist: I gave her money. I hoped that she would spend it on something that might provide a moment of relief from her anguished life.
For the most part, it was interesting work, and often, it felt useful to make psychological interventions, to validate the distress the patients felt and to reorient them to seeing their own strengths. The people talked of holding their problems close, and of a relief and ease that came with sharing their difficulties.
In the end, I did feel helpful for at least some of the patients some of the time. At the very least, I felt appreciated – in one clinic, we were greeted by the mayor and a band – and patients expressed their thanks to both me and my cadre of interpreters, sometimes profusely. In the end, it was an adventure, from the vacation with 16 people to Lima, the Sacred Valley, and Machu Picchu, to my foray into high-volume, single-session psychiatry in a culture so vastly different from my own.
Dr. Miller is a coauthor of “Shrink Rap: Three Psychiatrists Explain Their Work” (Baltimore: Johns Hopkins University Press, 2011).
The woman sitting across from me talked, through two translators (Quechua to Spanish to English) about how sad she had been since the death of her husband last year. “I eat alone,” she said, and my Spanish translator, a native Peruvian, explained the cultural significance of such a phrase to me. Eating alone is not a good thing; sometimes it’s how people are shunned. The woman talked about her adult children and how little contact she had with them, a continual disappointment in a poor rural area where the younger generation often flocked to the city and the hope of a better life.
She was in her 60s and dressed in the traditional attire of the indigenous people of the Andes: a high bowler hat, layers of sweaters, a long skirt, and woolen stockings. Her long black braids remained ageless in a land where somehow hair does not turn gray, but her bronze skin was leathery from generations in the sun. Her problems – grief and loneliness – are universal issues, and while she had moments where she longed for death, she felt her animals, and her cow in particular, needed her now.
Months ago, a friend – an internist – asked if my husband and I would join him, his wife, and some other families we knew on a volunteer medical mission to Peru. Hands Across the Americas is an organization founded by Jennifer Diamond and it has sent 27 medical and surgical missions to Latin America to serve those with limited access to medical treatments. I hesitated when I heard the request, and in case I wasn’t entranced by the idea of spending a week addressing the mental health needs of indigenous people in remote Andean villages, he added that another friend of ours, Patricia Poppe, a native of Peru and an expert on health communications at the Johns Hopkins School of Public Health, was eager to show our group of friends around her homeland before we all joined the mission. With this, I was sold on the whole adventure. I will spare you the details of our wonderful vacation, but will share with you, instead, what I learned about psychiatry in the Andes.
The mission orientation began in Cusco, Peru’s second-largest city and a way station for travelers headed to Machu Picchu. The tourist district of Cusco is a beautiful and fascinating city that reflects both Incan and pre-Incan Latin America and the heavy Spanish influence brought by the 16th- century conquistadors. While the city is beautiful, and the worlds have intertwined over the centuries, it remains a land where there is tension between the different cultures.
At just over 11,000 feet, the air is thin and visitors get easily winded just walking the hills. The villages we worked in were all about an hour outside of Cusco. They were impoverished and dilapidated, with some of the homes still constructed of bricks made from mud and straw. Dogs and farm animals roamed the streets. July is midwinter there, and it’s the dry season, so everything – and everyone – was covered in a layer of Andean grit. By the end of each day, we were as well.
I wish I could say that I wasn’t anxious about the work, but I was. What can a psychiatrist do in a single visit, much less a single session that requires one, and occasionally two, translators, in a population where I had no knowledge of their culture or resources? I didn’t know what types of patients I might see, if using medication would be reasonable, or if follow-up of any kind would be feasible. In the 27 missions of Hands Across the Americas, I was to be the first psychiatrist.
Four years earlier, a psychologist, Dr. David Doolittle, had gone with another psychologist, and when we spoke on the phone, he was very enthusiastic. He told me that this had been one of the best experiences of his professional life, and he was pleased to hear that mental health would continue to be a part of the agenda.
Finally, I should add that despite my hesitation about how helpful I might be as part of a medical team offering one-time services, I did have a similar experience in a different setting; In 2005, I volunteered for 2 weeks with the Substance Abuse and Mental Health Services Administration’s Katrina Assistance Project, and while I wondered then if my efforts were helpful to those I was trying to serve, I walked away feeling that I personally had gotten a great deal from the experience. I decided I would go to Peru with limited expectations and one simple agenda: I would try to be helpful.
The mission started with a brief orientation in Cusco, and it didn’t escape me when the medical director announced that patients could be seen by internal medicine, pediatrics, ENT, gynecology, and optometry. Psychiatry was strangely missing from the list, and when I pointed this out, he told me he had a special job for me: to run the pharmacy. While I was happy to help dispense medications, I had the sense that this population might have unmet mental health needs and suggested that it could be worthwhile to offer psychiatry as a specialty as well!
While the group came with an extensive supply of medications, vitamins, reading glasses, toothbrushes, and some wheelchairs, canes, and walkers, there were no psychotropic medications in the stash. I spoke with a local doctor who served as a liaison, and learned that he was familiar only with diazepam and alprazolam. Psychiatric patients were referred to doctors in Cusco, and local doctors did not prescribe antidepressants. For complex issues that required medical or surgical subspecialization, the referrals were even more complex: Patients traveled 18 hours by bus to be treated in Lima.
On the morning of our first clinic, I was given a small supply of fluoxetine (per my request) and alprazolam. Over 5 days we worked in three sites. On the first day, we were at the municipal center in Huarocondo, a little more than an hour outside of Cusco. Tents were set up inside the building, with the waiting room, triage, and pharmacy all stationed outside on the dirt. Inside, there was very little light, and like the other places we’d set up, no heat. My tent had a table and two chairs meant for primary school children, and I absconded with an adult-sized plastic chair for my interpreter. We had no access to medical records, no labs or radiographic equipment, and no clear place to send anyone for follow-up – this was true across all specialties, though the ENT who was working with us had come with suitcases full of his own equipment. Patients didn’t know what a psychiatrist or psychologist was, and some responded to questions about depression by saying that their blood pressure was just fine. Triage resorted to asking people if they felt sad and wanted to talk to a doctor about it.
The next 2 days, we worked in medical clinics in Ancahuasi and Anta, and while the conditions were more conducive to providing medical care, there was still no heat, the lighting was poor, and the buildings had not seen new coats of paint or furniture in many years. The clinics did not have psychiatrists, but they did each have a psychologist, and a couple of the people I saw had been seen. I was also told that fluoxetine could be obtained in Anta.
Hundreds of patients came each day, and all told, more than a thousand patients were seen by nine doctors in those 5 days. My official psychiatry tally was 79, but my personal count was less – I imagine some people became impatient with the long line and left without being seen – I recorded visits with 8-15 people each day.
First, let me say that I was surprised at the lack of pure psychopathology; the issues were more reactions to tremendous deprivation, violence, loneliness, medical and developmental disorders, and chronic struggles. I saw only two adult men, the rest of the patients were women and a few children. No one I saw had ever seen a psychiatrist before, and no one had taken psychotropic medications (not even the diazepam or alprazolam, which I was told could be obtained), and in fact, very few were on any medications of any kind. No one had ever been in a psychiatric hospital. Poverty was rampant, as was domestic violence: Men beat their wives, parents beat their children, and there seemed to be no societal means to interrupt this. One bruised woman said her husband had been released from jail in a day, and several women spoke of living in fear for their lives; still, their families encouraged them to stay with men who were abusive or unfaithful. I was told that the statistic for spousal abuse in Peru was 60%, in Cusco it was 75%; I suspect it was even higher in these outlying villages. Families were fractured; employment was physically very difficult; and stress was extreme. Low mood and poor sleep were pervasive, but given the fact that I was unsure if people could get follow-up or even afford to refill medications, I gave out very little in the way of medications, and used the fluoxetine only for a few people where I felt their mood and circumstances were so dire that perhaps it would help – and it seemed unlikely to hurt. I was able to hospitalize one 18-year-old mother who was suicidal and said she had tried to hang herself, though she was released early the next morning before she was ever seen by a doctor; she did note she felt much better and was grateful for the help.
Despite tremendous stresses and limited access to care, the suicide rate in Peru are quite low at 3.2 per 100,000 (as compared with nearly 14 per 100,000 in the United States), and despite the fact that some of the patients I saw had considered it, most said that their children or animals needed them, and there are religious prohibitions.
At moments, I wondered what I could possibly offer. One woman came in with a 5-year-old child with Down syndrome strapped to her, and another, older, developmentally delayed child in tow. There were other children at home, and while many women noted that their husbands beat them while they were drunk, this woman said her husband was calmer when he was drinking; he beat her when he was sober. I asked her what would help, and she said she needed money. Feeling I had nothing else to offer, I did something I have never done in my years as a psychiatrist: I gave her money. I hoped that she would spend it on something that might provide a moment of relief from her anguished life.
For the most part, it was interesting work, and often, it felt useful to make psychological interventions, to validate the distress the patients felt and to reorient them to seeing their own strengths. The people talked of holding their problems close, and of a relief and ease that came with sharing their difficulties.
In the end, I did feel helpful for at least some of the patients some of the time. At the very least, I felt appreciated – in one clinic, we were greeted by the mayor and a band – and patients expressed their thanks to both me and my cadre of interpreters, sometimes profusely. In the end, it was an adventure, from the vacation with 16 people to Lima, the Sacred Valley, and Machu Picchu, to my foray into high-volume, single-session psychiatry in a culture so vastly different from my own.
Dr. Miller is a coauthor of “Shrink Rap: Three Psychiatrists Explain Their Work” (Baltimore: Johns Hopkins University Press, 2011).
CMS Proposes Major Initiative for Hip and Knee Replacements
In an attempt to reduce the rate and cost of complications following hip and knee replacements among Medicare beneficiaries, the Centers for Medicare & Medicaid Services (CMS) announced a new Comprehensive Care for Joint Replacement payment model. With this new measure, the CMS proposes to hold hospitals accountable for the quality of care they deliver to Medicare fee-for-service beneficiaries for hip and knee replacements from surgery through recovery.
“We are committed to changing our health care system to pay for quality over quantity, so that we spend our dollars more wisely and improve care for patients,” said Sylvia M. Burwell, Secretary of Health and Human Services.
Through the proposed 5-year payment model, health care providers in 75 geographic areas would continue to be paid under existing Medicare payment systems. However, the hospital where the hip or knee replacement is performed would be held liable for the quality and costs of care for the duration of care, from the time of the surgery through 90 days after discharge.
Depending on the hospital’s quality and cost performance during the episode, the hospital may receive an additional payment or be required to repay Medicare for a portion of the episode costs. As a result, hospitals would have an incentive to work with physicians, home health agencies, and nursing facilities to ensure that beneficiaries receive the coordinated care they need, with the goal of reducing avoidable hospitalizations and complications. Hospitals would receive tools, such as spending and utilization data and sharing of best practices, to improve the effectiveness of care coordination.
These bundled payments for joint replacement surgeries would build upon successful demonstration programs already underway in Medicare. This model is also consistent with the private sector, where major employers and leading providers and care systems are moving towards bundled payments for orthopedic services.
“Today, we are taking another important step to improve the quality of care for the hundreds of thousands of Americans who have hip and knee replacements through Medicare every year. By focusing on episodes of care, rather than a piecemeal system, hospitals and physicians have an incentive to work together to deliver more effective and efficient care. This model will incentivize providing patients with the right care the first time and finding better ways to help them recover successfully. It will reward providers and doctors for helping patients get and stay healthy, ” stated Ms. Burwell.
In an attempt to reduce the rate and cost of complications following hip and knee replacements among Medicare beneficiaries, the Centers for Medicare & Medicaid Services (CMS) announced a new Comprehensive Care for Joint Replacement payment model. With this new measure, the CMS proposes to hold hospitals accountable for the quality of care they deliver to Medicare fee-for-service beneficiaries for hip and knee replacements from surgery through recovery.
“We are committed to changing our health care system to pay for quality over quantity, so that we spend our dollars more wisely and improve care for patients,” said Sylvia M. Burwell, Secretary of Health and Human Services.
Through the proposed 5-year payment model, health care providers in 75 geographic areas would continue to be paid under existing Medicare payment systems. However, the hospital where the hip or knee replacement is performed would be held liable for the quality and costs of care for the duration of care, from the time of the surgery through 90 days after discharge.
Depending on the hospital’s quality and cost performance during the episode, the hospital may receive an additional payment or be required to repay Medicare for a portion of the episode costs. As a result, hospitals would have an incentive to work with physicians, home health agencies, and nursing facilities to ensure that beneficiaries receive the coordinated care they need, with the goal of reducing avoidable hospitalizations and complications. Hospitals would receive tools, such as spending and utilization data and sharing of best practices, to improve the effectiveness of care coordination.
These bundled payments for joint replacement surgeries would build upon successful demonstration programs already underway in Medicare. This model is also consistent with the private sector, where major employers and leading providers and care systems are moving towards bundled payments for orthopedic services.
“Today, we are taking another important step to improve the quality of care for the hundreds of thousands of Americans who have hip and knee replacements through Medicare every year. By focusing on episodes of care, rather than a piecemeal system, hospitals and physicians have an incentive to work together to deliver more effective and efficient care. This model will incentivize providing patients with the right care the first time and finding better ways to help them recover successfully. It will reward providers and doctors for helping patients get and stay healthy, ” stated Ms. Burwell.
In an attempt to reduce the rate and cost of complications following hip and knee replacements among Medicare beneficiaries, the Centers for Medicare & Medicaid Services (CMS) announced a new Comprehensive Care for Joint Replacement payment model. With this new measure, the CMS proposes to hold hospitals accountable for the quality of care they deliver to Medicare fee-for-service beneficiaries for hip and knee replacements from surgery through recovery.
“We are committed to changing our health care system to pay for quality over quantity, so that we spend our dollars more wisely and improve care for patients,” said Sylvia M. Burwell, Secretary of Health and Human Services.
Through the proposed 5-year payment model, health care providers in 75 geographic areas would continue to be paid under existing Medicare payment systems. However, the hospital where the hip or knee replacement is performed would be held liable for the quality and costs of care for the duration of care, from the time of the surgery through 90 days after discharge.
Depending on the hospital’s quality and cost performance during the episode, the hospital may receive an additional payment or be required to repay Medicare for a portion of the episode costs. As a result, hospitals would have an incentive to work with physicians, home health agencies, and nursing facilities to ensure that beneficiaries receive the coordinated care they need, with the goal of reducing avoidable hospitalizations and complications. Hospitals would receive tools, such as spending and utilization data and sharing of best practices, to improve the effectiveness of care coordination.
These bundled payments for joint replacement surgeries would build upon successful demonstration programs already underway in Medicare. This model is also consistent with the private sector, where major employers and leading providers and care systems are moving towards bundled payments for orthopedic services.
“Today, we are taking another important step to improve the quality of care for the hundreds of thousands of Americans who have hip and knee replacements through Medicare every year. By focusing on episodes of care, rather than a piecemeal system, hospitals and physicians have an incentive to work together to deliver more effective and efficient care. This model will incentivize providing patients with the right care the first time and finding better ways to help them recover successfully. It will reward providers and doctors for helping patients get and stay healthy, ” stated Ms. Burwell.
PHM15: Challenging Diagnoses, Ethical Dilemmas in Pediatric Immigrant, Refugee Patient Cases
Presenters: Nichole Chandler MD, Suresh Nagappan MD MSPH, Angela Hartsell MD MPH, and Emily Hodnett MD
This workshop focused on interactive cases to highlight healthcare issues specific to the population of refugee/immigrant children in the US. It was an interactive format with small groups to allow the participants to work through the diagnoses by discovery. The cases included a Burmese infant with macrocephaly due to congenital toxoplasmosis and a school-age Eritrean child with abdominal pain due to Plasmodium vivax malaria. In addition to discussing the clinical presentation and work up of the patients, there were accompanying ethical dilemmas that were a part of taking care these patients. The presenters emphasized the importance of culturally sensitive communication and seeking competent translation for key clinical discussions. At the end, they supplied a list of resources for more information on refugees in the US and refugee healthcare.
Bethany Hodge MD MPH
Just for Kids Pediatric Hospitalists, Kosair Children’s Hospital
Assistant professor, Department of Pediatrics
Director of the Distinction in Global Health Track
University of Louisville School of Medicine
Presenters: Nichole Chandler MD, Suresh Nagappan MD MSPH, Angela Hartsell MD MPH, and Emily Hodnett MD
This workshop focused on interactive cases to highlight healthcare issues specific to the population of refugee/immigrant children in the US. It was an interactive format with small groups to allow the participants to work through the diagnoses by discovery. The cases included a Burmese infant with macrocephaly due to congenital toxoplasmosis and a school-age Eritrean child with abdominal pain due to Plasmodium vivax malaria. In addition to discussing the clinical presentation and work up of the patients, there were accompanying ethical dilemmas that were a part of taking care these patients. The presenters emphasized the importance of culturally sensitive communication and seeking competent translation for key clinical discussions. At the end, they supplied a list of resources for more information on refugees in the US and refugee healthcare.
Bethany Hodge MD MPH
Just for Kids Pediatric Hospitalists, Kosair Children’s Hospital
Assistant professor, Department of Pediatrics
Director of the Distinction in Global Health Track
University of Louisville School of Medicine
Presenters: Nichole Chandler MD, Suresh Nagappan MD MSPH, Angela Hartsell MD MPH, and Emily Hodnett MD
This workshop focused on interactive cases to highlight healthcare issues specific to the population of refugee/immigrant children in the US. It was an interactive format with small groups to allow the participants to work through the diagnoses by discovery. The cases included a Burmese infant with macrocephaly due to congenital toxoplasmosis and a school-age Eritrean child with abdominal pain due to Plasmodium vivax malaria. In addition to discussing the clinical presentation and work up of the patients, there were accompanying ethical dilemmas that were a part of taking care these patients. The presenters emphasized the importance of culturally sensitive communication and seeking competent translation for key clinical discussions. At the end, they supplied a list of resources for more information on refugees in the US and refugee healthcare.
Bethany Hodge MD MPH
Just for Kids Pediatric Hospitalists, Kosair Children’s Hospital
Assistant professor, Department of Pediatrics
Director of the Distinction in Global Health Track
University of Louisville School of Medicine
New hope for treating fatal subtype of ALL
Photo by Aaron Logan
Preclinical research has revealed potential therapeutic options for TCF3-HLF-positive acute lymphoblastic leukemia (ALL).
Investigators discovered a range of mutations in this subtype of ALL and identified features that appear to contribute to treatment resistance.
However, the team also found that TCF3-HLF-positive ALL is sensitive to treatment with glucocorticoids, anthracyclines, and certain agents in clinical development.
The BCL2-specific inhibitor venetoclax (ABT-199) proved particularly active against the disease.
Jean-Pierre Bourquin, MD, PhD, of the University Children’s Hospital Zurich in Switzerland, and his colleagues reported these findings in Nature Genetics.
The investigators sequenced samples from patients with TCF3-HLF-positive ALL and found a range of mutations. Most samples (67%) had deletions in PAX5, and most of the samples without PAX5 deletions had deletions in VPREB1.
The team also found recurrent mutations of TCF3, a new fusion gene (KHDRBS1-LCK), and activating mutations in RAS signaling pathway genes (NRAS, KRAS, and PTPN11), among other mutations.
After additional investigation, Dr Bourquin and his colleagues hypothesized that the initiating TCF3-HLF fusion in this disease occurs in a B-cell progenitor, and the specific lineage context is constrained further in a restricted developmental stage by additional mutations.
The investigators also tested various treatments in mouse models of TCF3-HLF-positive ALL. They observed resistance to dasatinib, nucleotide analogs, mitotic spindle inhibitors, and polo-like and aurora kinase inhibitors.
On the other hand, the disease was sensitive to glucocorticoids, mTOR inhibitors, anthracyclines, bortezomib, the HSP90 inhibitor AUY922, and panobinostat.
The team also found evidence suggesting that BCL2 might promote leukemic cell survival and constitute a druggable target in TCF3-HLF-positive ALL. So they tested the BCL2 inhibitor venetoclax in the mice.
A 2-week course of daily venetoclax significantly delayed leukemia progression, and xenografts from relapsed patients and those with minimal residual disease remained sensitive to venetoclax. The drug also exhibited synergistic effects when combined with vincristine or dexamethasone.
“Further studies are now needed to test how the results of our study might be used for therapeutic possibilities,” Dr Bourquin concluded.
Photo by Aaron Logan
Preclinical research has revealed potential therapeutic options for TCF3-HLF-positive acute lymphoblastic leukemia (ALL).
Investigators discovered a range of mutations in this subtype of ALL and identified features that appear to contribute to treatment resistance.
However, the team also found that TCF3-HLF-positive ALL is sensitive to treatment with glucocorticoids, anthracyclines, and certain agents in clinical development.
The BCL2-specific inhibitor venetoclax (ABT-199) proved particularly active against the disease.
Jean-Pierre Bourquin, MD, PhD, of the University Children’s Hospital Zurich in Switzerland, and his colleagues reported these findings in Nature Genetics.
The investigators sequenced samples from patients with TCF3-HLF-positive ALL and found a range of mutations. Most samples (67%) had deletions in PAX5, and most of the samples without PAX5 deletions had deletions in VPREB1.
The team also found recurrent mutations of TCF3, a new fusion gene (KHDRBS1-LCK), and activating mutations in RAS signaling pathway genes (NRAS, KRAS, and PTPN11), among other mutations.
After additional investigation, Dr Bourquin and his colleagues hypothesized that the initiating TCF3-HLF fusion in this disease occurs in a B-cell progenitor, and the specific lineage context is constrained further in a restricted developmental stage by additional mutations.
The investigators also tested various treatments in mouse models of TCF3-HLF-positive ALL. They observed resistance to dasatinib, nucleotide analogs, mitotic spindle inhibitors, and polo-like and aurora kinase inhibitors.
On the other hand, the disease was sensitive to glucocorticoids, mTOR inhibitors, anthracyclines, bortezomib, the HSP90 inhibitor AUY922, and panobinostat.
The team also found evidence suggesting that BCL2 might promote leukemic cell survival and constitute a druggable target in TCF3-HLF-positive ALL. So they tested the BCL2 inhibitor venetoclax in the mice.
A 2-week course of daily venetoclax significantly delayed leukemia progression, and xenografts from relapsed patients and those with minimal residual disease remained sensitive to venetoclax. The drug also exhibited synergistic effects when combined with vincristine or dexamethasone.
“Further studies are now needed to test how the results of our study might be used for therapeutic possibilities,” Dr Bourquin concluded.
Photo by Aaron Logan
Preclinical research has revealed potential therapeutic options for TCF3-HLF-positive acute lymphoblastic leukemia (ALL).
Investigators discovered a range of mutations in this subtype of ALL and identified features that appear to contribute to treatment resistance.
However, the team also found that TCF3-HLF-positive ALL is sensitive to treatment with glucocorticoids, anthracyclines, and certain agents in clinical development.
The BCL2-specific inhibitor venetoclax (ABT-199) proved particularly active against the disease.
Jean-Pierre Bourquin, MD, PhD, of the University Children’s Hospital Zurich in Switzerland, and his colleagues reported these findings in Nature Genetics.
The investigators sequenced samples from patients with TCF3-HLF-positive ALL and found a range of mutations. Most samples (67%) had deletions in PAX5, and most of the samples without PAX5 deletions had deletions in VPREB1.
The team also found recurrent mutations of TCF3, a new fusion gene (KHDRBS1-LCK), and activating mutations in RAS signaling pathway genes (NRAS, KRAS, and PTPN11), among other mutations.
After additional investigation, Dr Bourquin and his colleagues hypothesized that the initiating TCF3-HLF fusion in this disease occurs in a B-cell progenitor, and the specific lineage context is constrained further in a restricted developmental stage by additional mutations.
The investigators also tested various treatments in mouse models of TCF3-HLF-positive ALL. They observed resistance to dasatinib, nucleotide analogs, mitotic spindle inhibitors, and polo-like and aurora kinase inhibitors.
On the other hand, the disease was sensitive to glucocorticoids, mTOR inhibitors, anthracyclines, bortezomib, the HSP90 inhibitor AUY922, and panobinostat.
The team also found evidence suggesting that BCL2 might promote leukemic cell survival and constitute a druggable target in TCF3-HLF-positive ALL. So they tested the BCL2 inhibitor venetoclax in the mice.
A 2-week course of daily venetoclax significantly delayed leukemia progression, and xenografts from relapsed patients and those with minimal residual disease remained sensitive to venetoclax. The drug also exhibited synergistic effects when combined with vincristine or dexamethasone.
“Further studies are now needed to test how the results of our study might be used for therapeutic possibilities,” Dr Bourquin concluded.
Corrected iPSCs fight hemophilia A in mice
Image from the Salk Institute
Researchers say they have found a way to correct the chromosomal inversions that can cause severe hemophilia A.
The team used CRISPR-Cas9 RNA-guided engineered nucleases (RGENs) to correct the inversions and reverse factor VIII (FVIII) deficiency in patient-specific induced pluripotent stem cells (iPSCs).
Once the iPSCs had matured into endothelial cells, the group transplanted those cells into mice with hemophilia A.
This increased FVIII activity in the mice without any off-target effects.
The researchers described this work in Cell Stem Cell.
“We used CRISPR RGENs to repair two recurrent, large chromosomal inversions responsible for almost half of all severe hemophilia A cases,” said Jin-Soo Kim, PhD, of the Institute for Basic Science in Seoul, Korea.
The inversions involve the FVIII intron 1 homolog (responsible for about 5% of severe hemophilia A cases) and the intron 22 homolog (responsible for about 40% of cases).
The researchers first collected urinary cells from patients with these inversions, using the cells to generate iPSCs. The team then applied CRISPR-Cas9 RGENs.
The gene-editing technique effectively repaired the FVIII gene in iPSCs that had harbored either inversion. The researchers then forced the corrected iPSCs to differentiate into mature endothelial cells and found these cells successfully expressed the FVIII protein.
To verify that the endothelial cells could reverse FVIII deficiency, the team transplanted the cells into mice with hemophilia A.
The mice soon began producing FVIII on their own, although the FVIII activity in these mice was 10% that of wild-type mice. The activity was higher than FVIII activity in control mice with hemophilia A (3.3% of wild-type mice), but the difference was not statistically significant.
“To the best of our knowledge, this report is the first demonstration that chromosomal inversions or other large rearrangements can be corrected using RGENs or any other programmable nuclease in patient iPSCs,” said Dong-Wook Kim, PhD, of Yonsei University College of Medicine in Seoul, Korea.
The researchers also noted that there was no evidence of off-target mutations with the 3 RGENS used in this study.
Image from the Salk Institute
Researchers say they have found a way to correct the chromosomal inversions that can cause severe hemophilia A.
The team used CRISPR-Cas9 RNA-guided engineered nucleases (RGENs) to correct the inversions and reverse factor VIII (FVIII) deficiency in patient-specific induced pluripotent stem cells (iPSCs).
Once the iPSCs had matured into endothelial cells, the group transplanted those cells into mice with hemophilia A.
This increased FVIII activity in the mice without any off-target effects.
The researchers described this work in Cell Stem Cell.
“We used CRISPR RGENs to repair two recurrent, large chromosomal inversions responsible for almost half of all severe hemophilia A cases,” said Jin-Soo Kim, PhD, of the Institute for Basic Science in Seoul, Korea.
The inversions involve the FVIII intron 1 homolog (responsible for about 5% of severe hemophilia A cases) and the intron 22 homolog (responsible for about 40% of cases).
The researchers first collected urinary cells from patients with these inversions, using the cells to generate iPSCs. The team then applied CRISPR-Cas9 RGENs.
The gene-editing technique effectively repaired the FVIII gene in iPSCs that had harbored either inversion. The researchers then forced the corrected iPSCs to differentiate into mature endothelial cells and found these cells successfully expressed the FVIII protein.
To verify that the endothelial cells could reverse FVIII deficiency, the team transplanted the cells into mice with hemophilia A.
The mice soon began producing FVIII on their own, although the FVIII activity in these mice was 10% that of wild-type mice. The activity was higher than FVIII activity in control mice with hemophilia A (3.3% of wild-type mice), but the difference was not statistically significant.
“To the best of our knowledge, this report is the first demonstration that chromosomal inversions or other large rearrangements can be corrected using RGENs or any other programmable nuclease in patient iPSCs,” said Dong-Wook Kim, PhD, of Yonsei University College of Medicine in Seoul, Korea.
The researchers also noted that there was no evidence of off-target mutations with the 3 RGENS used in this study.
Image from the Salk Institute
Researchers say they have found a way to correct the chromosomal inversions that can cause severe hemophilia A.
The team used CRISPR-Cas9 RNA-guided engineered nucleases (RGENs) to correct the inversions and reverse factor VIII (FVIII) deficiency in patient-specific induced pluripotent stem cells (iPSCs).
Once the iPSCs had matured into endothelial cells, the group transplanted those cells into mice with hemophilia A.
This increased FVIII activity in the mice without any off-target effects.
The researchers described this work in Cell Stem Cell.
“We used CRISPR RGENs to repair two recurrent, large chromosomal inversions responsible for almost half of all severe hemophilia A cases,” said Jin-Soo Kim, PhD, of the Institute for Basic Science in Seoul, Korea.
The inversions involve the FVIII intron 1 homolog (responsible for about 5% of severe hemophilia A cases) and the intron 22 homolog (responsible for about 40% of cases).
The researchers first collected urinary cells from patients with these inversions, using the cells to generate iPSCs. The team then applied CRISPR-Cas9 RGENs.
The gene-editing technique effectively repaired the FVIII gene in iPSCs that had harbored either inversion. The researchers then forced the corrected iPSCs to differentiate into mature endothelial cells and found these cells successfully expressed the FVIII protein.
To verify that the endothelial cells could reverse FVIII deficiency, the team transplanted the cells into mice with hemophilia A.
The mice soon began producing FVIII on their own, although the FVIII activity in these mice was 10% that of wild-type mice. The activity was higher than FVIII activity in control mice with hemophilia A (3.3% of wild-type mice), but the difference was not statistically significant.
“To the best of our knowledge, this report is the first demonstration that chromosomal inversions or other large rearrangements can be corrected using RGENs or any other programmable nuclease in patient iPSCs,” said Dong-Wook Kim, PhD, of Yonsei University College of Medicine in Seoul, Korea.
The researchers also noted that there was no evidence of off-target mutations with the 3 RGENS used in this study.
Some AEs not reported according to regulations
Photo courtesy of the FDA
A new study indicates that drug manufacturers fail to report about 10% of serious and unexpected adverse events (AEs) within the timeframe set out in federal regulations.
Manufacturers are required to report a serious AE (death, hospitalization, disability, etc.) or unexpected AE (anything not listed in the drug’s label) to the US Food and Drug Administration (FDA) within 15 calendar days of learning about the event.
But an analysis of more than 1.6 million AE reports showed that manufacturers failed to meet this requirement for nearly 10% of AEs.
Pinar Karaca-Mandic, PhD, of the University of Minnesota School of Public Health in Minneapolis, and her colleagues conducted the analysis and detailed the results in JAMA Internal Medicine.
The team examined data from the FDA Adverse Event Reporting System for AE reports made from January 2004 through June 2014. The final study sample included only reports that were subject to the regulation requiring submission within 15 days—a total of 1,613,079 reports.
The researchers found that 9.94% of reports were not received by the FDA within the 15-day timeframe. This was a total of 160,383 reports—40,464 cases in which patients died and 119,919 in which they did not.
So 90.06% of reports (n=1,452,696) were reported within 15 days, 5.28% (n=85,161) were reported within 16 to 90 days, 2.19% (n=35,392) were reported within 91 to 180 days, and 2.47% (n=39,830) were reported after 180 days.
Multivariate analysis revealed that patient death was positively associated with delayed AE reporting. About 91% (90.71%) of AEs that did not involve death were reported within 15 days, compared to 88.25% of AEs that did involve death.
The percentage of reports received within 16 to 90 days was 5.19% for AEs without death and 6.42% for AEs with death. The percentage of reports received within 91 to 180 days was 1.98% and 2.53%, respectively. And the percentage of reports received after 180 days was 2.12% and 2.80%, respectively.
The researchers said perhaps manufacturers spend additional time verifying reports concerning deaths, but this discretion is outside the scope of the current regulatory regime.
In a related Editor’s Note, Rita F. Redberg, MD, editor of JAMA Internal Medicine, wrote that delays in reporting AEs should never occur because they mean exposing patients to serious harm, including death, that could potentially be avoided.
“One improvement would be for AE reports to go directly to the FDA instead of via the manufacturer . . . ,” she wrote. “Physicians and their patients must be knowledgeable of benefits, harms, and alternatives for a wide choice of treatments, especially those recently approved for which clinical experience is limited.”
Photo courtesy of the FDA
A new study indicates that drug manufacturers fail to report about 10% of serious and unexpected adverse events (AEs) within the timeframe set out in federal regulations.
Manufacturers are required to report a serious AE (death, hospitalization, disability, etc.) or unexpected AE (anything not listed in the drug’s label) to the US Food and Drug Administration (FDA) within 15 calendar days of learning about the event.
But an analysis of more than 1.6 million AE reports showed that manufacturers failed to meet this requirement for nearly 10% of AEs.
Pinar Karaca-Mandic, PhD, of the University of Minnesota School of Public Health in Minneapolis, and her colleagues conducted the analysis and detailed the results in JAMA Internal Medicine.
The team examined data from the FDA Adverse Event Reporting System for AE reports made from January 2004 through June 2014. The final study sample included only reports that were subject to the regulation requiring submission within 15 days—a total of 1,613,079 reports.
The researchers found that 9.94% of reports were not received by the FDA within the 15-day timeframe. This was a total of 160,383 reports—40,464 cases in which patients died and 119,919 in which they did not.
So 90.06% of reports (n=1,452,696) were reported within 15 days, 5.28% (n=85,161) were reported within 16 to 90 days, 2.19% (n=35,392) were reported within 91 to 180 days, and 2.47% (n=39,830) were reported after 180 days.
Multivariate analysis revealed that patient death was positively associated with delayed AE reporting. About 91% (90.71%) of AEs that did not involve death were reported within 15 days, compared to 88.25% of AEs that did involve death.
The percentage of reports received within 16 to 90 days was 5.19% for AEs without death and 6.42% for AEs with death. The percentage of reports received within 91 to 180 days was 1.98% and 2.53%, respectively. And the percentage of reports received after 180 days was 2.12% and 2.80%, respectively.
The researchers said perhaps manufacturers spend additional time verifying reports concerning deaths, but this discretion is outside the scope of the current regulatory regime.
In a related Editor’s Note, Rita F. Redberg, MD, editor of JAMA Internal Medicine, wrote that delays in reporting AEs should never occur because they mean exposing patients to serious harm, including death, that could potentially be avoided.
“One improvement would be for AE reports to go directly to the FDA instead of via the manufacturer . . . ,” she wrote. “Physicians and their patients must be knowledgeable of benefits, harms, and alternatives for a wide choice of treatments, especially those recently approved for which clinical experience is limited.”
Photo courtesy of the FDA
A new study indicates that drug manufacturers fail to report about 10% of serious and unexpected adverse events (AEs) within the timeframe set out in federal regulations.
Manufacturers are required to report a serious AE (death, hospitalization, disability, etc.) or unexpected AE (anything not listed in the drug’s label) to the US Food and Drug Administration (FDA) within 15 calendar days of learning about the event.
But an analysis of more than 1.6 million AE reports showed that manufacturers failed to meet this requirement for nearly 10% of AEs.
Pinar Karaca-Mandic, PhD, of the University of Minnesota School of Public Health in Minneapolis, and her colleagues conducted the analysis and detailed the results in JAMA Internal Medicine.
The team examined data from the FDA Adverse Event Reporting System for AE reports made from January 2004 through June 2014. The final study sample included only reports that were subject to the regulation requiring submission within 15 days—a total of 1,613,079 reports.
The researchers found that 9.94% of reports were not received by the FDA within the 15-day timeframe. This was a total of 160,383 reports—40,464 cases in which patients died and 119,919 in which they did not.
So 90.06% of reports (n=1,452,696) were reported within 15 days, 5.28% (n=85,161) were reported within 16 to 90 days, 2.19% (n=35,392) were reported within 91 to 180 days, and 2.47% (n=39,830) were reported after 180 days.
Multivariate analysis revealed that patient death was positively associated with delayed AE reporting. About 91% (90.71%) of AEs that did not involve death were reported within 15 days, compared to 88.25% of AEs that did involve death.
The percentage of reports received within 16 to 90 days was 5.19% for AEs without death and 6.42% for AEs with death. The percentage of reports received within 91 to 180 days was 1.98% and 2.53%, respectively. And the percentage of reports received after 180 days was 2.12% and 2.80%, respectively.
The researchers said perhaps manufacturers spend additional time verifying reports concerning deaths, but this discretion is outside the scope of the current regulatory regime.
In a related Editor’s Note, Rita F. Redberg, MD, editor of JAMA Internal Medicine, wrote that delays in reporting AEs should never occur because they mean exposing patients to serious harm, including death, that could potentially be avoided.
“One improvement would be for AE reports to go directly to the FDA instead of via the manufacturer . . . ,” she wrote. “Physicians and their patients must be knowledgeable of benefits, harms, and alternatives for a wide choice of treatments, especially those recently approved for which clinical experience is limited.”
Improved HSCT outcomes due to conditioning or chemo?
Photo courtesy of NHS
Investigators have reported favorable results of allogeneic hematopoietic stem cell transplant (HSCT) in a small study of patients with juvenile myelomonocytic leukemia (JMML).
The team said the positive outcomes may be a result of conditioning with busulfan and melphalan (BuMel) or the conventional-dose chemotherapy some patients received before HSCT.
Regardless, all 7 patients studied are in remission at more than 1 year of follow-up.
“The lack of transplant-related mortality in the group of children we studied . . . suggests that BuMel may represent a successful HSCT high-dose chemotherapy regimen,” said study author Hisham Abdel-Azim, MD, of Children’s Hospital Los Angeles in California.
“It is also possible that administering conventional-dose chemotherapy before HSCT to patients with more progressive disease may have contributed to the improved outcomes.”
Dr Abdel-Azim and his colleagues described this research in a letter to Blood.
Conventional chemo and transplant
The investigators retrospectively analyzed 7 JMML patients with a median age of 2.6 years at HSCT.
Five patients received conventional-dose chemotherapy before transplant. All of these patients received mercaptopurine. One received hydroxyurea as well, and another patient received fludarabine, cytarabine, and cis-retinoic acid.
As for transplant, 2 patients received a 10/10 HLA-matched related bone marrow graft, 1 received a 9/10 HLA-matched related bone marrow graft, 1 received a 9/10 HLA-matched unrelated bone marrow graft, and 3 patients received cord blood grafts.
The median total nucleated cell count was 4.2 × 108 cells/kg, and the median CD34 cell dose was 3.3 × 106 cells/kg.
Conditioning and GVHD prophylaxis
All 7 patients received backbone conditioning with BuMel: Bu at 1 mg/kg dose every 6 hours intravenously on days −8 to −5 (with therapeutic drug monitoring to achieve overall concentration steady state [CSS] of 800-1000 ng/mL) and Mel at 45 mg/m2 per day intravenously on days −4 to −2.
The median Bu CSS and area under the curve were 884 µg/L (range, 560-1096) and 1293 µmol/L-minute (range, 819-1601), respectively.
The patient with a 9/10 HLA-matched related graft received BuMel and fludarabine at 35 mg/m2 per day intravenously on days −7 to −4.
The patient with the 9/10 HLA-matched unrelated graft received BuMel and alemtuzumab at 12 mg/m2 intravenously on day −10 and 20 mg/m2 on day −9, with methylprednisolone at 2 mg/kg per day in divided doses during the alemtuzumab infusion.
The patients who received cord blood grafts received BuMel and rabbit antithymocyte globulin at 2.5 mg/kg per day intravenously on days −4 to −1. They also received methylprednisolone at 2 mg/kg per day in divided doses during antithymocyte globulin infusion, then tapered over 6 weeks.
All patients received tacrolimus as graft-vs-host disease (GVHD) prophylaxis. Patients who received bone marrow grafts also received methotrexate at 5 mg/m2 on days 3, 6, and 11.
Outcomes
The median time to neutrophil engraftment (≥500/mm3) was 20 days, and the median time to platelet engraftment (≥20 000/mm3) was 36 days.
Six patients (85.7%) achieved predominant (>95%) donor hematopoietic stem cell engraftment.
One patient who received a cord blood graft had autologous recovery at day 54. She went on to receive a related haploidentical HSCT on day 105. One hundred days later, she is in remission, with predominant donor chimerism.
The patient who received the 9/10 HLA-matched related graft developed grade 4 acute GVHD, followed by severe chronic GVHD that required bowel resection.
This patient and one of the patients who received a 10/10 HLA-matched related graft developed severe sinusoidal obstructive syndrome, which resolved with supportive care.
At a median follow-up of 25.3 months (range, 6-99.3), all 7 patients are in remission.
The investigators said their target Bu CSS may have contributed to the improved outcomes they observed, or pre-HSCT chemotherapy may have been a contributing factor. A prospective clinical trial could provide answers.
Photo courtesy of NHS
Investigators have reported favorable results of allogeneic hematopoietic stem cell transplant (HSCT) in a small study of patients with juvenile myelomonocytic leukemia (JMML).
The team said the positive outcomes may be a result of conditioning with busulfan and melphalan (BuMel) or the conventional-dose chemotherapy some patients received before HSCT.
Regardless, all 7 patients studied are in remission at more than 1 year of follow-up.
“The lack of transplant-related mortality in the group of children we studied . . . suggests that BuMel may represent a successful HSCT high-dose chemotherapy regimen,” said study author Hisham Abdel-Azim, MD, of Children’s Hospital Los Angeles in California.
“It is also possible that administering conventional-dose chemotherapy before HSCT to patients with more progressive disease may have contributed to the improved outcomes.”
Dr Abdel-Azim and his colleagues described this research in a letter to Blood.
Conventional chemo and transplant
The investigators retrospectively analyzed 7 JMML patients with a median age of 2.6 years at HSCT.
Five patients received conventional-dose chemotherapy before transplant. All of these patients received mercaptopurine. One received hydroxyurea as well, and another patient received fludarabine, cytarabine, and cis-retinoic acid.
As for transplant, 2 patients received a 10/10 HLA-matched related bone marrow graft, 1 received a 9/10 HLA-matched related bone marrow graft, 1 received a 9/10 HLA-matched unrelated bone marrow graft, and 3 patients received cord blood grafts.
The median total nucleated cell count was 4.2 × 108 cells/kg, and the median CD34 cell dose was 3.3 × 106 cells/kg.
Conditioning and GVHD prophylaxis
All 7 patients received backbone conditioning with BuMel: Bu at 1 mg/kg dose every 6 hours intravenously on days −8 to −5 (with therapeutic drug monitoring to achieve overall concentration steady state [CSS] of 800-1000 ng/mL) and Mel at 45 mg/m2 per day intravenously on days −4 to −2.
The median Bu CSS and area under the curve were 884 µg/L (range, 560-1096) and 1293 µmol/L-minute (range, 819-1601), respectively.
The patient with a 9/10 HLA-matched related graft received BuMel and fludarabine at 35 mg/m2 per day intravenously on days −7 to −4.
The patient with the 9/10 HLA-matched unrelated graft received BuMel and alemtuzumab at 12 mg/m2 intravenously on day −10 and 20 mg/m2 on day −9, with methylprednisolone at 2 mg/kg per day in divided doses during the alemtuzumab infusion.
The patients who received cord blood grafts received BuMel and rabbit antithymocyte globulin at 2.5 mg/kg per day intravenously on days −4 to −1. They also received methylprednisolone at 2 mg/kg per day in divided doses during antithymocyte globulin infusion, then tapered over 6 weeks.
All patients received tacrolimus as graft-vs-host disease (GVHD) prophylaxis. Patients who received bone marrow grafts also received methotrexate at 5 mg/m2 on days 3, 6, and 11.
Outcomes
The median time to neutrophil engraftment (≥500/mm3) was 20 days, and the median time to platelet engraftment (≥20 000/mm3) was 36 days.
Six patients (85.7%) achieved predominant (>95%) donor hematopoietic stem cell engraftment.
One patient who received a cord blood graft had autologous recovery at day 54. She went on to receive a related haploidentical HSCT on day 105. One hundred days later, she is in remission, with predominant donor chimerism.
The patient who received the 9/10 HLA-matched related graft developed grade 4 acute GVHD, followed by severe chronic GVHD that required bowel resection.
This patient and one of the patients who received a 10/10 HLA-matched related graft developed severe sinusoidal obstructive syndrome, which resolved with supportive care.
At a median follow-up of 25.3 months (range, 6-99.3), all 7 patients are in remission.
The investigators said their target Bu CSS may have contributed to the improved outcomes they observed, or pre-HSCT chemotherapy may have been a contributing factor. A prospective clinical trial could provide answers.
Photo courtesy of NHS
Investigators have reported favorable results of allogeneic hematopoietic stem cell transplant (HSCT) in a small study of patients with juvenile myelomonocytic leukemia (JMML).
The team said the positive outcomes may be a result of conditioning with busulfan and melphalan (BuMel) or the conventional-dose chemotherapy some patients received before HSCT.
Regardless, all 7 patients studied are in remission at more than 1 year of follow-up.
“The lack of transplant-related mortality in the group of children we studied . . . suggests that BuMel may represent a successful HSCT high-dose chemotherapy regimen,” said study author Hisham Abdel-Azim, MD, of Children’s Hospital Los Angeles in California.
“It is also possible that administering conventional-dose chemotherapy before HSCT to patients with more progressive disease may have contributed to the improved outcomes.”
Dr Abdel-Azim and his colleagues described this research in a letter to Blood.
Conventional chemo and transplant
The investigators retrospectively analyzed 7 JMML patients with a median age of 2.6 years at HSCT.
Five patients received conventional-dose chemotherapy before transplant. All of these patients received mercaptopurine. One received hydroxyurea as well, and another patient received fludarabine, cytarabine, and cis-retinoic acid.
As for transplant, 2 patients received a 10/10 HLA-matched related bone marrow graft, 1 received a 9/10 HLA-matched related bone marrow graft, 1 received a 9/10 HLA-matched unrelated bone marrow graft, and 3 patients received cord blood grafts.
The median total nucleated cell count was 4.2 × 108 cells/kg, and the median CD34 cell dose was 3.3 × 106 cells/kg.
Conditioning and GVHD prophylaxis
All 7 patients received backbone conditioning with BuMel: Bu at 1 mg/kg dose every 6 hours intravenously on days −8 to −5 (with therapeutic drug monitoring to achieve overall concentration steady state [CSS] of 800-1000 ng/mL) and Mel at 45 mg/m2 per day intravenously on days −4 to −2.
The median Bu CSS and area under the curve were 884 µg/L (range, 560-1096) and 1293 µmol/L-minute (range, 819-1601), respectively.
The patient with a 9/10 HLA-matched related graft received BuMel and fludarabine at 35 mg/m2 per day intravenously on days −7 to −4.
The patient with the 9/10 HLA-matched unrelated graft received BuMel and alemtuzumab at 12 mg/m2 intravenously on day −10 and 20 mg/m2 on day −9, with methylprednisolone at 2 mg/kg per day in divided doses during the alemtuzumab infusion.
The patients who received cord blood grafts received BuMel and rabbit antithymocyte globulin at 2.5 mg/kg per day intravenously on days −4 to −1. They also received methylprednisolone at 2 mg/kg per day in divided doses during antithymocyte globulin infusion, then tapered over 6 weeks.
All patients received tacrolimus as graft-vs-host disease (GVHD) prophylaxis. Patients who received bone marrow grafts also received methotrexate at 5 mg/m2 on days 3, 6, and 11.
Outcomes
The median time to neutrophil engraftment (≥500/mm3) was 20 days, and the median time to platelet engraftment (≥20 000/mm3) was 36 days.
Six patients (85.7%) achieved predominant (>95%) donor hematopoietic stem cell engraftment.
One patient who received a cord blood graft had autologous recovery at day 54. She went on to receive a related haploidentical HSCT on day 105. One hundred days later, she is in remission, with predominant donor chimerism.
The patient who received the 9/10 HLA-matched related graft developed grade 4 acute GVHD, followed by severe chronic GVHD that required bowel resection.
This patient and one of the patients who received a 10/10 HLA-matched related graft developed severe sinusoidal obstructive syndrome, which resolved with supportive care.
At a median follow-up of 25.3 months (range, 6-99.3), all 7 patients are in remission.
The investigators said their target Bu CSS may have contributed to the improved outcomes they observed, or pre-HSCT chemotherapy may have been a contributing factor. A prospective clinical trial could provide answers.
Small Bowel Block in Elderly Merits Full Hospitalization
NEW YORK (Reuters Health) - The "vast majority" of elderly patients admitted with small bowel obstruction (SBO) are hospitalized for more than two days, and the diagnosis alone should allow appropriate Medicare coverage, according to a new study.
In a paper online July 1 in Annals of Surgery, Dr. Zara Cooper, of Brigham and Women's Hospital, Boston, and colleagues noted that their study was prompted by the Two-Midnight Rule established by the Centers for Medicare & Medicaid Services (CMS) in 2013.
The authors explained that if a physician expects a patient to need a hospital stay that crosses two midnights and thus admits the patient, related costs may be covered. However, shorter stays are deemed as observational and can raise the possibility of non-reimbursement for hospitals.
For example, if someone is admitted as an inpatient, but discharged in less than two days, payment will be made only if it can be documented that a longer stay was reasonably expected and unforeseen circumstances led to the shorter stay. Hospital stays that are incorrectly classified or have improperly documented changes in admission status will not be paid.
However, Dr. Cooper told Reuters Health by email, "Older patients with SBO, a very common diagnosis, should be presumed to be admitted for more than two midnights and hospitals should not get penalized."
She and her colleagues pointed out that SBO accounts for about 15% of surgical admissions to U.S. hospitals and more than $1 billion in annual hospital charges. However, diagnosis requires surgeons to observe patients to determine if surgery is warranted.
Thus, the authors wrote, "It is critically important for surgeons to correctly assign admission status for patients with SBO to ensure that hospitals are reimbursed appropriately, and patients are not unduly burdened."
The investigators examined data on 855 older patients admitted with SBO from 2006 and 2013. Of these, 816 (95%) stayed for two midnights or longer. This was true of all patients aged 85 years or older (n=108, approximately 13%).
The only significant difference in clinical characteristics was the presence of inflammatory bowel disease. Of five such patients, only one stayed for less than two midnights.
"Based on our study and others," the investigators wrote, "we propose that hospital admission for SBO in elderly patients is sufficient justification for the reasonable expectation" of the required length of stay for reimbursement.
This also may be true of other conditions. Dr. Cooper concluded, "More studies like this are needed in surgical patients to better understand the impact of CMS admission guidelines. The rule may not make sense in certain populations, leading to heavy and unfair penalties for hospitals."
The authors reported no disclosures.
NEW YORK (Reuters Health) - The "vast majority" of elderly patients admitted with small bowel obstruction (SBO) are hospitalized for more than two days, and the diagnosis alone should allow appropriate Medicare coverage, according to a new study.
In a paper online July 1 in Annals of Surgery, Dr. Zara Cooper, of Brigham and Women's Hospital, Boston, and colleagues noted that their study was prompted by the Two-Midnight Rule established by the Centers for Medicare & Medicaid Services (CMS) in 2013.
The authors explained that if a physician expects a patient to need a hospital stay that crosses two midnights and thus admits the patient, related costs may be covered. However, shorter stays are deemed as observational and can raise the possibility of non-reimbursement for hospitals.
For example, if someone is admitted as an inpatient, but discharged in less than two days, payment will be made only if it can be documented that a longer stay was reasonably expected and unforeseen circumstances led to the shorter stay. Hospital stays that are incorrectly classified or have improperly documented changes in admission status will not be paid.
However, Dr. Cooper told Reuters Health by email, "Older patients with SBO, a very common diagnosis, should be presumed to be admitted for more than two midnights and hospitals should not get penalized."
She and her colleagues pointed out that SBO accounts for about 15% of surgical admissions to U.S. hospitals and more than $1 billion in annual hospital charges. However, diagnosis requires surgeons to observe patients to determine if surgery is warranted.
Thus, the authors wrote, "It is critically important for surgeons to correctly assign admission status for patients with SBO to ensure that hospitals are reimbursed appropriately, and patients are not unduly burdened."
The investigators examined data on 855 older patients admitted with SBO from 2006 and 2013. Of these, 816 (95%) stayed for two midnights or longer. This was true of all patients aged 85 years or older (n=108, approximately 13%).
The only significant difference in clinical characteristics was the presence of inflammatory bowel disease. Of five such patients, only one stayed for less than two midnights.
"Based on our study and others," the investigators wrote, "we propose that hospital admission for SBO in elderly patients is sufficient justification for the reasonable expectation" of the required length of stay for reimbursement.
This also may be true of other conditions. Dr. Cooper concluded, "More studies like this are needed in surgical patients to better understand the impact of CMS admission guidelines. The rule may not make sense in certain populations, leading to heavy and unfair penalties for hospitals."
The authors reported no disclosures.
NEW YORK (Reuters Health) - The "vast majority" of elderly patients admitted with small bowel obstruction (SBO) are hospitalized for more than two days, and the diagnosis alone should allow appropriate Medicare coverage, according to a new study.
In a paper online July 1 in Annals of Surgery, Dr. Zara Cooper, of Brigham and Women's Hospital, Boston, and colleagues noted that their study was prompted by the Two-Midnight Rule established by the Centers for Medicare & Medicaid Services (CMS) in 2013.
The authors explained that if a physician expects a patient to need a hospital stay that crosses two midnights and thus admits the patient, related costs may be covered. However, shorter stays are deemed as observational and can raise the possibility of non-reimbursement for hospitals.
For example, if someone is admitted as an inpatient, but discharged in less than two days, payment will be made only if it can be documented that a longer stay was reasonably expected and unforeseen circumstances led to the shorter stay. Hospital stays that are incorrectly classified or have improperly documented changes in admission status will not be paid.
However, Dr. Cooper told Reuters Health by email, "Older patients with SBO, a very common diagnosis, should be presumed to be admitted for more than two midnights and hospitals should not get penalized."
She and her colleagues pointed out that SBO accounts for about 15% of surgical admissions to U.S. hospitals and more than $1 billion in annual hospital charges. However, diagnosis requires surgeons to observe patients to determine if surgery is warranted.
Thus, the authors wrote, "It is critically important for surgeons to correctly assign admission status for patients with SBO to ensure that hospitals are reimbursed appropriately, and patients are not unduly burdened."
The investigators examined data on 855 older patients admitted with SBO from 2006 and 2013. Of these, 816 (95%) stayed for two midnights or longer. This was true of all patients aged 85 years or older (n=108, approximately 13%).
The only significant difference in clinical characteristics was the presence of inflammatory bowel disease. Of five such patients, only one stayed for less than two midnights.
"Based on our study and others," the investigators wrote, "we propose that hospital admission for SBO in elderly patients is sufficient justification for the reasonable expectation" of the required length of stay for reimbursement.
This also may be true of other conditions. Dr. Cooper concluded, "More studies like this are needed in surgical patients to better understand the impact of CMS admission guidelines. The rule may not make sense in certain populations, leading to heavy and unfair penalties for hospitals."
The authors reported no disclosures.