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Sheela Maru - One of the best experts on this subject based on the ideXlab platform.
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An integrated Community Health Worker intervention in rural Nepal: a type 2 hybrid effectiveness-implementation study protocol
Implementation Science, 2018Co-Authors: Sheela Maru, Isha Nirola, Aradhana Thapa, Poshan Thapa, Lal Kunwar, Scott Halliday, David Citrin, Ryan Schwarz, Indira Basnett, Khem KarkiAbstract:Background Evidence-based medicines, technologies, and protocols exist to prevent many of the annual 300,000 maternal, 2.7 million neonatal, and 9 million child deaths, but they are not being effectively implemented and utilized in rural areas. Nepal, one of South Asia’s poorest countries with over 80% of its population living in rural areas, exemplifies this challenge. Community Health Workers are an important cadre in low-income countries where human resources for Health and Health care infrastructure are limited. As local women, they are uniquely positioned to understand and successfully navigate barriers to Health care access. Recent case studies of large Community Health Worker programs have highlighted the importance of training, both initial and ongoing, and accountability through structured management, salaries, and ongoing monitoring and evaluation. A gap in the evidence regarding whether such Community Health Worker systems can change Health outcomes, as well as be sustainably adopted at scale, remains. In this study, we plan to evaluate a Community Health Worker system delivering an evidence-based integrated reproductive, maternal, newborn, and child Health intervention as it is scaled up in rural Nepal. Methods We will conduct a type 2 hybrid effectiveness-implementation study to test both the effect of an integrated reproductive, maternal, newborn, and child Health intervention and the implementation process via a professional Community Health Worker system. The intervention integrates five evidence-based approaches: (1) home-based antenatal care and post-natal care counseling and care coordination; (2) continuous surveillance of all reproductive age women, pregnancies, and children under age 2 years via a mobile application; (3) Community-Based Integrated Management of Newborn and Childhood Illness; (4) group antenatal and postnatal care; and 5) the Balanced Counseling Strategy to post-partum contraception. We will evaluate effectiveness using a pre-post quasi-experimental design with stepped implementation and implementation using the RE-AIM framework. Discussion This is the first hybrid effectiveness-implementation study of an integrated reproductive, maternal, newborn, and child Health intervention in rural Nepal that we are aware of. As Nepal takes steps towards achieving the Sustainable Development Goals, the data from this three-year study will be useful in the detailed planning of a professionalized Community Health Worker cadre delivering evidence-based reproductive, maternal, newborn, and child Health interventions to the country’s rural population.
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an integrated Community Health Worker intervention in rural nepal a type 2 hybrid effectiveness implementation study protocol
Implementation Science, 2018Co-Authors: Sheela Maru, Isha Nirola, Aradhana Thapa, Poshan Thapa, Lal Kunwar, Scott HallidayAbstract:Evidence-based medicines, technologies, and protocols exist to prevent many of the annual 300,000 maternal, 2.7 million neonatal, and 9 million child deaths, but they are not being effectively implemented and utilized in rural areas. Nepal, one of South Asia’s poorest countries with over 80% of its population living in rural areas, exemplifies this challenge. Community Health Workers are an important cadre in low-income countries where human resources for Health and Health care infrastructure are limited. As local women, they are uniquely positioned to understand and successfully navigate barriers to Health care access. Recent case studies of large Community Health Worker programs have highlighted the importance of training, both initial and ongoing, and accountability through structured management, salaries, and ongoing monitoring and evaluation. A gap in the evidence regarding whether such Community Health Worker systems can change Health outcomes, as well as be sustainably adopted at scale, remains. In this study, we plan to evaluate a Community Health Worker system delivering an evidence-based integrated reproductive, maternal, newborn, and child Health intervention as it is scaled up in rural Nepal. We will conduct a type 2 hybrid effectiveness-implementation study to test both the effect of an integrated reproductive, maternal, newborn, and child Health intervention and the implementation process via a professional Community Health Worker system. The intervention integrates five evidence-based approaches: (1) home-based antenatal care and post-natal care counseling and care coordination; (2) continuous surveillance of all reproductive age women, pregnancies, and children under age 2 years via a mobile application; (3) Community-Based Integrated Management of Newborn and Childhood Illness; (4) group antenatal and postnatal care; and 5) the Balanced Counseling Strategy to post-partum contraception. We will evaluate effectiveness using a pre-post quasi-experimental design with stepped implementation and implementation using the RE-AIM framework. This is the first hybrid effectiveness-implementation study of an integrated reproductive, maternal, newborn, and child Health intervention in rural Nepal that we are aware of. As Nepal takes steps towards achieving the Sustainable Development Goals, the data from this three-year study will be useful in the detailed planning of a professionalized Community Health Worker cadre delivering evidence-based reproductive, maternal, newborn, and child Health interventions to the country’s rural population. ClinicalTrials.gov Identifier: NCT03371186 , registered 04 December 2017, retrospectively registered.
Scott Halliday - One of the best experts on this subject based on the ideXlab platform.
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An integrated Community Health Worker intervention in rural Nepal: a type 2 hybrid effectiveness-implementation study protocol
Implementation Science, 2018Co-Authors: Sheela Maru, Isha Nirola, Aradhana Thapa, Poshan Thapa, Lal Kunwar, Scott Halliday, David Citrin, Ryan Schwarz, Indira Basnett, Khem KarkiAbstract:Background Evidence-based medicines, technologies, and protocols exist to prevent many of the annual 300,000 maternal, 2.7 million neonatal, and 9 million child deaths, but they are not being effectively implemented and utilized in rural areas. Nepal, one of South Asia’s poorest countries with over 80% of its population living in rural areas, exemplifies this challenge. Community Health Workers are an important cadre in low-income countries where human resources for Health and Health care infrastructure are limited. As local women, they are uniquely positioned to understand and successfully navigate barriers to Health care access. Recent case studies of large Community Health Worker programs have highlighted the importance of training, both initial and ongoing, and accountability through structured management, salaries, and ongoing monitoring and evaluation. A gap in the evidence regarding whether such Community Health Worker systems can change Health outcomes, as well as be sustainably adopted at scale, remains. In this study, we plan to evaluate a Community Health Worker system delivering an evidence-based integrated reproductive, maternal, newborn, and child Health intervention as it is scaled up in rural Nepal. Methods We will conduct a type 2 hybrid effectiveness-implementation study to test both the effect of an integrated reproductive, maternal, newborn, and child Health intervention and the implementation process via a professional Community Health Worker system. The intervention integrates five evidence-based approaches: (1) home-based antenatal care and post-natal care counseling and care coordination; (2) continuous surveillance of all reproductive age women, pregnancies, and children under age 2 years via a mobile application; (3) Community-Based Integrated Management of Newborn and Childhood Illness; (4) group antenatal and postnatal care; and 5) the Balanced Counseling Strategy to post-partum contraception. We will evaluate effectiveness using a pre-post quasi-experimental design with stepped implementation and implementation using the RE-AIM framework. Discussion This is the first hybrid effectiveness-implementation study of an integrated reproductive, maternal, newborn, and child Health intervention in rural Nepal that we are aware of. As Nepal takes steps towards achieving the Sustainable Development Goals, the data from this three-year study will be useful in the detailed planning of a professionalized Community Health Worker cadre delivering evidence-based reproductive, maternal, newborn, and child Health interventions to the country’s rural population.
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an integrated Community Health Worker intervention in rural nepal a type 2 hybrid effectiveness implementation study protocol
Implementation Science, 2018Co-Authors: Sheela Maru, Isha Nirola, Aradhana Thapa, Poshan Thapa, Lal Kunwar, Scott HallidayAbstract:Evidence-based medicines, technologies, and protocols exist to prevent many of the annual 300,000 maternal, 2.7 million neonatal, and 9 million child deaths, but they are not being effectively implemented and utilized in rural areas. Nepal, one of South Asia’s poorest countries with over 80% of its population living in rural areas, exemplifies this challenge. Community Health Workers are an important cadre in low-income countries where human resources for Health and Health care infrastructure are limited. As local women, they are uniquely positioned to understand and successfully navigate barriers to Health care access. Recent case studies of large Community Health Worker programs have highlighted the importance of training, both initial and ongoing, and accountability through structured management, salaries, and ongoing monitoring and evaluation. A gap in the evidence regarding whether such Community Health Worker systems can change Health outcomes, as well as be sustainably adopted at scale, remains. In this study, we plan to evaluate a Community Health Worker system delivering an evidence-based integrated reproductive, maternal, newborn, and child Health intervention as it is scaled up in rural Nepal. We will conduct a type 2 hybrid effectiveness-implementation study to test both the effect of an integrated reproductive, maternal, newborn, and child Health intervention and the implementation process via a professional Community Health Worker system. The intervention integrates five evidence-based approaches: (1) home-based antenatal care and post-natal care counseling and care coordination; (2) continuous surveillance of all reproductive age women, pregnancies, and children under age 2 years via a mobile application; (3) Community-Based Integrated Management of Newborn and Childhood Illness; (4) group antenatal and postnatal care; and 5) the Balanced Counseling Strategy to post-partum contraception. We will evaluate effectiveness using a pre-post quasi-experimental design with stepped implementation and implementation using the RE-AIM framework. This is the first hybrid effectiveness-implementation study of an integrated reproductive, maternal, newborn, and child Health intervention in rural Nepal that we are aware of. As Nepal takes steps towards achieving the Sustainable Development Goals, the data from this three-year study will be useful in the detailed planning of a professionalized Community Health Worker cadre delivering evidence-based reproductive, maternal, newborn, and child Health interventions to the country’s rural population. ClinicalTrials.gov Identifier: NCT03371186 , registered 04 December 2017, retrospectively registered.
David M Levine - One of the best experts on this subject based on the ideXlab platform.
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Community outreach and cardiovascular Health coach trial a randomized controlled trial of nurse practitioner Community Health Worker cardiovascular disease risk reduction in urban Community Health centers
Circulation-cardiovascular Quality and Outcomes, 2011Co-Authors: Jerilyn K Allen, Lee R Bone, Martha N Hill, David M Levine, Cheryl Dennisonhimmelfarb, Sarah L Szanton, Murray West, Amy Barlow, Lapricia Lewisboyer, Mary DonnellystrozzoAbstract:Background—Despite well-publicized guidelines on the appropriate management of cardiovascular disease and type 2 diabetes, the implementation of risk-reducing practices remains poor. This report describes the results of a randomized, controlled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reduction delivered by nurse practitioner /Community Health Worker (NP/CHW) teams versus enhanced usual care (EUC) to improve lipids, blood pressure, glycated hemoglobin (HbA1c), and patient perceptions of the quality of their chronic illness care in patients in urban Community Health centers. Methods and Results—A total of 525 patients with documented cardiovascular disease, type 2 diabetes, hypercholesterolemia, or hypertension and levels of LDL cholesterol, blood pressure, or HbA1c that exceeded goals established by national guidelines were randomly assigned to NP/CHW (n=261) or EUC (n=264) groups. The NP/CHW intervention included aggressive pharmacological mana...
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Community outreach and cardiovascular Health coach trial a randomized controlled trial of nurse practitioner Community Health Worker cardiovascular disease risk reduction in urban Community Health centers
Circulation-cardiovascular Quality and Outcomes, 2011Co-Authors: Jerilyn K Allen, Lee R Bone, Martha N Hill, David M Levine, Cheryl Dennisonhimmelfarb, Sarah L Szanton, Murray West, Amy Barlow, Lapricia Lewisboyer, Mary DonnellystrozzoAbstract:Background— Despite well-publicized guidelines on the appropriate management of cardiovascular disease and type 2 diabetes, the implementation of risk-reducing practices remains poor. This report describes the results of a randomized, controlled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reduction delivered by nurse practitioner /Community Health Worker (NP/CHW) teams versus enhanced usual care (EUC) to improve lipids, blood pressure, glycated hemoglobin (HbA1c), and patient perceptions of the quality of their chronic illness care in patients in urban Community Health centers. Methods and Results— A total of 525 patients with documented cardiovascular disease, type 2 diabetes, hypercholesterolemia, or hypertension and levels of LDL cholesterol, blood pressure, or HbA1c that exceeded goals established by national guidelines were randomly assigned to NP/CHW (n=261) or EUC (n=264) groups. The NP/CHW intervention included aggressive pharmacological management and tailored educational and behavioral counseling for lifestyle modification and problem solving to address barriers to adherence and control. Compared with EUC, patients in the NP/CHW group had significantly greater 12-month improvement in total cholesterol (difference, 19.7 mg/dL), LDL cholesterol (difference,15.9 mg/dL), triglycerides (difference, 16.3 mg/dL), systolic blood pressure (difference, 6.2 mm Hg), diastolic blood pressure (difference, 3.1 mm Hg), HbA1c (difference, 0.5%), and perceptions of the quality of their chronic illness care (difference, 1.2 points). Conclusions— An intervention delivered by an NP/CHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illness care in high-risk patients. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00241904.
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coach trial a randomized controlled trial of nurse practitioner Community Health Worker cardiovascular disease risk reduction in urban Community Health centers rationale and design
Contemporary Clinical Trials, 2011Co-Authors: Lee R Bone, Martha N Hill, David M Levine, Jerilyn K Allen, Sarah L Szanton, Cheryl Dennison HimmelfarbAbstract:Abstract Background Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/Community Health Worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban Community Health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. Methods The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified Community Health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. Results A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. Conclusions This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded Health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a Community clinic-based intervention is potentially enormous.
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randomized controlled trial of the effects of nurse case manager and Community Health Worker interventions on risk factors for diabetes related complications in urban african americans
Preventive Medicine, 2003Co-Authors: Tiffany L Gary, Lee R Bone, Martha N Hill, David M Levine, Maura Mcguire, Christopher D Saudek, Frederick L BrancatiAbstract:Abstract Background African Americans suffer disproportionately from diabetes complications, but little research has focused on how to improve diabetic control in this population. There are also few or no data on a combined primary care and Community-based intervention approach. Methods We randomly assigned 186 urban African Americans with type 2 diabetes (76% female, mean A SD age 59 A 9 years) to 1 of 4 parallel arms: (1) usual care only; (2) usual care + nurse case manager (NCM); (3) usual care + Community Health Worker (CHW); (4) usual care + nurse case manager/Community Health Worker team. Using the framework of the Precede–Proceed behavioral model, interventions included patient counseling regarding self-care practices and physician reminders. Results The 2-year follow-up visit was completed by 149 individuals (84%). Compared to the Usual care group, the NCM group and the CHW group had modest declines in HbA 1c over 2 years (0.3 and 0.3%, respectively), and the combined NCM/CHW group had a greater decline in HbA 1c (0.8%. P = 0.137). After adjustment for baseline differences and/or follow-up time, the combined NCM/CHW group showed improvements in triglycerides (−35.5 mg/dl; P = 0.041) and diastolic blood pressure, compared to the usual care group (−5.6 mmHg; P = 0.042). Conclusions Combined NCM/CHW interventions may improve diabetic control in urban African Americans with type 2 diabetes. Although results were clinically important, they did not reach statistical significance. This approach deserves further attention as a means to reduce the excess risk of diabetic complications in African Americans.
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using participant information to develop a tool for the evaluation of Community Health Worker outreach services
Ethnicity & Disease, 2002Co-Authors: Kaytura L Felixaaron, Lee R Bone, David M Levine, Haya R RubinAbstract:OBJECTIVE Because there is no instrument that measures how clients judge Community Health Worker (CHW) services, we sought to develop such a questionnaire. We report how we used client information to develop a brief questionnaire evaluating CHW services. DESIGN We conducted and content-analyzed 18 in-depth semi-structured interviews of clients receiving CHW services to determine aspects of care salient to clients. Based on the results of these analyses, we developed and administered an in-person survey measuring the importance of 57 aspects of CHW services to 84 clients in 3 programs using CHWs to help control hypertension or diabetes. RESULTS Clients perceived a broad array of aspects of CHW care including CHW attributes, services, benefits or outcomes of service and service arrangements. The 15 aspects ranking highest included: 1) CHW knows job; 2) CHW keeps client alive; 3) CHW gives information on high blood pressure; 4) CHW shows respect; 5) blood pressure is lowered; 6) CHW pays attention; 7) client gets better medical care; 8) CHW speaks understandably; and 9) client gets needed care. CONCLUSION We used client information to generate and determine the relative importance of a pool of aspects that we and others can use to construct brief questionnaires to measure clients' judgments of CHW services. Such questionnaires are needed for ongoing evaluation as more providers and managed care organizations increase their use of CHWs for outreach programs.
Jerilyn K Allen - One of the best experts on this subject based on the ideXlab platform.
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Community outreach and cardiovascular Health coach trial a randomized controlled trial of nurse practitioner Community Health Worker cardiovascular disease risk reduction in urban Community Health centers
Circulation-cardiovascular Quality and Outcomes, 2011Co-Authors: Jerilyn K Allen, Lee R Bone, Martha N Hill, David M Levine, Cheryl Dennisonhimmelfarb, Sarah L Szanton, Murray West, Amy Barlow, Lapricia Lewisboyer, Mary DonnellystrozzoAbstract:Background—Despite well-publicized guidelines on the appropriate management of cardiovascular disease and type 2 diabetes, the implementation of risk-reducing practices remains poor. This report describes the results of a randomized, controlled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reduction delivered by nurse practitioner /Community Health Worker (NP/CHW) teams versus enhanced usual care (EUC) to improve lipids, blood pressure, glycated hemoglobin (HbA1c), and patient perceptions of the quality of their chronic illness care in patients in urban Community Health centers. Methods and Results—A total of 525 patients with documented cardiovascular disease, type 2 diabetes, hypercholesterolemia, or hypertension and levels of LDL cholesterol, blood pressure, or HbA1c that exceeded goals established by national guidelines were randomly assigned to NP/CHW (n=261) or EUC (n=264) groups. The NP/CHW intervention included aggressive pharmacological mana...
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Community outreach and cardiovascular Health coach trial a randomized controlled trial of nurse practitioner Community Health Worker cardiovascular disease risk reduction in urban Community Health centers
Circulation-cardiovascular Quality and Outcomes, 2011Co-Authors: Jerilyn K Allen, Lee R Bone, Martha N Hill, David M Levine, Cheryl Dennisonhimmelfarb, Sarah L Szanton, Murray West, Amy Barlow, Lapricia Lewisboyer, Mary DonnellystrozzoAbstract:Background— Despite well-publicized guidelines on the appropriate management of cardiovascular disease and type 2 diabetes, the implementation of risk-reducing practices remains poor. This report describes the results of a randomized, controlled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reduction delivered by nurse practitioner /Community Health Worker (NP/CHW) teams versus enhanced usual care (EUC) to improve lipids, blood pressure, glycated hemoglobin (HbA1c), and patient perceptions of the quality of their chronic illness care in patients in urban Community Health centers. Methods and Results— A total of 525 patients with documented cardiovascular disease, type 2 diabetes, hypercholesterolemia, or hypertension and levels of LDL cholesterol, blood pressure, or HbA1c that exceeded goals established by national guidelines were randomly assigned to NP/CHW (n=261) or EUC (n=264) groups. The NP/CHW intervention included aggressive pharmacological management and tailored educational and behavioral counseling for lifestyle modification and problem solving to address barriers to adherence and control. Compared with EUC, patients in the NP/CHW group had significantly greater 12-month improvement in total cholesterol (difference, 19.7 mg/dL), LDL cholesterol (difference,15.9 mg/dL), triglycerides (difference, 16.3 mg/dL), systolic blood pressure (difference, 6.2 mm Hg), diastolic blood pressure (difference, 3.1 mm Hg), HbA1c (difference, 0.5%), and perceptions of the quality of their chronic illness care (difference, 1.2 points). Conclusions— An intervention delivered by an NP/CHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illness care in high-risk patients. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00241904.
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coach trial a randomized controlled trial of nurse practitioner Community Health Worker cardiovascular disease risk reduction in urban Community Health centers rationale and design
Contemporary Clinical Trials, 2011Co-Authors: Lee R Bone, Martha N Hill, David M Levine, Jerilyn K Allen, Sarah L Szanton, Cheryl Dennison HimmelfarbAbstract:Abstract Background Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/Community Health Worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban Community Health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. Methods The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified Community Health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. Results A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. Conclusions This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded Health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a Community clinic-based intervention is potentially enormous.
Martha N Hill - One of the best experts on this subject based on the ideXlab platform.
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Community outreach and cardiovascular Health coach trial a randomized controlled trial of nurse practitioner Community Health Worker cardiovascular disease risk reduction in urban Community Health centers
Circulation-cardiovascular Quality and Outcomes, 2011Co-Authors: Jerilyn K Allen, Lee R Bone, Martha N Hill, David M Levine, Cheryl Dennisonhimmelfarb, Sarah L Szanton, Murray West, Amy Barlow, Lapricia Lewisboyer, Mary DonnellystrozzoAbstract:Background—Despite well-publicized guidelines on the appropriate management of cardiovascular disease and type 2 diabetes, the implementation of risk-reducing practices remains poor. This report describes the results of a randomized, controlled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reduction delivered by nurse practitioner /Community Health Worker (NP/CHW) teams versus enhanced usual care (EUC) to improve lipids, blood pressure, glycated hemoglobin (HbA1c), and patient perceptions of the quality of their chronic illness care in patients in urban Community Health centers. Methods and Results—A total of 525 patients with documented cardiovascular disease, type 2 diabetes, hypercholesterolemia, or hypertension and levels of LDL cholesterol, blood pressure, or HbA1c that exceeded goals established by national guidelines were randomly assigned to NP/CHW (n=261) or EUC (n=264) groups. The NP/CHW intervention included aggressive pharmacological mana...
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Community outreach and cardiovascular Health coach trial a randomized controlled trial of nurse practitioner Community Health Worker cardiovascular disease risk reduction in urban Community Health centers
Circulation-cardiovascular Quality and Outcomes, 2011Co-Authors: Jerilyn K Allen, Lee R Bone, Martha N Hill, David M Levine, Cheryl Dennisonhimmelfarb, Sarah L Szanton, Murray West, Amy Barlow, Lapricia Lewisboyer, Mary DonnellystrozzoAbstract:Background— Despite well-publicized guidelines on the appropriate management of cardiovascular disease and type 2 diabetes, the implementation of risk-reducing practices remains poor. This report describes the results of a randomized, controlled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reduction delivered by nurse practitioner /Community Health Worker (NP/CHW) teams versus enhanced usual care (EUC) to improve lipids, blood pressure, glycated hemoglobin (HbA1c), and patient perceptions of the quality of their chronic illness care in patients in urban Community Health centers. Methods and Results— A total of 525 patients with documented cardiovascular disease, type 2 diabetes, hypercholesterolemia, or hypertension and levels of LDL cholesterol, blood pressure, or HbA1c that exceeded goals established by national guidelines were randomly assigned to NP/CHW (n=261) or EUC (n=264) groups. The NP/CHW intervention included aggressive pharmacological management and tailored educational and behavioral counseling for lifestyle modification and problem solving to address barriers to adherence and control. Compared with EUC, patients in the NP/CHW group had significantly greater 12-month improvement in total cholesterol (difference, 19.7 mg/dL), LDL cholesterol (difference,15.9 mg/dL), triglycerides (difference, 16.3 mg/dL), systolic blood pressure (difference, 6.2 mm Hg), diastolic blood pressure (difference, 3.1 mm Hg), HbA1c (difference, 0.5%), and perceptions of the quality of their chronic illness care (difference, 1.2 points). Conclusions— An intervention delivered by an NP/CHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illness care in high-risk patients. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00241904.
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coach trial a randomized controlled trial of nurse practitioner Community Health Worker cardiovascular disease risk reduction in urban Community Health centers rationale and design
Contemporary Clinical Trials, 2011Co-Authors: Lee R Bone, Martha N Hill, David M Levine, Jerilyn K Allen, Sarah L Szanton, Cheryl Dennison HimmelfarbAbstract:Abstract Background Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/Community Health Worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban Community Health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. Methods The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified Community Health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. Results A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. Conclusions This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded Health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a Community clinic-based intervention is potentially enormous.
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randomized controlled trial of the effects of nurse case manager and Community Health Worker interventions on risk factors for diabetes related complications in urban african americans
Preventive Medicine, 2003Co-Authors: Tiffany L Gary, Lee R Bone, Martha N Hill, David M Levine, Maura Mcguire, Christopher D Saudek, Frederick L BrancatiAbstract:Abstract Background African Americans suffer disproportionately from diabetes complications, but little research has focused on how to improve diabetic control in this population. There are also few or no data on a combined primary care and Community-based intervention approach. Methods We randomly assigned 186 urban African Americans with type 2 diabetes (76% female, mean A SD age 59 A 9 years) to 1 of 4 parallel arms: (1) usual care only; (2) usual care + nurse case manager (NCM); (3) usual care + Community Health Worker (CHW); (4) usual care + nurse case manager/Community Health Worker team. Using the framework of the Precede–Proceed behavioral model, interventions included patient counseling regarding self-care practices and physician reminders. Results The 2-year follow-up visit was completed by 149 individuals (84%). Compared to the Usual care group, the NCM group and the CHW group had modest declines in HbA 1c over 2 years (0.3 and 0.3%, respectively), and the combined NCM/CHW group had a greater decline in HbA 1c (0.8%. P = 0.137). After adjustment for baseline differences and/or follow-up time, the combined NCM/CHW group showed improvements in triglycerides (−35.5 mg/dl; P = 0.041) and diastolic blood pressure, compared to the usual care group (−5.6 mmHg; P = 0.042). Conclusions Combined NCM/CHW interventions may improve diabetic control in urban African Americans with type 2 diabetes. Although results were clinically important, they did not reach statistical significance. This approach deserves further attention as a means to reduce the excess risk of diabetic complications in African Americans.