CardioMetabolic Health Alliance: Metabolic Syndrome Model
CardioMetabolic Health Alliance: Metabolic Syndrome Model
The final challenge for TT participants was implementation of a new care model for MetS. Clear consensus was that stakeholders from the community and public health arena, the health care system, and industry must be involved and that patient advocates, community health workers, and peer leaders are essential to bridging the community and the health care system. Stakeholders include physicians, nurse practitioners, and physician assistants, as well as ancillary health professionals such as dietitians, exercise physiologists, psychologists, behavioral specialists, and certified diabetes educators. Disciplines to be involved include family practice, pediatrics, internal medicine, obstetrics and gynecology, geriatrics, and specialists in cardiology (hypertension and lipid) and endocrinology (diabetes and obesity). Other medical specialties that may also be involved with this population presenting with a particular phenotype include gastroenterology (NAFLD), sleep medicine (obstructive sleep apnea), nephrology (cardiorenal syndrome), surgery (bariatric, vascular, and cardiothoracic), psychiatry (depression, other behavioral), and oncology (obesity-associated malignancies). Finally, industry is another key stakeholder, as pharmaceuticals and surgical interventions comprise important treatment options for patients with MetS. It is important to note that many of the provisions of the Affordable Care Act (ACA) would support this implementation.
Dissemination of the Diabetes Prevention Program (DPP) in community settings can serve as a model for the MetS population. The DEPLOY (Diabetes Education & Prevention with a Lifestyle Intervention Offered at the YMCA) study was a pilot cluster-randomized trial comparing group-based DPP lifestyle intervention through a Young Men's Christian Association (16 group sessions with goals of 5% to 7% reduction in baseline body weight and 150 min/week of moderate exercise) with brief counseling. Among 92 randomized participants, at both 4 to 6 and 12 to 14 months, the percent change in weight and BMI, as well as the change in total cholesterol, was significantly greater in the intervention group. An extension study in which both the control and intervention arms were offered an 8-month lifestyle maintenance program found that both groups maintained weight changes compared with baseline, and those in the initial intervention group lost a further 1.5% of body weight, with significant decreases in total cholesterol and systolic blood pressure. A larger implementation of the DPP intervention across 14 Young Men's Christian Associations in New York demonstrated that among 254 participants, 40.2% and 60.8% achieved a weight loss ≥5% at 16 weeks and 10 months, respectively. Lessons could be drawn from these interventions to benefit other communities, such as the workplace, where many large employers already offer wellness programs. A systematic review of randomized controlled trials on worksite wellness programs demonstrated a statistically significant 3-lb weight reduction and 0.5 kg/m BMI reduction over 6 to 12 months.
The TT also recognized the National Physical Activity Plan as an overarching framework for implementation. The plan has 5 primary strategies and proposes evidence-based interventions within 8 economic sectors. Strategies include launching advocacy efforts to increase public support, mounting a national physical activity education program, disseminating best practice models, creating a national resource center, and establishing a center for physical activity policy development and research. Involved sectors include: business and industry; education; health care; mass media; parks, recreation, fitness, and sports; public health; transportation; land use; community design; volunteer; and nonprofit. Specific strategies within these sectors include providing incentives to increase active transportation (walking, biking) through community design, making physical activity a "vital sign" in the health care setting, and ensuring access to high-quality physical activity programs in early childhood education and grade school.
The TT proposed that community health workers and peer leaders play an integral role in implementing the new care model and discussed several examples. The Healthy Living Partnerships to Prevent Diabetes Study implemented a DPP-like lifestyle weight-loss program over 2 years by using a local diabetes education program with community health workers, involving weekly visits over the first 6 months and twice monthly visits over the next 18 months. Among 301 randomized patients, the intervention group achieved significant reductions in weight, BMI, waist circumference, glucose, insulin, and homeostatic model assessment of insulin resistance measures compared with control subjects, with 46.5% of the intervention group achieving ≥5% weight loss and 21.3% achieving ≥10 % weight loss. The Look AHEAD (Action for Health in Diabetes) trial provides the longest-term evidence of the effect of an intensive lifestyle intervention in overweight and obese adults with T2D. The curriculum was modified from the DPP and included structured meal plans and moderate exercise up to 200 min/week. At 8 years, 50.3% in the intervention group versus 35.7% in the usual care group lost ≥5% of body weight, and 26.9% versus 17.2% lost ≥10% of body weight.
In Colorado Heart Healthy Solutions, community health workers conducted screenings, assessed readiness for change, and provided education and medical referrals to patients with an uncontrolled risk factor for coronary heart disease or a Framingham Risk Score ≥10%. They provided further phone follow-up, and found significant reductions in Framingham Risk score, blood pressure, and cholesterol at retesting. In multivariable models, those receiving a follow-up call had greater improvement in Framingham Risk Score than those who did not. A randomized controlled trial in 2 community health centers enrolled 525 patients with uncontrolled ASCVD, T2D, hypertension, or hyperlipidemia; results showed that pairing nurse practitioners and community health workers demonstrated significant reductions in blood pressure, cholesterol, and HbA1c over 1 year of follow-up compared with usual care. Finally, peer leaders can effectively provide education and support for lifestyle. This was demonstrated in a study where 116 Latino adults with T2D were randomized to receive diabetes self-management education and either 12 months of weekly group sessions with peer leaders or 12 months of telephone outreach with health workers. Both groups achieved significant HbA1c, blood pressure, and waist circumference reductions and improved diabetes support with less distress. However, only the peer leader group sustained HbA1c and blood pressure reductions over 18 months.
To further highlight lifestyle change, the TT proposed campaigns such as the Exercise is Medicine initiative, which assesses patient readiness for exercise and provides handouts to help patients start a program. It also provides materials to help fitness professionals communicate with health care personnel. To emphasize the importance of addressing disparities, the TT discussed key studies such as the Lawrence Latino Diabetes Prevention project, which recruited 312 participants at high risk for T2D for a lifestyle intervention involving 3 individual and 13 group sessions over 12 months versus usual care. The curriculum was adapted to address knowledge gaps and language barriers, customize dietary advice to Latino cuisine, and use the popular novella media format to deliver messages. At 1 year, there was a significant reduction in weight, BMI, and HbA1c in the intervention group as compared with usual care. Another cultural adaptation of the DPP in African-American churches involved 37 participants and compared an abbreviated 6-week program to a longer 16-week program; it found that fasting glucose and BMI decreased significantly in both groups at 12 months. A program targeting a predominantly low-income non-Caucasian urban population delivered a lifestyle intervention in 12 weeks using group sessions and found significant reductions in the proportion of subjects meeting the MetS waist circumference (90% to 68%; p = 0.009) and hypertension (68% to 48%; p = 0.04) criteria over 6 months. At 3 months, 46.4% lost ≥5% of body weight and 26% lost ≥7% of body weight, with 87.5% and 66.7% sustaining these losses at 6 months, respectively. Araneta et al. piloted a 12-week Zumba fitness program in sedentary obese women with ≥2 MetS criteria (77% ethnic minorities), demonstrating significant blood pressure and fasting triglyceride reductions among the participants. The investigators also conducted a 48-week randomized controlled trial comparing restorative yoga to active stretching among adults with MetS, finding significantly lower fasting glucose in the yoga group at 12 months.
Principles for implementing a new care model within the health care system should include: care coordination and team-based care; education in MetS recognition and treatment; technology to facilitate communication among providers and patients; disease registries for population management; social media for distributing health messages; reimbursement alignment to facilitate coordinated care; and further development of strategies to address health care disparities and barriers to care. The TT recognized that the ACA supports 2 emerging models that seek to address these issues and improve integrated care for complex patients.
To varying degrees, the PCMH addresses each of the aforementioned principles of care model implementation. The PCMH is organized around several core principles: 1) comprehensive team-based care; 2) patient-centered care; 3) care coordination; 4) accessible services; and 5) quality improvement and safety. A systematic review of 31 studies found a positive effect of components of the PCMH model on patient and staff experiences, as well as positive effects on preventive services, with reduction in emergency department visits in older adults, but no effect on hospital admissions or total costs. However, comparisons across studies on the PCMH are often difficult because of differences in definition and focus. In another study of 36 family practices implementing PCMH components over 26 months, improvement was seen in prevention and chronic care quality metrics, but not in patient-assessed outcomes. Long-term data is also limited, as most of these models were implemented over the last 5 to 10 years.
The Group Health Cooperative reduced physician panel sizes, increased ancillary staff, lengthened visit times, and provided time for team care planning, in addition to expanding technology to better engage patients. Comparison with control clinics in the area demonstrated better patient satisfaction scores, reduced provider burnout, improved performance on quality of care metrics, and reduced emergency department visits and inpatient admissions for ambulatory sensitive conditions over a 12- to 24-month follow-up. The PCMH model affects MetS sequelae and outcomes. For example, the Geisinger ProvenHealth Navigator demonstrated a reduction in the incidence of end-stage renal disease and amputation among patients with T2D over 4 years, although without a change in myocardial infarction or stroke. Evaluation of another such model in West Virginia found that an EHR-based screening tool identified 11% of over 94,000 patients as being at risk for T2D, enabling the facility to better screen and connect patients to local lifestyle intervention programs.
There is less published data available to assess PCMH reimbursement strategies to facilitate coordinated care or on how this model addresses health care disparities. Although different financial models have been proposed and are incorporated in some PCMH models, evaluations do not specifically address the effectiveness of these strategies, nor have most studies demonstrated overall short-term cost savings. A recent review of 27 PCMH studies found that only 11 provided any detail on their financial models. There is also a limited evidence base for addressing disparities. In fact, in a retrospective cohort study of 1,457 diabetic patients receiving care in a PCMH academic practice, African-American patients were less likely to receive HbA1c testing or influenza vaccination or to meet LDL or blood pressure targets than non-Hispanic Caucasians, after adjusting for multiple demographic factors and comorbidities. Similar to the cultural adaptations of the community-level interventions discussed earlier, new PCMH models must be modified to specifically address the needs of particular populations.
The ACO is another mechanism relevant to implementing a new MetS care model. Although the PCMH focuses on coordination at the level of primary care, the ACO is a larger organization that includes hospitals and specialty care. Compared with many PCMH models, the ACO's reimbursement changes and cost-saving goals are more explicit and are better aligned to facilitate coordinated care. Most ACO models are very new, but available evaluations indicate that health care spending has declined. Medicare beneficiaries in the same market as a commercial ACO realized decreases in total health care spending over 2 years, primarily due to reduced outpatient office visits, minor procedures, imaging, and laboratories. There were some improvements in LDL testing for patients with T2D and ASCVD but not on other quality metrics. An evaluation of Medicare enrollees in the Medicare Physician Group Practice Demonstration compared with control subjects found that the savings were highest for acute care and dually-eligible beneficiaries, with an overall reduction in 30-day medical readmissions. According to a Centers for Medicare & Medicaid Services release of 1-year data, ACOs have also slowed cost growth (0.3% vs. 0.8% in 2012), reduced readmission rates, improved blood pressure control, and better assessed LDL in patients with T2D.
In addition to cost savings, ACOs have successfully implemented quality improvement initiatives, as demonstrated by 1 evaluation in 11 primary care clinics that employed care coordination, a care gap summary tool, staff education, and workflow redesign. Although integration of care into larger organizations may address health care disparities, this has not been specifically addressed in ACO design. An evaluation examining differences in care provided to Caucasian and African-American Medicare beneficiaries according to size of provider group found that beneficiaries assigned to larger groups were more likely to be Caucasian with lower poverty rates and higher educational attainment compared with those in small or medium groups. African-American beneficiaries with T2D were less likely to receive LDL testing and retinal examinations and were more likely to be hospitalized than Caucasian beneficiaries. Although larger provider groups attenuated racial disparities in some areas, they did not change disparities on other metrics, such as hospitalization rates. ACOs will need to specifically address health care disparities among patients with MetS.
What Is the Optimal Strategy for Implementing a New Care Model for MetS?
The final challenge for TT participants was implementation of a new care model for MetS. Clear consensus was that stakeholders from the community and public health arena, the health care system, and industry must be involved and that patient advocates, community health workers, and peer leaders are essential to bridging the community and the health care system. Stakeholders include physicians, nurse practitioners, and physician assistants, as well as ancillary health professionals such as dietitians, exercise physiologists, psychologists, behavioral specialists, and certified diabetes educators. Disciplines to be involved include family practice, pediatrics, internal medicine, obstetrics and gynecology, geriatrics, and specialists in cardiology (hypertension and lipid) and endocrinology (diabetes and obesity). Other medical specialties that may also be involved with this population presenting with a particular phenotype include gastroenterology (NAFLD), sleep medicine (obstructive sleep apnea), nephrology (cardiorenal syndrome), surgery (bariatric, vascular, and cardiothoracic), psychiatry (depression, other behavioral), and oncology (obesity-associated malignancies). Finally, industry is another key stakeholder, as pharmaceuticals and surgical interventions comprise important treatment options for patients with MetS. It is important to note that many of the provisions of the Affordable Care Act (ACA) would support this implementation.
Dissemination of the Diabetes Prevention Program (DPP) in community settings can serve as a model for the MetS population. The DEPLOY (Diabetes Education & Prevention with a Lifestyle Intervention Offered at the YMCA) study was a pilot cluster-randomized trial comparing group-based DPP lifestyle intervention through a Young Men's Christian Association (16 group sessions with goals of 5% to 7% reduction in baseline body weight and 150 min/week of moderate exercise) with brief counseling. Among 92 randomized participants, at both 4 to 6 and 12 to 14 months, the percent change in weight and BMI, as well as the change in total cholesterol, was significantly greater in the intervention group. An extension study in which both the control and intervention arms were offered an 8-month lifestyle maintenance program found that both groups maintained weight changes compared with baseline, and those in the initial intervention group lost a further 1.5% of body weight, with significant decreases in total cholesterol and systolic blood pressure. A larger implementation of the DPP intervention across 14 Young Men's Christian Associations in New York demonstrated that among 254 participants, 40.2% and 60.8% achieved a weight loss ≥5% at 16 weeks and 10 months, respectively. Lessons could be drawn from these interventions to benefit other communities, such as the workplace, where many large employers already offer wellness programs. A systematic review of randomized controlled trials on worksite wellness programs demonstrated a statistically significant 3-lb weight reduction and 0.5 kg/m BMI reduction over 6 to 12 months.
The TT also recognized the National Physical Activity Plan as an overarching framework for implementation. The plan has 5 primary strategies and proposes evidence-based interventions within 8 economic sectors. Strategies include launching advocacy efforts to increase public support, mounting a national physical activity education program, disseminating best practice models, creating a national resource center, and establishing a center for physical activity policy development and research. Involved sectors include: business and industry; education; health care; mass media; parks, recreation, fitness, and sports; public health; transportation; land use; community design; volunteer; and nonprofit. Specific strategies within these sectors include providing incentives to increase active transportation (walking, biking) through community design, making physical activity a "vital sign" in the health care setting, and ensuring access to high-quality physical activity programs in early childhood education and grade school.
The TT proposed that community health workers and peer leaders play an integral role in implementing the new care model and discussed several examples. The Healthy Living Partnerships to Prevent Diabetes Study implemented a DPP-like lifestyle weight-loss program over 2 years by using a local diabetes education program with community health workers, involving weekly visits over the first 6 months and twice monthly visits over the next 18 months. Among 301 randomized patients, the intervention group achieved significant reductions in weight, BMI, waist circumference, glucose, insulin, and homeostatic model assessment of insulin resistance measures compared with control subjects, with 46.5% of the intervention group achieving ≥5% weight loss and 21.3% achieving ≥10 % weight loss. The Look AHEAD (Action for Health in Diabetes) trial provides the longest-term evidence of the effect of an intensive lifestyle intervention in overweight and obese adults with T2D. The curriculum was modified from the DPP and included structured meal plans and moderate exercise up to 200 min/week. At 8 years, 50.3% in the intervention group versus 35.7% in the usual care group lost ≥5% of body weight, and 26.9% versus 17.2% lost ≥10% of body weight.
In Colorado Heart Healthy Solutions, community health workers conducted screenings, assessed readiness for change, and provided education and medical referrals to patients with an uncontrolled risk factor for coronary heart disease or a Framingham Risk Score ≥10%. They provided further phone follow-up, and found significant reductions in Framingham Risk score, blood pressure, and cholesterol at retesting. In multivariable models, those receiving a follow-up call had greater improvement in Framingham Risk Score than those who did not. A randomized controlled trial in 2 community health centers enrolled 525 patients with uncontrolled ASCVD, T2D, hypertension, or hyperlipidemia; results showed that pairing nurse practitioners and community health workers demonstrated significant reductions in blood pressure, cholesterol, and HbA1c over 1 year of follow-up compared with usual care. Finally, peer leaders can effectively provide education and support for lifestyle. This was demonstrated in a study where 116 Latino adults with T2D were randomized to receive diabetes self-management education and either 12 months of weekly group sessions with peer leaders or 12 months of telephone outreach with health workers. Both groups achieved significant HbA1c, blood pressure, and waist circumference reductions and improved diabetes support with less distress. However, only the peer leader group sustained HbA1c and blood pressure reductions over 18 months.
To further highlight lifestyle change, the TT proposed campaigns such as the Exercise is Medicine initiative, which assesses patient readiness for exercise and provides handouts to help patients start a program. It also provides materials to help fitness professionals communicate with health care personnel. To emphasize the importance of addressing disparities, the TT discussed key studies such as the Lawrence Latino Diabetes Prevention project, which recruited 312 participants at high risk for T2D for a lifestyle intervention involving 3 individual and 13 group sessions over 12 months versus usual care. The curriculum was adapted to address knowledge gaps and language barriers, customize dietary advice to Latino cuisine, and use the popular novella media format to deliver messages. At 1 year, there was a significant reduction in weight, BMI, and HbA1c in the intervention group as compared with usual care. Another cultural adaptation of the DPP in African-American churches involved 37 participants and compared an abbreviated 6-week program to a longer 16-week program; it found that fasting glucose and BMI decreased significantly in both groups at 12 months. A program targeting a predominantly low-income non-Caucasian urban population delivered a lifestyle intervention in 12 weeks using group sessions and found significant reductions in the proportion of subjects meeting the MetS waist circumference (90% to 68%; p = 0.009) and hypertension (68% to 48%; p = 0.04) criteria over 6 months. At 3 months, 46.4% lost ≥5% of body weight and 26% lost ≥7% of body weight, with 87.5% and 66.7% sustaining these losses at 6 months, respectively. Araneta et al. piloted a 12-week Zumba fitness program in sedentary obese women with ≥2 MetS criteria (77% ethnic minorities), demonstrating significant blood pressure and fasting triglyceride reductions among the participants. The investigators also conducted a 48-week randomized controlled trial comparing restorative yoga to active stretching among adults with MetS, finding significantly lower fasting glucose in the yoga group at 12 months.
Principles for implementing a new care model within the health care system should include: care coordination and team-based care; education in MetS recognition and treatment; technology to facilitate communication among providers and patients; disease registries for population management; social media for distributing health messages; reimbursement alignment to facilitate coordinated care; and further development of strategies to address health care disparities and barriers to care. The TT recognized that the ACA supports 2 emerging models that seek to address these issues and improve integrated care for complex patients.
Patient-Centered Medical Home
To varying degrees, the PCMH addresses each of the aforementioned principles of care model implementation. The PCMH is organized around several core principles: 1) comprehensive team-based care; 2) patient-centered care; 3) care coordination; 4) accessible services; and 5) quality improvement and safety. A systematic review of 31 studies found a positive effect of components of the PCMH model on patient and staff experiences, as well as positive effects on preventive services, with reduction in emergency department visits in older adults, but no effect on hospital admissions or total costs. However, comparisons across studies on the PCMH are often difficult because of differences in definition and focus. In another study of 36 family practices implementing PCMH components over 26 months, improvement was seen in prevention and chronic care quality metrics, but not in patient-assessed outcomes. Long-term data is also limited, as most of these models were implemented over the last 5 to 10 years.
The Group Health Cooperative reduced physician panel sizes, increased ancillary staff, lengthened visit times, and provided time for team care planning, in addition to expanding technology to better engage patients. Comparison with control clinics in the area demonstrated better patient satisfaction scores, reduced provider burnout, improved performance on quality of care metrics, and reduced emergency department visits and inpatient admissions for ambulatory sensitive conditions over a 12- to 24-month follow-up. The PCMH model affects MetS sequelae and outcomes. For example, the Geisinger ProvenHealth Navigator demonstrated a reduction in the incidence of end-stage renal disease and amputation among patients with T2D over 4 years, although without a change in myocardial infarction or stroke. Evaluation of another such model in West Virginia found that an EHR-based screening tool identified 11% of over 94,000 patients as being at risk for T2D, enabling the facility to better screen and connect patients to local lifestyle intervention programs.
There is less published data available to assess PCMH reimbursement strategies to facilitate coordinated care or on how this model addresses health care disparities. Although different financial models have been proposed and are incorporated in some PCMH models, evaluations do not specifically address the effectiveness of these strategies, nor have most studies demonstrated overall short-term cost savings. A recent review of 27 PCMH studies found that only 11 provided any detail on their financial models. There is also a limited evidence base for addressing disparities. In fact, in a retrospective cohort study of 1,457 diabetic patients receiving care in a PCMH academic practice, African-American patients were less likely to receive HbA1c testing or influenza vaccination or to meet LDL or blood pressure targets than non-Hispanic Caucasians, after adjusting for multiple demographic factors and comorbidities. Similar to the cultural adaptations of the community-level interventions discussed earlier, new PCMH models must be modified to specifically address the needs of particular populations.
Accountable Care Organizations
The ACO is another mechanism relevant to implementing a new MetS care model. Although the PCMH focuses on coordination at the level of primary care, the ACO is a larger organization that includes hospitals and specialty care. Compared with many PCMH models, the ACO's reimbursement changes and cost-saving goals are more explicit and are better aligned to facilitate coordinated care. Most ACO models are very new, but available evaluations indicate that health care spending has declined. Medicare beneficiaries in the same market as a commercial ACO realized decreases in total health care spending over 2 years, primarily due to reduced outpatient office visits, minor procedures, imaging, and laboratories. There were some improvements in LDL testing for patients with T2D and ASCVD but not on other quality metrics. An evaluation of Medicare enrollees in the Medicare Physician Group Practice Demonstration compared with control subjects found that the savings were highest for acute care and dually-eligible beneficiaries, with an overall reduction in 30-day medical readmissions. According to a Centers for Medicare & Medicaid Services release of 1-year data, ACOs have also slowed cost growth (0.3% vs. 0.8% in 2012), reduced readmission rates, improved blood pressure control, and better assessed LDL in patients with T2D.
In addition to cost savings, ACOs have successfully implemented quality improvement initiatives, as demonstrated by 1 evaluation in 11 primary care clinics that employed care coordination, a care gap summary tool, staff education, and workflow redesign. Although integration of care into larger organizations may address health care disparities, this has not been specifically addressed in ACO design. An evaluation examining differences in care provided to Caucasian and African-American Medicare beneficiaries according to size of provider group found that beneficiaries assigned to larger groups were more likely to be Caucasian with lower poverty rates and higher educational attainment compared with those in small or medium groups. African-American beneficiaries with T2D were less likely to receive LDL testing and retinal examinations and were more likely to be hospitalized than Caucasian beneficiaries. Although larger provider groups attenuated racial disparities in some areas, they did not change disparities on other metrics, such as hospitalization rates. ACOs will need to specifically address health care disparities among patients with MetS.
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