A Team-Based Approach to Type 2 Diabetes and Cardiovascular Care

ABSTRACT

The Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA) program is an innovative, patient-centered system of care developed by the University Hospitals Harrington Heart and Vascular Institute in Cleveland, Ohio in the US for the management of high-risk patients with type 2 diabetes (T2D) and prediabetes at high risk for cardiovascular-kidney-metabolic (CKM) syndrome and its consequences. At its core, CINEMA is a multidisciplinary team of care experts, working together outside of traditional silos. The patient meets with the entire team up to 4 times each year to address all aspects of cardiovascular (CV) and T2D care. At the first visit, the team formulates a personalized approach that is evidence based and centered on optimal strategies to improve the patient’s lifestyle, reduce their risk of CV and kidney disease events, and increase their access and adherence to guideline-directed pharmacologic therapies. A community health worker is utilized to address social determinants of health as needed. The program has a substantial research component, with the intent of developing evidence for novel care paradigms. The multiyear results of the CINEMA program indicate that a multidisciplinary approach to management of high-risk patients is highly effective in reducing CKM syndrome risk factors and increases use of guideline-directed therapies. The aim of this review is to describe the structure, operation, and eligibility criteria for admission to the CINEMA program, provide an overview of how CKM syndrome risks are determined and managed for each patient, and discuss how the integrated approach to care is supported by current recommendations from professional societies and results from other coordinated care/multidisciplinary programs. Lastly, the scalability challenges of a wider rollout of the CINEMA program are considered.

Am J Manag Care. 2024;30(suppl 10):S197-S204. https://doi.org/10.37765/ajmc.2024.89672

For author information and disclosures, see end of text.

Introduction

Historically, cardiovascular (CV), kidney, and metabolic diseases have been managed in silos, which has often resulted in fragmented care, treatment delays, and increased health care delivery costs. As highlighted by the American Heart Association (AHA) Presidential Advisory on cardiovascular-kidney-metabolic (CKM) health, provision of optimum care for patients with CKM syndrome requires a multidisciplinary team approach involving high levels of stakeholder collaboration to reduce fragmentation of care.1

The Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA) program is a patient-centered, team-based intervention developed and implemented at the University Hospitals Harrington Heart and Vascular Institute and Research Education Institute, in Cleveland, Ohio, for patients with type 2 diabetes (T2D) or prediabetes, with a high risk for CKM.2-4 The program aims to reduce CV risk factors and increase utilization of evidence-based therapies to improve deficiencies in diabetes care and lower the risk for CV and kidney events in this high-risk population. Here we review the main features of the CINEMA program, the outcomes observed, and the next steps in expanding the program.2,3

CINEMA Program and Participants

The CINEMA program was funded through an investment by the Research Education Institute in 2019. It began enrollment in May 2020, was initially offered at 4 sites in the Cleveland metroplex, and expanded to 3 additional sites in 2024 (Figure 1).2,3 It comprises a multidisciplinary team of 4 cardiologists and 1 advanced practice provider with special interest/training in T2D management and prevention, 2 nurse navigators, 2 registered dietitians, 3 certified diabetes care and education specialists (CDCESs), a dedicated pharmacist, a program coordinator, a community health worker (CHW), and a program administrator. There is also mandated communication and care coordination with primary care, endocrinology, nephrology, and bariatric surgery providers when needed (ie, these were not included routinely in CINEMA care visits).3

Patients could be referred to the CINEMA program by internal/family medicine practitioners, cardiologists, endocrinologists, nephrologists, neurologists, bariatric and other surgeons, and population health specialists, or via webinars, patient navigator calls, CINEMA website referrals, accountable care organization referrals, or self-referrals. In year 1, individuals were included with either (1) self- or physician-reported T2D (with medical care and/or hemoglobin A1c [HbA1c] ≥6.5%), and/or (2) established or high risk for atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), and/or chronic heart failure (HF) with reduced ejection fraction (HFrEF), per the 2021 American Diabetes Association (ADA) Professional Practice Committee pathway.2,5 Patients with type 1 diabetes or HbA1c <5.7% without a diagnosis of T2D were excluded. In year 2, due to high demand and patient interest, the inclusion criteria were expanded to include individuals with prediabetes (defined as HbA1c ≥5.7% and <6.5%) and those with T2D or prediabetes and concomitant metabolic syndrome and/or a coronary artery calcium (CAC) score ≥100 Agatston units.3

Determining CKM Syndrome Risk and Optimizing Health

The CINEMA program is structured around up to 4 visits per year, with additional follow-up as needed.2,3 Unlike the traditional model of care, where the patient travels to different providers in several locations over multiple time points in the hope of receiving a comprehensive evaluation, CINEMA is unique in that the care team comes to the patient via an in-person or virtual platform in a single initial visit that attempts to address all aspects of CV and T2D care. The traditional model is well known to have a high probability of defects in care, meaning critically important aspects of care are not acted upon promptly. There is extensive empirical evidence of physician inertia in multiple diabetes-related end points including glycemic control, lipid management, and initiation of treatments known to have cardiorenal benefit.6-9 A substantial component of CINEMA is dedicated to patient education about T2D and its complications including knowledge around pharmacologic and lifestyle approaches, by nonphysician CINEMA personnel.2,3 This empowers the patient, builds confidence, and reduces the likelihood of patient and physician inertia.10

At the outset, providers in CINEMA seek to determine the patient’s overall risk for long-term CKM outcomes and then formulate an evidence-based, personalized care plan. The plan is centered upon T2D lifestyle and pharmacologic strategies for reducing CKM events by weighing additional personal and precision factors. Providers use baseline measurements to determine the patient’s overall risk for future CV and kidney events, including multiple novel measures. They recommend both lifestyle modification and a pharmacologic strategy including use of sodium glucose co-transporter 2 inhibitors (SGLT2is) and/or glucagon-like peptide-1 receptor agonists (GLP-1 RAs) (as recommended by the ADA and the European Association for the Study of Diabetes).11 Patients on Medicaid and those without access to insurance are referred for visits with a CHW who evaluates social determinants of health and directs patients to appropriate resources. Prior studies have suggested that CHW models increase adherence to medical care.12,13 Patient well-being is emphasized with utmost attention to lifestyle, diet, and sleep including periodic assessment of target organ complications through visits to ophthalmology, podiatry, endocrinology, nephrology, and other specialties, if warranted.

All patients undergo a standardized assessment of body weight, height, and laboratory testing including chemistries, lipids, HbA1c, and urine albumin-to-creatinine ratio (UACR), using standard assays. Laboratory studies are performed for the initial visit and for each subsequent follow-up visit (as applicable). In addition, CINEMA assesses CKM risk including precision measures of cardiovascular risk such as University Hospitals No-Cost Coronary Artery Calcium Score Test.14 This allows early initiation of therapies in many patients and also increases patient understanding of the health implications of T2D and CKM risk. Other precision measures for CKM risk include use of continuous glucose monitoring (CGM) and circulating- and/or imaging-based markers of CKM risk. These are used extensively to assemble a comprehensive portrait of each patient’s risk.15,16

The team works with insurance, pharmacy, and assistance programs to obtain patients’ medication in the most affordable way.2,3 This involves working around insurance barriers and identifying prescription assistance for patients otherwise unable to obtain these medications. This approach enables initiation of novel agents and continuation of these therapies in the CINEMA program. A CHW is involved early on if social determinants of health needs are identified and/or patients are on Medicaid or are dual eligible. A pathways hub model available in the state of Ohio is used to open pathways that can lead to reimbursement.17,18

During the CINEMA journey, the nurse navigator and dietitian/CDCES provide continued support, coordination of care, and education (including weekly podcast-type educational sessions with video broadcast over a virtual meeting platform and peer-led support groups), and additional resources between physician visits. All patients requiring initiation and dose escalation of therapies, such as GLP-1 RAs, are contacted by a pharmacist working with CINEMA for a virtual appointment to review the use and anticipated adverse effects with treatments as well as treatment goals. The pharmacy team coordinates medication adjustments in conjunction with the CINEMA team with documentation of these visits in the electronic medical record. The University Hospitals pharmacy services provide direct delivery of prescriptions for the majority of patients, obviating the need for a visit to the pharmacy. Moreover, for patients with economic barriers, the pharmacy team attempts to alleviate cost considerations through corporate incentives and discounts from pharmacy benefit managers.

Patients return approximately 3 months later, following repeat clinical and laboratory testing, to discuss their progress, review medical events that may have occurred between visits, and discuss laboratory results. Every 3 to 6 months the patient contacts their nurse coordinator, dietitian/CDCES, and physician using a combination of telephone and/or a virtual video telehealth platform to ensure continued support, engagement, and metabolic recovery. Patients continue their routine follow-up appointments with primary care and specialty physicians during this time. CINEMA physicians and support staff partner closely with primary care providers to ensure continuity of care, prevent fragmentation, and overcome barriers to communication.

To further foster patient engagement, optional patient-oriented virtual activities are available to all study participants. These include weekly podcast-type educational sessions and peer/patient-led support group discussions about diabetes, the patient journey, CV disease, and lifestyle optimization. There are also cooking classes and grocery store tours to educate patients about nutrition, a weekly home or office-based exercise session, CINEMA Studio (a patient advocacy group of volunteers discussing how to improve CINEMA), and a monthly CINEMA Blockbuster series open to medical professionals, patients, and lay people, where world-renowned experts discuss various topics.

Key Findings of the CINEMA Program

A total of 426 patients were enrolled in the CINEMA program from 2020 through 2022: 206 patients in year 1 and 220 in year 2. The mean age was 60 years, 47% of patients were women, and White and Black patients constituted 58% and 37% of the study population, respectively. In year 1, most referrals were from cardiologists (53%) and internal/family medicine practitioners (26%), with <1% from endocrinologists (0.5%) and nephrologists (0.2%).2 In year 2, cardiologists and internal/family medicine practitioners were still responsible for most of the referrals (85%), but there was an increase in referrals from endocrinologists (9%).3

Overall, 85% of patients (n = 363/426) had prevalent T2D, 48% (n = 204/426) had established ASCVD, 29% (n = 125/426) had HFrEF, and 27% (n = 113/426) had CKD. The mean baseline 10-year estimated risk of ASCVD was 25.1%. ASCVD risk factors were improved after the first year and continued to improve in year 2 (Figure 2).3 There were statistically significant changes from baseline in body weight, body mass index, systolic and diastolic blood pressure (BP), HbA1c, total cholesterol, low-density lipoprotein cholesterol (LDL-C), and triglycerides (P < .05 for each risk factor). Trends over time for changes in high-density lipoprotein cholesterol and UACR were favorable but not statistically significant. Stratified analyses provided similar findings when the model was adjusted by factors such as single vs multiple follow-up visits, and the baseline prevalence of ASCVD, T2D, CKD, or HF. In total, the absolute 10-year predicted risk of ASCVD decreased by 2.4% (P <.001) with the CINEMA program intervention.3

Year 1 data showed an increase in guideline-directed cardiometabolic medication prescriptions, which continued into year 2 (Figure 3).3 The largest increases were in use of SGLT2is and GLP-1 RAs, with an approximately 3-fold increase from baseline to follow-up (SGLT2is: 21%-57%, P <.001; GLP1-RAs: 18%-65%, P <.001). As the follow-up duration and overall program timeline was relatively brief (median: 4 months), no inference could be made on associations with event-related outcomes, such as myocardial infarction, stroke, or CV death.3

Discussion

The patient-centered, team-based approach utilized in the CINEMA program resulted in reductions in ASCVD risk factors and increased use of guideline-directed medical therapy (GDMT; eg, SGLT2is and GLP-1 RAs). These improvements were maintained over the course of the 2-year study period and were applicable across the spectrum of CKM conditions, regardless of baseline T2D, ASCVD, HF, or CKD status.3

The approach taken by the CINEMA program is supported by current recommendations from professional societies. For example, the ADA Standards of Care recommend alignment of approaches in diabetes management with the Chronic Care Model, emphasizing person-centered team care, integrated long-term treatment of diabetes and comorbidities, and ongoing collaborative communication and goal setting.19 The AHA has also stated that the management of CKM conditions should involve a multidisciplinary team led by a coordinator.16 However, who should act as care coordinator is less well defined. In one US survey, primary care physicians (PCPs) self-identified as a patient’s coordinator of care in 54% of cases for CKD and 59% for ASCVD (59%), whereas only 25% and 9% of patients viewed their PCP as their care coordinator for CKD and ASCVD, respectively.20 One approach is to appoint a nonphysician, such as a nurse navigator with CDCES certification, as the care coordinator. A registered nurse with specialty training in diabetes care is well positioned to be the coordinator and provide education, counseling, and medical advice to patients (with the assistance of the physician when needed), and to form a long-term relationship with patients for continuity of care. Additionally, the use of pharmacists in the CINEMA program to educate, initiate, and help adjust medications such as GLP-1 RAs is critical to the rapid attainment of goals as seen in this program. This approach prevents therapeutic inertia and helps adjudicate the time of the CINEMA staff in addressing other needs including scaling the operation to reach more patients. The CHW model is also important in addressing social determinants of health needs that are often barriers in optimizing CKM health. The results of the CINEMA program are in line with those observed in other multidisciplinary/coordinated care programs in T2D and non-T2D populations. For example, in a 5-year prospective cohort study in patients with T2D in China, Wan and colleagues evaluated a multidisciplinary risk assessment and management program with initial risk assessment and review by specialist nurses who also provide individual care advice. Information was then shared among the multidisciplinary heath care team (doctors, nurses, optometrists, podiatrists, dieticians, physiotherapists).21 There was a risk reduction of 40.6% (HR, 0.594; P <.001) in CVD/microvascular complications and a 66.1% (HR, 0.339; P <.001) risk reduction in all-cause mortality in patients in the coordinated care group vs the usual care group.21

In the COORDINATE trial (NCT03936660) in 43 US cardiology clinics, patients with T2D and ASCVD, who were not taking all 3 classes of evidence-based therapies (statins; angiotensin-converting enzyme inhibitors/angiotensin receptor blockers; SGLT2i or GLP1-RAs), entered a multidisciplinary program where their care was managed by a cardiologist, endocrinologist, and implementation specialist. At the last follow-up visit (12 months for 97.3% of the participants), those in the intervention group were more likely to be prescribed all 3 therapies (173/457 [37.9%]) vs the usual care group (85/588 [14.5%]), with a difference of 23.4% (adjusted odds ratio [OR], 4.38 [95% CI, 2.49-7.71]; P <.001). However, unlike the CINEMA program, this intervention was not associated with changes in ASCVD risk factors, and was not powered to detect clinical events.22

Lastly, initial reports from the Cardiometabolic Center Alliance (CMCA) site at Saint Luke’s Mid America Heart Institute demonstrated that the use of guideline-directed medical therapies for eligible patients (N = 129) was improved using the cardiometabolic clinic model compared with usual care, including higher rates of SGLT2i and/or GLP-1 RA use.23 A follow-up report from the CMCA in 2023 evaluated 606 individuals with T2D and CVD/CKD from 6 sites. Patients were a mean age of 64 years, 44% were female, 78% were White, and the median follow-up time was 6 months. After initiation of care at CMCA sites, large improvements in GDMT and reductions in weight, HbA1c, BP, total cholesterol, LDL-C, triglycerides, and insulin requirements were observed. The authors concluded that CMCA-directed implementation of coordinated team-based care produced rapid and large improvements in GDMT and quality of care across multiple sites.24

To address the concern that a specialist-driven cardiometabolic clinic care model may devalue the role of PCPs in managing comorbid T2D and ASCVD, the CINEMA program works closely with primary care colleagues and seeks to directly address the fragmentation of care and management of multiple health conditions by working as a partnership. A key element of this partnership is to improve ASCVD prevention by increasing utilization of evidence-based therapies for the intensification of care, which appears to be both efficacious and cost effective. As the experience of the CINEMA program and other programs demonstrates, use of GDMTs in patients with T2D and ASCVD continues to be relatively low, despite routine primary and endocrinology specialist care. This demonstrates an unmet need for aggressive prevention, which can be provided by cardiometabolic specialty programs. A key component of CINEMA is the ability to risk-stratify patients with prediabetes and T2D appropriately. In this regard, the availability of the no-charge CAC score program helps risk stratification and early initiation of CKM therapies in patients with subclinical ASCVD, many of whom would not otherwise be identified. The Community Benefit of No-Charge Calcium Score Screening (CLARIFY) program established at University Hospitals provides free CAC testing for all patients within CINEMA and those with multiple risk factors, and this is an important part of the success of the CINEMA program.25-28

Challenges remain for the successful implementation and scalability of this multifaceted, integrated, patient-centered, team-based intervention for patients with T2D or prediabetes and high CV risk. Although several prior implementation strategies have been effective in single-system settings, scalability and dissemination of programs like CINEMA to other health systems and settings may prove difficult due to a lack of system-cohesiveness, infrastructure, and funding. Coordination of care is fundamental to the success of programs like CINEMA, and is facilitated by a strong network of outpatient sites, an integrated electronic medical record, important synergistic initiatives such as CLARIFY, presence of a CHW to address social determinants of health, and value-based care through the accountable care organization. Furthermore, incentives to join CINEMA, such as no-copay visits for employees at University Hospitals and institutional-led patient assistance programs, increase patient attendance and adherence to lifestyle and pharmacologic therapies.2,3

The use of precision measures for risk assessment such as CAC score is a unique facet of the CINEMA program. The availability of this diagnostic at no charge to the patient greatly simplifies decision-making and allows early initiation of pharmacologic approaches in patients with elevated CAC, which is akin to established coronary artery disease.25,26,29

Additional precision measures such as CGM and other remote monitoring devices can be effective tools to increase adherence to lifestyle and medical interventions and assist with patient self-monitoring and behavioral modification. The CINEMA program found that when the Dexcom G6 CGM system was used as an adjunct to a healthy meal plan, increased physical activity, and optimized medical therapy, it resulted in significantly improved glycemic control and reduced CV risk within 90 days in a cohort of adults with T2D who were not using insulin.15 There was a significant reduction in average glucose levels and an increase in time in range, with a trend toward less glycemic variability. When users of the Dexcom system were surveyed, they reported significant reductions in several cardiometabolic risk factors including HbA1c, triglycerides, BP, and cholesterol, as well as less diabetes distress. Furthermore, CGM use was associated with a reduced absolute 10-year predicted risk for ASCVD of ≈8% and a significant increase in GDMT for diabetes and CV disease. The Dexcom system was well tolerated with no serious adverse events and no episodes of hypoglycemia during the study. To our knowledge, this is the first study to assess the impact of the Dexcom G6 CGM system on glycemic control and CV risk in a cohort of individuals with T2D who are not using insulin. It demonstrates the feasibility and effectiveness of CGM use for this patient population at high risk for adverse CV outcomes. Additional remote monitoring devices for BP, weight, sleep, activity, etc, can also assist patients in their health journey, and are planned for inclusion in CINEMA in the next year.

Conclusion

The integrated, team-based, patient-centered approach to managing patients with T2D/prediabetes at high risk for CKM syndrome utilized in the CINEMA program resulted in improvements in patient outcomes and use of GDMT. Implementation of a team-based approach is critical to enhancing patient understanding, buy-in, and ultimately, treatment adherence. CINEMA utilizes novel approaches including deployment of a CHW to address social determinants of health, targeted use of remote monitoring such as CGM devices, and precision assessment with imaging and biomarker-based measures to further refine CKM risk. Further research is in progress to evaluate the scalability of the CINEMA program and dissemination to other health care settings. Multidisciplinary teams of specialists in CKM conditions, with the addition of other disciplines such as primary care, pharmacy, and nurse practitioners, should be the standard of care for patients with CKM syndrome to optimize the management of these high-risk patients.

Acknowledgments

The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors. The authors did not receive payment related to the development of the manuscript. Writing support was provided by Debra Brocksmith of Elevate Scientific Solutions, LLC, contracted and funded by Boehringer Ingelheim Pharmaceuticals, Inc (BIPI) and Lilly USA, LLC. BIPI and Lilly were given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.

Author Affiliations: Case Western Reserve University School of Medicine and Division of Cardiovascular Medicine, University Hospitals Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center (IJN), Cleveland, OH; Cardiovascular Research Institute, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center (SR), Cleveland, OH.

Funding Source: This supplement was supported by Boehringer Ingelheim Pharmaceuticals, Inc and Lilly USA, LLC.

Author Disclosures: Dr Neeland reports receiving honoraria, consulting, and speakers’ bureau fees from Boehringer Ingelheim/Lilly Alliance. He also reports receiving consulting and honoraria from Bayer, and has participated in paid scientific advisory boards for AMRA Medical, Boehringer Ingelheim, Lilly, and Novo Nordisk. Dr Rajagopalan reports receiving consulting honoraria and advisory board fees from Bayer and Novo Nordisk.

Authorship Information: Concept and design (SR); acquisition of data (IJN); drafting of the manuscript (IJN,SR); and critical revision of the manuscript for important intellectual content (IJN,SR).

Address Correspondence to: Ian J. Neeland, MD. University Hospitals Harrington Heart and Vascular Institute, 11100 Euclid Ave, Cleveland, OH 44106. Email: ian.neeland@uhhospitals.org

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