Cost-effectiveness of Community-Based Depression Interventions for Rural and Urban Adults With Type 2 Diabetes: Projections From Program ACTIVE (Adults Coming Together to Increase Vital Exercise) II.

OBJECTIVE: We estimated the cost-effectiveness of the Program ACTIVE (Adults Coming Together to Increase Vital Exercise) II community-based exercise (EXER), cognitive behavioral therapy (CBT), and EXER+CBT interventions in adults with type 2 diabetes and depression relative to usual care (UC) and each other. RESEARCH DESIGN AND METHODS: Data were integrated into the Michigan Model for Diabetes to estimate cost and health outcomes over a 10-year simulation time horizon from the health care sector and societal perspectives, discounting costs and benefits at 3% annually. Primary outcome was cost per quality-adjusted life-year (QALY) gained. RESULTS: From the health care sector perspective, the EXER intervention strategy saved $313 (USD) per patient and produced 0.38 more QALY (cost saving), the CBT intervention strategy cost $596 more and gained 0.29 more QALY ($2,058/QALY), and the EXER+CBT intervention strategy cost $403 more and gained 0.69 more QALY ($585/QALY) compared with UC. Both EXER and EXER+CBT interventions dominated the CBT intervention. Compared with EXER, the EXER+CBT intervention strategy cost $716 more and gained 0.31 more QALY ($2,323/QALY). From the societal perspective, compared with UC, the EXER intervention strategy saved $126 (cost saving), the CBT intervention strategy cost $2,838/QALY, and the EXER+CBT intervention strategy cost $1,167/QALY. Both EXER and EXER+CBT interventions still dominated the CBT intervention. In comparison with EXER, the EXER+CBT intervention strategy cost $3,021/QALY. Results were robust in sensitivity analyses. CONCLUSIONS: All three Program ACTIVE II interventions represented a good value for money compared with UC. The EXER+CBT intervention was highly cost-effective or cost saving compared with the CBT or EXER interventions.

Recruitment effort and costs from a multi-center randomized controlled trial for treating depression in type 2 diabetes.

BACKGROUND: Participant recruitment for clinical trials is a significant challenge for the scientific research community. Federal funding agencies have made continuation of funding of clinical trials contingent on meeting recruitment targets. It is incumbent on investigators to carefully set study recruitment timelines and resource needs to meet those goals as required under current funding mechanisms. This paper highlights the cost, labor, and barriers to recruitment for Program ACTVE II, a successful multisite randomized controlled trial of behavioral treatments for depression in adults with type 2 diabetes, conducted in rural and urban settings in three states. METHODS: Quantitative and qualitative data on recruitment were gathered from study staff throughout the study recruitment period and were used to calculate costs and effort. The study utilized two main approaches to recruitment: (1) relying on potential participants to see ads in the community and call a toll-free number; and (2) direct phone calls to potential participants by study staff. RESULTS: Contact was attempted with 18,925 people to obtain the enrolled sample of 140. The cost of recruitment activities during the 4.5-year recruitment period totaled $190,056, an average cost of $1358 per enrolled participant. Qualitative evaluations identified multiple barriers to recruitment. CONCLUSIONS: Recruitment for Program ACTIVE II exemplifies the magnitude of resources needed to reach recruitment targets in the current era. Continuous evaluation, flexibility, and adaptation are required on the part of investigators, community partners, and funding agencies to successfully reach high-risk populations in rural and urban areas. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03371940 . Registered on 13 December 2017.

Effect on Health Care Expenditures During Nationwide Implementation of the Diabetes Prevention Program as a Health Insurance Benefit.

OBJECTIVE: Lifestyle interventions slow development of type 2 diabetes by half, but the impact of health payer reimbursement for delivery of intervention programs is not well known. We evaluated net commercial health payer expenditures when offering reimbursement for access to YMCA's Diabetes Prevention Program (YDPP) in 42 states. RESEARCH DESIGN AND METHODS: We used a nonequivalent comparison group design to evaluate net health care expenditures for adults with prediabetes who attended one or more YDPP visit between 1 July 2009 and 31 May 2013 ("YDPP users"). Rolling, 1:1 nearest neighbor propensity score (PS) matching was used to identify a comparison group of nonusers. Administrative data provided measures of YDPP attendance, body weight at YDPP visits, and health care expenditures. Random effects, difference-in-difference regression was used to estimate quarterly health care expenditures before and after participants' first visit to YDPP. RESULTS: Worksite screening identified 9.7% of the target population; 39.1% of those identified (19,933 participants through June 2015) became YDPP users. Mean weight loss for YDPP users enrolled before June 2013 (n = 1,725) was 7.5 lb (3.4%); 29% achieved ≥5% weight loss. Inclusive of added costs to offer YDPP, there were no statistically significant differences in mean per-person net health care expenditures between YDPP users and PS-matched nonusers over 2 years ($0.2 lower [95% CI $56 lower to $56 higher]). Mean reimbursement to the YMCA was $212 per YDPP user, with 92.8% of all expenditures made for those who attended at a high rate (≥9 completed YDPP visits). CONCLUSIONS: Worksite screening was inefficient for identifying the population with prediabetes, but those identified achieved modest YDPP attendance and clinically meaningful weight loss. Over 2 years, added costs to offer the intervention were modest, with neutral effects on net health care costs.

Valuing health for oneself versus one's child or elderly parent.

The aim of this study was to determine if adults value health states or are willing to accept risk differently for themselves than for their children or elderly parents. Participants (701) were asked to rate four hypothetical health states for themselves using both the standard gamble and time trade-off methodologies. They then did the same assessments for a real or hypothetical child as well as an elderly parent. Participants were willing to take more risk or trade more years of life to avoid bilateral vision loss and mental impairment for themselves than they were for their children and elderly parents.

Rationale and design of a comparative effectiveness trial to prevent type 2 diabetes in mothers and children: the ENCOURAGE healthy families study.

The number of youth with type 2 diabetes (T2D) is expected to quadruple over 4 decades. Gestational diabetes mellitus (GDM) is also increasing and is linked with development of T2D in women, and greater risk for T2D in adolescents exposed to GDM. Despite the increasing prevalence of T2D, approaches to prevent diabetes in high-risk youth and families are rare. To address this, we are conducting the Encourage Health Families Study (ENCOURAGE). This is a randomized trial evaluating the comparative effectiveness and costs of an adaptation of the Diabetes Prevention Program (DPP) directed at mothers who had GDM or prediabetes and their children. The intervention is a group-based lifestyle program which we developed and implemented in partnership with the YMCA. We are comparing the ENCOURAGE intervention targeted to 1) mothers who have had GDM or prediabetes, and 2) mothers who have had GDM or prediabetes along with their school-aged children. This manuscript provides 1) the rationale for a targeted approach to preventing T2D and the interventions, 2) description of the translation of the DPP curriculum, and 3) the study design and methodology. The primary aims are to determine if participation leads to 1) weight loss in high-risk mothers, and 2) youth having healthier weights and lifestyle habits. We will also evaluate costs associated with each approach. These data are essential to build a translation model of T2D prevention that is both realistic and feasible to address this growing problem in both youth and adults.

Rationale, design, and baseline characteristics of a community-based comparative effectiveness trial to prevent type 2 diabetes in economically disadvantaged adults: the RAPID Study.

Reaching Out and Preventing Increases in Diabetes (RAPID) is a community-based randomized trial evaluating the comparative costs and effectiveness of a group-based adaption of the DPP lifestyle intervention developed and implemented in partnership with the YMCA. RAPID enrolled adult primary care patients, with BMI 24 kg/m(2) or higher and abnormal glucose metabolism (HbA1c 5.7-6.9% or fasting plasma glucose 100-125 mg/dL). 509 participants were enrolled and randomized to one of two groups: standard clinical advice plus free-of-charge access to a group-based adaption of the DPP offered by the Y, versus standard clinical advice alone. Key outcomes for future analysis will include differences in body weight and other cardiovascular risk factors over a 24-month intervention period. At baseline, RAPID participants had a mean (SD) age of 51 ± 12.1 years, weight of 225.1 ± 56.2 lbs, and BMI of 36.9 ± 8.6 kg/m(2). 70.7% were women, 57.2% were African American, 35.4% were non-Hispanic White, and 3.2% were Hispanic. Mean HbA1c was 6.05 ± 0.34%. Additionally, 55.4% of participants had a baseline systolic blood pressure of ≥130 mmHg, 33.1% had a total blood cholesterol exceeding 200mg/dL, and 74% reported a household income of <$25,000. The RAPID Study successfully randomized a large cohort of participants with a wide distribution of age, body weight, and race who are at high risk for developing type 2 diabetes.

Promotion and tenure for community-engaged research: an examination of promotion and tenure support for community-engaged research at three universities collaborating through a Clinical and Translational Science Award.

INTRODUCTION: Community-engaged health research, an approach to research which includes the participation of communities, promotes the translation of research to address and improve social determinants of health. As a way to encourage community-engaged research, the National Institutes of Health required applicants to the Clinical and Translational Science Award (CTSA) to include a community engagement component. Although grant-funding may support an increase in community-engaged research, faculties also respond to the rewards and demands of university promotion and tenure standards. This paper measures faculty perception of how three institutions funded by a CTSA support community-engaged research in the promotion and tenure process. METHODS: At three institutions funded by a CTSA, tenure track and nontenure track faculty responded to a survey regarding perceptions of how promotion and tenure committees value community-engaged research. RESULTS: Faculty view support for community-engaged research with some reserve. Only 36% agree that community-engaged research is valued in the promotion and tenure process. DISCUSSION: Encouraging community-engaged scholarship requires changing the culture and values behind promotion and tenure decisions. Institutions will increase community-engaged research and more faculty will adopt its principles, when it is rewarded by promotion and tenure committees.

Designing a natural experiment to evaluate a national health care-community partnership to prevent type 2 diabetes.

To address the growing incidence of type 2 diabetes in the United States, UnitedHealth Group, the YMCA of the USA, and the Centers for Disease Control and Prevention have partnered to bring a group-based adaptation of the Diabetes Prevention Program lifestyle intervention to a national scale. Researchers at Northwestern and Indiana universities are collaborating with these partners to design a robust evaluation of the reach, effectiveness, and costs of this natural experiment. We will employ a quasi-experimental, cluster-randomized study design and combine administrative, clinical, and programmatic data from existing sources to derive reliable, timely, and policy-relevant estimates of the program's impact and potential for sustainability. In this context, evaluation results will provide information about the unique role of a health care-community partnership to prevent type 2 diabetes.

Effect of advanced access scheduling on processes and intermediate outcomes of diabetes care and utilization.

BACKGROUND: The impact of open access (OA) scheduling on chronic disease care and outcomes has not been studied. OBJECTIVE: To assess the effect of OA implementation at 1 year on: (1) diabetes care processes (testing for A1c, LDL, and urine microalbumin), (2) intermediate outcomes of diabetes care (SBP, A1c, and LDL level), and (3) health-care utilization (ED visits, hospitalization, and outpatient visits). METHODS: We used a retrospective cohort study design to compare process and outcomes for 4,060 continuously enrolled adult patients with diabetes from six OA clinics and six control clinics. Using a generalized linear model framework, data were modeled with linear regression for continuous, logistic regression for dichotomous, and Poisson regression for utilization outcomes. RESULTS: Patients in the OA clinics were older, with a higher percentage being African American (51% vs 34%) and on insulin. In multivariate analyses, for A1c testing, the odds ratio for African-American patients in OA clinics was 0.47 (CI: 0.29-0.77), compared to non-African Americans [OR 0.27 (CI: 0.21-0.36)]. For urine microablumin, the odds ratio for non-African Americans in OA clinics was 0.37 (CI: 0.17-0.81). At 1 year, in adjusted analyses, patients in OA clinics had significantly higher SBP (mean 6.4 mmHg, 95% CI 5.4 - 7.5). There were no differences by clinic type in any of the three health-care utilization outcomes. CONCLUSION: OA scheduling was associated with worse processes of care and SBP at 1 year. OA clinic scheduling should be examined more critically in larger systems of care, multiple health-care settings, and/or in a randomized controlled trial.

Comparison of health and effective functioning in Russia and the United States.

BACKGROUND: Global aging may increase the societal burden of providing more resources to augment elders' disabilities. The implications of functional disabilities can vary depending on the society in which they occur. OBJECTIVE: To determine differences in US and Russian elder citizens' function. RESEARCH DESIGN: Convenience sample of persons 60 years and older were surveyed and evaluated. SUBJECTS: One hundred community dwelling residents, half from Galesburg, Illinois and half from Moscow, Russia. MEASUREMENTS: An interviewer administered questionnaire and functional assessment examination. RESULTS: The Russian sample was younger than the American sample with a mean age of 67 years versus 78 years, and less likely to be widowed or living alone. Sixty percent of Russians took no medications compared with 14% of Americans, but Russians reported more cardiovascular disease, angina, and hypertension. Forty-four percent of Russians screened as being depressed and only 4% of the Americans. Self-assessed health was good for 77% of Americans and only 6% of Russians. The Medical Outcomes Study SF-36 Health Survey (MOS) eight health concepts showed favorable results for the Americans except for physical functioning, which indicated no difference. CONCLUSIONS: Marked health and functional differences exist between our samples. Russians had more cardiovascular disease, took less medication, drank and smoked more and were much more likely to be depressed than the US subjects.