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IIR 13-053 – HSR&D Study

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IIR 13-053
Jump Starting Shared Medical Appointments for Diabetes with Weight Management
William S Yancy MD MHS
Durham VA Medical Center, Durham, NC
Durham, NC
Funding Period: May 2014 - August 2018

BACKGROUND/RATIONALE:
Shared medical appointments (SMAs) involve groups of patients who share a common chronic condition and meet over time to receive education, self-management enhancement, and medication management to improve clinical outcomes. A systematic review by VA found that SMAs modestly improve glycemia in patients with diabetes. Although these SMA programs sometimes included diet and physical activity counseling, weight management (WM) was not a primary goal, and weight typically was not reduced. Instead, medication intensification was the primary strategy for improving glycemia, and this strategy can lead to weight gain.

For overweight patients with diabetes, weight loss is first-line therapy because it can improve glycemic control and because excess weight leads to poorer outcomes. Moreover, many antiglycemic medications cause weight gain and hypoglycemic events, which may counteract the potential macrovascular benefits of glycemic control. Dietary interventions, however, can lower weight and improve glycemic control while reducing antiglycemic medication needs and, therefore, subsequent risk for hypoglycemic episodes.

In our prior research, we induced weight loss and improved glycemic control while decreasing antiglycemic medications. A combination of an intensive weight management program with the diabetes management offered in SMAs has potential to further improve diabetes outcomes, reduce complications, decrease costs and increase health-related quality of life. Such a combined intervention is ideal for patients with diabetes because of their unique dietary considerations, and their need for careful glycemic and medication management during weight loss.

OBJECTIVE(S):
We examined whether an intensive, group-based weight management program followed by an SMA intervention (WM/SMA arm) was comparably effective (non-inferior) to the SMA intervention alone for improving glycemic control while using less antiglycemic medication and resulting in fewer hypoglycemic events and lower healthcare costs.

METHODS:
A total of 263 overweight VA outpatients with uncontrolled (hemoglobin A1c >= 8.0%) type 2 diabetes participated in this RCT. Similar to prior SMAs, the SMA visits occurred every 4 weeks for 16 weeks and then every 8 weeks for 32 weeks for a total of 9 visits. Sessions were led by a physician and trained interventionists, and included educational topics related to diabetes management (including diet and physical activity), self-management training, and medication adjustment. Similar to our prior weight management trials, the WM/SMA group met every 2 weeks for 16 weeks and then every 8 weeks for 32 weeks for a total of 13 visits. The weight management program focused on a low carbohydrate dietary pattern because of its potential to lower glycemia, leading to reduced antiglycemic medication needs. After 16 weeks, meeting content shifted to the SMA intervention content but weight management continued to be addressed at the meetings. The primary outcome was glycemic control assessed by hemoglobin A1c measured at baseline and at 16, 32, and 48 weeks. Secondary outcomes included hypoglycemic events, changes in the antiglycemic medication regimen as assessed by a summary score, and weight and healthcare costs. Diabetes-specific health-related quality of life and medication adherence was also examined.

FINDINGS/RESULTS:
Initial findings were that both the WM/SMA and SMA interventions improved participants' HbA1c. The WM/SMA intervention had a greater initial improvement in HbA1c at weeks 16 and 32 but was not significantly different from SMA at the final outcome visit at week 48.

Diabetes quality of life improved more in the WM/WMA intervention initially but was not significantly different than SMA at the final outcome visit.

WM/SMA participants had lower diabetes medication utilization (using a medication effect score) and greater weight loss than SMA participants at week 16 that was maintained at week 48.

Limitations of the study are that WM/SMA intervention had more frequent visits in the first 16 weeks compared to SMA intervention, study physicians who performed medication adjustments were not blinded to treatment arm, and the medication effect score presumes linear relationship between dosage and HbA1c.


IMPACT:
We tested a novel intervention that combined intensive weight and diabetes management using the SMA platform. This research addresses an important mission to VA because diabetes is more prevalent in Veterans than in the general population, and because weight management is more challenging and complex in patients with diabetes. This study has the potential to enhance diabetes management strategies and benefit Veterans with diabetes by delivering effective disease and weight management in a novel, economical and efficient clinical system design.

The study demonstrated that shared medical appointments incorporating intensive weight management led to substantial initial improvements in important diabetes outcomes. Maintaining intensity of WM/SMA intervention over time may increase durability of outcomes.

PUBLICATIONS:

Journal Articles

  1. Crowley MJ, Edelman D, Voils CI, Maciejewski ML, Coffman CJ, Jeffreys AS, Turner MJ, Gaillard LA, Hinton TA, Strawbridge E, Zervakis J, Barton AB, Yancy WS. Jump starting shared medical appointments for diabetes with weight management: Rationale and design of a randomized controlled trial. Contemporary clinical trials. 2017 Jul 1; 58:1-12.
Conference Presentations

  1. Yancy WS, Hinton T, Turner M. Jump Starting Shared Medical Appointments for Diabetes With Weight Management (JumpStart). Poster session presented at: VA Durham VAMC Annual Research Week; 2016 May 2; Durham, NC.


DRA: Aging, Older Veterans' Health and Care, Diabetes and Related Disorders
DRE: Treatment - Efficacy/Effectiveness Clinical Trial, Treatment - Comparative Effectiveness
Keywords: Diabetes, Decision-Making, Outcomes - Patient
MeSH Terms: none