Edelman shares VA research project

Wednesday, November 21, 2018

We are proud to show off the work of Dr. David Edelman, a member of Duke general internal medicine and a researcher in the Center for Health Services Research in Primary Care in the Durham VA Health Care System. Dr. Edelman is the lead investigator of this study about cardiovascular risk reduction.

Background/Rationale

The study team already knows that the prevention of cardiovascular events are critically important and group interventions work well for the management of individual chronic illnesses. It would seem that group strategies might be promising for cardiovascular risk reduction, but different people want or need to do different things to reduce their cardiovascular risk (e.g., exercise, lose weight, quit smoking).

Here is the project summary:

Name of Study: The Group Prevention Study (GPS): Design and Baseline Characteristics

Primary Hypothesis: The GPS intervention will lower Framingham Risk Score by 2 percentage points among patients with elevated, reversible cardiovascular risk.

GPS Intervention, a randomized, controlled trial (RCT): Based on Problem-Solving Theory, a cognitive psychotherapeutic strategy, patients identify a particular behavior they want to adopt that will improve cardiovascular risk.

  • Healthier eating, OR
  • Increased physical activity, OR
  • Smoking cessation

Patients are taught to identify barriers to achieving these behaviors, and then problem-solve around solutions to these barriers. Problem-solving is taught in groups; patients in the same group need not be addressing the same healthful behavior, but patients still help each other work towards these disparate goals.

The groups met 6 times over 18 weeks. The early sessions focused on problem-solving technique and the later sessions worked around patient’s specific problems, brought to the group at large.

The healthcare coach calls each patient between each group session to reinforce behavior change and uses motivational interviewing techniques.

The Control group received treatment as usual.

Outcomes:

  • Framingham Risk Score (Primary)
  • BP, lipids, weight
  • Activity, smoking cessation, caloric intake (all self report by well-validated measures)
  • Patient Activation, measured by a validated questionnaire
  • Primary end point was 6 months
  • 12 months also ascertained to determine if any effect is sustained after leaving the intervention.

Study Team: 
David Edelman, MD, MHS
Laura Wray, PhD
Jason Nieuwsma, PhD
George L. Jackson, PhD
Cynthia J. Coffman, PhD
Jennifer Gierisch, PhD
Margaret Dundon, PhD
Amy Jeffreys, MStat
Amy Harris, BA
Michael Owings, BA
Corrine Voils, PhD

Status

  • The intervention is complete.
  • 6-month (primary) outcome closed 11/15/18
  • Primary Analyses ready by 1/15/19
  • 12 month sustainability to follow

Funding Agency: VA Health Services Research & Development – CRE 12-285. Read more here.

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