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Clinical Trials/NCT02132676
NCT02132676
Completed
Not Applicable

Peer Support to Enhance Diabetes Shared Medical Appointments: Examining Comparative Effectiveness in VA Health Systems

VA Office of Research and Development5 sites in 1 country1,536 target enrollmentApril 25, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Insipidus
Sponsor
VA Office of Research and Development
Enrollment
1536
Locations
5
Primary Endpoint
Change in Glycemic Control
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the effectiveness of a peer-to-peer program (P2P) in addition to Shared Medical Appointments (SMAs) compared to SMAs alone for the treatment of diabetes in five VA health systems, and to study the implementation process in order to gather information required to disseminate the program more broadly in the VHA system.

Detailed Description

Providers are often unable to communicate as frequently as needed with diabetes patients who have poor risk factor control and face significant self-management challenges. Moreover, many VA patients face barriers to attending frequent face-to-face visits. This project will evaluate the implementation of a novel program found in a recent VA randomized, controlled trial to significantly improve VA patients' diabetes-specific social support, insulin starts, and glycemic control compared to usual nurse care management. The program uses periodic group sessions in conjunction with calls between paired patients with diabetes to promote more effective care management as well as peer-to-peer (P2P) communication among diabetes patients who both have poor glycemic control and are working on similar care goals. "Peer buddies" are encouraged to talk by phone at least weekly to provide mutual support and share their progress on meeting their self-management goals. The goal of this service is to enhance the effect of shared medical appointments (SMAs), a service model demonstrated to be effective in improving outcomes among patients with diabetes and other chronic conditions and now being widely implemented in VA. Based on the success of the efficacy trial of this intervention, the investigators now seek to evaluate a wider-scale implementation of this program. During implementation of the P2P program in conjunction with shared medical appointments (SMAs) in five diverse VA facilities, the investigators will evaluate the effectiveness of SMAs alone and SMAs+P2P compared to usual care, and study the implementation process in order to gather information required to disseminate the program more broadly in Veterans Health Administration (VHA).

Registry
clinicaltrials.gov
Start Date
April 25, 2016
End Date
July 30, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Veterans enrolled into diabetes Shared Medical Appointments (SMAs) at participating sites, and a random subset of those meeting criteria for diabetes SMAs who have not yet participated:
  • Veteran receiving care at a participating VA Medical Center
  • Meets at least one of the following criteria in the past 2 years;
  • at least 1 VA hospitalization with a diabetes-related International Classification Of Diseases-9 (ICD-9) code,
  • at least 2 VA outpatient visits with a diabetes-related ICD-9 code, or
  • At least 1 VA prescription for a glucose control medication (insulin or oral agent) or monitoring supplies
  • Poor glycemic control, indicated by a HbA1c in the past 6 months or:
  • at least 7.5% if age \<70, or
  • at least 8% if age 70+
  • Has a current address and telephone number listed in VA databases

Exclusion Criteria

  • For no intervention control group:
  • Active substance abuse disorder (smoking cigarettes is not an exclusion)
  • Serious psychiatric illness (bipolar disorder, dementia, schizophrenia, or personality disorders)
  • Terminally ill

Outcomes

Primary Outcomes

Change in Glycemic Control

Time Frame: 6 months and 12 months post-enrollment

Glycemic control (measured by Hemoglobin A1c) in each group will be assessed by the comparison of an average of the values obtained during routine outpatient clinical practice in 6-month windows preceding baseline and following the 6 and 12-month post-enrollment evaluation periods. In addition to measuring absolute values of A1c, the investigators will also examine the change in the percentage of patients with an average A1c \> 8%.

Secondary Outcomes

  • Statin Starts(6 months and 12 months post-enrollment)
  • Emergency Department (ED) Visits(6 months and 12 months post-enrollment)
  • Insulin Starts(6 months and 12 months post-enrollment)
  • Change in Number of Classes of Anti-hypertensive Meds(6 months and 12 months post-enrollment)
  • Change in Patient-reported Degree of Self-Efficacy(6 months and 12 months post-enrollment)
  • PCP Visits(6 months and 12 months post-enrollment)
  • Endocrinology Visits(6 months and 12 months post-enrollment)
  • Change in Systolic Blood Pressure (SBP)(6 months and 12 months post-enrollment)
  • Change in Patient-reported Satisfaction With VA Care(6 months and 12 months post-enrollment)
  • Change in Patient-reported Degree of Diabetes Support(6 months and 12 months post-enrollment)
  • Change in Patient-reported Diabetes Distress(6 months and 12 months post-enrollment)
  • Hospitalizations(6 months and 12 months post-enrollment)
  • Length of Hospitalizations(6 months and 12 months post-enrollment)
  • Nurse Case Manager Visits(6 months and 12 months post-enrollment)

Study Sites (5)

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