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Shared Health Appointments and Reciprocal Enhanced Support (SHARES)

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VA Office of Research and Development

Status

Completed

Conditions

Diabetes Insipidus

Study type

Observational

Funder types

Other U.S. Federal agency

Identifiers

NCT02132676
IIR 15-321

Details and patient eligibility

About

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.

Full 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).

Enrollment

1,536 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

  • Is competent to provide informed consent

  • Can communicate in English and by telephone

  • Able to participate in an outpatient program

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
  • Prisoner

Trial design

1,536 participants in 2 patient groups

Active treatment
Description:
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether the Peer to Peer (P2P) program was offered.
Usual Care
Description:
The randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA).

Trial documents
1

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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