Shared Health Appointments and Reciprocal Enhanced Support (SHARES)

August 19, 2020 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

1536

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304-1290
        • VA Palo Alto Health Care System, Palo Alto, CA
      • Sacramento, California, United States, 95655
        • VA Northern California Health Care System, Mather, CA
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor Healthcare System, Ann Arbor, MI
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Providence VA Medical Center, Providence, RI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

VA outpatients with uncontrolled diabetes receiving care at a participating VA Medical Center during implementation of a P2P program for diabetes management in conjunction with SMAs

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
6 months and 12 months post-enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure (SBP)
Time Frame: 6 months and 12 months post-enrollment
Systolic blood pressure (SBP) 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, the investigators will also examine the change in percentage of patients with an average SBP > 140.
6 months and 12 months post-enrollment
Insulin Starts
Time Frame: 6 months and 12 months post-enrollment
The number of participants who are not on insulin at baseline and are started on insulin during the 6 and 12-month post-enrollment periods will be totaled and compared for the SMA group and the no intervention control group. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA group, baseline will be the date of the first SMA.
6 months and 12 months post-enrollment
Emergency Department (ED) Visits
Time Frame: 6 months and 12 months post-enrollment
Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).
6 months and 12 months post-enrollment
Statin Starts
Time Frame: 6 months and 12 months post-enrollment
The number of participants who are not on a statin at baseline and are started on insulin during the 6 and 12-month post-enrollment periods will be totaled and compared for the SMA group and the no intervention control group. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA group, baseline will be the date of the first SMA.
6 months and 12 months post-enrollment
Change in Number of Classes of Anti-hypertensive Meds
Time Frame: 6 months and 12 months post-enrollment
Change in antihypertensive use (number of classes of prescribed anti-hypertensives) in each group will be assessed at baseline and following the 6 and 12-month post-enrollment evaluation periods. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA group, baseline will be the date of the first SMA.
6 months and 12 months post-enrollment
Change in Patient-reported Satisfaction With VA Care
Time Frame: 6 months and 12 months post-enrollment

Patients' satisfaction with VA care will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used:

Scale name: VA Healthcare Satisfaction Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome
6 months and 12 months post-enrollment
Change in Patient-reported Diabetes Distress
Time Frame: 6 months and 12 months post-enrollment

Patients' level of diabetes distress will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used:

Scale name: Diabetes Distress Scale Scale ranges: 1-5 (Not a Problem=1, Minor Problem=2, Moderate Problem=3, Somewhat Serious Problem=4, Serious Problem=5) Direction of range: Lower score indicates a better outcome
6 months and 12 months post-enrollment
Change in Patient-reported Degree of Diabetes Support
Time Frame: 6 months and 12 months post-enrollment

Patients' degree of diabetes support will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used:

Scale name: Diabetes Support Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome
6 months and 12 months post-enrollment
Change in Patient-reported Degree of Self-Efficacy
Time Frame: 6 months and 12 months post-enrollment

Patients' degree of self-efficacy will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used:

Scale name: Williams Self-Efficacy Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome
6 months and 12 months post-enrollment
Hospitalizations
Time Frame: 6 months and 12 months post-enrollment
Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).
6 months and 12 months post-enrollment
Length of Hospitalizations
Time Frame: 6 months and 12 months post-enrollment
Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).
6 months and 12 months post-enrollment
PCP Visits
Time Frame: 6 months and 12 months post-enrollment
Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).
6 months and 12 months post-enrollment
Nurse Case Manager Visits
Time Frame: 6 months and 12 months post-enrollment
Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).
6 months and 12 months post-enrollment
Endocrinology Visits
Time Frame: 6 months and 12 months post-enrollment
Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).
6 months and 12 months post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Mary Ellen M Heisler, MD MPA, VA Ann Arbor Healthcare System, Ann Arbor, MI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 25, 2016

Primary Completion (ACTUAL)

June 28, 2019

Study Completion (ACTUAL)

July 30, 2019

Study Registration Dates

First Submitted

August 21, 2013

First Submitted That Met QC Criteria

May 5, 2014

First Posted (ESTIMATE)

May 7, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 15-321

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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