Shared Health Appointments and Reciprocal Enhanced Support

NCT ID: NCT02132676

Last Updated: 2020-09-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1536 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-25

Study Completion Date

2019-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Insipidus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active treatment

All those scheduled for a Shared Medical Appointment (SMA), regardless of whether the Peer to Peer (P2P) program was offered.

No interventions assigned to this group

Usual Care

The randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA).

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mary Ellen M Heisler, MD MPA

Role: PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System, Ann Arbor, MI

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Site Status

VA Northern California Health Care System, Mather, CA

Sacramento, California, United States

Site Status

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States

Site Status

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Site Status

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Heisler M, Burgess J, Cass J, Chardos JF, Guirguis AB, Jeffery SM, Strohecker LA, Tremblay AS, Wu WC, Zulman DM. The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial. Trials. 2017 May 26;18(1):239. doi: 10.1186/s13063-017-1959-7.

Reference Type BACKGROUND
PMID: 28549471 (View on PubMed)

Kowalski CP, Veeser M, Heisler M. Formative evaluation and adaptation of pre-and early implementation of diabetes shared medical appointments to maximize sustainability and adoption. BMC Fam Pract. 2018 Jul 7;19(1):109. doi: 10.1186/s12875-018-0797-3.

Reference Type BACKGROUND
PMID: 29981568 (View on PubMed)

Heisler M, Burgess J, Cass J, Chardos JF, Guirguis AB, Strohecker LA, Tremblay AS, Wu WC, Zulman DM. Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial. J Gen Intern Med. 2021 Jun;36(6):1648-1655. doi: 10.1007/s11606-020-06570-y. Epub 2021 Feb 2.

Reference Type DERIVED
PMID: 33532956 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IIR 15-321

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Value For Veterans (V4V)
NCT05026684 UNKNOWN NA