Clinical trial NCT02132676: Shared Health Appointments and Reciprocal Enhanced Support
Official title: Peer Support to Enhance Diabetes Shared Medical Appointments: Examining Comparative Effectiveness in VA Health Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Insipidus
Keywords: Self-Management
Patient Care Management
Peer Group
Disease Management
Health Plan Implementation
Diabetes Mellitus
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-05-07
Enrollment: 1536
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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).

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
* 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

Primary outcomes:
measure: Change in Glycemic Control
timeFrame: 6 months and 12 months post-enrollment
Secondary outcomes:
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: 6 months and 12 months post-enrollment
measure: Insulin Starts
timeFrame: 6 months and 12 months post-enrollment
measure: Emergency Department (ED) Visits
timeFrame: 6 months and 12 months post-enrollment
measure: Statin Starts
timeFrame: 6 months and 12 months post-enrollment
measure: Change in Number of Classes of Anti-hypertensive Meds
timeFrame: 6 months and 12 months post-enrollment
measure: Change in Patient-reported Satisfaction With VA Care
timeFrame: 6 months and 12 months post-enrollment
measure: Change in Patient-reported Diabetes Distress
timeFrame: 6 months and 12 months post-enrollment
measure: Change in Patient-reported Degree of Diabetes Support
timeFrame: 6 months and 12 months post-enrollment
measure: Change in Patient-reported Degree of Self-Efficacy
timeFrame: 6 months and 12 months post-enrollment
measure: Hospitalizations
timeFrame: 6 months and 12 months post-enrollment
measure: Length of Hospitalizations
timeFrame: 6 months and 12 months post-enrollment
measure: PCP Visits
timeFrame: 6 months and 12 months post-enrollment
measure: Nurse Case Manager Visits
timeFrame: 6 months and 12 months post-enrollment
measure: Endocrinology Visits
timeFrame: 6 months and 12 months post-enrollment
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: Sacramento
country: United States
facility: VA Northern California Health Care System, Mather, CA
state: California
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Mary Ellen M Heisler, MD MPA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.