Shared Health Appointments and Reciprocal Enhanced Support

NCT02132676 | Completed Results

• 1 other identifier: IIR 15-321
• Study Type: observational
• Target: 1,536
• Locations: 1 country
• Sites: 5

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.

Conditions

Diabetes Insipidus

Keywords

Self-Management; Patient Care Management; Peer Group; Disease Management; Health Plan Implementation; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in Glycemic Control

  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 Outcomes (14)

• Change in Systolic Blood Pressure (SBP)

  6 months and 12 months post-enrollment

• Insulin Starts

  6 months and 12 months post-enrollment

• Emergency Department (ED) Visits

  6 months and 12 months post-enrollment

• Statin Starts

  6 months and 12 months post-enrollment

• Change in Number of Classes of Anti-hypertensive Meds

  6 months and 12 months post-enrollment

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• For no intervention control group:
• Serious psychiatric illness (bipolar disorder, dementia, schizophrenia, or personality disorders)
• Terminally ill
• Prisoner

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (5)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

Location

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

West Haven, Connecticut, 06516, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

Location

Related Publications (3)

• 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.

  PMID: 28549471 BACKGROUND

• 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.

  PMID: 29981568 BACKGROUND

• 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.

  PMID: 33532956 DERIVED

MeSH Terms

Conditions

Diabetes Insipidus; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

1. Our study sites were VAs. 2. We did not collect survey data from the usual care group, so were unable to compare responses between the two arms. 3. All clinical outcomes were gathered from EHR data gathered through clinical visits.

Results Point of Contact

• Title: Dr. Michele Heisler
• Organization: VA Ann Arbor Healthcare System Center for Clinical Management & Research

mheisler@umich.edu

734-845-3502

Study Officials

• Mary Ellen M Heisler, MD MPA

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: May 7, 2014
• Study Start: April 25, 2016
• Primary Completion: June 28, 2019
• Study Completion: July 30, 2019
• Last Updated: September 2, 2020
• Results First Posted: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)