ACTIVE_NOT_RECRUITING

Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Type 2 diabetes is a significant condition in VA affecting 20% of VA patients. Adherence to medication regimens and lifestyle factors is important to achieve care goals for these patients. Patients who use active participatory communication behaviors with their providers have better adherence to treatment and better biomedical outcomes, yet many patients are not prepared to engage in active communication with their providers. Existing coaching interventions have not been adopted in practice because of the cost of trained personnel. The investigators have shown the efficacy of a low-cost video that did not require trained personnel. This proposal proposes to test implementation strategies to deliver that video in VA primary care clinics and to test the effectiveness of the video to improve outcomes in a Hybrid Type 2 effectiveness-implementation trial using a cluster randomized stepped wedge design at eight sites. This proposal will test feasibility of implementing the video and if successful will generate the evidence to justify widespread dissemination of the video.

Official Title

Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial

Quick Facts

Study Start:2022-10-01
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05169359

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Dx of T2D
  2. * Hemoglobin A1c ("A1c") 7 or greater
  3. * Adults, age 18 or older
  4. * Visit at a participating site
  5. * Receives care from primary care provider more than once a year at VA
  1. * Lives in skilled nursing facility
  2. * Dementia (abnormal SBT)63
  3. * Creatinine \>3 (or eGFR\<20), recent MI or admission for HF
  4. * Terminal medical condition
  5. * Drug- (e.g., steroid) induced diabetes.
  6. * Blind or deaf (e.g., unable to view/hear video

Contacts and Locations

Principal Investigator

Howard S. Gordon, MD BS
PRINCIPAL_INVESTIGATOR
Jesse Brown VA Medical Center, Chicago, IL

Study Locations (Sites)

Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
United States
Adam Benjamin Jr VA Outpatient Clinic, Crown Point, IN
Crown Point, Indiana, 46307
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Howard S. Gordon, MD BS, PRINCIPAL_INVESTIGATOR, Jesse Brown VA Medical Center, Chicago, IL

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 Registration Dates

Study Start Date2022-10-01
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2022-10-01
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus (Type 2)