The Effect of Clinic Visit Audio Recordings for Self-management in Older Adults (REPLAY)

The objective of this study is to conduct a multisite trial evaluating the impact of adding an audio recording of clinic visits (AUDIO) to usual care in older adults with multimorbidity, including diabetes, compared to After Visit Summary (AVS) alone (Usual Care; UC).

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes
• Intervention / Treatment: Other: Clinic visit audio recordings for self-management in older adults; Other: Usual Care

Detailed Description

The objective of this study is to conduct a multisite trial evaluating the impact of adding an audio recording of clinic visits (AUDIO) to usual care in older adults with multimorbidity, including diabetes, compared to AVS alone (Usual Care; UC). The specific aims are: Aim 1 Conduct a three-site trial in primary care where older patients with multimorbidity including diabetes (n=336) will be randomized to receive an audio recording as well as AVS (AUDIO) versus AVS alone (UC) for all scheduled clinic visits over 12 months; patients will be assessed at baseline, 1 week, 6 months and 12 months. Applicants hypothesize (Main Effect) that: compared to those receiving UC, patients randomized to also receive audio recordings (AUDIO) of clinic visits will report a greater self-management ability (Primary Outcome), with improved quality of life, medication adherence, and satisfaction (Secondary Outcomes) at 12 months.

• Study Type: Interventional
• Enrollment (Estimated): 336
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Manchester, New Hampshire, United States, 03104
      • Dartmouth-Hitchcook Manchester
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbit University Medical Center
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Patients participants:

Inclusion Criteria:

• Patients who are ≥ 65 years;
• Patients with multimorbidity (i.e. patient has diabetes and one or more chronic conditions including: arthritis, asthma, atrial fibrillation, cancer, chronic obstructive pulmonary disease, heart disease, depression, heart failure, hypertension, osteoporosis, kidney disease and stroke);
• Have had two or more clinic visits in the previous 12 months;
• Plan on receiving ongoing care at the clinic for the subsequent 12 months;
• Do not have any vision or hearing problems that cannot be corrected;
• Have not recorded a clinic visit for personal use i the past 6 months.

Exclusion Criteria:

• Without capacity to consent to the project;
• With schizophrenia and other psychotic disorders, substance-use disorders, uncorrectable hearing or visual impairment or a six item screener (SIS) cognitive function score ≤ 4;
• Living in skilled nursing homes or hospice;
• Patients who have audio- recorded a clinic visit for their personal use in the previous six months;
• Patients who do not speak English or Spanish;
• Patients who lack internet access;
• Patients who (a) do not have access to a personal email, (b) do not have an email address shared with a family member or patient-identified caregiver, and (c) are not interested in creating an email account between the time they are first contacted by the study team to the time that the study team requires an email address to initiate the online recording software registration.

Clinician participants:

Inclusion criteria:

• Licensed clinician (MD including clinician residents at Dartmouth Health locations, DO, APRN, NP, PA)
• Are based at the study clinic;
• Who treat adult patients.

Exclusion criteria:

• Are trainees, e.g., fellows, medical students or residents, with the exception of clinician residents at Dartmouth Health;
• Commonly audio or video record clinic visits for patient's personal use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Audio; Researchers will audio record both in-person and telehealth visits of participants in the intervention group.	Other: Clinic visit audio recordings for self-management in older adults; The intervention is audio-recordings of primary care clinic visits that are shared with participating patients. All scheduled visits with study clinicians will be recorded and shared with patients randomized to the intervention group (AUDIO) for 12 months.
Placebo Comparator: Usual care; Participants will receive Usual Care	Other: Usual Care; The Usual Care arm participants will receive After Visit Summaries (AVS) per the standard delivery at each institution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Activation Measure-Short Form	The Patient Activation Measure-Short Form is a 13-item patient reported measure. Scores range from 0 (low activation) to 100 (high activation).	Patient activation at 12-months from enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Refills and Medications-D (ARMS-D)	Eleven-item measure of medication adherence in diabetes. Two domains: i) Medication taking; and ii) medication refill.	Adherence at 12-months from enrollment
Global PROMIS 10	Global PROMIS (Patient-Reported Outcome Measurement Information System) is a 10-item patient reported measure with two domains: mental and physical health. Domain scores range from 4 to 20, with higher scores representing better health.	Global PROMIS 10 at 12 month from enrollment
Patient Satisfaction Questionnaire-18	Patient Satisfaction Questionnaire-18 (PSQ-18) is a patient reported measure of satisfaction. It assesses seven sub-scales of satisfaction with care with scores ranging from 1 - 5 for each. We will use the two-item domain assessing general satisfaction.	Patient satisfaction at 12-months from enrollment

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Institutes of Health (NIH); National Institute on Aging (NIA); Vanderbilt University Medical Center; The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Paul J Barr, PhD, Dartmouth College; Principal Investigator: Kerri L Cavanaugh, MD, Vanderbilit University Medical Center; Principal Investigator: Meredith C Masel, PhD, University Texas Medical Branch

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2026
• Last Update Submitted That Met QC Criteria: August 5, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Older adults; Self-management; Technology; Multimorbidity; Audio recording; Patient-centered communication; Doctor patient communication
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Growth and Development; Aging; Self-Management
• Other Study ID Numbers: STUDY02001844; 1R01AG074959-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon publication of results in peer-reviewed journals, access to the de-identified data for research purposes will be considered if a request is made by a qualified individual (i.e., a researcher from a research institute), IRB secured, and mutually agreed upon by the PIs. Any potential users of the data will sign an agreement that no attempt to reveal personal or private information may be made. The investigators will follow the Safe Harbour Methods outlined in the guidance regarding methods for de-identification of protected health information in accordance with the HIPAA Privacy Rule.
• IPD Sharing Time Frame: At the completion of data analysis
• IPD Sharing Access Criteria: Contact PI to request data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

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