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

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Other: Clinic visit audio recordings for self-management in older adults Other: Usual Care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

336 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be randomly allocated to AUDIO or UC alone using a block randomization technique with the clinician acting as the blocking variable; this strategy will ensure an equal number of patients per clinician will be randomly assigned to each study armPatients will be randomly allocated to AUDIO or UC alone using a block randomization technique with the clinician acting as the blocking variable; this strategy will ensure an equal number of patients per clinician will be randomly assigned to each study arm

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 30, 2025

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Adherence to Refills and Medications-D (ARMS-D) [Adherence at 12-months from enrollment]
Eleven-item measure of medication adherence in diabetes. Two domains: i) Medication taking; and ii) medication refill.
Global PROMIS 10 [Global PROMIS 10 at 12 month from enrollment]
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.
Patient Satisfaction Questionnaire-18 [Patient satisfaction at 12-months from enrollment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Patients participants:

Inclusion Criteria:

Patients who are (1) ≥ 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 with their enrolled provider 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.

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:

Are based at the study clinic;
Who treat adult patients.

Exclusion criteria:

Are trainees, e.g., fellows, medical students or residents;
Commonly audio or video record clinic visits for patient's personal use.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth-Hitchcook Manchester	Manchester	New Hampshire	United States	03104
2	Vanderbit University Medical Center	Nashville	Tennessee	United States	37232
3	University of Texas Medical Branch	Galveston	Texas	United States	77555

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center
Vanderbilt University Medical Center
The University of Texas Medical Branch, Galveston
National Institute on Aging (NIA)
National Institutes of Health (NIH)

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