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

Diabetes Clinical Trial

— REPLAY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05824572
• Other study ID #: STUDY02001844
• Secondary ID: 1R01AG074959-01A
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: May 31, 2027

Study information

• Verified date: May 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Paul J Barr, PhD
• Phone: 603 646 7016
• Email: paul.j.barr[@]dartmouth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. completion date: May 31, 2027
• Est. primary completion date: January 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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, 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;

• Commonly audio or video record clinic visits for patient's personal use.

Related Conditions & MeSH terms

• Diabetes

Intervention

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.
• Usual Care
The Usual Care arm participants will receive After Visit Summaries (AVS) per the standard delivery at each institution

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas
United States	Dartmouth-Hitchcook Manchester	Manchester	New Hampshire
United States	Vanderbit University Medical Center	Nashville	Tennessee

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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