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

Not Applicable

Recruiting

• Conditions: Diabetes
• Interventions: Other: Clinic visit audio recordings for self-management in older adults; Other: Usual Care

• Registration Number: NCT05824572
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief 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).

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 Timeline

• Study First Submitted: 2023-04-07
• Study First Submitted QC: 2023-04-19
• Study First Posted: 2023-04-21
• Study Start: 2023-12-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2027-01-28
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 336

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Audio	Clinic visit audio recordings for self-management in older adults	Researchers will audio record both in-person and telehealth visits of participants in the intervention group.
Usual care	Usual Care	Participants will receive Usual Care

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (3)

Vanderbit University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Dartmouth-Hitchcook Manchester; 🇺🇸 Manchester, New Hampshire, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States