Clinical trial NCT05824572: The Effect of Clinic Visit Audio Recordings for Self-management in Older Adults
Official title: The Effect of Clinic Visit Audio Recordings for Self-management in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Keywords: Audio recording
Diabetes Mellitus
Patient-centered communication
Self-management
Older adults
Doctor patient communication
Technology
Multimorbidity
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
name: The University of Texas Medical Branch, Galveston
name: National Institute on Aging (NIA)
name: National Institutes of Health (NIH)
First posted: 2023-04-21
Enrollment: 336
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 arm
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Activation Measure-Short Form
timeFrame: Patient activation at 12-months from enrollment
Secondary outcomes:
measure: Adherence to Refills and Medications-D (ARMS-D)
timeFrame: Adherence at 12-months from enrollment
measure: Global PROMIS 10
timeFrame: Global PROMIS 10 at 12 month from enrollment
measure: Patient Satisfaction Questionnaire-18
timeFrame: Patient satisfaction at 12-months from enrollment
Other outcomes:
Locations:
city: Manchester
country: United States
facility: Dartmouth-Hitchcook Manchester
state: New Hampshire
city: Nashville
country: United States
facility: Vanderbit University Medical Center
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: Dartmouth College
name: Paul J Barr, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilit University Medical Center
name: Kerri L Cavanaugh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Texas Medical Branch
name: Meredith C Masel, PhD
role: PRINCIPAL_INVESTIGATOR
References: