The Effect of Clinic Visit Audio Recordings for Self-management in Older Adults (REPLAY)
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About
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).
Full 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.
Enrollment
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Inclusion and exclusion 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 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
336 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Paul J Barr, PhD; Susan M Tarczewski
Data sourced from clinicaltrials.gov
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