The Impact of Sharing Audio Recorded Clinic Visits on Self-management in Older Adults

Study Overview
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Brief Summary
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The investigators will conduct a multi-site, two-arm, parallel-group, patient-randomized, blocked, controlled, pilot trial with a 3-month follow up in older adults (≥65 years) with diabetes and hypertension. Participants will be randomized to receive AUDIO recordings of their clinic visits (AUDIO) in addition to After Visit Summary (AVS), or their AVS alone (Usual Care (UC). The investigators will recruit 90 adults (30 per site) over the targeted recruitment period of approximately 6 months. The primary outcome of interest is the feasibility of the trial and acceptability of the AUDIO intervention. The investigators will also explore the impact of AUDIO on patients' ability to self-manage care (as well as other exploratory health-related outcomes and healthcare utilization) at regular intervals from enrollment (T1 = 1 week, T2 = 3 months) compared to baseline (T0 = pre-visit) and usual care. The investigators will recruit patients from consented clinicians at three sites: Dartmouth-Hitchcock Primary Care (D-H; Manchester, NH), Vanderbilt University Medical Center (VUMC; Nashville, TN), and University of Texas Medical Branch, (UTMB; Galveston, TX).

Detailed Description
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Up to eighty percent of clinic visit information is forgotten by patients immediately post-visit. This is a significant barrier to self-management, especially in older adults with multimorbidity leading to poor health outcomes. After visit summaries (AVS) can improve recall, yet concerns exist about their layout, accuracy and low patient uptake. Patients and clinicians have begun audio recording clinic visits. When patients receive an audio recording of the visit, 71% listen and 68% share it with a caregiver, resulting in greater recall. Despite its growing use, to date, there is no research on the impact of recording and sharing clinic visits of patient self-management ability, health-related outcomes or healthcare utilization. The objective of this proposal is to conduct a multi-site pilot trial evaluating the feasibility and acceptability of routinely sharing audio recordings of clinic visits (AUDIO) in older adults (≥65 years) with diabetes and hypertension. Conduct a multi-site, two-arm, parallel-group, patient-randomized, blocked, controlled, pilot trial with 3-month follow up, to determine the feasibility and acceptability of sharing audio recordings of clinic visits (AUDIO) on self-management in older adults with diabetes and hypertension, compared to the after visit written summary (AVS) alone (Usual Care). Investigators will determine: 1.1 Feasibility of a larger trial by meeting recruitment targets at each site (n=30 per site; total n=90) and determining the optimal strategy to achieve a high retention rate and adherence to the study protocol. 1.2 Acceptability by assessing the proportion of patients and clinicians who agree to take part in the project and the proportion of patients who listen to the recording. 1.3 Potential effectiveness by collecting data on the impact of audio recordings on self-management, health-related outcomes, healthcare utilization, and clinician behavior. Investigators hypothesize that compared to those receiving UC, patients randomized to also receive audio recordings (AUDIO) of clinic visits will report a greater self-management activation (Patient Activation Measure - Short Form) at 3 months. Investigators will also explore whether the effect of AUDIO on self-management activation compared to UC is greater for patients with low health literacy than those with high health literacy.

Official Title
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The Impact of Sharing Audio Recorded Clinic Visits on Self-management in Older Adults: a Multi-site Trial

Conditions
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Diabetes Mellitus, Hypertension

Intervention / Treatment
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* Other: Audio recording


Participation Criteria
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Eligibility Criteria
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Aim 1 Inclusion Criteria Age 65 years or older Diagnosed with diabetes mellitus (Type 1 or 2) and hypertension, and receiving medication for both Are patients of clinicians at the study clinic Have had one or more clinic visits in the previous seven months Plan on receiving care at the study clinic for the next six months Exclusion Criteria Without the capacity to provide informed consent Diagnosis of dementia Diagnosis of schizophrenia and other psychotic disorders Current substance-abuse use disorder Diagnosis of an uncorrectable hearing or visual impairment Six item screener of cognitive function score 4 or less Living in a skilled nursing home or hospice Have audio-recorded a clinic visit for personal use within the past six months Do not have a personal email, do not have an email address shared with a family member or patient-identified caregiver, and/or are not willing to create an email account between the first contact from the study team and the initiation of online recording software registration

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AUDIO<br>Participant clinic visits will be audio recorded locally on a secure, HIPAA-compliant server. Patient access to recordings will be performed via a secure web-based platform. Additionally, participants will be offered the After Visit Summary (AVS) prior to clinic departure, per Usual Care (UC) | Other: Audio recording<br>* The investigators will audio record the visits of patients in the intervention group. An RA will enter the exam room and begin the recording with the patient's permission. The patient and clinician can choose to stop or start the recording at any time. Once the visit is complete, the RA will enter the room, turn off the recording, and bring the patient to a private room where the RA will follow standardized instructions demonstrating how to access recordings. Patient access to recordings will be possible via a secure web-based platform. Patients will also receive reminders to listen to their recordings.<br>|
| No Intervention: Usual Care<br>During the trial, patients will be offered to receive the AVS prior to clinic departure as is the current standard at each site. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Retention (Feasibility) | The proportion of included participants completing the 3-month (T2) follow up assessment. | 3 months from baseline | 
| Intervention Fidelity (Feasibility) | The proportion of participants in the intervention arm that received the audio recording intervention with full adherence to a pre-defined protocol fidelity checklist. Any deviations will be documented. | 3 months from baseline | 
| Feasibility of Intervention Measure (FIM) | The FIM is a four-item patient-reported measure of intervention feasibility. Each item is scored from 1 (completely disagree) to 5 (completely agree), with a higher score indicating greater feasibility. We consider a score of ≥ 3 or higher to indicate the acceptable Feasibility of the intervention. We report the proportion of patients in the Intervention arm who scored ≥ 3. | 3 months from baseline | 
| Participant Recruitment Rate (Acceptability) | We considered our trial to be acceptable to patients if we could meet recruitment targets at each site of 30 patients. We also calculated our recruitment rate based on the number of potentially eligible patients contacted. | Baseline | 
| Intervention Use (Acceptability) | The proportion of participants in the intervention arm that listen to the recordings received during the study period. | 3 months from baseline | 
| Acceptability of Intervention Measure (AIM) | The AIM is a four-item patient-reported measure of intervention acceptability. Each item is scored from 1 (completely disagree) to 5 (completely agree), with a higher score indicating greater acceptability. We consider a score of ≥ 3 or higher to indicate adequate acceptability of the intervention. We report the proportion of patients in the Intervention arm who scored ≥ 3. | 3 months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Audio recording, Diabetes Mellitus, Hypertension, Patient-centered communication, Self-management, Older adults