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

Overview

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).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2021

Detailed Description

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.

Interventions

  • Other: Audio recording
    • 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.

Arms, Groups and Cohorts

  • Experimental: AUDIO
    • 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)
  • No Intervention: Usual Care
    • During the trial, patients will be offered to receive the AVS prior to clinic departure as is the current standard at each site.

Clinical Trial Outcome Measures

Primary Measures

  • Participant retention (Feasibility)
    • Time Frame: 3 months from baseline
    • The proportion of included participants completing the 3-month (T2) follow up assessment.
  • Intervention fidelity (Feasibility)
    • Time Frame: 3 months from baseline
    • 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.
  • Feasibility of Intervention Measure (FIM)
    • Time Frame: 3 months from baseline
    • The proportion of included participants scoring ≥ 3.
  • Participant recruitment rate (Acceptability)
    • Time Frame: Baseline
    • Recruitment of 30 patients per site over our six month recruitment period.
  • Intervention use (Acceptability)
    • Time Frame: 3 months from baseline
    • The proportion of participants in the intervention arm that listen to the recordings received during the study period.
  • Acceptability of Intervention Measure (AIM)
    • Time Frame: 3 months from baseline
    • The proportion of included participants scoring ≥ 3.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dartmouth-Hitchcock Medical Center
  • Collaborator
    • The University of Texas Medical Branch, Galveston
  • Provider of Information About this Clinical Study
    • Principal Investigator: Paul J. Barr, Assistant Professor – Trustees of Dartmouth College
  • Overall Official(s)
    • Paul J Barr, PhD, Principal Investigator, Dartmouth College
    • Kerri L Cavanaugh, MD, Principal Investigator, Vanderbilit University Medical Center
    • Meredith C Masel, PhD, Principal Investigator, University Texas Medical Branch
  • Overall Contact(s)
    • Paul J Barr, PhD, 603-646-7016, paul.j.barr@dartmouth.edu

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