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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
91
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.
Dartmouth-Hitchcock Manchester
Manchester, New Hampshire, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
Participant Retention (Feasibility)
The proportion of included participants completing the 3-month (T2) follow up assessment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Intervention Use (Acceptability)
The proportion of participants in the intervention arm that listen to the recordings received during the study period.
Time frame: 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.
Time frame: 3 months from baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.