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

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

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).

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes Mellitus
• Intervention / Treatment: Other: Audio recording

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.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Manchester, New Hampshire, United States, 03104
      • Dartmouth-Hitchcock Manchester
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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.
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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
EURO-QoL (EQ-5D)	EURO-QOL is patient reported measure of quality of life (QOL) that can be calculated using responses to Global PROMIS.	Baseline,1-Week, and 3-Months from enrollment
Comprehensive Diabetes Stigma Scale (CDSS-15)	The comprehensive diabetes stigma scale (CDSS-15) is a validated 15-item assessment of diabetes-related stigma.	Baseline,1-Week, and 3-Months from enrollment
Stigma Scale for Chronic Illness (SSCI-8)	The Stigma Scale for Chronic Illness (SSCI-8) is validated, eight-item assessment of stigma related to chronic disease.	Baseline,1-Week, and 3-Months from enrollment
Patient Activation Measure-Short Form (PAM-SF)	The Patient Activation Measure-Short Form is a 13-item patient reported measure. Scores range from 0 (low activation) to 100 (high activation).	3-Months from enrollment
Interpersonal Processes of Care Scale (IPC)	Interpersonal Processes of Care Scale is an 18-item patient-reported measure assessing 7 sub-domains of interpersonal communication (Hurried communication; Elicited concerns, responded; Explained results, medications; Patient-centered decision making; Compassionate, respectful; Discrimination; Disrespectful office staff ). Direction of scoring: All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process. Thus, higher scores sometimes indicate better processes (e.g., decided together) and sometimes worse processes (e.g., lack of clarity). Calculating scores: All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Scale scores are calculated as the mean of non-missing responses to the corresponding items (i.e., item responses are averaged). Thus, scores have a possible range of 1-5 and can be calculated for an individual if at least one item per scale has a valid response.	1-Week from baseline visit
Patient Satisfaction Questionnaire-18 (PSQ-18)	Patient Satisfaction Questionnaire-18 is a patient reported measure of satisfaction with seven dimensions: general satisfaction; technical quality; interpersonal manner; communication; financial aspects; time spent with doctor; accessibility and convenience. Responses are on a 5-point scale (Strongly agree - strongly disagree). Scores are averaged between 1 - 5; items 1,2,3,5,6,8,11,15,18 should be reversed scored i.e., 1 to 5, 2 to 4, 4 to 2, 5 to 1. Higher agreement reflects higher satisfaction with care.	Baseline,1-Week, and 3-Months from enrollment
Medical Outcomes Study General Adherence Measure	The Medical Outcomes Study General Adherence measure, is a five-item patient reported measure of general treatment adherence.	3-Months from enrollment
Adherence to Refills and Medications (ARMS- 7)	Adherence to Refills and Medications is a Seven-item patient reported measure of medication adherence.	3-Months from enrollment
Global PROMIS-10	Global PROMIS (Patient-Reported Outcome Measurement Information System) is a 10-item patient reported measure with two domains: mental and physical health.	3-Months from enrollment
Primary Care Contact, ER Visits & Hospitalization	Information on primary care contacts (phone calls, visits), ER visits & hospitalization will be collected via EMR. Baseline assessment will calculate primary care contacts, ER visits & hospitalization for each participant.	3-Months from enrollment
Quality of Diabetes and Hypertension Care	Information on quality of diabetes and hypertension, including referrals to specialists and intensification of medication therapy, will be collected via EMR.	3-Months from enrollment
Patient Health Questionnaire (PHQ- 8)	The eight-item depression scale PHQ-8 is a patient-reported multipurpose instrument to diagnose and measure the severity of depression. Scores range from 0 (no symptoms) - 24 (severe symptoms).	Baseline,1-Week, and 3-Months from enrollment
Generalized Anxiety Disorder (GAD-7)	The seven-item GAD-7 is a patient reported measure assessing severity of anxiety.	3-Months from enrollment

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Institutes of Health (NIH); National Institute on Aging (NIA); Vanderbilt University Medical Center; The University of Texas Medical Branch, Galveston; Dartmouth College
• Investigators: Principal Investigator: Paul J Barr, PhD, Dartmouth College; Principal Investigator: Kerri L Cavanaugh, MD, Vanderbilit University Medical Center; Principal Investigator: Meredith C Masel, PhD, University Texas Medical Branch

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Actual): February 14, 2022
• Study Completion (Actual): February 14, 2022

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Diabetes Mellitus; Older adults; Self-management; Audio recording; Patient-centered communication
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hypertension; Diabetes Mellitus
• Other Study ID Numbers: D20072; 1R56AG061522-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon publication of results in peer-reviewed journals, access to the de-identified data for research purposes will be considered if a request is made by a qualified individual (i.e., a researcher from a research institute), IRB secured, and mutually agreed upon by the PIs. Any potential users of the data will sign an agreement that no attempt to reveal personal or private information may be made. The investigators will follow the Safe Harbour Methods outlined in the guidance regarding methods for de-identification of protected health information in accordance with the HIPAA Privacy Rule.
• IPD Sharing Time Frame: At the completion of data analysis
• IPD Sharing Access Criteria: Contact PI to request data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No