Trial Outcomes & Findings for The Impact of Sharing Audio Recorded Clinic Visits on Self-management in Older Adults (NCT NCT04344301)

Results Overview

The proportion of included participants completing the 3-month (T2) follow up assessment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

91 participants

Primary outcome timeframe

3 months from baseline

Results posted on

2025-07-18

Participant Flow

Participant recruitment began with study clinicians who were recruited beginning in August 2020. Patient participants were recruited from study clinicians at three academic medical center-affiliated primary care clinics between October 2020 and September 2021. Letters were sent to potentially eligible patients, and after a two-week opt-out period, study coordinators contact patients to determine the patient's interest in the project and eligibility.

Of 420 potential patients who received a mailed study invitation letter, we recruited 91: 120 patients were ineligible; 15 patients opted out; 122 declined during a screening call; 65 could not be reached and 7 could not take part for other reasons

Participant milestones

Participant milestones
Measure	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) 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.	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.
Overall Study STARTED	45	46
Overall Study COMPLETED	44	45
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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) 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.	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.
Overall Study Withdrawal by Subject	1	0
Overall Study Death	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AUDIO n=45 Participants 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) 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.	Usual Care n=46 Participants During the trial, patients will be offered to receive the AVS prior to clinic departure as is the current standard at each site.	Total n=91 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	46 participants n=7 Participants	91 participants n=5 Participants
Age, Continuous	73.7 Years STANDARD_DEVIATION 5.8 • n=5 Participants	73.7 Years STANDARD_DEVIATION 5.6 • n=7 Participants	73.7 Years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	32 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	43 Participants n=7 Participants	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months from baseline

The proportion of included participants completing the 3-month (T2) follow up assessment.

Outcome measures

Outcome measures
Measure	AUDIO n=45 Participants 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) 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.	Usual Care n=46 Participants During the trial, patients will be offered to receive the AVS prior to clinic departure as is the current standard at each site.
Participant Retention (Feasibility)	44 Participants	45 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	AUDIO n=45 Participants 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) 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.	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.
Intervention Fidelity (Feasibility)	42 Participants	—

PRIMARY outcome

Timeframe: 3 months from baseline

Population: Of 45 patients assigned to the Intervention arm, 42 completed the FIM survey. As such the overall number of participants analyzed for this outcome is 42.

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.

Outcome measures

Outcome measures
Measure	AUDIO n=42 Participants 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) 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.	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.
Feasibility of Intervention Measure (FIM)	41 Participants	—

PRIMARY outcome

Timeframe: Baseline

Population: Of 420 potential patients who received a mailed study invitation letter, we recruited 91; 120 patients were ineligible; 15 patients opted out; 122 declined during a screening call; 65 could not be reached and 7 could not take part for other reasons (e.g., natural disaster, study staff COVID Quarantine). This resulted in 228 potentially eligible patients.

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.

Outcome measures

Outcome measures
Measure	AUDIO n=228 Participants 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) 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.	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.
Participant Recruitment Rate (Acceptability)	91 Participants	—

PRIMARY outcome

Timeframe: 3 months from baseline

The proportion of participants in the intervention arm that listen to the recordings received during the study period.

Outcome measures

Outcome measures
Measure	AUDIO n=45 Participants 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) 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.	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.
Intervention Use (Acceptability)	40 Participants	—

PRIMARY outcome

Timeframe: 3 months from baseline

Population: Of 45 patients assigned to the Intervention arm, 42 completed the AIM survey. As such the overall number of participants analyzed for this outcome is 42.

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.

Outcome measures

Outcome measures
Measure	AUDIO n=42 Participants 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) 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.	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.
Acceptability of Intervention Measure (AIM)	39 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3-Months from enrollment

The Patient Activation Measure-Short Form is a 13-item patient reported measure. Scores range from 0 (low activation) to 100 (high activation).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-Week from baseline visit

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline,1-Week, and 3-Months from enrollment

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3-Months from enrollment

The Medical Outcomes Study General Adherence measure, is a five-item patient reported measure of general treatment adherence.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3-Months from enrollment

Adherence to Refills and Medications is a Seven-item patient reported measure of medication adherence.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3-Months from enrollment

Global PROMIS (Patient-Reported Outcome Measurement Information System) is a 10-item patient reported measure with two domains: mental and physical health.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline,1-Week, and 3-Months from enrollment

EURO-QOL is patient reported measure of quality of life (QOL) that can be calculated using responses to Global PROMIS.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3-Months from enrollment

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3-Months from enrollment

Information on quality of diabetes and hypertension, including referrals to specialists and intensification of medication therapy, will be collected via EMR.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline,1-Week, and 3-Months from enrollment

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).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3-Months from enrollment

The seven-item GAD-7 is a patient reported measure assessing severity of anxiety.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline,1-Week, and 3-Months from enrollment

The comprehensive diabetes stigma scale (CDSS-15) is a validated 15-item assessment of diabetes-related stigma.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline,1-Week, and 3-Months from enrollment

The Stigma Scale for Chronic Illness (SSCI-8) is validated, eight-item assessment of stigma related to chronic disease.

Outcome measures

Outcome data not reported

Adverse Events

AUDIO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paul Barr

Dartmouth College

Phone: +1-603-653-0863

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place