Assessing Open Access Audio (OAA)

March 13, 2025 updated by: VA Office of Research and Development

An Assessment of Open Access Audio of the Clinical Encounter on Veterans and Their Care

The medical encounter can be overwhelming in term of the amount of information discussed, its technical nature, and the anxiety it can generate. Easy access to a secure audio recording from any internet enabled device is an available low cost technology that allows patients to "revisit the visit" either alone or sharing with caretakers and family. It has been introduced and tested outside the VA with evidence that it increases patient recall and understanding and may even improve physician performance. Little is known, however, about whether and to what extent these effects lead to better outcomes, such as improved treatment plan adherence and chronic disease self-management. This study is a randomized controlled trial designed ascertain whether easy access to audio recordings of the medical visit improves patients perception that they understand and can manage their own care, and leads to a variety of improved outcomes, such as better blood pressure and diabetes control, and fewer emergency department visits and hospitalizations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study aims to assess (1) the impact of an open access audio (OAA) program on two behaviors (patient activation, treatment plan adherence), and two chronic condition measures (glycosylated hemoglobin, blood pressure); (2) the impact of open access audio on provider communication and on their attention to patient contextual factors (i.e. individual Veteran's needs and circumstances relevant to planning effective care); and (3) patient, provider, and leadership perceptions of the extent to which the program is safe, not burdensome, and worthwhile at both the start and at two years into the program. A secondary analysis will descriptively measure the effect size of OAA on ED visits and hospital admissions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1553

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Jesse Brown VA Medical Center, Chicago, IL
    • Ohio
      • Cleveland, Ohio, United States, 44106-1702
        • Louis Stokes VA Medical Center, Cleveland, OH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All patients with scheduled appointments at the participating sites: primary care and diabetes clinics at Jesse Brown VA Medical Center and the Louis Stokes Cleveland VA Medical Center

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OAA Intervention
Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit
Other: Open Access Audio
Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.
Other Names:
  • OAA
Sham Comparator: OAA Physician Aware Control
Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit
Other: No Access, Patient and Provider Aware of Recording
Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
Other Names:
  • OAA All Aware
Placebo Comparator: OAA Physician Unaware Control
Visit recorded, patient aware but provider unaware, neither patient nor provider have access to audio post-visit
Other: No Access, Provider Unaware of Recording
Patient does not obtain access to audio recording and provider is unaware visit is being recorded.
Other Names:
  • OAA Provider Unaware

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycosylated Hemoglobin (HgB A1c)
Time Frame: 4-6 months
This outcome tests the hypothesis that HgB A1c improves in patients with Hgb A1c > 7 when they have access to an audio recording of their discussion with their provider regarding diabetes management compared to when they do no. An improvement is defined as a decrease of 1% or more.
4-6 months
Patient Activation Measure (PAM)
Time Frame: 2 weeks
This outcome tests the hypothesis that patient activation is higher in patients when they have access to an audio recording of their visit with their provider compared to when they do not. Patients are called by phone post visit to answer PAM 10, a 10 item questionnaire with a 5 point Likert response that scores their perceived knowledge, skills, and confident in their capacity to follow their treatment plan with scores from 0-100. A higher score indicates higher patient activation.
2 weeks
Blood Pressure
Time Frame: 6 months
This outcome tests the hypothesis that blood pressure control improves in patients with blood pressure > 140/90 when they have access to an audio recording of their visit with their provider regarding blood pressure management compared to those who do not. An improvement in blood pressure is defined as a reduction of 10 or more mmHg in either the systolic or diastolic blood pressure.
6 months
Return Visit Adherence (RVA)
Time Frame: From index visit to end of study data collection, an average of 512 days
This outcome tests the hypothesis that return visit adherence (RVA) improves in patients with non-adherence when they have access to an audio recording of their discussion with their provider. The outcome is the predicted proportion of visits scheduled between the time of the index visit and the end of the study that the patient attends (adjusted for clinic). For example, a value of 0.73 means that, adjusted for clinic, a patient in the given arm attends 73% of visits scheduled between their index visit and the study end date.
From index visit to end of study data collection, an average of 512 days
Prescription Refill Rate (Probability That Proportion Days Covered >= 80%)
Time Frame: 6 months
This outcome tests the hypothesis that prescription adherence improves in patients when they have access to an audio recording of their discussion with their provider compared to when they do not. Adherence is defined as having at least 80% proportion days covered (PDF). PDC is the total number of days covered by refills in a measurement period divided by the number of days between the first fill and the end of the measurement period. Non-adherence is defined as a PDC<80% during the 6 months prior to the audio recorded visit. The outcome is the probability that a patient's PDC is at least 80% following their participation, adjusted for clinic.
6 months
SEGUE Framework for Evaluating and Scoring Communication Behavior.
Time Frame: Recorded visit
This outcome tests the hypothesis that physicians communicate more effectively when they are aware the visit is being recorded for the patient to when they are not. Communication behavior will be rated off the audio recording by a research assistant utilizing the SEGUE checklist. Outcome measure is total proportion achieved score on 32 item SEGUE instrument, ranging from 0 to 1 with a higher score indicating more effective communication.
Recorded visit
Contextualization of Care
Time Frame: Recorded visit
This outcome tests the hypothesis that physicians are more likely to contextualize the care plan when they are aware the visit is being recorded for the patient to when they are not. Contextualization of care will be rated off of the audio recording by a research assistant trained in Content Coding for Contextualization of Care (4C Coding), which determines each contextual red flag audible during the visit, whether the physician probed each red flag, each contextual factor identified by physician probe, and whether the physician addressed the contextual factor in the care plan. Outcome measure is the predicted probability of an encounter in which the care plan was contextualized (either the physician found no contextual factors present after investigating red flags, or physician found a contextual factor(s) and incorporated them into the plan), adjusted for clinic.
Recorded visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Emergency Department Utilization
Time Frame: 6 months
This outcome tests the hypothesis that emergency department visit rates are lower following encounters in which patients have access to an audio recording of their visit with their provider compared to when they do not. Outcome measure is the average number of ED visits made by the patient in the 6 months following the audio recorded visit, adjusted for clinic.
6 months
Hospital Admission Rate
Time Frame: 6 months
This outcome tests the hypothesis that inpatient admission rates are lower following encounters in which patients have access to an audio recording of their visit with their provider compared to when they do not. Outcome measure is the average number of inpatient hospital admissions of the patient (of any duration) during the 6 month period following the audio recorded visit.
6 months
Glycated Hemoglobin (Access vs. Non-access)
Time Frame: Six month
Comparison of HgA1c among Arm 1 patients who did and did not access their visit recording
Six month
ED Visit Rate (Access vs. Non-access)
Time Frame: Six month
Comparison of ED visit rate among Arm 1 patients who did and did not access their visit recording. The ED visit rate is the number of emergency department visits in the 6 months following the patient's recorded visit, adjusted for clinic.
Six month
Return Visit Attendance (Access vs. Non-access)
Time Frame: From recorded visit to study end date, an average of 512 days
Comparison of RVA among Arm 1 patients who did and did not access their visit recording. The outcome is the predicted proportion of visits scheduled between the time of the index visit and the end of the study that the patient attends (adjusted for clinic). For example, a value of 0.73 means that, adjusted for clinic, a patient in the given arm attends 73% of visits scheduled between their index visit and the study end date.
From recorded visit to study end date, an average of 512 days
Probability That Proportion of Days Covered by Prescription >= 80% (Access vs. Non-access)
Time Frame: 6 months
Comparison of probability of prescription refill adherence (PDC>=80%) among Arm 1 patients who did and did not access their visit recording. Adherence is defined as having at least 80% proportion days covered (PDF). PDC is the total number of days covered by refills in a measurement period divided by the number of days between the first fill and the end of the measurement period. Non-adherence is defined as a PDC<80% during the 6 months prior to the audio recorded visit. The outcome is the probability that a patient's PDC is at least 80% following their participation, adjusted for clinic.
6 months
Blood Pressure (Access vs. Non-access)
Time Frame: Six month
Comparison of blood pressure among Arm 1 patients who did and did not access their visit recording
Six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Saul J. Weiner, MD, Jesse Brown VA Medical Center, Chicago, IL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIR 19-068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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