Assessing Open Access Audio

NCT04452331 | Completed Results DMC

• 1 other identifier: IIR 19-068
• Study Type: interventional
• Target: 1,553
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hypertension; Diabetes

Outcome Measures

Primary Outcomes (7)

• Blood Pressure

  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

• Glycosylated Hemoglobin (HgB A1c)

  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

• Return Visit Adherence (RVA)

  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%)

  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

• Patient Activation Measure (PAM)

  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

• SEGUE Framework for Evaluating and Scoring Communication Behavior.

  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

  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 Outcomes (7)

• Emergency Department Utilization

  6 months

• Hospital Admission Rate

  6 months

• Glycated Hemoglobin (Access vs. Non-access)

  Six month

• ED Visit Rate (Access vs. Non-access)

  Six month

• Return Visit Attendance (Access vs. Non-access)

  From recorded visit to study end date, an average of 512 days

Study Arms (3)

OAA Intervention

EXPERIMENTAL

Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit

Other: Open Access Audio

OAA Physician Aware Control

SHAM COMPARATOR

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

OAA Physician Unaware Control

PLACEBO COMPARATOR

Visit recorded, patient aware but provider unaware, neither patient nor provider have access to audio post-visit

Other: No Access, Provider Unaware of Recording

Interventions

Open Access Audio OTHER

Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.

Also known as: OAA

OAA Intervention

No Access, Patient and Provider Aware of Recording OTHER

Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.

Also known as: OAA All Aware

OAA Physician Aware Control

No Access, Provider Unaware of Recording OTHER

Patient does not obtain access to audio recording and provider is unaware visit is being recorded.

Also known as: OAA Provider Unaware

OAA Physician Unaware Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Alan Schwartz
• Organization: University of Illinois Chicago

alansz@uic.edu

3129962070

Study Officials

• Saul J. Weiner, MD

  Jesse Brown VA Medical Center, Chicago, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Arm 1 is the intervention, with both provider and patient aware of the recording. It is designed to represent how OAA would be utilized in actual practice. In Arm 2 all parties are also aware of the audio recording, but this time neither gets access to the audio after the visit (although the research team does). Arm 2 is a control for isolating the effect of patient access after the visit to the audio in Arm 1. Both patient and physician are blind to whether they are in Arm 1 or 2 until after the visit. Arm 3 is a second kind of control, as the audio is again not shared with the patient. In this arm, however, the patient conceals the audio recorder, so that the provider is unaware they are being audio recorded until after the visit.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The setting will be primary care and diabetes clinics, at two facilities for generalizability. To achieve aims 1 and 2, the investigators plan a randomized controlled three arm design: (1) the encounter is recorded, with provider and patient aware, and uploaded to a server the Veteran, provider, and research team can access post visit; (2) the encounter is recorded, with both parties aware, and uploaded to a server only the research team can access; and (3) the encounter is recorded, with only the patient aware, and uploaded to a server only the research team can access. Resource utilization and disease measures indicated in aims 1 and 2 will be collected in all arms.

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 30, 2020
• Study Start: October 5, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: April 3, 2025
• Results First Posted: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)