Assessing Open Access Audio (OAA)

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: Recruiting
• Conditions: Hypertension; Diabetes
• Intervention / Treatment: Other: Open Access Audio; Other: No Access, Patient and Provider Aware of Recording; Other: No Access, Provider Unaware of Recording

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: Interventional
• Enrollment (Estimated): 2308
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saul J Weiner, MD; Phone Number: (312) 413-2799; Email: saul.weiner@va.gov
• Study Contact Backup: Name: Gunjan S Sharma, PhD; Phone Number: (312) 569-6486; Email: Gunjan.Sharma2@va.gov

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Jesse Brown VA Medical Center, Chicago, IL
      • Contact: Karen M Lenehan; Phone Number: 312-569-6343; Email: Karen.Lenehan@va.gov
      • Principal Investigator: Saul J. Weiner, MD
  • Ohio
    • Cleveland, Ohio, United States, 44106-1702
      • Not yet recruiting
      • Louis Stokes VA Medical Center, Cleveland, OH
      • Contact: Corinna D Falck-Ytter, MD; Email: Corinna.Falck-Ytter@va.gov
      • Contact: Sherry L Ball, PhD; Phone Number: 5830 (216) 791-2300; Email: sherry.ball@va.gov
      • Sub-Investigator: Corinna D. Falck-Ytter, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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. RVA is the percentage of all scheduled visits to any clinics at the facility that the patient attends. Non-adherence is defined as an RVA < 80% during the 6 months prior to the audio recorded visit. A reduction in the RVA of 10% or more is an improved outcome.	6 months
Prescription Refill Rate (PDC -- Proportion of Days Covered)	This outcome tests the hypothesis that PDC improves in patients with non-adherence when they have access to an audio recording of their discussion with their provider compared to when they do not. 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. An improved outcome is defined as a 10% or greater improvement post visit in any patient classified as non-adherent pre-visit.	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 score on 32 item SEGUE instrument with a higher score indicating more effective communication.	2 weeks
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). Outcome measure is the percentage of encounters in which the care plan was coded as contextualized.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency department utilization	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 during the designated (6 month) time period following the audio recorded visit.	6 months
hospital admission rate	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 admissions during the designated (6 month) time period following the audio recorded visit.	6 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Saul J. Weiner, MD, Jesse Brown VA Medical Center, Chicago, IL

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID 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