Clinical trial NCT04452331: Assessing Open Access Audio
Official title: An Assessment of Open Access Audio of the Clinical Encounter on Veterans and Their Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-06-30
Enrollment: 1553
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Pressure
timeFrame: 6 months
measure: Glycosylated Hemoglobin (HgB A1c)
timeFrame: 4-6 months
measure: Return Visit Adherence (RVA)
timeFrame: From index visit to end of study data collection, an average of 512 days
measure: Prescription Refill Rate (Probability That Proportion Days Covered >= 80%)
timeFrame: 6 months
measure: Patient Activation Measure (PAM)
timeFrame: 2 weeks
measure: SEGUE Framework for Evaluating and Scoring Communication Behavior.
timeFrame: Recorded visit
measure: Contextualization of Care
timeFrame: Recorded visit
Secondary outcomes:
measure: Emergency Department Utilization
timeFrame: 6 months
measure: Hospital Admission Rate
timeFrame: 6 months
measure: Glycated Hemoglobin (Access vs. Non-access)
timeFrame: Six month
measure: ED Visit Rate (Access vs. Non-access)
timeFrame: Six month
measure: Return Visit Attendance (Access vs. Non-access)
timeFrame: From recorded visit to study end date, an average of 512 days
measure: Probability That Proportion of Days Covered by Prescription >= 80% (Access vs. Non-access)
timeFrame: 6 months
measure: Blood Pressure (Access vs. Non-access)
timeFrame: Six month
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center, Chicago, IL
state: Illinois
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
Study officials:
affiliation: Jesse Brown VA Medical Center, Chicago, IL
name: Saul J. Weiner, MD
role: PRINCIPAL_INVESTIGATOR
References: