Assessing Open Access Audio (OAA)

VA Office of Research and Development

Status: Completed

Conditions: Hypertension; Diabetes

Treatments: Other: No Access, Provider Unaware of Recording; Other: Open Access Audio; Other: No Access, Patient and Provider Aware of Recording

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04452331

IIR 19-068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,553 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,553 participants in 3 patient groups, including a placebo group

OAA Intervention

Experimental group

Description:

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

Treatment:

Other: Open Access Audio

OAA Physician Aware Control

Sham Comparator group

Description:

Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit

Treatment:

Other: No Access, Patient and Provider Aware of Recording

OAA Physician Unaware Control

Placebo Comparator group

Description:

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

Treatment:

Other: No Access, Provider Unaware of Recording