Assessing Open Access Audio

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1553 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

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OAA Intervention

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

Group Type EXPERIMENTAL

Open Access Audio

Intervention Type OTHER

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

OAA Physician Aware Control

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

Group Type SHAM_COMPARATOR

No Access, Patient and Provider Aware of Recording

Intervention Type OTHER

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

OAA Physician Unaware Control

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

Group Type PLACEBO_COMPARATOR

No Access, Provider Unaware of Recording

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

No Access, Provider Unaware of Recording

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

Intervention Type OTHER

Other Intervention Names

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OAA OAA All Aware OAA Provider Unaware

Eligibility Criteria

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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