HEARt Sounds: Audio Recordings to Improve Discharge Communication for Cardiology Inpatients

NCT ID: NCT03735342

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-12

Study Completion Date

2019-12-30

Brief Summary

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Ineffective hospital discharge communication can significantly impact patient understanding, safety, and treatment adherence. This is especially true for cardiology patients, who leave the hospital with complex discharge plans, a multitude of high-risk medications, post-procedural care instructions and recommendations for drastic lifestyle changes, all delivered in a time-pressured discharge discussion. The goal of this pilot trial is to determine if it is possible to use audio recordings to supplement usual discharge communication to improve cardiology patients' ability to understand and self-manage care after leaving the hospital.

Detailed Description

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The study objective is to assess the feasibility and acceptability of providing audio recorded discharge instructions to patients discharged from an inpatient cardiology service using a two-arm randomized controlled design. Specifically, this pilot study aims to: 1) Determine whether providing audio recorded discharge instructions as a supplemental discharge communication tool is feasible for cardiology providers and patients to use during the inpatient discharge discussion, 2) Determine whether it is acceptable for patients and families to use audio recorded discharge instructions after hospital discharge to self-manage care, and 3) Explore the impact of audio recording on patients' understanding of discharge instructions, ability to self-manage care and ability to adhere to prescribed medications.

On the day of discharge, enrolled patients will be randomized to a usual care arm, which includes bedside discussion and review of written discharge instructions with the discharging provider, or to an intervention arm, which includes bedside discussion and review of written discharge instructions with the discharging provider and an audio recording of that bedside discharge discussion using block randomization at the provider level. All participants randomized to the intervention arm will receive a portable, electronic recording device with audio playback that contains a recording of the bedside discharge discussion, and will also have the option to record the discharge discussion on a smartphone or receive access to the recording online, via the Open Recording Automated Logging System (ORALS). The hypothesis is providing audio recordings of discharge instructions will be feasible and acceptable to cardiology patients and providers.

One week after discharge, all enrolled patients (both arms) will be contacted via telephone to complete an interview about the use of written discharge instructions and a survey about understanding of discharge instructions, confidence and ability to self-manage care, and medication adherence. In addition, patients in the intervention arm will be interviewed about how the audio recording of the discharge discussion was used.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators
To minimize selection bias, study research assistants and enrolled discharging providers are blinded to participants' (patients') study arm allocation until after participants are enrolled in the study.

Study Groups

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Audio Recording

Participants receive a verbal discharge discussion with a provider, written discharge instructions and a re-playable audio recording of the discharge discussion with the discharging provider.

Group Type EXPERIMENTAL

Audio Recording

Intervention Type OTHER

All participants will be provided with a re-playable audio recording of the discharge discussion on a portable electronic device. In addition, participants will have the option to record the discharge discussion on a personally-owned smartphone or receive access to the recording online, via the Open Recording Automated Logging System (ORALS).

Usual care

Participants receive a verbal discharge discussion with a provider and written discharge instructions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Audio Recording

All participants will be provided with a re-playable audio recording of the discharge discussion on a portable electronic device. In addition, participants will have the option to record the discharge discussion on a personally-owned smartphone or receive access to the recording online, via the Open Recording Automated Logging System (ORALS).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Cardiology inpatients
* Comfortable reading and writing in English
* Willing to have discharge conversation recorded

Exclusion Criteria

* Patients who are unable or unwilling to provide written informed consent
* Diagnosis of dementia, schizophrenia and other psychotic disorders
* Have a substance-abuse disorder
* Severe uncorrected vision or hearing problems
* Currently living in skilled nursing facility or hospice
* Planned discharge to a structured facility (e.g., skilled nursing facility, intermediate care facility, hospice)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth College

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Paul J. Barr

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul J Barr, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Stacey L Schott, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

References

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Schott SL, Dannenberg MD, Dodge SE, Schoonmaker JA, Caisse MM, Barr PJ, O'Malley AJ, Bruce ML. Heart sounds: a pilot randomised trial to determine the feasibility and acceptability of audio recordings to improve discharge communication for cardiology inpatients protocol. Open Heart. 2019 Jul 11;6(2):e001062. doi: 10.1136/openhrt-2019-001062. eCollection 2019.

Reference Type DERIVED
PMID: 31363416 (View on PubMed)

Other Identifiers

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D18184

Identifier Type: -

Identifier Source: org_study_id

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