NCT03735342

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

November 12, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

October 30, 2018

Last Update Submit

June 28, 2021

Conditions

Keywords

Hospital dischargeAudio-recordingCardiologyProvider-patient communication

Outcome Measures

Primary Outcomes (3)

  • Patient enrollment (Feasibility)

    The proportion of eligible cardiology inpatients who agreed to take part in the research.

    Time 1-Day of discharge, immediately post randomization

  • Intervention fidelity (Feasibility)

    The proportion of cardiology inpatients in the intervention arm that received the audio recording intervention with full adherence to a pre-defined protocol fidelity checklist. Any deviations will be documented.

    Time 1-Day of discharge, immediately post randomization

  • Patient use of intervention (Acceptability)

    The proportion of discharged cardiology patients in the intervention arm who used the audio recording between the day of discharge and a one-week follow up telephone call initiated by the research team.

    Time 2-One week after discharge, post randomization

Other Outcomes (7)

  • Change in patient activation

    Time 0-Day of discharge, before randomization, Time 1-Day of discharge, immediately post randomization, Time 2-One week after discharge, post randomization

  • Change in patient health confidence

    Time 0-Day of discharge, before randomization, Time 1-Day of discharge, immediately post randomization, immediately post randomization, Time 2-One week after discharge, post randomization

  • Change in patient ability to understand health information

    Time 0-Day of discharge, before randomization, Time 1-Day of discharge, immediately post randomization, immediately post randomization, Time 2-One week after discharge, post randomization

  • +4 more other outcomes

Study Arms (2)

Audio Recording

EXPERIMENTAL

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.

Other: Audio Recording

Usual care

NO INTERVENTION

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

Interventions

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).

Audio Recording

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Sound Recordings

Intervention Hierarchy (Ancestors)

Audiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Paul J Barr, PhD, MSc

    Dartmouth College

    PRINCIPAL INVESTIGATOR
  • Stacey L Schott, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 30, 2018

First Posted

November 8, 2018

Study Start

November 12, 2018

Primary Completion

April 19, 2019

Study Completion

December 30, 2019

Last Updated

June 30, 2021

Record last verified: 2021-06

Locations