Clinical trial NCT03735342: HEARt Sounds: Audio Recordings to Improve Discharge Communication for Cardiology Inpatients
Official title: HEARt Sounds: A Pilot Randomized Trial to Determine the Feasibility and Acceptability of Audio Recordings to Improve Discharge Communication for Cardiology Inpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Hospital discharge
Audio-recording
Cardiology
Provider-patient communication
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth College
First posted: 2018-11-08
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Patient enrollment (Feasibility)
timeFrame: Time 1-Day of discharge, immediately post randomization
measure: Intervention fidelity (Feasibility)
timeFrame: Time 1-Day of discharge, immediately post randomization
measure: Patient use of intervention (Acceptability)
timeFrame: Time 2-One week after discharge, post randomization
Secondary outcomes:
Other outcomes:
measure: Change in patient activation
timeFrame: Time 0-Day of discharge, before randomization, Time 1-Day of discharge, immediately post randomization, Time 2-One week after discharge, post randomization
measure: Change in patient health confidence
timeFrame: 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
measure: Change in patient ability to understand health information
timeFrame: 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
measure: Change in patient general medical adherence
timeFrame: Time 0-Day of discharge, before randomization, Time 2-One week after discharge, post randomization
measure: Patient assessment of discharging provider communication ability
timeFrame: Time 1-Day of discharge, immediately post randomization
measure: Patient adherence to medications
timeFrame: Time 2-One week after discharge, post randomization
measure: Rate of patient-generated post-discharge phone calls
timeFrame: Time 2-One week after discharge, post randomization
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Paul J Barr, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth-Hitchcock Medical Center
name: Stacey L Schott, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.