Cardiovascular DiseaseNCT03735342
HEARt Sounds: Audio Recordings to Improve Discharge Communication for Cardiology Inpatients
A study testing Audio Recording in people with Cardiovascular Disease, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Audio Recording
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Cardiology inpatients
- Comfortable reading and writing in English
- Willing to have discharge conversation recorded
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: HEARt Sounds: A Pilot Randomized Trial to Determine the Feasibility and Acceptability of Audio Recordings to Improve Discharge Communication for Cardiology Inpatients
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Audio Recording
- Keywords
- Hospital discharge, Audio-recording, Cardiology, Provider-patient communication
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio RecordingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Audio Recording |
| Usual care | No intervention | Participants receive a verbal discharge discussion with a provider and written discharge instructions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient enrollment (Feasibility)
The proportion of eligible cardiology inpatients who agreed to take part in the research.
Measured: 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.
Measured: 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.
Measured: Time 2-One week after discharge, post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start12 Nov 2018
- Primary completion19 Apr 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College
- Responsible party
- Principal investigator, Paul J. Barr, Trustees of Dartmouth College
- Investigators
- Paul J Barr, PhD, MSc, Principal investigator, Dartmouth CollegeStacey L Schott, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735342
- Sponsor's protocol ID
- D18184
- Status last verified
- Jun 2021
- First submitted
- 30 Oct 2018
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31363416
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEARt Sounds: A Pilot Randomized Trial to Determine the Feasibility and Acceptability of Audio Recordings to Improve Discharge Communication for Cardiology Inpatients
- ClinicalTrials.gov ID
- NCT03735342
- Acronym / sponsor ID
- D18184
- Conditions
- Cardiovascular Disease
- Keywords
- Hospital discharge, Audio-recording, Cardiology, Provider-patient communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth College
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Audio Recording | Experimental | Other: Audio RecordingParticipants 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. |
| Usual care | No intervention | –Participants receive a verbal discharge discussion with a provider and written discharge instructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Cardiology inpatients
- Comfortable reading and writing in English
- Willing to have discharge conversation recorded
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio RecordingAll 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). | Other | Audio Recording |
Primary outcome
Patient enrollment (Feasibility)
Time frame: Time 1-Day of discharge, immediately post randomization
The proportion of eligible cardiology inpatients who agreed to take part in the research.
Intervention fidelity (Feasibility)
Time frame: Time 1-Day of discharge, immediately post randomization
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.
Patient use of intervention (Acceptability)
Time frame: Time 2-One week after discharge, post randomization
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Derived from this study: PubMed 31363416Schott 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Barr, PhD, MSc principal investigator
Dartmouth College
Stacey L Schott, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio Recording in people with Cardiovascular Disease, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient enrollment (Feasibility) (time frame: Time 1-Day of discharge, immediately post randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03735342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.