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临床试验/NCT03735342
NCT03735342已完成不适用

HEARt Sounds: A Pilot Randomized Trial to Determine the Feasibility and Acceptability of Audio Recordings to Improve Discharge Communication for Cardiology Inpatients

Dartmouth-Hitchcock Medical Center2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2018年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
2
主要终点
Patient enrollment (Feasibility)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)

结局指标

主要结局

Patient enrollment (Feasibility)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul J. Barr

Associate Professor

Trustees of Dartmouth College

研究点 (2)

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