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OpenTrials
Completed

NCT Number: NCT05232656

PREventing Adverse Events Post-Discharge Through Proactive Identification, Multidisciplinary Communication, and Technology

The goal of this study is to expand the use of previously developed patient safety dashboards and patient-centered discharge checklists to three general medicine units in an affiliated community hospital. The safety dashboard and interactive pre-discharge checklist are cognitive aids for clinicians and patients, respectively, that serve to facilitate early detection of patients at risk for preventable harm, including suboptimal discharge preparation. The aims of this study are to:

1. Enhance the safety dashboard and interactive pre-discharge checklist to include "smart" notifications for hospital-based clinicians when patients are at high risk for adverse events or have identified specific concerns related to discharge based on their checklist responses. 2. Expand intervention to general medical units at our community hospital-affiliate, BWFH. 3. Evaluate impact on post-discharge AEs for patients discharged from BWFH who are at risk for preventable harm and hospital readmission.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

Our project proposes to address gaps in functionality of commercially available EHR systems through evaluation of novel, EHR-integrated HIT tools. We previously designed, developed, and implemented the patient safety dashboard and interactive pre-discharge checklist to engage clinicians and patients in systematically addressing safety threats in each of several domains. By integrating clinical data of several different types, these tools serve to reduce cognitive load and improve decision-making for clinicians. In this way, these tools represent a preventative intervention that mitigates risk in each domain by suggesting corrective action corresponding to institutional safety guidelines.

Studying the effectiveness of these tools on post-discharge outcomes will improve knowledge, technical capability, and clinical practice related to patient safety during transitions of care. Specifically, our project will advance scientific knowledge by quantifying the post-discharge impact of an intervention that changes clinical practice by enabling hospital-based clinicians to proactively institute corrective action for "at risk" patients who may require additional surveillance and supportive services during transitions. Also, we will establish the technical feasibility of spreading customized, third-party digital health applications that fill critical safety gaps in commercially available EHRs; expanding to a community hospital has clear implications for adoption and validation of this technology in different practice settings.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, >18 years of age, English-speaking
  • Caregivers >18 years of age designated by patient or patient's healthcare proxy
  • Two or more patient safety risk factors

Exclusion criteria

  • Non-English speaking patients for whom we cannot identify an English-speaking healthcare proxy

Treatment and study plan

Pre-Discharge Checklist and Patient Safety Dashboard

Behavioral

Pre-discharge preparation checklist for patients to assess discharge readiness. Patient safety dashboard for clinicians to proactively identify at-risk patients.

Primary outcomes

  1. Potential Post-Discharge Adverse Events

    Time frame: 24 months

    Potential post-discharge adverse events will be measured as the number of new or worsening symptoms or signs per patient

Secondary outcomes

  1. Actual Post-Discharge Adverse Events

    Time frame: 24 months

    Actual post-discharge adverse events will be measured as the number of adverse events per patient

  2. Preventable Post-Discharge Adverse Events

    Time frame: 24 months

    Actual post-discharge adverse events related to preventable harm will be measured as the number of post-discharge adverse events per patient related to a specific safety risk domain identified during index hospitalization

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Crico

Registry information

Official study title

Impact of an Epic-integrated Safety Dashboard and Interactive Pre-discharge Checklist on Post-discharge Adverse Events

Acronym: PREDICT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2022
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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