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

Adverse Event Clinical Trial

— PREDICT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05232656
• Other study ID #: 2018P001137
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: September 30, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Event
• Discharge Checklist
• General Medicine
• Transitions of Care

Intervention

Behavioral:
• Pre-Discharge Checklist and Patient Safety Dashboard
Pre-discharge preparation checklist for patients to assess discharge readiness. Patient safety dashboard for clinicians to proactively identify at-risk patients.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Crico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Potential Post-Discharge Adverse Events	Potential post-discharge adverse events will be measured as the number of new or worsening symptoms or signs per patient	24 months
Secondary	Actual Post-Discharge Adverse Events	Actual post-discharge adverse events will be measured as the number of adverse events per patient	24 months
Secondary	Preventable Post-Discharge Adverse Events	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	24 months