Validation and Implementation Design of an Epic Systems 30-day Unplanned Readmission Risk Model

December 28, 2023 updated by: Wake Forest University Health Sciences

Validation and Implementation Design of a Pragmatic Randomized Controlled Trial Leveraging Epic Systems 30-day Unplanned Readmission Risk Model

The objective is to assess the implementation of a computerized clinical decision support (cCDS) tool for identifying patients at high risk of unplanned readmission who could benefit from existing care programs aimed at reducing readmissions

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Providers from either service, which includes attending physicians, residents, hospitalists, and advanced practice providers (APPs), will be randomly allocated to an intervention group (IG) or control group (CG). The IG will consist of placing the Epic 30-day unplanned readmission risk score in the story board of providers. If a patient is identified as having a high risk of readmission defined as readmission risk >20%, a link to transitional and supportive care services (TSC) will be appear in the story board. Providers will determine which TSC is best for the patient and may order whichever TSC is appropriate for the patient. The study team will not recommend TSCs. The risk of readmission score will be present from the time of admission for those in the IG. The CG will have the same TSC orders available to them; however, they will not have the risk of readmission score present in their workflow, as such the embedded link to TSC will also not be present.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of Atrium Health Wake Forest Baptist Hospital (AHWFBH)
  • 18 years or older
  • meeting inpatient criteria
  • admitted to hospitalist or general medicine teaching services
  • Providers on the hospitalist or general medicine teaching services

Exclusion Criteria:

  • Psychiatric diagnoses during index or subsequent admission
  • left Against Medical Advice (AMA)
  • planned readmission
  • died during index admission
  • Providers who opt out of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group (IG)
The IG will consist of placing the Epic 30-day unplanned readmission risk score in the story board of providers - If a patient is identified as having a high risk of readmission defined as readmission risk >20%, a link to transitional and supportive care services (TSC) will be appear in the story board
Behavioral: Epic 30-day unplanned readmission risk score
If a patient is identified as having a high risk of readmission defined as readmission risk >20%, a link to transitional and supportive care services (TSC) will be appear in the story board.
No Intervention: control group (CG)
The CG will have the same transitional and supportive care services (TSC) orders available to them; however, they will not have the risk of readmission score present in their workflow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group
Time Frame: Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group
Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Control group
Time Frame: Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Control group
Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Faith Health
Time Frame: Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Faith Health
Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Control group - High Risk Readmission Program (HRI)
Time Frame: Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Control group - High Risk Readmission Program (HRI)
Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Care Plus
Time Frame: Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Care Plus
Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Population Health Pharmacy
Time Frame: Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Population Health Pharmacy
Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Geriatrics Transitional Care
Time Frame: Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Geriatrics Transitional Care
Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Mobile Health Clinic
Time Frame: Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Mobile Health Clinic
Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Faith Health
Time Frame: Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Faith Health
Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group- High Risk Readmission Program (HRI)
Time Frame: Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - High Risk Readmission Program (HRI)
Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Care Plus
Time Frame: Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Care Plus
Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Population Health Pharmacy
Time Frame: Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Population Health Pharmacy
Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Geriatrics Transitional Care
Time Frame: Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Geriatrics Transitional Care
Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Mobile Health Clinic
Time Frame: Day 30
Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Mobile Health Clinic
Day 30
Provider Satisfaction Score
Time Frame: Day 30
Provider satisfaction with clinical decision support tool measured by survey
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 day Readmission Rate
Time Frame: Day 30
proportion of index inpatient visits with an inpatient readmission within 30 days of index discharge
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Donna Williams, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2023

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

August 17, 2023

Study Registration Dates

First Submitted

June 6, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00079395

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR)

IPD Sharing Time Frame

Data will be available beginning 3 months and ending 5 years following article publication

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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