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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Dietary Supplements

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Locations

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