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Unplanned Hospital ReadmissionsNCT05413889

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

A study testing Epic 30-day unplanned readmission risk score in people with Unplanned Hospital Readmissions and Patients at High Risk of Unplanned Readmission, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Epic 30-day unplanned readmission risk score
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteUnited States
Study dates
2 Feb 2023to 17 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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

Read the 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.

Being tested
Epic 30-day unplanned readmission risk score

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epic 30-day unplanned readmission risk scoreBehavioural

    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.

Study groups in NCT05413889
Study groupRoleWhat they receive
intervention group (IG)ExperimentalThe 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
Receives: Behavioral: Epic 30-day unplanned readmission risk score
control group (CG)No interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group

    Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group

    Measured: Day 30

  2. Number of transitional and supportive care services (TSC) referrals by providers in the Control group

    Number of transitional and supportive care services (TSC) referrals by providers in the Control group

    Measured: Day 30

  3. Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Faith Health

    Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Faith Health

    Measured: Day 30

  4. Number of transitional and supportive care services (TSC) referrals by providers in the Control group - High Risk Readmission Program (HRI)

    Number of transitional and supportive care services (TSC) referrals by providers in the Control group - High Risk Readmission Program (HRI)

    Measured: Day 30

  5. Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Care Plus

    Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Care Plus

    Measured: Day 30

  6. Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Population Health Pharmacy

    Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Population Health Pharmacy

    Measured: Day 30

  7. Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Geriatrics Transitional Care

    Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Geriatrics Transitional Care

    Measured: Day 30

  8. Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Mobile Health Clinic

    Number of transitional and supportive care services (TSC) referrals by providers in the Control group - Mobile Health Clinic

    Measured: Day 30

  9. Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Faith Health

    Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Faith Health

    Measured: Day 30

  10. Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group- High Risk Readmission Program (HRI)

    Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - High Risk Readmission Program (HRI)

    Measured: Day 30

  11. Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Care Plus

    Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Care Plus

    Measured: Day 30

  12. Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Population Health Pharmacy

    Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Population Health Pharmacy

    Measured: Day 30

  13. Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Geriatrics Transitional Care

    Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Geriatrics Transitional Care

    Measured: Day 30

  14. Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Mobile Health Clinic

    Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group - Mobile Health Clinic

    Measured: Day 30

  15. Provider Satisfaction Score

    Provider satisfaction with clinical decision support tool measured by survey

    Measured: Day 30

Secondary outcomes (1)

  1. 30 day Readmission Rate

    proportion of index inpatient visits with an inpatient readmission within 30 days of index discharge

    Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2022
  2. Study start2 Feb 2023
  3. Primary completion15 Aug 2023
  4. Study completion17 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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 or any is appropriate for the patient. 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. Providers, in both IG and CG, will have the option to order one or multiple TSC at their discretion.
Masking
Single blind
Who is masked
Participant
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05413889
Sponsor's protocol ID
IRB00079395
Status last verified
May 2023
First submitted
6 Jun 2022
Last updated
29 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR)

Questions about this trial

What is this clinical trial studying?

A study testing Epic 30-day unplanned readmission risk score in people with Unplanned Hospital Readmissions and Patients at High Risk of Unplanned Readmission, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of transitional and supportive care services (TSC) referrals by providers in the Intervention group (time frame: Day 30). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05413889.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.

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