Validation of EPIC's Readmission Risk Model, the LACE+ Index and SQLape as Predictors of Unplanned Hospital Readmissions

October 18, 2020 updated by: Aljoscha Hwang, Luzerner Kantonsspital

External Validation of EPIC's Readmission Risk Model, the LACE+ Index and SQLape as Predictors of Unplanned Hospital Readmissions: A Monocentric, Retrospective, Diagnostic Cohort Study in Switzerland

The primary objective of this study is to externally validate the EPIC's Readmission Risk model and to compare it with the LACE+ index and the SQLape Readmission model.

As secondary objective, the EPIC's Readmission Risk model will be adjusted based on the validation sample, and finally, it´s performance will be compared with machine learning algorithms.

Study Overview

Detailed Description

Introduction: Readmissions after an acute care hospitalization are relatively common, costly to the health care system and are associated with significant burden for patients. As one way to reduce costs and simultaneously improve quality of care, hospital readmissions receive increasing interest from policy makers. It is only relatively recently that strategies were developed with the specific aim of reducing unplanned readmissions by applying prediction models. EPIC's Readmission Risk model, developed in 2015 for the U.S. acute care hospital setting, promises superior calibration and discriminatory abilities. However, its routine application in the Swiss hospital setting requires external validation first. Therefore, the primary objective of this study is to externally validate the EPIC's Readmission Risk model and to compare it with the LACE+ index (Length of stay, Acuity, Comorbidities, Emergency Room visits index) and the SQLape (Striving for Quality Level and analysing of patient expenditures) Readmission model.

Methods: For this reason, a monocentric, retrospective, diagnostic cohort study will be conducted. The study will include all inpatients, who were hospitalized between the 1st January 2018 and the 31st of January 2019 in the Lucerne Cantonal hospital in Switzerland. Cases will be inpatients that experienced an unplanned (all-cause) readmission within 18 or 30 days after the index discharge. The control group will consist of individuals who had no unscheduled readmission.

For external validation, discrimination of the scores under investigation will be assessed by calculating the area under the receiver operating characteristics curves (AUC). For calibration, the Hosmer-Lemeshow goodness-of-fit test will be graphically illustrated by plotting the predicted outcomes by decile against the observations. Other performance measures to be estimated will include the Brier Score, Net Reclassification Improvement (NRI) and the Net Benefit (NB).

All patient data will be retrieved from clinical data warehouses.

Study Type

Observational

Enrollment (Actual)

23116

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

    • Canton Lucerne
      • Lucerne, Canton Lucerne, Switzerland, 6000
        • Cantonal Hospital of Lucerne

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

4 months to 98 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inpatients from an acute care hospital in Central-Switzerland

Description

Inclusion Criteria:

- All inpatients, aged one year or older (max. 100 years), who were hospitalized either between the 1st of January 2018 and the 31st of December 2018, or between the 23rd of September and the 31st of December 2019 will be included.

Exclusion criteria:

  • admission/transfer from another psychiatric, rehabilitative or acute care ward from the same institution,
  • discharge destination other than the patient's home or
  • transfer to another acute care hospital, both being considered as treatment continuation;
  • foreign residence,
  • deceased before discharge,
  • discharged on admission day,
  • refusal of general consent, and
  • unknown patient residence or discharge destination.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Readmitted inpatients/Cases

Outcome 1: Patients who were readmitted within 18 days of index hospitalization discharge date to the same hospital, with a diagnosis leading to the same Major Diagnostic Group as the index stay (definition according to Swiss Diagnosis Related Groups system, case merger)

Outcome 2: Patients with an unplanned readmission within 30 days of index hospitalization discharge date to the same hospital. An unplanned readmission was defined as a readmission through the emergency department.

Logistic regression model that predicts the risk of all-cause unplanned readmissions developed by the privately held healthcare software company EPIC.
The LACE+ score is a point score that can be used to predict the risk of post-discharge death or urgent readmission. It was developed based on administrative data in Ontario, Canada.
The readmission risk model (Striving for Quality Level and analyzing of patient expenditures), is a computerized validated algorithm and was developed in 2002 to identify potentially avoidable readmissions.
Non-Readmitted inpatients/Controls
Outcome 1 & 2: Patients who were not readmitted within 30 days of index hospitalization discharge date.
Logistic regression model that predicts the risk of all-cause unplanned readmissions developed by the privately held healthcare software company EPIC.
The LACE+ score is a point score that can be used to predict the risk of post-discharge death or urgent readmission. It was developed based on administrative data in Ontario, Canada.
The readmission risk model (Striving for Quality Level and analyzing of patient expenditures), is a computerized validated algorithm and was developed in 2002 to identify potentially avoidable readmissions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discrimination at 18 days
Time Frame: 18 days after index discharge date
For discrimination of the scores under investigation, the area under the receiver operating characteristics curves (AUC) will be calculated.
18 days after index discharge date
Discrimination at 30 days
Time Frame: 30 days after index discharge date
For discrimination of the scores under investigation, the area under the receiver operating characteristics curves (AUC) will be calculated.
30 days after index discharge date
Calibration at 18 days
Time Frame: 18 days after index discharge date
For calibration, the Hosmer-Lemeshow goodness-of-fit test will be graphically illustrated by plotting the predicted outcomes by decile against the observations.
18 days after index discharge date
Calibration at 30 days
Time Frame: 30 days after index discharge date
For calibration, the Hosmer-Lemeshow goodness-of-fit test will be graphically illustrated by plotting the predicted outcomes by decile against the observations.
30 days after index discharge date
Overall Performance at 18 days
Time Frame: 18 days after index discharge date
Brier Score (The Brier score is a quadratic scoring rule, where the squared difference between actual binary outcomes Y and predictions p are calculated. The Brier score can range from 0 for a perfect model to 0.25 for a non-informative model with a 50% incidence of the outcome.)
18 days after index discharge date
Overall Performance at 30 days
Time Frame: 30 days after index discharge date
Brier Score (The Brier score is a quadratic scoring rule, where the squared difference between actual binary outcomes Y and predictions p are calculated. The Brier score can range from 0 for a perfect model to 0.25 for a non-informative model with a 50% incidence of the outcome.)
30 days after index discharge date
Clinical usefulness (NRI) at 18 days
Time Frame: 18 days after index discharge date
Net Reclassification Improvement (NRI): In the calculation of the NRI, the improvement in sensitivity and the improvement in specificity are summed. The NRI ranges from 0 for no improvement and 1 for perfect improvement.
18 days after index discharge date
Clinical usefulness (NRI) at 30 days
Time Frame: 30 days after index discharge date
Net Reclassification Improvement (NRI): In the calculation of the NRI, the improvement in sensitivity and the improvement in specificity are summed. The NRI ranges from 0 for no improvement and 1 for perfect improvement.
30 days after index discharge date
Clinical usefulness (NB) at 18 days
Time Frame: 18 days after index discharge date
Net Benefit (NB): NB = (TP - w FP) / N, where TP is the number of true positive decisions, FP the number of false positive decisions, N is the total number of patients and w is a weight equal to the odds of the cut-off (pt/(1-pt), or the ratio of harm to benefit
18 days after index discharge date
Clinical usefulness (NB) at 30 days
Time Frame: 30 days after index discharge date
Net Benefit (NB): NB = (TP - w FP) / N, where TP is the number of true positive decisions, FP the number of false positive decisions, N is the total number of patients and w is a weight equal to the odds of the cut-off (pt/(1-pt), or the ratio of harm to benefit
30 days after index discharge date

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Aljoscha B. Hwang, University Lucerne (Switzerland)
  • Principal Investigator: Stefan Boes, University Lucerne (Switzerland)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

March 10, 2020

Primary Completion (Actual)

April 10, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 12, 2020

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 18, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • LUKS_RRM_2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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