NCT04306172

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23,116

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

March 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

1 month

First QC Date

March 6, 2020

Last Update Submit

October 18, 2020

Conditions

Keywords

Prediction modelhospital readmissionexternal validation

Outcome Measures

Primary Outcomes (10)

  • Discrimination at 18 days

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

Study Arms (2)

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.

Other: An US Readmission Risk Prediction ModelOther: LACE+ scoreOther: SQLAPE model

Non-Readmitted inpatients/Controls

Outcome 1 \& 2: Patients who were not readmitted within 30 days of index hospitalization discharge date.

Other: An US Readmission Risk Prediction ModelOther: LACE+ scoreOther: SQLAPE model

Interventions

Logistic regression model that predicts the risk of all-cause unplanned readmissions developed by the privately held healthcare software company EPIC.

Non-Readmitted inpatients/ControlsReadmitted inpatients/Cases

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.

Non-Readmitted inpatients/ControlsReadmitted inpatients/Cases

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/ControlsReadmitted inpatients/Cases

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients from an acute care hospital in Central-Switzerland

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cantonal Hospital of Lucerne

Lucerne, Canton Lucerne, 6000, Switzerland

Location

Related Publications (2)

  • van Walraven C, Wong J, Forster AJ. LACE+ index: extension of a validated index to predict early death or urgent readmission after hospital discharge using administrative data. Open Med. 2012 Jul 19;6(3):e80-90. Print 2012.

    PMID: 23696773BACKGROUND
  • Halfon P, Eggli Y, Pretre-Rohrbach I, Meylan D, Marazzi A, Burnand B. Validation of the potentially avoidable hospital readmission rate as a routine indicator of the quality of hospital care. Med Care. 2006 Nov;44(11):972-81. doi: 10.1097/01.mlr.0000228002.43688.c2.

    PMID: 17063128BACKGROUND

Study Officials

  • Aljoscha B. Hwang

    University Lucerne (Switzerland)

    PRINCIPAL INVESTIGATOR
  • Stefan Boes

    University Lucerne (Switzerland)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Project Manager & Advanced Analytics Analyst

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 12, 2020

Study Start

March 10, 2020

Primary Completion

April 10, 2020

Study Completion

October 1, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations