Assessing Efficacy of the Rothman Index

Not Applicable

Withdrawn

• Conditions: Inpatients Who Generate at Least Two Rothman Index Scores
• Interventions: Device: Rothman Index

• Registration Number: NCT04403737
• Lead Sponsor: Yale University

Brief Summary

This study is designed to assess the efficacy of the Rothman Index in combination with a set of recommended-use protocols to improve rates of mortality and/or rates of discharge to hospice care in hospitalized patients.

Detailed Description

The Rothman Index (RI), created by PeraHealth, Inc., is a clinical support system used to recognize the early stages of clinical deterioration. It uses time-updated physiological data (vital signs, lab values, nursing assessments) to calculate a single score that objectively quantifies a patient's condition in real-time. The score is used to detect a patient's declining health and predict risk of decompensation and death. Various risk thresholds exist to describe a patient's status. "Medium" risk is defined by a 30% reduction in a patient's RI score over 24 hours, "high" risk is defined by a 40% drop in the RI score over 12 hours, and "very high" risk" is having a score less than or equal to 20 on the RI. Some institutions have created protocols to be followed by providers when an RI risk threshold is reached (such as triggering rapid response team mobilization), however, there are no standardized protocols shared between hospitals, and none which have been rigorously tested to determine whether they effectively reduce mortality and adverse outcomes.

This is a randomized controlled trial to determine the efficacy of the Rothman Index and an associated set of RI-triggered recommended-use protocol sin improving rates of mortality and/or discharge to hospice care among inpatients of two hospitals within the Yale New Haven Health System. All inpatients admitted to any unit within the study sites who generate at least 2 RI index scores will be automatically enrolled and randomized to either usual care, in which the patient's RI score is calculated but remains unavailable to providers (and available only to the study team), or to the intervention group in which the RI is calculated and visible to providers who will be encouraged to follow recommended protocols appropriate to the RI risk threshold achieved.

The primary outcome is the rates of mortality and/or discharge to hospice care. Secondary outcomes include rates of inpatient mortality, ICU transfer, length of hospital stay, incurred costs, 30 day readmission and mortality rates, and rates of transfer to home.

Study Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Study Start: 2021-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-15
• Primary Completion: 2023-01
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adults inpatients greater than or equal to 18 years of age
• Admitted to any inpatient unit at two study sites within the Yale New Haven Health System
• Has generated at least 2 Rothman Index scores during the present hospital admission

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Exclusion Criteria

• Prior admission in which patient was randomized
• Patient has opted out of electronic health record consent
• Patient in observation status
• Patient admitted to hospice service

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Rothman Index	Patients in the intervention arm will have a Rothman Index calculated and will be visible to providers. Providers will be given a set of clinician-specific recommended-use protocols that they will be encouraged to follow based on the RI thresholds achieved by patients.

Primary Outcome Measures

Name	Time	Method
Mortality and/or discharge to hospice care	Assessed from the date of randomization to the date of the first documented death or discharge to hospice during patient's current hospitalization, up to 365 days	A composite outcome of mortality and discharge to hospice care as determined by medical record review. Either will be adequate to meet this endpoint.

Secondary Outcome Measures

Name	Time	Method
ICU transfer	Assessed from the date of randomization to the date of first documented ICU transfer during patient's current hospitalization, up to 365 days	ICU transfer as determined by medical record review.
Incurred hospital costs	Assessed as costs accrued from the date of randomization to the patient's first documented discharge, up to 365 days	Hospital costs incurred from post-randomization to discharge, as determined by review of hospital billing records.
Length of stay	Assessed as the number of days from the date of randomization to the first documented discharge, up to 365 days	Patient's length of stay with a start time beginning immediately post-randomization and ending at discharge of the present admission.
30 day mortality	30 days post-randomization	Mortality within 30 days of randomization as determined by medical record review.
Readmission	30 days post-randomization	Readmission within 30 days post-randomization as determined by medical record review.
Discharge to home	Assessed from the date of randomization to the date of the first document discharge to home, up to 365 days	As determined by medical record review

Trial Locations

Locations (2)

Greenwich Hospital; 🇺🇸 Greenwich, Connecticut, United States

Lawrence + Memorial Hospital; 🇺🇸 New London, Connecticut, United States