Assessing Efficacy of the Rothman Index

A Pragmatic Randomized Trial Assessing Efficacy of the Rothman Index

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.

Study Overview

• Status: Withdrawn
• Conditions: Inpatients Who Generate at Least Two Rothman Index Scores
• Intervention / Treatment: Device: Rothman Index

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Greenwich, Connecticut, United States, 06830
      • Greenwich Hospital
    • New London, Connecticut, United States, 06320
      • Lawrence + Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Usual Care; Patients in the control arm will have a Rothman Index calculated but this will not be visible to providers.
EXPERIMENTAL: Intervention; 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.	Device: Rothman Index; The Rothman Index score will be calculated and visible to providers. Providers will be encouraged to follow a set of recommended-use protocols in response to different levels of the RI threshold.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality and/or discharge to hospice care	A composite outcome of mortality and discharge to hospice care as determined by medical record review. Either will be adequate to meet this endpoint.	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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: PeraHealth

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2021
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (ACTUAL): May 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2000027462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data underlying results for publication will be made available upon publication of results.
• IPD Sharing Time Frame: After publication of results; indefinitely.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes