Assessing Efficacy of the Rothman Index

• ClinicalTrials.gov Identifier: NCT04403737
• Recruitment Status: Withdrawn
• First Posted: May 27, 2020
• Last Update Posted: February 15, 2022
• Sponsor: Yale University
• Collaborator: PeraHealth
• Information provided by (Responsible Party): Yale University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Inpatients Who Generate at Least Two Rothman Index Scores	Device: Rothman Index	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: A Pragmatic Randomized Trial Assessing Efficacy of the Rothman Index
• Estimated Study Start Date: November 2021
• Estimated Primary Completion Date: January 2023
• Estimated Study Completion Date: June 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Mortality and/or discharge to hospice care [ Time Frame: 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 :

1. ICU transfer [ Time Frame: 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.
2. Length of stay [ Time Frame: 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.
3. Incurred hospital costs [ Time Frame: 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.
4. Readmission [ Time Frame: 30 days post-randomization ]
   Readmission within 30 days post-randomization as determined by medical record review.
5. 30 day mortality [ Time Frame: 30 days post-randomization ]
   Mortality within 30 days of randomization as determined by medical record review.
6. Discharge to home [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Connecticut

Greenwich Hospital

Greenwich, Connecticut, United States, 06830

Lawrence + Memorial Hospital

New London, Connecticut, United States, 06320

Sponsors and Collaborators

Yale University

PeraHealth

Investigators

• Principal Investigator: Francis P Wilson, MD MSCE; Yale University

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT04403737
• Other Study ID Numbers: 2000027462
• First Posted: May 27, 2020
• Last Update Posted: February 15, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Deidentified data underlying results for publication will be made available upon publication of results.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: After publication of results; indefinitely.

• 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