Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing Efficacy of the Rothman Index

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04403737
Recruitment Status : Withdrawn (Not started)
First Posted : May 27, 2020
Last Update Posted : February 15, 2022
Sponsor:
Collaborator:
PeraHealth
Information provided by (Responsible Party):
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.

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hospice Care

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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04403737


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Francis P Wilson, MD MSCE Yale University
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04403737    
Other Study ID Numbers: 2000027462
First Posted: May 27, 2020    Key Record Dates
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.

Layout table for additional information
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