Assessing Efficacy of the Rothman Index

Inpatients Who Generate at Least Two Rothman Index Scores Clinical Trial

Official title:

A Pragmatic Randomized Trial Assessing Efficacy of the Rothman Index

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04403737
• Other study ID #: 2000027462
• Status: Withdrawn
• Phase: N/A
• Start date: November 2021
• Est. completion date: June 2023

Study information

• Verified date: February 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inpatients Who Generate at Least Two Rothman Index Scores

Intervention

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.

Locations

Country	Name	City	State
United States	Greenwich Hospital	Greenwich	Connecticut
United States	Lawrence + Memorial Hospital	New London	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	PeraHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Readmission	Readmission within 30 days post-randomization as determined by medical record review.	30 days post-randomization
Secondary	30 day mortality	Mortality within 30 days of randomization as determined by medical record review.	30 days post-randomization
Secondary	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