Clinical trial NCT04403737: Assessing Efficacy of the Rothman Index
Official title: A Pragmatic Randomized Trial Assessing Efficacy of the Rothman Index
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Inpatients Who Generate at Least Two Rothman Index Scores
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: PeraHealth
First posted: 2020-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Mortality and/or discharge to hospice care
timeFrame: 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 outcomes:
measure: ICU transfer
timeFrame: Assessed from the date of randomization to the date of first documented ICU transfer during patient's current hospitalization, up to 365 days
measure: Length of stay
timeFrame: Assessed as the number of days from the date of randomization to the first documented discharge, up to 365 days
measure: Incurred hospital costs
timeFrame: Assessed as costs accrued from the date of randomization to the patient's first documented discharge, up to 365 days
measure: Readmission
timeFrame: 30 days post-randomization
measure: 30 day mortality
timeFrame: 30 days post-randomization
measure: Discharge to home
timeFrame: Assessed from the date of randomization to the date of the first document discharge to home, up to 365 days
Other outcomes:
Locations:
city: Greenwich
country: United States
facility: Greenwich Hospital
state: Connecticut
city: New London
country: United States
facility: Lawrence + Memorial Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Francis P Wilson, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References: