Assessing Efficacy of the Rothman Index
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|ClinicalTrials.gov Identifier: NCT04403737|
Recruitment Status : Withdrawn (Not started)
First Posted : May 27, 2020
Last Update Posted : February 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Inpatients Who Generate at Least Two Rothman Index Scores||Device: Rothman Index||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|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|
No Intervention: Usual Care
Patients in the control arm will have a Rothman Index calculated but this will not be visible to providers.
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.
- 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.
- 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.
- 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.
- 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.
- Readmission [ Time Frame: 30 days post-randomization ]Readmission within 30 days post-randomization as determined by medical record review.
- 30 day mortality [ Time Frame: 30 days post-randomization ]Mortality within 30 days of randomization as determined by medical record review.
- 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
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
|United States, Connecticut|
|Greenwich, Connecticut, United States, 06830|
|Lawrence + Memorial Hospital|
|New London, Connecticut, United States, 06320|
|Principal Investigator:||Francis P Wilson, MD MSCE||Yale University|