Prediction of Rehospitalization Following a Sepsis Admission Using a Wearable Biopatch

NCT ID: NCT05806762

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2027-05-02

Brief Summary

The goal of this observational study is to learn about the utility of biopatches predicting 30-day readmissions in patients discharged from the hospital with sepsis.

The main question[s] it aims to answer are:

• Does the application of a biopatch provide data that can improve prediction of an unplanned 30-day readmission following a hospitalization for sepsis.

Participants will be asked to wear a biopatch on their chest for 30-days following hospital discharge or until readmission to the hospital.

Detailed Description

Study Design: Longitudinal cohort study with repeated measure of outcomes and predictors.

The BioIntelliSense patch is an FDA approved wearable device that is applied to the chest with a 30-day battery lifespan and allows for real-time monitoring of heart rate, respiratory rate, skin temperature, general activity, severe cough episodes, and sedentary body position, among others.

Outcomes of Interest: Hospital readmission within 30 days of discharge following an index admission with a diagnosis of sepsis is the primary outcome of interest for this study. We will calculate the positive predictive value (PPV) of readmission prediction as the the primary outcome of interest from the following approaches: analytic score plus biopatch, analytic score alone, LACE+ score. Secondary outcomes include area under the curve of the receiver operator characteristic (AUCroc) of predictive scores (analytic score and biopatch, analytic score alone, LACE+ score) and number of patients readmitted to the hospital within 30 days of discharge.

Protocol for Patient Selection and Application of Biopatch: Patients who meet "Sepsis 3" definition will be identified with institutional review board (IRB)-approved screening protocols. Our previously derived and validated machine-learning algorithm to predict unplanned 30-day readmissions will then generate daily predictions about 30-day readmission probability which will be recorded, as well as LACE+ scores. As a patient approaches discharge, the treatment team and patient (or legally authorized representative) will be approached about potential enrollment. If there is agreement to enroll in this prospective study, then we will apply the patch at the time of discharge. Patients will then be followed with the BioIntellisence patch with augmented and real-time risk predictions based on data obtained from this. For this proposal, we will use data from the BioIntelliSense patch and are not providing clinicians with data on risk of readmission.

Conditions

Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sepsis Patients Discharged From the Hospital

We aim to apply a wearable biopatch to sepsis patients discharged from the hospital to determine if the additional data afforded by the biopatch can improve prediction of readmissions.

BioIntellisense

Intervention Type: DEVICE

Enrolled patients will have a Fitbit placed on their wrist. There is no comparator group enrolled.

Interventions

BioIntellisense

Enrolled patients will have a Fitbit placed on their wrist. There is no comparator group enrolled.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Age >= 18 years Development of sepsis, defined by recent international guidelines (Suspected infection AND 2-point change in sequential organ failure assessment (SOFA) score), in emergency department or hospital Admission to hospital from emergency department

Exclusion Criteria

Transition to comfort measures within 6 hours of time of sepsis Discharge from the emergency department Admission to bone marrow transplant service Severe burn or other dermatologic condition that will prevent application to skin

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Gabriel Wardi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UC San Diego Health

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gabriel Wardi

Role: CONTACT

gwardi@health.ucsd.edu

6195436463

Shamim Nemati

Role: CONTACT

Facility Contacts

Gabriel Wardi

Role: primary

gwardi@health.ucsd.edu

619-543-6463

Other Identifiers

Gabriel.Wardi

Identifier Type: -

Identifier Source: org_study_id