Analyzing and managing hospital readmissions for sepsis patients

Discharge Readmission Analysis and Management in Sepsis (DReAMS-2): Augmenting Readmission Risk Models With Smartphone PPG Signals and Deep Learning, an Adaptive Platform

This study is testing a smartphone app that helps sepsis patients track their health after leaving the hospital to see if it can help predict and reduce their chances of being readmitted within 30 days.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Measure Labs, Inc. (industry)
• Locations: 3 sites (Durham, North Carolina and 2 other locations)
• Trial ID: NCT06099756 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect data on patients with sepsis and other health conditions to identify trends related to hospital readmissions within 30 days post-discharge. Participants will use a smartphone app to monitor their health by taking daily temperature readings and recording blood flow signals through their fingertip. The data collected will be utilized to develop a predictive tool for assessing the risk of readmission. The study involves close monitoring and support from the research team to ensure accurate data collection.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been hospitalized for sepsis for at least 48 hours.

Not a fit: Patients who are in imminent death or receiving comfort care or hospice services will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved prediction and management of hospital readmissions for sepsis patients, enhancing patient outcomes.

How similar studies have performed: Other studies have shown promise in using technology for monitoring patient health post-discharge, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Age 18 years or older
* Admitted to the hospital for 48 hours or greater
* Admitted with an index diagnoses of sepsis. We defined sepsis based on the 2018 Centers for Disease Control and Prevention's Adult Sepsis Event (ASE).

  \[1\] A subject must have an order for blood cultures, at least 4 qualifying antimicrobial days AND Evidence of at least 1 end organ dysfunction (new vasopressors, initiation of mechanical ventilation, doubling of serum creatinine (or GFR reduction by 50%), total bilirubin ≥ 2.0 mg/dl, an increase by 100% from baseline, platelet count \< 100 cells/ul, and lactate ≥ 2.0.
* The adaptive design will allow the expansion into additional index hospitalization diagnosis (for example, heart failure exacerbation, sickle cell crises, COPD exacerbation, hip fractures, pneumonia, post surgical patients, diabetes mellitus)

Exclusion Criteria:

* Imminent death or anticipated death during index admission (to include comfort care or hospice)
* Patients due to be transferred to another acute care facility
* Participants not proficient with written and spoken English.
* Participants who do not have a smartphone and valid mobile number to receive text messages.
* Participants leaving the hospital against medical advice.
* Participants with essential tremor.
* Participants deemed non-compliant or not suitable for the study due to cognitive impairment or serious mental health conditions as determined by the Principal Investigator.
* Participants unable to independently navigate and operate smartphone applications.
* Participants with diminished decision-making capability.
* Participants likely to not be available to complete all protocol-required procedures (e.g., Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.
* Participants with history or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or study team, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
* Vulnerable Subjects, this study will not enroll children \< 18 years of age, pregnant women, or prisoners.

Where this trial is running

Durham, North Carolina and 2 other locations

• Duke Regional Hospital — Durham, North Carolina, United States (RECRUITING)
• Duke University Hospital — Durham, North Carolina, United States (RECRUITING)
• Duke Raleigh Hospital — Raleigh, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Lana Wahid, MD — Duke University
• Study coordinator: Lana Wahid, MD

Conditions: Sepsis