Discharge Readmission Analysis and Management in Sepsis (DReAMS-2)

Status unconfirmed

Conditions studied: Sepsis

In brief

This is an adaptive platform. This study is being done to collect information that will help us identify trends in patients with sepsis and other health conditions being readmitted into hospitals within 30 days of being discharged. This information will be used to create a computer tool that will help predict a patient's risk of being readmitted into the hospital after being discharged. Participants will allow the study team to follow their health after they are discharged by taking their temperature once a day and placing their index finger over their smartphone camera when prompted by a text message. Participants will receive the text messages twice a day. When the participant receives the text message, they will click on the link and follow the instructions. Instructions include how to long to keep your finger on your phone camera and how to report your daily temperature. Additional questions will also be asked. After 30 days, the text messages will stop, and participation will be complete.

Key facts

Study ID: NCT06099756
Run by: Measure Labs, Inc.
People needed: 2000
Starts: 2023-10-26
Expected to finish: 2024-10-01
Last updated by the study team: 2023-11-07

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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 it is running

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

Full record on ClinicalTrials.gov

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