Discharge Readmission Analysis and Management in Sepsis (DReAMS-2)
1 other identifier
observational
2,000
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2023
CompletedFirst Posted
Study publicly available on registry
October 25, 2023
CompletedStudy Start
First participant enrolled
October 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedNovember 7, 2023
November 1, 2023
11 months
October 19, 2023
November 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Unplanned readmissions
Number of unplanned readmissions in 30 days
From discharge date to 30, 60, 90 days post discharge
Secondary Outcomes (2)
All cause mortality
Date of discharge to 30, 60, 90 days post discharge
Emergency Department Visits
Date of discharge to 30, 60, 90 days post discharge
Eligibility Criteria
Hospitalized adults who have been diagnosed to include but not limited to sepsis and heart failure.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Measure Labs, Inc.lead
- Duke Universitycollaborator
Study Sites (3)
Duke Regional Hospital
Durham, North Carolina, 27704, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Duke Raleigh Hospital
Raleigh, North Carolina, 27609, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lana Wahid, MD
Duke University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2023
First Posted
October 25, 2023
Study Start
October 26, 2023
Primary Completion
October 1, 2024
Study Completion
October 1, 2024
Last Updated
November 7, 2023
Record last verified: 2023-11