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NCT04495946 · ClinicalTrials.gov registry record · NA
Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship
A NA study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 3,894
- Enrollment target
NCT04495946: Completed NA study, sponsored by Wake Forest University Health Sciences.
NCT04495946 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 3,894 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (177% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04495946, a NA study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 3,894 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate if implementation of the Sepsis Transition and Recovery (STAR) program within a large healthcare system will improve outcomes for high-risk patients with suspected sepsis, while concurrently examining contextual factors related to STAR program delivery within routine care to generate knowledge of best practices for implementation and dissemination of post sepsis transitions of care. To address persistent morbidity and mortality for sepsis survivors, Atrium Health developed the Sepsis Treatment and Recovery (STAR) program which uses a nurse navigator to deliver a bundle of best-practice care elements for the delivery of longitudinal post-sepsis care for up to 90 days. These care elements are directed towards the specific challenges and sequelae following a sepsis hospitalization and include: 1) identification and treatment of new physical, mental, and cognitive deficits; 2) review and adjustment of medications; 3) surveillance of treatable conditions that commonly lead to poor outcomes including chronic conditions that may de-stabilize during sepsis and recovery; and 4) focus on palliative care when appropriate. ENCOMPASS (Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship) is an effectiveness-implementation hybrid type I trial, with the evaluation designed as a two-arm, pragmatic, stepped-wedge cluster randomized controlled trial conducted at eight regional hospitals in which each participating hospital begins in a usual care control phase and transitions to the STAR program intervention in a randomly assigned sequence. Patients are allocated to receive the treatment condition (i.e., usual care or STAR) assigned to their admission hospital at time of enrollment. ENCOMPASS will test the hypothesis that patients who receive care through the STAR program will have reduced mortality and hospital readmission assessed 90 days post index hospital discharge compared to patients who receive usual care.
Primary Outcome
Combined death or unplanned hospital readmission due to any cause, assessed 90 days after the index hospital discharge
Interventions
- BEHAVIORAL Usual care
- BEHAVIORAL Sepsis Transition and Recovery (STAR) program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,894 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2024-04-01 |
| Phase | NA |
What the finished NCT04495946 record still lists
NCT04495946 is an interventional study that assigns participants to a tested intervention. Its 3,894 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (177% higher).
The record links to 0 conditions, and to 2 interventions - of which Usual care is the first listed.
NCT04495946 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04495946 about?
NCT04495946 is a clinical study titled "Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship". The purpose of this study is to evaluate if implementation of the Sepsis Transition and Recovery (STAR) program within a large healthcare system will improve outcomes for high-risk patients with suspected sepsis, while concurrently examining contextual factors related to STAR program delivery within...
What is the current status of trial NCT04495946?
This trial is currently completed. It is a NA study. The enrollment target is 3,894 participants. The study started on 2020-07-01. Estimated completion is 2024-04-01.
What interventions are being tested in trial NCT04495946?
The interventions under investigation include: Usual care (BEHAVIORAL), Sepsis Transition and Recovery (STAR) program (BEHAVIORAL).
Who is sponsoring clinical trial NCT04495946?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04495946's enrollment target sits among peer trials
3,894 36th of 2000 higher than 1,965 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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