Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03865602 · ClinicalTrials.gov registry record · NA
Improving Morbidity During Post-Acute Care Transitions for Sepsis
A NA study of Clinical Sepsis, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 712
- Enrollment target
- 1
- Study location
NCT03865602: Completed NA study of Clinical Sepsis, sponsored by Wake Forest University Health Sciences.
NCT03865602 is a NA study of Clinical Sepsis that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 712 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03865602, a NA study of Clinical Sepsis, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 712 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to improve transitions of care for the highest risk, complex patients with suspected sepsis. Atrium Health has developed a nurse-navigator facilitated care transition strategy, called the Sepsis Transition and Recovery (STAR) program, to improve the implementation of recommended care practices and bridge care gaps for patients in the post-sepsis transition period. During their hospitalization, STAR program patients enter into a transition pathway facilitated by a centrally located nurse navigator and including the following evidence-based post-sepsis care components: i) review and recommendation for adjustment of medications; ii) identification of and referral for new physical, mental, and cognitive deficits; iii) surveillance for treatable conditions that commonly lead to poor outcomes; and iv) referral to palliative care when appropriate. IMPACTS (Improving Morbidity during Post-Acute Care Transitions for Sepsis) is a pragmatic, randomized program evaluation to compare clinical outcomes between sepsis survivors who receive usual care versus care delivered through the STAR program following hospitalization. IMPACTS will test the hypothesis that patients that receive care through STAR will have decreased composite all cause, 30-day hospital readmission and mortality compared to patients that receive usual care.
Primary Outcome
Hospital readmission will be captured from healthcare utilization data in the Atrium Health enterprise data warehouse. Index visit is defined by the Centers for Medicaid and Medicare Services (CMS) with additional inclusion of observation patients at any Atrium Health facility. Vital status verification data is ascertained via monthly Social Security Administration Limited Access Death Master File (DMF) data feed and validated record linkage process into the Atrium Health data warehouse. For the
Conditions Studied
Interventions
- BEHAVIORAL Usual care
- BEHAVIORAL Sepsis Transition And Recovery (STAR)
Study Locations (1)
North Carolina
- Atrium Health - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 712 participants |
| Start Date | 2019-01-29 |
| Est. Completion | 2021-12-31 |
| Phase | NA |
What the finished NCT03865602 record still lists
NCT03865602 is an interventional study that assigns participants to a tested intervention. The registered 712 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Clinical Sepsis appearing as the primary indexed condition, and to 2 interventions - of which Usual care is the first listed.
NCT03865602 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03865602 about?
NCT03865602 is a clinical study titled "Improving Morbidity During Post-Acute Care Transitions for Sepsis". The purpose of this study is to improve transitions of care for the highest risk, complex patients with suspected sepsis. Atrium Health has developed a nurse-navigator facilitated care transition strategy, called the Sepsis Transition and Recovery (STAR) program, to improve the implementation of rec...
What is the current status of trial NCT03865602?
This trial is currently completed. It is a NA study. The enrollment target is 712 participants. The study started on 2019-01-29. Estimated completion is 2021-12-31.
What conditions does trial NCT03865602 study?
This clinical trial studies the following conditions: Clinical Sepsis.
What interventions are being tested in trial NCT03865602?
The interventions under investigation include: Usual care (BEHAVIORAL), Sepsis Transition And Recovery (STAR) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03865602?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03865602 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03865602's enrollment target sits among peer trials
712 147th of 2000 higher than 1,854 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05208762 · 714 participants · Phase 1
A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
- NCT06758401 · 714 participants · Phase 3
This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.
- NCT06179160 · 710 participants · Phase 1
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
- NCT06235697 · 710 participants · Phase 3
Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI