CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 712 enrolled
Drug / intervention
Sepsis Transition And Recovery (STAR) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03865602
NCT03865602N/ACompleted

Improving Morbidity During Post-Acute Care Transitions for Sepsis (IMPACTS): A Pragmatic Randomized Evaluation of Implementing Best Practice Care for Sepsis Survivors to Reduce Morbidity and Mortality

Wake Forest University Health Sciences·interventional·Posted Mar 7, 2019·Updated Apr 25, 2022

In Brief

A clinical study evaluating Sepsis Transition And Recovery (STAR) and Usual care for Clinical Sepsis. Completed, enrolled 712 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClinical Sepsis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 7, 2019
Enrollment StartJan 29, 2019
Primary CompletionDec 31, 2020
Study CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.3 years ago

Interventions

Sepsis Transition And Recovery (STAR)behavioral

In the STAR program intervention, a centrally located nurse navigator facilitates the application of four evidence-based core components of post-sepsis care (i.e., review of medications, new impairments, comorbidities, and palliative care) to patients prior to and during the 30 days after hospital discharge. The STAR navigator will provide telephone and EHR-based support within the hospitalization and to patients across all discharge settings with remote monitoring at specified intervals following hospital discharge. Patients will continue to receive STAR directed services for 30 days following their discharge and then will be transitioned back to the next appropriate care location.

Usual carebehavioral

Patients and their providers will not have access to the STAR program. Patients will continue to receive usual care throughout their stay and discharge, consisting of: patient education and follow-up instructions at discharge, which are not specific to sepsis; routine recommendations for follow-up visits with primary care providers; arrangements for home health services or care management follow-up based on each patient's needs but not specifically tailored to the sepsis population; discharge to post-acute setting with no sepsis-specific follow-up. All aspects of usual care will be determined by treating clinicians independent of trial assignment.