NCT03865602: IMPACTS

Improving Morbidity During Post-Acute Care Transitions for Sepsis

Completed NA Last updated 25 April 2022

What this trial tests

NA trial testing Sepsis Transition And Recovery (STAR) in Clinical Sepsis in 712 participants. Completed in 31 December 2021.

Timeline

29 January 2019

Primary endpoint
31 December 2020

31 December 2021

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	712
Start date	29 January 2019
Primary completion	31 December 2020
Estimated completion	31 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Sepsis Transition And Recovery (STAR)
• Usual care

Conditions studied

• Clinical Sepsis — all drugs for Clinical Sepsis →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Clinical Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of a Multicomponent Sepsis Transition and Recovery Program on Mortality and Readmissions After Sepsis: The Improving Morbidity During Post-Acute Care Transitions for Sepsis Randomized Clinical Trial.
   Taylor SP, Murphy S, Rios A, McWilliams A, et al · · 2022 · cited 79× · PMID 34534130 · DOI 10.1097/ccm.0000000000005300
2. Association between Adherence to Recommended Care and Outcomes for Adult Survivors of Sepsis.
   Taylor SP, Chou SH, Sierra MF, Shuman TP, et al · · 2020 · cited 53× · PMID 31644304 · DOI 10.1513/annalsats.201907-514oc
3. Structured, proactive care coordination versus usual care for Improving Morbidity during Post-Acute Care Transitions for Sepsis (IMPACTS): a pragmatic, randomized controlled trial.
   Kowalkowski M, Chou SH, McWilliams A, Lashley C, et al · · 2019 · cited 22× · PMID 31783900 · DOI 10.1186/s13063-019-3792-7
4. Deficits in Identification of Goals and Goal-Concordant Care After Sepsis Hospitalization.
   Taylor SP, Kowalkowski MA, Courtright KR, Burke HL, et al · · 2021 · cited 13× · PMID 34730507 · DOI 10.12788/jhm.3714
5. Unpacking the challenges of conducting embedded, learning health system research: The winning entries of a Challenge Contest sponsored by AcademyHealth.
   · 2022 · cited 2× · PMID 36263265 · DOI 10.1002/lrh2.10346