COMPLETED

Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up

Conditions

Sepsis critical illness recovery care transitions survivorship mortality hospital readmission

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS) study is an effectiveness-implementation hybrid design. The effectiveness evaluation is designed as a multiple interrupted time series (mITS) analysis to test the impact of implementing an adapted Sepsis Transition and Recovery (STAR) program on enhancing post sepsis outcomes in new hospital settings.

Official Title

Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS)

Quick Facts

Study Start:2024-01-16

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05997420

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* adults 18 years of age and older; * clinically suspected infection 1. two or more markers of systemic inflammatory response syndrome within 24 h of presentation; AND 2. antibiotics initiated within 24 hours and continued for at least one additional day * organ dysfunction 1. two or more points on admission Sequential Organ Failure Assessment (SOFA); OR 2. two or more points on admission quick-SOFA * deemed to be at high risk of hospital readmission within 90 days, defined as readmission risk probability of at least 25% * not discharged from the hospital at the time of patient identification each morning.	* change in code status (i.e., initially full code followed by change to do not resuscitate and/or do not intubate) within 24 hours after index presentation due to presumed limitation of aggressive treatment and exposure to STAR program components; * reside \> 2.5 hours drive time from the treating hospital due to the maximum reach of the community services leveraged within the STAR program and the general assumption that these patients may have less comprehensive utilization tracking within available electronic record systems for study outcomes; * are actively participating in a different care management program (e.g., cancer care patient navigation) documented in the electronic health record (EHR) at time of hospital admission.

Inclusion Criteria

Exclusion Criteria

* adults 18 years of age and older;
* clinically suspected infection
1. two or more markers of systemic inflammatory response syndrome within 24 h of presentation; AND
2. antibiotics initiated within 24 hours and continued for at least one additional day
* organ dysfunction
1. two or more points on admission Sequential Organ Failure Assessment (SOFA); OR
2. two or more points on admission quick-SOFA
* deemed to be at high risk of hospital readmission within 90 days, defined as readmission risk probability of at least 25%
* not discharged from the hospital at the time of patient identification each morning.

* change in code status (i.e., initially full code followed by change to do not resuscitate and/or do not intubate) within 24 hours after index presentation due to presumed limitation of aggressive treatment and exposure to STAR program components;
* reside \> 2.5 hours drive time from the treating hospital due to the maximum reach of the community services leveraged within the STAR program and the general assumption that these patients may have less comprehensive utilization tracking within available electronic record systems for study outcomes;
* are actively participating in a different care management program (e.g., cancer care patient navigation) documented in the electronic health record (EHR) at time of hospital admission.

Contacts and Locations

Principal Investigator

Marc A. Kowalkowski, PhD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Sarah Birken, PhD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Atrium Health

Charlotte, North Carolina, 28203

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Marc A. Kowalkowski, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences
Sarah Birken, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-16

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-01-16

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

critical illness recovery
care transitions
survivorship
mortality
hospital readmission

Additional Relevant MeSH Terms

Sepsis