Improving Morbidity During Post-Acute Care Transitions for Sepsis

NCT03865602 | Completed

• 2 other identifiers: IRB0008232601-19-24E
• Study Type: interventional
• Target: 712
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clinical Sepsis

Keywords

evidence based medicine; continuity of patient care; patient navigator; health services; pragmatic clinical trial

Outcome Measures

Primary Outcomes (1)

• Combined all-cause mortality or unplanned hospital readmission

  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 composite primary outcome, we will capture all patients with either date of death or eligible hospital readmission prior to 30 days post discharge as event-positive.

  30 days from index visit

Secondary Outcomes (20)

• All-cause mortality

  30 days from index visit

• All-cause mortality

  90 days from index visit

• All-cause unplanned hospital readmission

  30 days from index visit

• All-cause unplanned hospital readmission

  90 days from index visit

• Infection-related unplanned hospital readmission

  30 days from index visit

Study Arms (2)

Sepsis Transition And Recovery (STAR)

EXPERIMENTAL

Virtual sepsis navigation delivered across the peri-hospital discharge interval

Behavioral: Sepsis Transition And Recovery (STAR)

Usual Care

ACTIVE COMPARATOR

Patients and their providers will have no access to the STAR program. Aspects of usual care will be determined by treating clinicians independent of trial assignment.

Behavioral: Usual care

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.

Sepsis Transition And Recovery (STAR)

Usual care BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted from the emergency department to inpatient or observation status at one of: Carolinas Medical Center, Carolinas Medical Center - Mercy, or Atrium Health Northeast;
• ≥18 years of age upon admission;
• oral/parenteral antibiotic or bacterial culture order within 24 hours of emergency department presentation and
• culture drawn first, antibiotics ordered within 48 hours or
• antibiotics ordered first, culture ordered within 48 hours (adapted from criteria applied in development of the Third International Consensus Definitions for Sepsis and Septic Shock)
• deemed as high-risk for 30-day readmission (i.e., ≥ 20%) or 30-day mortality (i.e., ≥ 10%) using risk-scoring models
• not discharged at the time of patient list generation

You may not qualify if:

• prior randomization to either STAR or usual care study arms;
• not a North Carolina resident or residence \>2.5-hour drive time from treating hospital;
• the only antibiotic associated with patient is administered in the operating room as this likely represents pre-operative infection prophylaxis and not presumed infection;
• patients transferred from other acute care hospitals;
• patients with a change in code status (i.e., do not resuscitate, do not intubate) within 24 hours after admission due to the general assumption of increased risk of exposure to less aggressive treatment;
• patients with infection ruled out during the index hospitalization.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

Related Publications (23)

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  PMID: 26414292 BACKGROUND

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  PMID: 25756444 BACKGROUND

• Huang C, Daniels R, Lembo A, et al. Sepsis survivors' satisfaction with support services during and after their hospitalization. Crit Care Med. 2016;44(12):425.

  BACKGROUND

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• Nesseler N, Defontaine A, Launey Y, Morcet J, Malledant Y, Seguin P. Long-term mortality and quality of life after septic shock: a follow-up observational study. Intensive Care Med. 2013 May;39(5):881-8. doi: 10.1007/s00134-013-2815-1. Epub 2013 Jan 29.

  PMID: 23358541 BACKGROUND

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  PMID: 27189000 BACKGROUND

• Goodwin AJ, Rice DA, Simpson KN, Ford DW. Frequency, cost, and risk factors of readmissions among severe sepsis survivors. Crit Care Med. 2015 Apr;43(4):738-46. doi: 10.1097/CCM.0000000000000859.

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• Prescott HC, Langa KM, Liu V, Escobar GJ, Iwashyna TJ. Increased 1-year healthcare use in survivors of severe sepsis. Am J Respir Crit Care Med. 2014 Jul 1;190(1):62-9. doi: 10.1164/rccm.201403-0471OC.

  PMID: 24872085 BACKGROUND

• Jones TK, Fuchs BD, Small DS, Halpern SD, Hanish A, Umscheid CA, Baillie CA, Kerlin MP, Gaieski DF, Mikkelsen ME. Post-Acute Care Use and Hospital Readmission after Sepsis. Ann Am Thorac Soc. 2015 Jun;12(6):904-13. doi: 10.1513/AnnalsATS.201411-504OC.

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• Prescott HC, Angus DC. Enhancing Recovery From Sepsis: A Review. JAMA. 2018 Jan 2;319(1):62-75. doi: 10.1001/jama.2017.17687.

  PMID: 29297082 BACKGROUND

• Taylor S, Figueroa-Sierra M, Shuman T, et al. Post-sepsis care recommendations are associated with improved patient outcomes but adherence is low [abstract]. Critical Care Medicine. 2019;47(1):636.

  BACKGROUND

• Brownson RC, Allen P, Duggan K, Stamatakis KA, Erwin PC. Fostering more-effective public health by identifying administrative evidence-based practices: a review of the literature. Am J Prev Med. 2012 Sep;43(3):309-19. doi: 10.1016/j.amepre.2012.06.006.

  PMID: 22898125 BACKGROUND

• Bodenheimer T. Coordinating care--a perilous journey through the health care system. N Engl J Med. 2008 Mar 6;358(10):1064-71. doi: 10.1056/NEJMhpr0706165. No abstract available.

  PMID: 18322289 BACKGROUND

• Coleman EA, Berenson RA. Lost in transition: challenges and opportunities for improving the quality of transitional care. Ann Intern Med. 2004 Oct 5;141(7):533-6. doi: 10.7326/0003-4819-141-7-200410050-00009.

  PMID: 15466770 BACKGROUND

• Dellinger RP, Levy MM, Schorr CA, Townsend SR. 50 Years of Sepsis Investigation/Enlightenment Among Adults-The Long and Winding Road. Crit Care Med. 2021 Oct 1;49(10):1606-1625. doi: 10.1097/CCM.0000000000005203. No abstract available.

  PMID: 34342304 DERIVED

• Kowalkowski M, Chou SH, McWilliams A, Lashley C, Murphy S, Rossman W, Papali A, Heffner A, Russo M, Burke L, Gibbs M, Taylor SP; Atrium Health ACORN Investigators. Structured, proactive care coordination versus usual care for Improving Morbidity during Post-Acute Care Transitions for Sepsis (IMPACTS): a pragmatic, randomized controlled trial. Trials. 2019 Nov 29;20(1):660. doi: 10.1186/s13063-019-3792-7.

  PMID: 31783900 DERIVED

MeSH Terms

Interventions

Salvage Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Marc Kowalkowski, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Stephanie P Taylor, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 7, 2019
• Study Start: January 29, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: April 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)