Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship

NCT04495946 | Completed Results DMC

• 3 other identifiers: IRB00081729R01NR018434Pro00036873
• Study Type: interventional
• Target: 3,894
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate if implementation of the Sepsis Transition and Recovery (STAR) program within a large healthcare system will improve outcomes for high-risk patients with suspected sepsis, while concurrently examining contextual factors related to STAR program delivery within routine care to generate knowledge of best practices for implementation and dissemination of post sepsis transitions of care. To address persistent morbidity and mortality for sepsis survivors, Atrium Health developed the Sepsis Treatment and Recovery (STAR) program which uses a nurse navigator to deliver a bundle of best-practice care elements for the delivery of longitudinal post-sepsis care for up to 90 days. These care elements are directed towards the specific challenges and sequelae following a sepsis hospitalization and include: 1) identification and treatment of new physical, mental, and cognitive deficits; 2) review and adjustment of medications; 3) surveillance of treatable conditions that commonly lead to poor outcomes including chronic conditions that may de-stabilize during sepsis and recovery; and 4) focus on palliative care when appropriate. ENCOMPASS (Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship) is an effectiveness-implementation hybrid type I trial, with the evaluation designed as a two-arm, pragmatic, stepped-wedge cluster randomized controlled trial conducted at eight regional hospitals in which each participating hospital begins in a usual care control phase and transitions to the STAR program intervention in a randomly assigned sequence. Patients are allocated to receive the treatment condition (i.e., usual care or STAR) assigned to their admission hospital at time of enrollment. ENCOMPASS will test the hypothesis that patients who receive care through the STAR program will have reduced mortality and hospital readmission assessed 90 days post index hospital discharge compared to patients who receive usual care.

Conditions

Sepsis

Keywords

evidence based medicine; transition care; critical care; implementation science; pragmatic clinical trial

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality and Hospital Readmission Rate

  Combined death or unplanned hospital readmission due to any cause, assessed 90 days after the index hospital discharge

  90 days

Secondary Outcomes (15)

• Number of Days Alive and Outside the Hospital

  90 days

• All-cause Mortality Rate

  90 days

• All-cause Hospital Readmission Rate

  90 days

• Number of Outpatient Provider Visits

  90 days

• Number of Emergency Department Visits

  90 days

Study Arms (2)

Sepsis Transition and Recovery (STAR) Program

EXPERIMENTAL

Virtual sepsis navigation delivered across the peri-hospital discharge interval

Behavioral: Sepsis Transition and Recovery (STAR) program

Usual Care

ACTIVE COMPARATOR

Standard of care received through Atrium Health facilities for patients hospitalized with sepsis. Aspects of usual care will be determined by treating clinicians independent of trial assignment.

Behavioral: Usual care

Interventions

Sepsis Transition and Recovery (STAR) program 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 90 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 90 days following their discharge and then will be transitioned back to the next appropriate care location.

Sepsis Transition and Recovery (STAR) Program

Usual care BEHAVIORAL

Hospitals and their patients 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:

• At least 18 years of age upon admission
• Suspected infection
• Oral/parenteral antibiotic or bacterial culture order within 24 hours of emergency department presentation; and
• Evidence of systemic inflammatory response (i.e., at least two abnormal of temperature; heart rate; respiratory rate; and WBC count or bands)
• Evidence of organ dysfunction (i.e., at least two points on either Quick Sepsis-related Organ Failure Assessment or Sepsis-related Organ Failure Assessment risk tools)
• Deemed as high risk for 90-day readmission using risk-scoring models
• Not discharged at the time of patient list generation

You may not qualify if:

• Patients with a change in code status (i.e., do not resuscitate, do not intubate) within 24 hours after infection onset due to presumed limitation of aggressive treatment
• Patients who reside \> 2.5 hours drive time from the treating hospital
• Patients actively enrolled in a different care management program at time of admission
• Patient has been randomized previously.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

Related Publications (17)

• Fleischmann C, Scherag A, Adhikari NK, Hartog CS, Tsaganos T, Schlattmann P, Angus DC, Reinhart K; International Forum of Acute Care Trialists. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Respir Crit Care Med. 2016 Feb 1;193(3):259-72. doi: 10.1164/rccm.201504-0781OC.

  PMID: 26414292 BACKGROUND

• Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

  PMID: 28101605 BACKGROUND

• Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014 Apr 2;311(13):1308-16. doi: 10.1001/jama.2014.2637.

  PMID: 24638143 BACKGROUND

• Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553.

  PMID: 20978258 BACKGROUND

• Borges RC, Carvalho CR, Colombo AS, da Silva Borges MP, Soriano FG. Physical activity, muscle strength, and exercise capacity 3 months after severe sepsis and septic shock. Intensive Care Med. 2015 Aug;41(8):1433-44. doi: 10.1007/s00134-015-3914-y. Epub 2015 Jun 25.

  PMID: 26109398 BACKGROUND

• Annane D, Sharshar T. Cognitive decline after sepsis. Lancet Respir Med. 2015 Jan;3(1):61-9. doi: 10.1016/S2213-2600(14)70246-2. Epub 2014 Nov 28.

  PMID: 25434614 BACKGROUND

• Prescott HC, Langa KM, Iwashyna TJ. Readmission diagnoses after hospitalization for severe sepsis and other acute medical conditions. JAMA. 2015 Mar 10;313(10):1055-7. doi: 10.1001/jama.2015.1410. No abstract available.

  PMID: 25756444 BACKGROUND

• Mayr FB, Talisa VB, Balakumar V, Chang CH, Fine M, Yende S. Proportion and Cost of Unplanned 30-Day Readmissions After Sepsis Compared With Other Medical Conditions. JAMA. 2017 Feb 7;317(5):530-531. doi: 10.1001/jama.2016.20468. No abstract available.

  PMID: 28114505 BACKGROUND

• 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 SP, Chou SH, Sierra MF, Shuman TP, McWilliams AD, Taylor BT, Russo M, Evans SL, Rossman W, Murphy S, Cunningham K, Kowalkowski MA. Association between Adherence to Recommended Care and Outcomes for Adult Survivors of Sepsis. Ann Am Thorac Soc. 2020 Jan;17(1):89-97. doi: 10.1513/AnnalsATS.201907-514OC.

  PMID: 31644304 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

• Kim CS, Flanders SA. In the Clinic. Transitions of care. Ann Intern Med. 2013 Mar 5;158(5 Pt 1):ITC3-1. doi: 10.7326/0003-4819-158-5-201303050-01003. No abstract available.

  PMID: 23460071 BACKGROUND

• Taylor SP, Eaton T, Rios A, Boyd D, Tapp H, McWilliams A, Chou SH, Halpern S, Angus DC, McCurdy L, Ganesan A, Nguyen H, Connor CD, Kowalkowski M. Proactive Telehealth-Based Sepsis Transition and Recovery Support, Hospital Readmission, and Mortality: A Randomized Clinical Trial. JAMA Intern Med. 2025 Oct 1;185(10):1238-1246. doi: 10.1001/jamainternmed.2025.3699.

  PMID: 40788609 DERIVED

• Eaton TA, Kowalkowski M, Burns R, Tapp H, O'Hare K, Taylor SP. Pre-implementation planning for a sepsis intervention in a large learning health system: a qualitative study. BMC Health Serv Res. 2024 Aug 28;24(1):996. doi: 10.1186/s12913-024-11344-x.

  PMID: 39192331 DERIVED

• Kowalkowski M, Eaton T, McWilliams A, Tapp H, Rios A, Murphy S, Burns R, Gutnik B, O'Hare K, McCurdy L, Dulin M, Blanchette C, Chou SH, Halpern S, Angus DC, Taylor SP. Protocol for a two-arm pragmatic stepped-wedge hybrid effectiveness-implementation trial evaluating Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship (ENCOMPASS). BMC Health Serv Res. 2021 Jun 2;21(1):544. doi: 10.1186/s12913-021-06521-1.

  PMID: 34078374 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Marc Kowalkowski, PhD
• Organization: Wake Forest University School of Medicine

marc.kowalkowski@advocatehealth.org

704-355-9902

Study Officials

• Marc Kowalkowski, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Stephanie P Taylor, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, stepped-wedge cluster randomized controlled trial

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: August 3, 2020
• Study Start: July 1, 2020
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: September 19, 2025
• Results First Posted: September 19, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)