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

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ClinicalTrials.gov Identifier: NCT04495946
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : April 21, 2022
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Sepsis Behavioral: Sepsis Transition and Recovery (STAR) program Behavioral: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4032 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Pragmatic, stepped-wedge cluster randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship: A Hybrid Effectiveness-Implementation Randomized Controlled Trial
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: Sepsis Transition and Recovery (STAR) Program
Virtual sepsis navigation delivered across the peri-hospital discharge interval
Behavioral: Sepsis Transition and Recovery (STAR) program
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.

Active Comparator: Usual Care
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
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.




Primary Outcome Measures :
  1. All-cause mortality and hospital readmission rate [ Time Frame: 90 days ]
    Binary composite endpoint of mortality and hospital readmission assessed 90 days post index hospital discharge


Secondary Outcome Measures :
  1. Number of days alive and outside the hospital [ Time Frame: 90 days ]
    Continuous composite endpoint of days alive and outside of the hospital assessed 90 days post index hospital discharge

  2. All-cause mortality rate [ Time Frame: 90 days ]
    Binary endpoint of all-cause mortality rate assessed 90 days post index hospital discharge

  3. All-cause hospital readmission rate [ Time Frame: 90 days ]
    Binary endpoint of all-cause hospital readmission rate assessed 90 days post index hospital discharge

  4. Number of outpatient provider visits [ Time Frame: 90 days ]
    Number of outpatient provider visits assessed 90 days post index hospital discharge

  5. Number of emergency department visits [ Time Frame: 90 days ]
    Number of emergency department visits assessed 90 days post index hospital discharge

  6. Cause-specific hospital readmission rate [ Time Frame: 90 days ]
    Binary endpoint of cause-specific readmission rate for infection, chronic lung disease, heart failure, acute renal failure, and ambulatory care sensitive conditions assessed 90 days post index hospital discharge


Other Outcome Measures:
  1. Cost-Effectiveness [ Time Frame: 90 days, 1 year ]
    A comparison of the STAR and usual care strategies based on the incremental cost-effectiveness ratio (ICER). The ICER is defined as the difference in costs between interventions, divided by the difference in combined mortality and readmission rates

  2. Qualitative assessment of the barriers to STAR program implementation [ Time Frame: Pre-implementation, 8 months, 20 months, 32 months, 36 months (i.e., Post-implementation) ]
    Open-ended, qualitative assessment guided by the Consolidated Framework for Implementation Research to identify perceived barriers to implementing the STAR program into the peri-discharge setting. Themes will be categorized and reported as percentages of participants.

  3. Qualitative assessment of the facilitators to STAR program implementation [ Time Frame: Pre-implementation, 8 months, 20 months, 32 months, 36 months (i.e., Post-implementation) ]
    Open-ended, qualitative assessment guided by the Consolidated Framework for Implementation Research to identify perceived facilitators to implementing the STAR program into the peri-discharge setting. Themes will be categorized and reported as percentages of participants.

  4. Number of eligible patients reached by STAR program [ Time Frame: 8 months, 20 months, 32 months, 36 months (i.e., Post-implementation) ]
    Navigator use per eligible patients

  5. Number of providers included in STAR program adoption [ Time Frame: 8 months, 20 months, 32 months, 36 months (i.e., Post-implementation) ]
    Number of providers with patients enrolled



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 18 years of age upon admission
  2. Suspected infection

    1. Oral/parenteral antibiotic or bacterial culture order within 24 hours of emergency department presentation; and
    2. Evidence of systemic inflammatory response (i.e., at least two abnormal of temperature; heart rate; respiratory rate; and WBC count or bands)
  3. 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)
  4. Deemed as high risk for 90-day readmission using risk-scoring models
  5. Not discharged at the time of patient list generation

Exclusion Criteria:

  1. 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
  2. Patients who reside > 2.5 hours drive time from the treating hospital
  3. Patients actively enrolled in a different care management program at time of admission
  4. Patient has been randomized previously.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495946


Contacts
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Contact: Marc Kowalkowski, PhD 704-355-9902 marc.kowalkowski@atriumhealth.org
Contact: Stephanie Taylor, MD 704 355-3819 stephanie.p.taylor@atriumhealth.org

Locations
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United States, North Carolina
Atrium Health Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Marc Kowalkowski, PhD    704-355-9902    marc.kowalkowski@atriumhealth.org   
Principal Investigator: Stephanie P Taylor, MD         
Principal Investigator: Marc Kowalkowski, PhD         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Marc Kowalkowski, PhD Wake Forest University Health Sciences
Principal Investigator: Stephanie P Taylor, MD Wake Forest University Health Sciences
Publications:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04495946    
Other Study ID Numbers: Pro00036873
R01NR018434 ( U.S. NIH Grant/Contract )
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: April 21, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
evidence based medicine
transition care
critical care
implementation science
pragmatic clinical trial
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes