Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Morbidity During Post-Acute Care Transitions for Sepsis (IMPACTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03865602
Recruitment Status : Active, not recruiting
First Posted : March 7, 2019
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
Marc Kowalkowski, Atrium Health

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.

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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 712 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Morbidity During Post-Acute Care Transitions for Sepsis (IMPACTS): A Pragmatic Randomized Evaluation of Implementing Best Practice Care for Sepsis Survivors to Reduce Morbidity and Mortality
Actual Study Start Date : January 29, 2019
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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

Active Comparator: Usual Care
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
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.




Primary Outcome Measures :
  1. Combined all-cause mortality or unplanned hospital readmission [ Time Frame: 30 days from index visit ]
    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.


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days from index visit ]
    Death inside or outside of the hospital 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.

  2. All-cause mortality [ Time Frame: 90 days from index visit ]
    Death inside or outside of the hospital 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.

  3. All-cause unplanned hospital readmission [ Time Frame: 30 days from index visit ]
    Hospital readmission will be captured from any Atrium Health facility. Index visit is defined by the Centers for Medicaid and Medicare Services (CMS) with additional inclusion of observation patients at any Atrium Health facility.

  4. All-cause unplanned hospital readmission [ Time Frame: 90 days from index visit ]
    Hospital readmission will be captured from any Atrium Health facility. Index visit is defined by the Centers for Medicaid and Medicare Services (CMS) with additional inclusion of observation patients at any Atrium Health facility.

  5. Infection-related unplanned hospital readmission [ Time Frame: 30 days from index visit ]
    Hospital readmission with infection-related primary discharge diagnosis will be captured from any Atrium Health facility. Index visit is defined by the Centers for Medicaid and Medicare Services (CMS) with additional inclusion of observation patients at any Atrium Health facility.

  6. Infection-related unplanned hospital readmission [ Time Frame: 90 days from index visit ]
    Hospital readmission with infection-related primary discharge diagnosis will be captured from any Atrium Health facility. Index visit is defined by the Centers for Medicaid and Medicare Services (CMS) with additional inclusion of observation patients at any Atrium Health facility.

  7. Chronic lung disease-related unplanned hospital readmission [ Time Frame: 30 days from index visit ]
    Hospital readmission with chronic lung disease-related primary discharge diagnosis will be captured from any Atrium Health facility. Index visit is defined by the Centers for Medicaid and Medicare Services (CMS) with additional inclusion of observation patients at any Atrium Health facility.

  8. Chronic lung disease-related unplanned hospital readmission [ Time Frame: 90 days from index visit ]
    Hospital readmission with chronic lung disease-related primary discharge diagnosis will be captured from any Atrium Health facility. Index visit is defined by the Centers for Medicaid and Medicare Services (CMS) with additional inclusion of observation patients at any Atrium Health facility.

  9. Heart failure-related unplanned hospital readmission [ Time Frame: 30 days from index visit ]
    Hospital readmission with heart failure-related primary discharge diagnosis will be captured from any Atrium Health facility. Index visit is defined by the Centers for Medicaid and Medicare Services (CMS) with additional inclusion of observation patients at any Atrium Health facility.

  10. Heart failure-related unplanned hospital readmission [ Time Frame: 90 days from index visit ]
    Hospital readmission with heart failure-related primary discharge diagnosis will be captured from any Atrium Health facility. Index visit is defined by the Centers for Medicaid and Medicare Services (CMS) with additional inclusion of observation patients at any Atrium Health facility.

  11. Acute kidney injury-related unplanned hospital readmission [ Time Frame: 30 days from index visit ]
    Hospital readmission with acute kidney injury-related primary discharge diagnosis will be captured from any Atrium Health facility. Index visit is defined by the Centers for Medicaid and Medicare Services (CMS) with additional inclusion of observation patients at any Atrium Health facility.

  12. Acute kidney injury-related unplanned hospital readmission [ Time Frame: 90 days from index visit ]
    Hospital readmission with acute kidney injury-related primary discharge diagnosis will be captured from any Atrium Health facility. Index visit is defined by the Centers for Medicaid and Medicare Services (CMS) with additional inclusion of observation patients at any Atrium Health facility.

  13. All-cause emergency department visits [ Time Frame: 30 days from index visit ]
    Emergency department visits to any Atrium Health facility

  14. All-cause emergency department visits [ Time Frame: 90 days from index visit ]
    Emergency department visits to any Atrium Health facility

  15. Acute care costs [ Time Frame: 30 days from index visit ]
    Costs attributed to acute care received at any Atrium Health emergency department, observation, or inpatient hospital encounter

  16. Acute care costs [ Time Frame: 90 days from index visit ]
    Costs attributed to acute care received at any Atrium Health emergency department, observation, or inpatient hospital encounter

  17. Total healthcare costs [ Time Frame: 30 days from index visit ]
    Costs attributed to healthcare claims incurred at any Atrium Health or outside system facility (only in the subgroup of patients enrolled in a Medicare Shared Savings Plan)

  18. Total healthcare costs [ Time Frame: 90 days from index visit ]
    Costs attributed to healthcare claims incurred at any Atrium Health or outside system facility (only in the subgroup of patients enrolled in a Medicare Shared Savings Plan)

  19. Acute care-free days alive [ Time Frame: 30 days from index visit ]
    The sum of days alive without inpatient, observation, and emergency department encounters at any Atrium Health facility (rounded to full day for any day with acute care utilization) during the interval after discharge

  20. Acute care-free days alive [ Time Frame: 90 days from index visit ]
    The sum of days alive without inpatient, observation, and emergency department encounters at any Atrium Health facility (rounded to full day for any day with acute care utilization) during the interval after discharge



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Admitted from the emergency department to inpatient or observation status at one of: Carolinas Medical Center, Carolinas Medical Center - Mercy, or Atrium Health Northeast;
  2. ≥18 years of age upon admission;
  3. oral/parenteral antibiotic or bacterial culture order within 24 hours of emergency department presentation and

    1. culture drawn first, antibiotics ordered within 48 hours or
    2. 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)
  4. deemed as high-risk for 30-day readmission (i.e., ≥ 20%) or 30-day mortality (i.e., ≥ 10%) using risk-scoring models
  5. not discharged at the time of patient list generation

Exclusion Criteria:

  1. prior randomization to either STAR or usual care study arms;
  2. not a North Carolina resident or residence >2.5-hour drive time from treating hospital;
  3. the only antibiotic associated with patient is administered in the operating room as this likely represents pre-operative infection prophylaxis and not presumed infection;
  4. patients transferred from other acute care hospitals;
  5. 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;
  6. patients with infection ruled out during the index hospitalization.

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): NCT03865602


Locations
Layout table for location information
United States, North Carolina
Atrium Health
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Atrium Health
Investigators
Layout table for investigator information
Principal Investigator: Marc Kowalkowski, PhD Atrium Health
Principal Investigator: Stephanie P Taylor, MD Atrium Health
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.
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.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Marc Kowalkowski, Associate Professor, Atrium Health
ClinicalTrials.gov Identifier: NCT03865602    
Other Study ID Numbers: 01-19-24E
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marc Kowalkowski, Atrium Health:
evidence based medicine
continuity of patient care
patient navigator
health services
pragmatic clinical trial
Additional relevant MeSH terms:
Layout table for MeSH terms
Sepsis
Toxemia
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes