Improving Morbidity During Post-Acute Care Transitions for Sepsis (IMPACTS)
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ClinicalTrials.gov Identifier: NCT03865602 |
Recruitment Status :
Completed
First Posted : March 7, 2019
Last Update Posted : April 25, 2022
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Condition or disease | Intervention/treatment | Phase |
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Clinical Sepsis | Behavioral: Sepsis Transition And Recovery (STAR) Behavioral: Usual care | Not Applicable |

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 |
Actual Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
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Experimental: Sepsis Transition And Recovery (STAR)
Virtual sepsis navigation delivered across the peri-hospital discharge interval
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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.
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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. |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- All-cause emergency department visits [ Time Frame: 30 days from index visit ]Emergency department visits to any Atrium Health facility
- All-cause emergency department visits [ Time Frame: 90 days from index visit ]Emergency department visits to any Atrium Health facility
- 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
- 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
- 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)
- 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)
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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;
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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
Exclusion Criteria:
- 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.

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
United States, North Carolina | |
Atrium Health | |
Charlotte, North Carolina, United States, 28203 |
Principal Investigator: | Marc Kowalkowski, PhD | Wake Forest University Health Sciences | |
Principal Investigator: | Stephanie P Taylor, MD | Wake Forest University Health Sciences |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Wake Forest University Health Sciences |
ClinicalTrials.gov Identifier: | NCT03865602 |
Other Study ID Numbers: |
IRB00082326 01-19-24E ( Other Identifier: Atrium ) |
First Posted: | March 7, 2019 Key Record Dates |
Last Update Posted: | April 25, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
evidence based medicine continuity of patient care patient navigator health services pragmatic clinical trial |
Sepsis Toxemia Infections |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |