Trial Outcomes & Findings for Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship (NCT NCT04495946)
NCT ID: NCT04495946
Last Updated: 2025-09-19
Results Overview
Combined death or unplanned hospital readmission due to any cause, assessed 90 days after the index hospital discharge
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3894 participants
Primary outcome timeframe
90 days
Results posted on
2025-09-19
Participant Flow
This is a 36-month stepped-wedge cluster randomized trial. Each hospital begins enrolling patients under usual care and transitions to enrolling patients in STAR program one hospital at a time in a randomly determined sequence every 4 months. The randomization sequence was concealed to all hospitals until 1 month before each individual hospital transitioned to receive the STAR program. The trial was conducted at 7 hospitals in the Atrium Health system and one additional outside hospital.
The outside hospital affiliated with a different health system withdrew from the trial after randomization but prior to receiving the intervention. The number of participants to start a Period is not equal to the number who completed the previous Period since this is a pragmatic trial with cross-sectional sampling of eligible patients in each step at each participating study site.
Participant milestones
| Measure |
Sequence 1: 4m Usual Care Then 32m STAR (Hospital A)
During 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.
During 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.
|
Sequence 2: 8m Usual Care Then 28m STAR (Hospital B)
During 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.
During 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.
|
Sequence 3: 12m Usual Care Then 24m STAR (Hospital C)
During 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.
During 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.
|
Sequence 4: 16m Usual Care Then 20m STAR (Hospital D)
During 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.
During 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.
|
Sequence 5: 20m Usual Care Then 16m STAR (Hospital E)
During 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.
During 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.
|
Sequence 6: 24m Usual Care Then 12m STAR (Hospital F)
During 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.
During 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.
|
Sequence 7: 28m Usual Care Then 8m STAR (Hospital G)
During 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.
During 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.
|
Sequence 8: 32m Usual Care Then 4m STAR (Hospital H)
During 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.
During 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.
|
|---|---|---|---|---|---|---|---|---|
|
Step 1: 4m (July 2020-Oct 2020)
STARTED
|
98
|
8
|
48
|
79
|
88
|
37
|
44
|
66
|
|
Step 1: 4m (July 2020-Oct 2020)
COMPLETED
|
98
|
8
|
48
|
79
|
88
|
37
|
44
|
0
|
|
Step 1: 4m (July 2020-Oct 2020)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
66
|
|
Step 2: 4m (Nov 2020-Feb 2021)
STARTED
|
106
|
6
|
49
|
51
|
90
|
45
|
43
|
48
|
|
Step 2: 4m (Nov 2020-Feb 2021)
COMPLETED
|
106
|
6
|
49
|
51
|
90
|
45
|
43
|
0
|
|
Step 2: 4m (Nov 2020-Feb 2021)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
48
|
|
Step 3: 4m (Mar 2021-Jun 2021)
STARTED
|
108
|
6
|
45
|
67
|
94
|
41
|
27
|
60
|
|
Step 3: 4m (Mar 2021-Jun 2021)
COMPLETED
|
108
|
6
|
45
|
67
|
94
|
41
|
27
|
0
|
|
Step 3: 4m (Mar 2021-Jun 2021)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
60
|
|
Step 4: 4m (Jul 2021-Oct 2021)
STARTED
|
90
|
9
|
49
|
66
|
84
|
36
|
37
|
52
|
|
Step 4: 4m (Jul 2021-Oct 2021)
COMPLETED
|
90
|
9
|
49
|
66
|
84
|
36
|
37
|
0
|
|
Step 4: 4m (Jul 2021-Oct 2021)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
52
|
|
Step 5: 4m (Nov 2021-Feb 2022)
STARTED
|
92
|
9
|
57
|
62
|
75
|
44
|
39
|
63
|
|
Step 5: 4m (Nov 2021-Feb 2022)
COMPLETED
|
92
|
9
|
57
|
62
|
75
|
44
|
39
|
0
|
|
Step 5: 4m (Nov 2021-Feb 2022)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
63
|
|
Step 6: 4m (Mar 2022-Jun 2022)
STARTED
|
87
|
6
|
33
|
61
|
51
|
34
|
18
|
45
|
|
Step 6: 4m (Mar 2022-Jun 2022)
COMPLETED
|
87
|
6
|
33
|
61
|
51
|
34
|
18
|
0
|
|
Step 6: 4m (Mar 2022-Jun 2022)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
45
|
|
Step 7: 4m (Jul 2022-Oct 2022)
STARTED
|
114
|
9
|
36
|
81
|
88
|
44
|
33
|
12
|
|
Step 7: 4m (Jul 2022-Oct 2022)
COMPLETED
|
114
|
9
|
36
|
81
|
88
|
44
|
33
|
0
|
|
Step 7: 4m (Jul 2022-Oct 2022)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
|
Step 8: 4m (Nov 2022-Feb 2023)
STARTED
|
135
|
7
|
41
|
93
|
111
|
41
|
52
|
0
|
|
Step 8: 4m (Nov 2022-Feb 2023)
COMPLETED
|
135
|
7
|
41
|
93
|
111
|
41
|
52
|
0
|
|
Step 8: 4m (Nov 2022-Feb 2023)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 9: 4m (Mar 2023-Jun 2023)
STARTED
|
141
|
3
|
41
|
78
|
110
|
31
|
39
|
0
|
|
Step 9: 4m (Mar 2023-Jun 2023)
COMPLETED
|
141
|
3
|
41
|
78
|
110
|
31
|
39
|
0
|
|
Step 9: 4m (Mar 2023-Jun 2023)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship
Baseline characteristics by cohort
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
Total
n=3548 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.65 years
STANDARD_DEVIATION 15.07 • n=5 Participants
|
65.44 years
STANDARD_DEVIATION 15.37 • n=7 Participants
|
65.56 years
STANDARD_DEVIATION 15.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1056 Participants
n=5 Participants
|
787 Participants
n=7 Participants
|
1843 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1066 Participants
n=5 Participants
|
639 Participants
n=7 Participants
|
1705 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
499 Participants
n=5 Participants
|
368 Participants
n=7 Participants
|
867 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1537 Participants
n=5 Participants
|
1031 Participants
n=7 Participants
|
2568 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
39 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sequential Organ Failure Assessment (SOFA) score
|
4.635 units on a scale
STANDARD_DEVIATION 2.521 • n=5 Participants
|
4.647 units on a scale
STANDARD_DEVIATION 2.378 • n=7 Participants
|
4.637 units on a scale
STANDARD_DEVIATION 2.464 • n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysCombined death or unplanned hospital readmission due to any cause, assessed 90 days after the index hospital discharge
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
All-cause Mortality and Hospital Readmission Rate
|
1023 Participants
|
684 Participants
|
SECONDARY outcome
Timeframe: 90 daysThe total days alive without inpatient, observation, and emergency department care utilization beginning with the day of index hospital admission and ending 90 days after discharge or on the date of death if prior to 90 days.
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
Number of Days Alive and Outside the Hospital
|
72.2 Days
Interval 71.9 to 72.6
|
71.9 Days
Interval 70.5 to 73.3
|
SECONDARY outcome
Timeframe: 90 daysPatients with date of death prior to 90 days post discharge documented in the electronic health record or in linked national death records
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
All-cause Mortality Rate
|
367 Participants
|
292 Participants
|
SECONDARY outcome
Timeframe: 90 daysAny hospital readmission, including both inpatient and observation status hospitalizations, assessed 90 days post index hospital discharge.
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
All-cause Hospital Readmission Rate
|
763 Participants
|
478 Participants
|
SECONDARY outcome
Timeframe: 90 daysNumber of outpatient provider visits assessed 90 days post index hospital discharge
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
Number of Outpatient Provider Visits
|
3.0 count of visits
Interval 2.8 to 3.2
|
3.6 count of visits
Interval 3.4 to 3.9
|
SECONDARY outcome
Timeframe: 90 daysNumber of emergency department visits assessed 90 days post index hospital discharge
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
Number of Emergency Department Visits
|
0.50 count of visits
Interval 0.44 to 0.55
|
0.46 count of visits
Interval 0.4 to 0.51
|
SECONDARY outcome
Timeframe: 90 daysAny hospital readmission due to sepsis or other infection conditions assessed 90 days post index hospital discharge
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
Cause-specific Hospital Readmission Rate
|
370 Participants
|
222 Participants
|
SECONDARY outcome
Timeframe: Index hospital dischargeDocumented inpatient functional assessment or physical therapy consult completed and captured from electronic health records
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
Inpatient Functional Assessment or Physical Therapy Consult
|
1768 Participants
|
1196 Participants
|
SECONDARY outcome
Timeframe: Index hospital dischargeDocumented inpatient mental health assessment completed and captured from electronic health records
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
Inpatient Mental Health Assessment
|
2048 Participants
|
1385 Participants
|
SECONDARY outcome
Timeframe: 90 days after hospital dischargeOutpatient rehabilitation or physical, occupational, or speech therapy during follow-up
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
Count of Participants With Support Service Referrals
|
594 Participants
|
374 Participants
|
SECONDARY outcome
Timeframe: 7 days after dischargeThe completion of hospital follow-up visit with an outpatient provider within 7 days of hospital discharge captured from electronic health records
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
Early Outpatient Provider Follow up
|
468 Participants
|
348 Participants
|
SECONDARY outcome
Timeframe: 90 days after hospital dischargeCompletion of medication reconciliation in the electronic health record during the 90 days post hospital discharge
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
Outpatient Medication Reconciliation
|
1590 Participants
|
866 Participants
|
SECONDARY outcome
Timeframe: Index hospital dischargeDocumented completion of palliative care consult captured from electronic health records.
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
Palliative Care Consultation
|
430 Participants
|
234 Participants
|
SECONDARY outcome
Timeframe: Index hospital dischargeDocumented completion of patient care preferences form captured from electronic health records
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
Completed Care Preferences
|
526 Participants
|
309 Participants
|
SECONDARY outcome
Timeframe: Index hospital dischargeDischarge disposition of hospice care from initial sepsis hospitalization captured from electronic health records
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
Discharge to Hospice Care
|
97 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: 90 days after hospital dischargeIn-hospital, hospice, and home or other location of death captured from electronic health records
Outcome measures
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 Participants
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.
|
Usual Care
n=1426 Participants
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.
|
|---|---|---|
|
Place of Death
Home or other deaths
|
94 Participants
|
75 Participants
|
|
Place of Death
In hospital deaths
|
204 Participants
|
150 Participants
|
|
Place of Death
Hospice deaths
|
69 Participants
|
67 Participants
|
Adverse Events
Sepsis Transition and Recovery (STAR) Program
Serious events: 763 serious events
Other events: 0 other events
Deaths: 367 deaths
Usual Care
Serious events: 478 serious events
Other events: 0 other events
Deaths: 292 deaths
Serious adverse events
| Measure |
Sepsis Transition and Recovery (STAR) Program
n=2122 participants at risk
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.
|
Usual Care
n=1426 participants at risk
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.
|
|---|---|---|
|
General disorders
Disease complications experienced during 90 day follow up that required rehospitalization
|
36.0%
763/2122 • From enrollment until end of follow up, up to 90 days after hospital discharge
|
33.5%
478/1426 • From enrollment until end of follow up, up to 90 days after hospital discharge
|
Other adverse events
Adverse event data not reported
Additional Information
Marc Kowalkowski, PhD
Wake Forest University School of Medicine
Phone: 704-355-9902
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place