Trial · NCT04495946
Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship
NCT04495946, Not applicable, Completed, Wake Forest University Health Sciences; results first posted 2025-09-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship. Trials, record NCT04495946. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04495946
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship
- NCT number
- NCT04495946
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 3,894 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Sepsis
- Interventions
- Sepsis Transition and Recovery (STAR) program, Usual care
- First posted
- 2020-08-03
- Last updated
- 2025-09-19
- Results first posted
- 2025-09-19
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-cause Mortality and Hospital Readmission Rate | 90 days | Combined death or unplanned hospital readmission due to any cause, assessed 90 days after the index hospital discharge |
| Secondary | Number of Days Alive and Outside the Hospital | 90 days | The 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. |
| Secondary | All-cause Mortality Rate | 90 days | Patients with date of death prior to 90 days post discharge documented in the electronic health record or in linked national death records |
| Secondary | All-cause Hospital Readmission Rate | 90 days | Any hospital readmission, including both inpatient and observation status hospitalizations, assessed 90 days post index hospital discharge. |
| Secondary | Number of Outpatient Provider Visits | 90 days | Number of outpatient provider visits assessed 90 days post index hospital discharge |
| Secondary | Number of Emergency Department Visits | 90 days | Number of emergency department visits assessed 90 days post index hospital discharge |
| Secondary | Cause-specific Hospital Readmission Rate | 90 days | Any hospital readmission due to sepsis or other infection conditions assessed 90 days post index hospital discharge |
| Secondary | Inpatient Functional Assessment or Physical Therapy Consult | Index hospital discharge | Documented inpatient functional assessment or physical therapy consult completed and captured from electronic health records |
| Secondary | Inpatient Mental Health Assessment | Index hospital discharge | Documented inpatient mental health assessment completed and captured from electronic health records |
| Secondary | Count of Participants With Support Service Referrals | 90 days after hospital discharge | Outpatient rehabilitation or physical, occupational, or speech therapy during follow-up |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | All-cause Mortality and Hospital Readmission Rate | 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Days Alive and Outside the Hospital | 90 days | Days | MEAN | |
| SECONDARY | All-cause Mortality Rate | 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | All-cause Hospital Readmission Rate | 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Outpatient Provider Visits | 90 days | count of visits | MEAN | |
| SECONDARY | Number of Emergency Department Visits | 90 days | count of visits | MEAN | |
| SECONDARY | Cause-specific Hospital Readmission Rate | 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Inpatient Functional Assessment or Physical Therapy Consult | Index hospital discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Inpatient Mental Health Assessment | Index hospital discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Count of Participants With Support Service Referrals | 90 days after hospital discharge | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| All-cause Mortality and Hospital Readmission Rate | Sepsis Transition and Recovery (STAR) Program | 1023 | Participants | ||
| All-cause Mortality and Hospital Readmission Rate | Usual Care | 684 | Participants | ||
| Number of Days Alive and Outside the Hospital | Sepsis Transition and Recovery (STAR) Program | 72.2 | 95% Confidence Interval 71.9 to 72.6 | Days | |
| Number of Days Alive and Outside the Hospital | Usual Care | 71.9 | 95% Confidence Interval 70.5 to 73.3 | Days | |
| All-cause Mortality Rate | Sepsis Transition and Recovery (STAR) Program | 367 | Participants | ||
| All-cause Mortality Rate | Usual Care | 292 | Participants | ||
| All-cause Hospital Readmission Rate | Sepsis Transition and Recovery (STAR) Program | 763 | Participants | ||
| All-cause Hospital Readmission Rate | Usual Care | 478 | Participants | ||
| Number of Outpatient Provider Visits | Sepsis Transition and Recovery (STAR) Program | 3.0 | 95% Confidence Interval 2.8 to 3.2 | count of visits | |
| Number of Outpatient Provider Visits | Usual Care | 3.6 | 95% Confidence Interval 3.4 to 3.9 | count of visits |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow216
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Step 1: 4m (July 2020-Oct 2020) | STARTED | Sequence 1: 4m Usual Care Then 32m STAR (Hospital A) | 98 | |
| Step 1: 4m (July 2020-Oct 2020) | STARTED | Sequence 2: 8m Usual Care Then 28m STAR (Hospital B) | 8 | |
| Step 1: 4m (July 2020-Oct 2020) | STARTED | Sequence 3: 12m Usual Care Then 24m STAR (Hospital C) | 48 | |
| Step 1: 4m (July 2020-Oct 2020) | STARTED | Sequence 4: 16m Usual Care Then 20m STAR (Hospital D) | 79 | |
| Step 1: 4m (July 2020-Oct 2020) | STARTED | Sequence 5: 20m Usual Care Then 16m STAR (Hospital E) | 88 | |
| Step 1: 4m (July 2020-Oct 2020) | STARTED | Sequence 6: 24m Usual Care Then 12m STAR (Hospital F) | 37 | |
| Step 1: 4m (July 2020-Oct 2020) | STARTED | Sequence 7: 28m Usual Care Then 8m STAR (Hospital G) | 44 | |
| Step 1: 4m (July 2020-Oct 2020) | STARTED | Sequence 8: 32m Usual Care Then 4m STAR (Hospital H) | 66 | |
| Step 1: 4m (July 2020-Oct 2020) | COMPLETED | Sequence 1: 4m Usual Care Then 32m STAR (Hospital A) | 98 | |
| Step 1: 4m (July 2020-Oct 2020) | COMPLETED | Sequence 2: 8m Usual Care Then 28m STAR (Hospital B) | 8 |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 participant flowAdverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Disease complications experienced during 90 day follow up that required rehospitalization | General disorders | Sepsis Transition and Recovery (STAR) Program | 763 | 2,122 | |
| serious | Disease complications experienced during 90 day follow up that required rehospitalization | General disorders | Usual Care | 478 | 1,426 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sepsis Transition and Recovery (STAR) Program | 367 | 2,122 |
| Total, all-cause mortality | Usual Care | 292 | 1,426 |
| Total, other adverse events | Sepsis Transition and Recovery (STAR) Program | 0 | 2,122 |
| Total, other adverse events | Usual Care | 0 | 1,426 |
| Total, serious adverse events | Sepsis Transition and Recovery (STAR) Program | 763 | 2,122 |
| Total, serious adverse events | Usual Care | 478 | 1,426 |
Source ClinicalTrials.gov
Papers17
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NR018434 | A Sepsis Transition Program to Reduce Morbidity and Mortality in High Risk Individuals | KOWALKOWSKI, MARC; TAYLOR, STEPHANIE P | WAKE FOREST UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE OF NURSING RESEARCH | 2019 to 2023 |
Source NIH RePORTER
Trial comparisons14
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sepsis Transition and Recovery (STAR) Program vs Usual Care: Palliative Care Consultation | Trial comparisons |
| Sepsis Transition and Recovery (STAR) Program vs Usual Care: All-cause Mortality and Hospital Readmission Rate | Trial comparisons |
| Sepsis Transition and Recovery (STAR) Program vs Usual Care: Count of Participants With Support Service Referrals | Trial comparisons |
| Sepsis Transition and Recovery (STAR) Program vs Usual Care: All-cause Hospital Readmission Rate | Trial comparisons |
| Sepsis Transition and Recovery (STAR) Program vs Usual Care: Completed Care Preferences | Trial comparisons |
| Sepsis Transition and Recovery (STAR) Program vs Usual Care: Inpatient Mental Health Assessment | Trial comparisons |
| Sepsis Transition and Recovery (STAR) Program vs Usual Care: Inpatient Functional Assessment or Physical Therapy Consult | Trial comparisons |
| Sepsis Transition and Recovery (STAR) Program vs Usual Care: All-cause Mortality Rate | Trial comparisons |
| Sepsis Transition and Recovery (STAR) Program vs Usual Care: Outpatient Medication Reconciliation | Trial comparisons |
| Sepsis Transition and Recovery (STAR) Program vs Usual Care: Early Outpatient Provider Follow up | Trial comparisons |
1 to 10 of 14
See all 14 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04495946
GET https://conductscience.org/api/trials/v1/NCT04495946/results?page=2