Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04495946
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2020-07-07
Brief Title:
Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship A Hybrid Effectiveness-Implementation Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENCOMPASS
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 ie 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
Detailed Description:
BACKGROUND
Sepsis is a common and life-threatening condition defined by organ dysfunction due to a dysregulated response to infection Fleischmann 2016 Aggressive early sepsis identification and treatment initiatives have decreased hospital mortality for patients with sepsis Rhodes 2017 Kaukonen 2014 However sepsis survivors continue to face challenges after the acute illness episode experiencing new functional cognitive and psychological deficits and high rates of hospital readmission and mortality in the 90-days after hospital discharge Iwashyna 2010 Borges 2015 Annane 2015 Prescott 2015 Mayr 2017 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 destabilize during sepsis and recovery and 4 focus on palliative care when appropriate Prescott 2018 These care elements have good face-validity and have shown to be associated with improved outcomes for sepsis survivors in observational data Taylor 2020 However they are not widely applied in real-world settings for this vulnerable population likely hindered by a gap in understanding key contextual factors underlying how to best integrate this bundle of care elements into the complex and fragmented post-discharge setting Brownson 2012 Bodenheimer 2008 Coleman 2004 Kim 2013
RATIONALE
In randomized controlled trials RCTs successfully implemented care transition programs using nurse navigators have been shown to reduce hospital readmission and costs To better enhance transitions of care for the highest risk complex patients with suspected sepsis the investigators propose extending this evidence using a nurse-facilitated care transition program for patients in the post-sepsis transition period to improve the implementation of recommended care practices and bridge care gaps This approach called the Sepsis Transition and Recovery STAR program is the next step in the progression of the investigator teams work on improving discharge transitions and sepsis processes of care A key aspect of this initiative includes the ability to identify sepsis survivors at the greatest risk for poor outcomes For example one-quarter of sepsis survivors account for three-quarters of hospital readmission and costs indicating that identifying high-risk sepsis patients for targeted facilitation of best-practice care could efficiently impact quality and cost
The STAR program uses near real-time risk modeling to identify high-risk patients and a centrally located nurse virtually connected to participating hospitals to coordinate the application of evidence-based recommendations for post-sepsis care overcome barriers to recommended care and bridge gaps in service that can serve as points of failure for complex patients During hospitalization high-risk patients enter into a transition pathway integrated within Atrium Health Hospital Medicines Transition Services program and includes the following core components i Introduction to STAR process prior to discharge confirm provider consults eg PT ID palliative ii Disease-specific education and discharge playbook iii Virtual hospital follow-up evaluation within 48 hours including medication reconciliation iv Second post-acute virtual follow-up within 72-96 hours symptom monitoring confirm provider follow-up v Weekly contact with STAR team vi Referral to provider follow-up eg primary care provider transition clinic as appropriate vii Coordinated transition to the next appropriate care location after 90 days from time of discharge The STAR navigator also meets weekly with the Medical Director of the Atrium Health Transition Services program who provides additional clinical oversight of ongoing cases
The ENCOMPASS Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship evaluation will examine if implementation of the STAR program within a large healthcare system will improve outcomes for high-risk sepsis patients This cluster randomized program evaluation is designed to be a seamless part of routine care in a real-world setting to generate knowledge of best practices for implementation and dissemination of post-sepsis transitions of care
INVESTIGATIONAL PLAN
Overall Study Design ENCOMPASS is an effectiveness-implementation hybrid type I trial The evaluation component is 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 with one of eight hospitals assigned to transition at each four-month interval ie step During the time that a hospital is allocated to usual care all eligible patients will receive usual care Once a hospital has been allocated to the STAR arm all eligible patients will receive STAR during their index hospitalization and extending through 90 days from discharge or date of death The ENCOMPASS trial will compare the effectiveness of the Sepsis Transition And Recovery STAR program versus usual care on post-sepsis care and patient outcomes The STAR program is informed by existing evidence and designed using the Chronic Care Model to increase best-practice adherence and care coordination resulting in improved transitions between hospitals and post-acute care during sepsis recovery
ENCOMPASS will test the STAR program intervention within the course of providing usual care among a large and diverse population of post-sepsis patients admitted to eight hospitals within Atrium Health one of the largest vertically integrated health systems in the US The eight acute care hospitals participating in this study use the same EHR which connects across all points of care including outpatient practices urgent care locations emergency departments and hospitals Consistent with the pragmatic study design concept eligibility criteria are broad the sample size is large and diverse and study procedures are embedded into the context of routine care To be objective in patient selection and allow for program evaluation a data driven approach will be used to identify patients as eligible for program referral Each weekday morning actively admitted patients at eight study hospitals will be identified from the electronic health record and Enterprise Data Warehouse and output into daily eligibility lists based on the studys inclusionexclusion criteria Primary analyses will be conducted using an intent-to-treat approach such that all eligible patients will be included Planned enrollment is 4032 patients and STAR program follow-up will be completed 90 days after hospital discharge Outcomes data will be tracked for 90 days and captured from routinely collected data from the Atrium Health Enterprise Data Warehouse Given this evaluation protocol relies on using evidence-based interventions only utilizes data collected as part of routine care and is minimal risk to patients the institutional review board granted the request for waiver of informed consent
Sepsis is a common and life-threatening condition defined by organ dysfunction due to a dysregulated response to infection Fleischmann 2016 Aggressive early sepsis identification and treatment initiatives have decreased hospital mortality for patients with sepsis Rhodes 2017 Kaukonen 2014 However sepsis survivors continue to face challenges after the acute illness episode experiencing new functional cognitive and psychological deficits and high rates of hospital readmission and mortality in the 90-days after hospital discharge Iwashyna 2010 Borges 2015 Annane 2015 Prescott 2015 Mayr 2017 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 destabilize during sepsis and recovery and 4 focus on palliative care when appropriate Prescott 2018 These care elements have good face-validity and have shown to be associated with improved outcomes for sepsis survivors in observational data Taylor 2020 However they are not widely applied in real-world settings for this vulnerable population likely hindered by a gap in understanding key contextual factors underlying how to best integrate this bundle of care elements into the complex and fragmented post-discharge setting Brownson 2012 Bodenheimer 2008 Coleman 2004 Kim 2013
RATIONALE
In randomized controlled trials RCTs successfully implemented care transition programs using nurse navigators have been shown to reduce hospital readmission and costs To better enhance transitions of care for the highest risk complex patients with suspected sepsis the investigators propose extending this evidence using a nurse-facilitated care transition program for patients in the post-sepsis transition period to improve the implementation of recommended care practices and bridge care gaps This approach called the Sepsis Transition and Recovery STAR program is the next step in the progression of the investigator teams work on improving discharge transitions and sepsis processes of care A key aspect of this initiative includes the ability to identify sepsis survivors at the greatest risk for poor outcomes For example one-quarter of sepsis survivors account for three-quarters of hospital readmission and costs indicating that identifying high-risk sepsis patients for targeted facilitation of best-practice care could efficiently impact quality and cost
The STAR program uses near real-time risk modeling to identify high-risk patients and a centrally located nurse virtually connected to participating hospitals to coordinate the application of evidence-based recommendations for post-sepsis care overcome barriers to recommended care and bridge gaps in service that can serve as points of failure for complex patients During hospitalization high-risk patients enter into a transition pathway integrated within Atrium Health Hospital Medicines Transition Services program and includes the following core components i Introduction to STAR process prior to discharge confirm provider consults eg PT ID palliative ii Disease-specific education and discharge playbook iii Virtual hospital follow-up evaluation within 48 hours including medication reconciliation iv Second post-acute virtual follow-up within 72-96 hours symptom monitoring confirm provider follow-up v Weekly contact with STAR team vi Referral to provider follow-up eg primary care provider transition clinic as appropriate vii Coordinated transition to the next appropriate care location after 90 days from time of discharge The STAR navigator also meets weekly with the Medical Director of the Atrium Health Transition Services program who provides additional clinical oversight of ongoing cases
The ENCOMPASS Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship evaluation will examine if implementation of the STAR program within a large healthcare system will improve outcomes for high-risk sepsis patients This cluster randomized program evaluation is designed to be a seamless part of routine care in a real-world setting to generate knowledge of best practices for implementation and dissemination of post-sepsis transitions of care
INVESTIGATIONAL PLAN
Overall Study Design ENCOMPASS is an effectiveness-implementation hybrid type I trial The evaluation component is 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 with one of eight hospitals assigned to transition at each four-month interval ie step During the time that a hospital is allocated to usual care all eligible patients will receive usual care Once a hospital has been allocated to the STAR arm all eligible patients will receive STAR during their index hospitalization and extending through 90 days from discharge or date of death The ENCOMPASS trial will compare the effectiveness of the Sepsis Transition And Recovery STAR program versus usual care on post-sepsis care and patient outcomes The STAR program is informed by existing evidence and designed using the Chronic Care Model to increase best-practice adherence and care coordination resulting in improved transitions between hospitals and post-acute care during sepsis recovery
ENCOMPASS will test the STAR program intervention within the course of providing usual care among a large and diverse population of post-sepsis patients admitted to eight hospitals within Atrium Health one of the largest vertically integrated health systems in the US The eight acute care hospitals participating in this study use the same EHR which connects across all points of care including outpatient practices urgent care locations emergency departments and hospitals Consistent with the pragmatic study design concept eligibility criteria are broad the sample size is large and diverse and study procedures are embedded into the context of routine care To be objective in patient selection and allow for program evaluation a data driven approach will be used to identify patients as eligible for program referral Each weekday morning actively admitted patients at eight study hospitals will be identified from the electronic health record and Enterprise Data Warehouse and output into daily eligibility lists based on the studys inclusionexclusion criteria Primary analyses will be conducted using an intent-to-treat approach such that all eligible patients will be included Planned enrollment is 4032 patients and STAR program follow-up will be completed 90 days after hospital discharge Outcomes data will be tracked for 90 days and captured from routinely collected data from the Atrium Health Enterprise Data Warehouse Given this evaluation protocol relies on using evidence-based interventions only utilizes data collected as part of routine care and is minimal risk to patients the institutional review board granted the request for waiver of informed consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NR018434 | NIH | None | None |
| Pro00036873 | OTHER | Atrium Health | httpsreporternihgovquickSearchR01NR018434 |