Transitions of Care for Stroke Patients

Stroke Clinical Trial

Official title:

Collaborative Study to Reduce Length of Stay and Improve Transitions of Care for Stroke Patients at Robert Wood Johnson University Hospital & JFK Johnson Rehabilitation Institute

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011720
• Other study ID #: Pro2019000095
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: July 1, 2027

Study information

• Verified date: August 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Michelle Moccio, APN-C
• Phone: 732 235 8582
• Email: mocciomi[@]rutgers.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

For stroke patients, early initiation of therapy typically yields the best functional outcomes. Rehabilitation of stroke patients immediately after hospitalization minimizes deleterious effects of immobility and facilitates restoration of function. The investigators are testing if coordinated efforts between the medical and rehabilitation disciplines may improve stroke patient's functional recovery and subsequent follow-ups after discharge.

Description:

Stroke is the fifth leading cause of mortality, claiming the lives of 133,000 individuals in the United States annually. Approximately one-quarter of the 795,000 annual strokes are recurrent. It is estimated that up to 80% of all strokes can be prevented. Forty percent of stroke survivors sustain moderate functional impairments and 15% to 30% sustain severe disability. Approximately 25% of adult stroke patients are readmitted to the hospital within six to twelve months of their preliminary stroke. Identifying and implementing effective medical and rehabilitation interventions is critical in providing care to stroke patients. The goal is to provide optimal, cost-effective care that: 1) prevents secondary medical complications, readmissions, and recurrent disease, and 2) maximizes patient function physically, cognitively, and socially. JFK Johnson Rehabilitation Institute (JRI) proposes a collaborative study with Robert Wood Johnson University Hospital (RWJUH) that addresses this issue while proving beneficial to stroke patients at both institutions. Streamlining the physiatry consult process will improve access to rehabilitation medicine specialty care for acute patients at RWJUH and help facilitate the transfer of stroke patients to the next most appropriate level of care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stroke patients hospitalized within Robert Wood Johnson University Hospital system for Ischemic Stroke or Intracerebral Hemorrhage.

Exclusion Criteria:

• Those not in the Robert Wood Johnson University Hospital system.
• Those with a Subarachnoid Hemorrhage or Transient Ischemic Attack (< 24 hours).

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Ischemic Stroke
• Stroke

Intervention

Other:
• Improved transition of care.
Evaluation of how early physiatry consultation after acute stroke affects length of stay and resulting outcomes.

Locations

Country	Name	City	State
United States	Rutgers-RWJMS Department of Neurology	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kiwon Lee MD	JFK Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay (in hours and days).	We standardized the placement of early physiatry consults during patient admission. We will determine the effect this has on overall acute care length of stay in ischemic and hemorrhagic stroke patients.	Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.
Secondary	Rehospitalization rate.	We standardized placement of early physiatry consults during patient admission, and will determine the effect this has on acute care readmission rates (for the same stroke related problems). This will be measured as absolute value and mean number of readmissions in the preintervention group and the post-intervention group, as well as percent of patients with readmissions in each group.	Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.
Secondary	Functional independence	We standardized placement of early physiatry consults during patient admission, and will determine any differences in long term functional independence by means of a 90 day modified Rankin Scale (mRS) - a standard rater driven scale that characterizes patient's level of independence on a scale of 0-6 (0 being without symptoms and 6 being deceased).	Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.
Secondary	Stroke clinic outpatient follow-up.	We standardized placement of early physiatry consulted during patient admission, and will determine the rate of stroke clinic outpatient follow-up, as measured by absolute number of patients who follow-up at least once. We will further determine the relative percentage of patients who follow-up in stroke clinic for the preintervention and postintervention group.	Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.
Secondary	Pre-specified subanalyses for effect on primary outcome measures.	We will assess the independent effects of multiple variables on length of stay, functional independence and stroke clinic outpatient follow-up. The pre-specified variables include: presence/number/nature of medical comorbidities, stroke type (i.e. ischemic vs. hemorrhagic), insurance type (i.e. private insurance, Medicaid, managed Medicaid, etc.), severity of stroke on admission (measured by NIHSS or ICH score), prior antithrombotic use.	Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.
Secondary	Pre-specified subanalyses for effect on functional independence.	We will assess the independent effects of multiple variables on functional independence (mRS). The variables include: time between discharge and rehab admittance (days and hours), rehab length of stay (days and hours), and presence of outpatient follow-up.	Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.