Transitions of Care for Stroke Patients

Sponsor
Kiwon Lee MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT06011720
Collaborator
JFK Medical Center (Other)
3,000
1
98
30.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Improved transition of care.

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
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
Actual Study Start Date :
May 1, 2019
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Jul 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Stroke Patients July 1st 2015 - June 30th 2017

Stroke patients that have undergone hospitalization within the time frame July 1st 2015 - June 30th 2017 to be used as a baseline.

Stroke Patients January 1st 2018 - December 31st 2019

Stroke patients that have undergone hospitalization and undergone improvements to transition of care within the time frame January 1st 2018 - December 31st 2019.

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

Outcome Measures

Primary Outcome Measures

  1. Length of stay (in hours and days). [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.]

    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.

Secondary Outcome Measures

  1. Rehospitalization rate. [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.]

    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.

  2. Functional independence [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.]

    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).

  3. Stroke clinic 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.]

    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.

  4. Pre-specified subanalyses for effect on primary outcome measures. [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.]

    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.

  5. Pre-specified subanalyses for effect on functional independence. [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.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rutgers-RWJMS Department of Neurology New Brunswick New Jersey United States 08901

Sponsors and Collaborators

  • Kiwon Lee MD
  • JFK Medical Center

Investigators

  • Principal Investigator: Kiwon Lee, MD, Rutgers, The State University of New Jersey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kiwon Lee MD, Professor of Neurology, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT06011720
Other Study ID Numbers:
  • Pro2019000095
First Posted:
Aug 25, 2023
Last Update Posted:
Aug 25, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kiwon Lee MD, Professor of Neurology, Rutgers, The State University of New Jersey
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2023