StrokeNCT06011720
Transitions of Care for Stroke Patients
An observational study of Stroke and Ischemic Stroke, run by Deviyani Mehta, MD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic Stroke, Intracerebral Hemorrhage
- What is being tested?
- Improved transition of care.
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients hospitalized within Robert Wood Johnson University Hospital system for Ischemic Stroke or Intracerebral Hemorrhage within the two time frames, July 1st 2015 - June 30th 2017 and January 1st 2018 - December 31st 2019.
Who may be able to join
- Stroke patients hospitalized within Robert Wood Johnson University Hospital system for Ischemic Stroke or Intracerebral Hemorrhage.
Who cannot join
- Those not in the Robert Wood Johnson University Hospital system.
- Those with a Subarachnoid Hemorrhage or Transient Ischemic Attack (< 24 hours).
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers-RWJMS Department of Neurology
New Brunswick, New Jersey, 08901
About this study
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
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.
Read the 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.
- Conditions
- Stroke, Ischemic Stroke, Intracerebral Hemorrhage
- Being tested
- Improved transition of care.
- Keywords
- Stroke, physiatry, rehabilitation, PM&R consultation, Transient Ischemic Attack, Intracerebral Hemorrhage, Ischemic Stroke
- Medical subject headings
- Stroke, Ischemic Stroke, Cerebral Hemorrhage, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improved transition of care.Other
Evaluation of how early physiatry consultation after acute stroke affects length of stay and resulting outcomes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Improved transition of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (5)
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.
Measured: 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.
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).
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 May 2019
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deviyani Mehta, MD
- Sponsor type
- University, hospital or other
- Collaborators
- JFK Medical Center
- Responsible party
- Sponsor-investigator, Deviyani Mehta, MD, Rutgers, The State University of New Jersey
- Investigators
- Deviyani Mehta, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011720
- Sponsor's protocol ID
- Pro2019000095
- Status last verified
- Dec 2025
- First submitted
- 18 Feb 2022
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06011720
- Acronym / sponsor ID
- Pro2019000095
- Conditions
- Stroke, Ischemic Stroke, Intracerebral Hemorrhage
- Keywords
- Stroke, physiatry, rehabilitation, PM&R consultation, Transient Ischemic Attack, Intracerebral Hemorrhage, Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Deviyani Mehta, MDUniversity, hospital or other
- Collaborators
- JFK Medical Center
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Improved transition of care.Stroke patients that have undergone hospitalization and undergone improvements to transition of care within the time frame January 1st 2018 - December 31st 2019. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients hospitalized within Robert Wood Johnson University Hospital system for Ischemic Stroke or Intracerebral Hemorrhage within the two time frames, July 1st 2015 - June 30th 2017 and January 1st 2018 - December 31st 2019.
Key inclusion criteria (1 listed)
- Stroke patients hospitalized within Robert Wood Johnson University Hospital system for Ischemic Stroke or Intracerebral Hemorrhage.
Key exclusion criteria (2 listed)
- Those not in the Robert Wood Johnson University Hospital system.
- Those with a Subarachnoid Hemorrhage or Transient Ischemic Attack (< 24 hours).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improved transition of care.Evaluation of how early physiatry consultation after acute stroke affects length of stay and resulting outcomes. | Other | Stroke Patients January 1st 2018 - December 31st 2019 |
Primary outcome
Length of stay (in hours and days).
Time frame: 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.
5 secondary outcomes
Rehospitalization rate.
Time frame: 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.
Functional independence
Time frame: 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.
Stroke clinic outpatient follow-up.
Time frame: 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.
Pre-specified subanalyses for effect on primary outcome measures.
Time frame: 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.
Pre-specified subanalyses for effect on functional independence.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deviyani Mehta, MD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Ischemic Stroke, run by Deviyani Mehta, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (in hours and days). (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.