StrokeNCT04279977
Stroke Rehabilitation, Functional Recovery, and Cost-effectiveness
An observational study of Stroke, run by University of Utah at 1 site in United States.
Trial summary
The investigators will determine the client and non-client variables associated with discharge to an inpatient rehabilitation facility vs. skilled nursing facility in individuals' post-stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2020to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Acute ischemic stroke
Who may be able to join
- Adult patient 18 years of age
- acute ischemic stroke
Who cannot join
- hemorrhagic stroke
- prior living status was at a long-term care facility.
- Transient ischemic attack
- being discharged to home, home with rehab or long term care
- not able to provide consent.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Tamara Garff, 801-585-3122, tamara.garff@hsc.utah.edu
Heather A Hayes, PhD
About this study
Official title: Impact of Initial Stroke Rehabilitation Placement on Functional Recovery and Cost-effectiveness
The investigators will determine the client and non-client variables associated with discharge to an inpatient rehabilitation facility vs. skilled nursing facility in individuals' post-stroke. The investigators will determine how these variables are associated with short-term (discharge from facility) and long-term (6-months post-stroke) function and quality of life.
Read the detailed description
This is a K01 award application for Dr. Heather Hayes, a neurologic rehabilitation therapist and a young investigator pursuing rehabilitation health services research to optimize post-acute rehabilitation care for patients after stroke. A K01 award will provide Dr. Hayes with the means to acquire critical skills in three key career development areas: 1) health services and policy research, 2) comparative effectiveness and outcomes research, and 3) cost-effective analyses. By acquiring these skills, Dr. Hayes will fulfill the career goal of becoming an independent rehabilitation scientist in health services research. To pursue this goal, Dr. Hayes has assembled an exceptional mentoring team complemented by a strong statistical advisor and proposes strong research aims that provide experiential learning in support of the career development objectives.
Stroke is a leading cause of long-term disability in the United States. A large portion of the cost of stroke care is rehabilitation. Providing optimal rehabilitation services aids in mitigating long-term disability for people after stroke. There are a lack of clinical guidelines and poor understanding of long-term outcomes after discharge from acute care to an inpatient rehabilitation facility (IRF) or skilled nursing facility (SNF) for individuals poststroke. The current healthcare climate requires faster decision making and early discharge, and the results may be inappropriate discharge to an IRF or SNF, and thus not providing the patient with optimal outcomes. By completing the following specific aims, the applicant aims to inform clinicians in the acute care setting about discharge placement and which rehabilitation service will lead to optimal individual and cost-effective outcomes after stroke. Specific Aim 1 will determine client (e.g., stroke severity, co-morbidities, and sociodemographic) and non-client (e.g., bed availability and insurance) variables identified at the end of the acute hospital stay to determine which of these variables are associated with discharge to an IRF or SNF. Specific Aim 2 will follow the clients to determine which of these client and non-client variables are associated with functional change- based on the Activity Measure for Post-Acute Care (AM-PAC) Inpatient "6-Clicks" Basic Mobility, Daily Activity, and Applied Cognitive tools at short-term (after discharge from IRF or SNF) and long-term (6-months poststroke). Specific Aim 3 will identify cost-effective strategies of placement into an IRF, to a SNF, and a tailored approach to IRF vs. SNF placement, based on client characteristics. Markov modeling will be used to predict related costs and quality-adjusted life years using the Health-Related Quality of Life in Stroke Patients.
Understanding the outcomes within these similar post-acute care settings (IRF/SNF) for stroke is important in a rapidly evolving healthcare climate. This study is significant because it will provide data about what initial client and non-client variables predict long-term outcomes after discharge to an IRF or SNF and identify cost-effective strategies based on these variables.
- Conditions
- Stroke
- Keywords
- rehabilitation, discharge, inpatient rehabilitation, skilled nursing, activity measure for post-acute care
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient Rehabilitation Facility | Individuals post-stroke who are discharged to an inpatient rehabilitation facility. | |
| Skilled Nursing Facility | Individuals post-stroke who are discharged to a skilled nursing facility. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity Measure for Post-Acute Care, Basic Mobility, change over time
The Activity Measure for Post-Acute Care (AM-PAC) "6 Clicks" tools are comprised of six questions. Answers are based on a 4-point Likert scale ranging from 1-unable or total assistance to 4-no assistance or no difficulty. Scores range from 6 to 24, with lower scores indicating more assistance is required. The AM-PAC has a high degree of consistency between proxy (clinician or family) and client self-report in clients with stroke and has good reliability (ICC = 0.85) and validity (internal consistency = 0.96). The AM-PAC Basic Mobility domain assesses turning over in bed, sitting down and standing up, getting out of bed, transferring, walking, and stair climbing.
Measured: baseline (acute care hospital stay) to discharge from IRF / SNF or 60 days max
Activity Measure for Post-Acute Care, Daily Activity
The AM-PAC Daily Activity domain assesses putting on and off clothing, bathing, toileting, grooming, and eating.Answers are based on a 4-point Likert scale ranging from 1-unable or total assistance to 4-no assistance or no difficulty. Scores range from 6 to 24, with lower scores indicating more assistance is required. The AM-PAC has a high degree of consistency between proxy (clinician or family) and client self-report in clients with stroke and has good reliability (ICC = 0.85) and validity (internal consistency = 0.96).
Measured: baseline (acute care hospital stay) to discharge from IRF / SNF or 60 days max
Activity Measure for Post-Acute Care, Applied Cognition
The AM-PAC Applied Cognitive domain assesses comprehension and memory.Answers are based on a 4-point Likert scale ranging from 1-unable or total assistance to 4-no assistance or no difficulty. Scores range from 6 to 24, with lower scores indicating more assistance is required. The AM-PAC has a high degree of consistency between proxy (clinician or family) and client self-report in clients with stroke and has good reliability (ICC = 0.85) and validity (internal consistency = 0.96). .
Measured: baseline (acute care hospital stay) to discharge from IRF / SNF or 60 days max
Determination of client and non-client variables associated with discharge to an IRF / SNF
Client variables will include modified Rankin Scale, Stroke classification, hemiparetic side, presence of neglect, stroke severity, body mass index, comprehensive severity index, length of stay, co-morbidities, depression, age, gender, race, ethnicity, education, socioeconomic status, marital status, family / caregiver support. Non-client variables will include bed availability in facility, insurance, home set up, client / family preference, geographical location to facility and home.
Measured: discharge from acute hospital stay or 20 days max.
Identify cost-effective strategies for IRF / SNF placement after stroke based on client and non-client variables.
Evaluate the cost-effectiveness of three care strategies after stroke; 1) IRF placement; 2) SNF placement; and 3) tailored approach to an IRF vs. SNF placement, based on client characteristics. We will capture health related quality of life in stroke (HRQOLSP) patients to predict quality-adjusted life years and related costs.
Measured: Information will be collected on HRQOLSP at 6 months post-stroke.
Identify cost-effective strategies for IRF / SNF placement after stroke based on client and non-client variables.
Evaluate the cost-effectiveness of three care strategies after stroke; 1) IRF placement; 2) SNF placement; and 3) tailored approach to an IRF vs. SNF placement, based on client characteristics. We will capture EQ-5D to predict quality-adjusted life years and related costs.
Measured: Information will be collected on EQ-5D at 6 months post-stroke.
Secondary outcomes (5)
Activity Measure for Post-Acute Care, Basic Mobility, change over time
The Activity Measure for Post-Acute Care (AM-PAC) "6 Clicks" tools are comprised of six questions. Answers are based on a 4-point Likert scale ranging from 1-unable or total assistance to 4-no assistance or no difficulty. Scores range from 6 to 24, with lower scores indicating more assistance is required. The AM-PAC has a high degree of consistency between proxy (clinician or family) and client self-report in clients with stroke and has good reliability (ICC = 0.85) and validity (internal consistency = 0.96). The AM-PAC Basic Mobility domain assesses turning over in bed, sitting down and standing up, getting out of bed, transferring, walking, and stair climbing.
Measured: baseline (acute care hospital stay) to 6 months post-stroke
Activity Measure for Post-Acute Care, Daily Activity
The AM-PAC Daily Activity domain assesses putting on and off clothing, bathing, toileting, grooming, and eating.The Activity Measure for Post-Acute Care (AM-PAC) "6 Clicks" tools are comprised of six questions. Answers are based on a 4-point Likert scale ranging from 1-unable or total assistance to 4-no assistance or no difficulty. Scores range from 6 to 24, with lower scores indicating more assistance is required. The AM-PAC has a high degree of consistency between proxy (clinician or family) and client self-report in clients with stroke and has good reliability (ICC = 0.85) and validity (internal consistency = 0.96).
Measured: baseline (acute care hospital stay) to 6 months post-stroke
Activity Measure for Post-Acute Care, Applied Cognition
The AM-PAC Applied Cognitive domain assesses comprehension and memory.The Activity Measure for Post-Acute Care (AM-PAC) "6 Clicks" tools are comprised of six questions. Answers are based on a 4-point Likert scale ranging from 1-unable or total assistance to 4-no assistance or no difficulty. Scores range from 6 to 24, with lower scores indicating more assistance is required. The AM-PAC has a high degree of consistency between proxy (clinician or family) and client self-report in clients with stroke and has good reliability (ICC = 0.85) and validity (internal consistency = 0.96).
Measured: baseline (acute care hospital stay) to 6 months post-stroke
Identify cost-effective strategies for IRF / SNF placement after stroke based on client and non-client variables.
Evaluate the cost-effectiveness of three care strategies after stroke; 1) IRF placement; 2) SNF placement; and 3) tailored approach to an IRF vs. SNF placement, based on client characteristics. We will capture health related quality of life in stroke patients (HRQOLSP).
Measured: Information will be collected on HRQOLSP at 12 months post-stroke.
Identify cost-effective strategies for IRF / SNF placement after stroke based on client and non-client variables.
Evaluate the cost-effectiveness of three care strategies after stroke; 1) IRF placement; 2) SNF placement; and 3) tailored approach to an IRF vs. SNF placement, based on client characteristics. We will capture EQ-5D to predict quality-adjusted life years and related costs.
Measured: Information will be collected on EQ-5D at 6 months post-stroke.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start27 Jan 2020
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2025 (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.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Hayes, University of Utah
- Investigators
- Heather A Hayes, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279977
- Sponsor's protocol ID
- 1K01HD097280-01
- Status last verified
- May 2023
- First submitted
- 22 Nov 2019
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Looking into resources for where to store.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Initial Stroke Rehabilitation Placement on Functional Recovery and Cost-effectiveness
- ClinicalTrials.gov ID
- NCT04279977
- Acronym / sponsor ID
- 1K01HD097280-01
- Conditions
- Stroke
- Keywords
- rehabilitation, discharge, inpatient rehabilitation, skilled nursing, activity measure for post-acute care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 21 Feb 2020 (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.
The investigators will determine the client and non-client variables associated with discharge to an inpatient rehabilitation facility vs. skilled nursing facility in individuals' post-stroke. The investigators will determine how these variables are associated with short-term (discharge from facility) and long-term (6-months post-stroke) function and quality of life.
Detailed description
This is a K01 award application for Dr. Heather Hayes, a neurologic rehabilitation therapist and a young investigator pursuing rehabilitation health services research to optimize post-acute rehabilitation care for patients after stroke. A K01 award will provide Dr. Hayes with the means to acquire critical skills in three key career development areas: 1) health services and policy research, 2) comparative effectiveness and outcomes research, and 3) cost-effective analyses. By acquiring these skills, Dr. Hayes will fulfill the career goal of becoming an independent rehabilitation scientist in health services research. To pursue this goal, Dr. Hayes has assembled an exceptional mentoring team complemented by a strong statistical advisor and proposes strong research aims that provide experiential learning in support of the career development objectives.
Stroke is a leading cause of long-term disability in the United States. A large portion of the cost of stroke care is rehabilitation. Providing optimal rehabilitation services aids in mitigating long-term disability for people after stroke. There are a lack of clinical guidelines and poor understanding of long-term outcomes after discharge from acute care to an inpatient rehabilitation facility (IRF) or skilled nursing facility (SNF) for individuals poststroke. The current healthcare climate requires faster decision making and early discharge, and the results may be inappropriate discharge to an IRF or SNF, and thus not providing the patient with optimal outcomes. By completing the following specific aims, the applicant aims to inform clinicians in the acute care setting about discharge placement and which rehabilitation service will lead to optimal individual and cost-effective outcomes after stroke. Specific Aim 1 will determine client (e.g., stroke severity, co-morbidities, and sociodemographic) and non-client (e.g., bed availability and insurance) variables identified at the end of the acute hospital stay to determine which of these variables are associated with discharge to an IRF or SNF. Specific Aim 2 will follow the clients to determine which of these client and non-client variables are associated with functional change- based on the Activity Measure for Post-Acute Care (AM-PAC) Inpatient "6-Clicks" Basic Mobility, Daily Activity, and Applied Cognitive tools at short-term (after discharge from IRF or SNF) and long-term (6-months poststroke). Specific Aim 3 will identify cost-effective strategies of placement into an IRF, to a SNF, and a tailored approach to IRF vs. SNF placement, based on client characteristics. Markov modeling will be used to predict related costs and quality-adjusted life years using the Health-Related Quality of Life in Stroke Patients.
Understanding the outcomes within these similar post-acute care settings (IRF/SNF) for stroke is important in a rapidly evolving healthcare climate. This study is significant because it will provide data about what initial client and non-client variables predict long-term outcomes after discharge to an IRF or SNF and identify cost-effective strategies based on these variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient Rehabilitation Facility | – | –Individuals post-stroke who are discharged to an inpatient rehabilitation facility. |
| Skilled Nursing Facility | – | –Individuals post-stroke who are discharged to a skilled nursing facility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke
Key inclusion criteria (2 listed)
- Adult patient 18 years of age
- acute ischemic stroke
Key exclusion criteria (5 listed)
- hemorrhagic stroke
- prior living status was at a long-term care facility.
- Transient ischemic attack
- being discharged to home, home with rehab or long term care
- not able to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Activity Measure for Post-Acute Care, Basic Mobility, change over time
Time frame: baseline (acute care hospital stay) to discharge from IRF / SNF or 60 days max
The Activity Measure for Post-Acute Care (AM-PAC) "6 Clicks" tools are comprised of six questions. Answers are based on a 4-point Likert scale ranging from 1-unable or total assistance to 4-no assistance or no difficulty. Scores range from 6 to 24, with lower scores indicating more assistance is required. The AM-PAC has a high degree of consistency between proxy (clinician or family) and client self-report in clients with stroke and has good reliability (ICC = 0.85) and validity (internal consistency = 0.96). The AM-PAC Basic Mobility domain assesses turning over in bed, sitting down and standing up, getting out of bed, transferring, walking, and stair climbing.
Activity Measure for Post-Acute Care, Daily Activity
Time frame: baseline (acute care hospital stay) to discharge from IRF / SNF or 60 days max
The AM-PAC Daily Activity domain assesses putting on and off clothing, bathing, toileting, grooming, and eating.Answers are based on a 4-point Likert scale ranging from 1-unable or total assistance to 4-no assistance or no difficulty. Scores range from 6 to 24, with lower scores indicating more assistance is required. The AM-PAC has a high degree of consistency between proxy (clinician or family) and client self-report in clients with stroke and has good reliability (ICC = 0.85) and validity (internal consistency = 0.96).
Activity Measure for Post-Acute Care, Applied Cognition
Time frame: baseline (acute care hospital stay) to discharge from IRF / SNF or 60 days max
The AM-PAC Applied Cognitive domain assesses comprehension and memory.Answers are based on a 4-point Likert scale ranging from 1-unable or total assistance to 4-no assistance or no difficulty. Scores range from 6 to 24, with lower scores indicating more assistance is required. The AM-PAC has a high degree of consistency between proxy (clinician or family) and client self-report in clients with stroke and has good reliability (ICC = 0.85) and validity (internal consistency = 0.96). .
Determination of client and non-client variables associated with discharge to an IRF / SNF
Time frame: discharge from acute hospital stay or 20 days max.
Client variables will include modified Rankin Scale, Stroke classification, hemiparetic side, presence of neglect, stroke severity, body mass index, comprehensive severity index, length of stay, co-morbidities, depression, age, gender, race, ethnicity, education, socioeconomic status, marital status, family / caregiver support. Non-client variables will include bed availability in facility, insurance, home set up, client / family preference, geographical location to facility and home.
Identify cost-effective strategies for IRF / SNF placement after stroke based on client and non-client variables.
Time frame: Information will be collected on HRQOLSP at 6 months post-stroke.
Evaluate the cost-effectiveness of three care strategies after stroke; 1) IRF placement; 2) SNF placement; and 3) tailored approach to an IRF vs. SNF placement, based on client characteristics. We will capture health related quality of life in stroke (HRQOLSP) patients to predict quality-adjusted life years and related costs.
Identify cost-effective strategies for IRF / SNF placement after stroke based on client and non-client variables.
Time frame: Information will be collected on EQ-5D at 6 months post-stroke.
Evaluate the cost-effectiveness of three care strategies after stroke; 1) IRF placement; 2) SNF placement; and 3) tailored approach to an IRF vs. SNF placement, based on client characteristics. We will capture EQ-5D to predict quality-adjusted life years and related costs.
5 secondary outcomes
Activity Measure for Post-Acute Care, Basic Mobility, change over time
Time frame: baseline (acute care hospital stay) to 6 months post-stroke
Activity Measure for Post-Acute Care, Daily Activity
Time frame: baseline (acute care hospital stay) to 6 months post-stroke
Activity Measure for Post-Acute Care, Applied Cognition
Time frame: baseline (acute care hospital stay) to 6 months post-stroke
Identify cost-effective strategies for IRF / SNF placement after stroke based on client and non-client variables.
Time frame: Information will be collected on HRQOLSP at 12 months post-stroke.
Identify cost-effective strategies for IRF / SNF placement after stroke based on client and non-client variables.
Time frame: Information will be collected on EQ-5D at 6 months post-stroke.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Undecided. Looking into resources for where to store.
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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.
Heather A Hayes, PhD principal investigator
University of Utah
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, run by University of Utah 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamara Garff (8015818681, tamara.garff@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity Measure for Post-Acute Care, Basic Mobility, change over time (time frame: baseline (acute care hospital stay) to discharge from IRF / SNF or 60 days max). The study lists 6 primary outcomes in all. 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 3 May 2023.