- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04279977
Stroke Rehabilitation, Functional Recovery, and Cost-effectiveness
Impact of Initial Stroke Rehabilitation Placement on Functional Recovery and Cost-effectiveness
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Tamara Garff
- Phone Number: 8015818681
- Email: tamara.garff@hsc.utah.edu
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84108
- Recruiting
- University of Utah
-
Contact:
- Tamara Garff
- Phone Number: 801-585-3122
- Email: tamara.garff@hsc.utah.edu
-
Principal Investigator:
- Heather A Hayes, PhD
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Sub-Investigator:
- Rachel Hess, MD
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Sub-Investigator:
- Jacob Kean, PhD
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Sub-Investigator:
- Lorie G Richards, PhD
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Sub-Investigator:
- Elissa Ozanne, PhD
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Sub-Investigator:
- Angela Presson, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patient 18 years of age
- acute ischemic stroke
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline (acute care hospital stay) to discharge from IRF / SNF or 60 days max
|
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).
|
baseline (acute care hospital stay) to discharge from IRF / SNF or 60 days max
|
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). .
|
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
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.
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discharge from acute hospital stay or 20 days max.
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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.
|
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.
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.
|
Information will be collected on EQ-5D at 6 months post-stroke.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Information will be collected on EQ-5D at 6 months post-stroke.
|
Activity Measure for Post-Acute Care, Basic Mobility, change over time
Time Frame: baseline (acute care hospital stay) to 6 months post-stroke
|
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.
|
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
|
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).
|
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
|
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).
|
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.
|
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).
|
Information will be collected on HRQOLSP at 12 months post-stroke.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heather A Hayes, PhD, University of Utah
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1K01HD097280-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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