Clinical trial NCT04279977: Stroke Rehabilitation, Functional Recovery, and Cost-effectiveness
Official title: Impact of Initial Stroke Rehabilitation Placement on Functional Recovery and Cost-effectiveness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: rehabilitation
discharge
inpatient rehabilitation
skilled nursing
activity measure for post-acute care
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute ischemic stroke

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Activity Measure for Post-Acute Care, Basic Mobility, change over time
timeFrame: baseline (acute care hospital stay) to discharge from IRF / SNF or 60 days max
measure: Activity Measure for Post-Acute Care, Daily Activity
timeFrame: baseline (acute care hospital stay) to discharge from IRF / SNF or 60 days max
measure: Activity Measure for Post-Acute Care, Applied Cognition
timeFrame: baseline (acute care hospital stay) to discharge from IRF / SNF or 60 days max
measure: Determination of client and non-client variables associated with discharge to an IRF / SNF
timeFrame: discharge from acute hospital stay or 20 days max.
measure: Identify cost-effective strategies for IRF / SNF placement after stroke based on client and non-client variables.
timeFrame: Information will be collected on HRQOLSP at 6 months post-stroke.
measure: Identify cost-effective strategies for IRF / SNF placement after stroke based on client and non-client variables.
timeFrame: Information will be collected on EQ-5D at 6 months post-stroke.
Secondary outcomes:
measure: Activity Measure for Post-Acute Care, Basic Mobility, change over time
timeFrame: baseline (acute care hospital stay) to 6 months post-stroke
measure: Activity Measure for Post-Acute Care, Daily Activity
timeFrame: baseline (acute care hospital stay) to 6 months post-stroke
measure: Activity Measure for Post-Acute Care, Applied Cognition
timeFrame: baseline (acute care hospital stay) to 6 months post-stroke
measure: Identify cost-effective strategies for IRF / SNF placement after stroke based on client and non-client variables.
timeFrame: Information will be collected on HRQOLSP at 12 months post-stroke.
measure: Identify cost-effective strategies for IRF / SNF placement after stroke based on client and non-client variables.
timeFrame: Information will be collected on EQ-5D at 6 months post-stroke.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Heather A Hayes, PhD
role: PRINCIPAL_INVESTIGATOR
References: