Stroke Rehabilitation, Functional Recovery, and Cost-effectiveness

Stroke Clinical Trial

Official title:

Impact of Initial Stroke Rehabilitation Placement on Functional Recovery and Cost-effectiveness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04279977
• Other study ID #: 1K01HD097280-01
• Status: Recruiting
• Start date: January 27, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2023
• Source: University of Utah
• Contact: Tamara Garff
• Phone: 8015818681
• Email: tamara.garff[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline (acute care hospital stay) to discharge from IRF / SNF or 60 days max
Primary	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).	baseline (acute care hospital stay) to discharge from IRF / SNF or 60 days max
Primary	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). .	baseline (acute care hospital stay) to discharge from IRF / SNF or 60 days max
Primary	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.	discharge from acute hospital stay or 20 days max.
Primary	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.	Information will be collected on HRQOLSP at 6 months post-stroke.
Primary	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.	Information will be collected on EQ-5D at 6 months post-stroke.
Secondary	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.	baseline (acute care hospital stay) to 6 months post-stroke
Secondary	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).	baseline (acute care hospital stay) to 6 months post-stroke
Secondary	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).	baseline (acute care hospital stay) to 6 months post-stroke
Secondary	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).	Information will be collected on HRQOLSP at 12 months post-stroke.
Secondary	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.	Information will be collected on EQ-5D at 6 months post-stroke.