NCT04279977

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 27, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

4.3 years

First QC Date

November 22, 2019

Last Update Submit

May 2, 2023

Conditions

Stroke

Keywords

rehabilitationdischargeinpatient rehabilitationskilled nursingactivity measure for post-acute care

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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.

  • 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.

  • 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 Outcomes (5)

  • Activity Measure for Post-Acute Care, Basic Mobility, change over time

    baseline (acute care hospital stay) to 6 months post-stroke

  • Activity Measure for Post-Acute Care, Daily Activity

    baseline (acute care hospital stay) to 6 months post-stroke

  • Activity Measure for Post-Acute Care, Applied Cognition

    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.

    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.

    Information will be collected on EQ-5D at 6 months post-stroke.

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute ischemic stroke

You may qualify if:

  • Adult patient 18 years of age
  • acute ischemic stroke

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Heather A Hayes, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamara Garff

CONTACT

8015818681tamara.garff@hsc.utah.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 22, 2019

First Posted

February 21, 2020

Study Start

January 27, 2020

Primary Completion

April 30, 2024

Study Completion

April 30, 2025

Last Updated

May 3, 2023

Record last verified: 2023-05

Locations

US(1)