- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04479943
Improving Patient Walking During Hospitalization
Preventing Hospital-Acquired Disability: An Intervention to Improve Older Adult Patient Ambulation
Study Overview
Status
Intervention / Treatment
Detailed Description
Up to 65% of hospitalized older adults will lose the ability to ambulate independently during their hospital stay. Loss of independent ambulation has been identified as a hospital-acquired disability and is a critical patient safety concern, resulting in permanent loss of function for 50% of older adults one-year post discharge. Functional loss is associated with multiple negative outcomes including a 33% increase in new nursing home placement, increase in length of hospital stay, need for home health services, falls, caregiver burden, decreased quality of life, and increased mortality. Given the rapid increase in the elderly population, loss of independent ambulation primarily due to the process of care in hospital settings may significantly increase future healthcare costs and further exacerbate concerns related to patient care quality.
Lack of walking during hospitalization has been directly linked to loss of independent ambulation in older adults. Nurses are responsible for promoting and maintaining patient independent mobility. However, the investigators research has identified multiple personal and organizational barriers that prevent nurses from walking patients. The investigators have developed and pilot tested a novel systems based multi-component intervention to improve ambulation of older adult patients, Mobilizing Older adult patients Via a systems-based INtervention (MOVIN). MOVIN is comprised of five components: 1) psychomotor skills training; 2) communication tools; 3) ambulation pathways; 4) ambulation resources; and 5) unit ambulation culture. The Investigators pilot study of MOVIN demonstrated a statistically significant increase in frequency and weekly distance of patient ambulation as well as changes in nursing practice and unit culture. Notably, these changes have been sustained for greater than two years after completion of the study.
The investigators' goal is to eliminate loss of independent ambulation in hospitalized older adults. In pursuit of this goal, the specific aims are to:
- Test the effectiveness of MOVIN to improve functional ability of older adult patients at discharge, and 1, 3 and 6 months post discharge;
- Test the effectiveness of MOVIN to reduce healthcare utilization of older adults at discharge, and 1, 3 and 6 months post discharge;
- Measure change in nurse behaviors and unit culture and identify ongoing systems barriers that impact translation of MOVIN across inpatient units and different hospitals.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Linsey M Steege, PhD
- Phone Number: 608-263-5191
- Email: lsteege@wisc.edu
Study Contact Backup
- Name: Barb King, PhD
- Phone Number: 608-263-5319
- Email: bjking2@wisc.edu
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53792
- Recruiting
- UW Health-University Hospital
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Contact:
- Rudy Jackson, DNP
- Phone Number: 608-263-8665
- Email: rjackson@uwhealth.org
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Milwaukee, Wisconsin, United States, 53215
- Active, not recruiting
- Aurora St. Luke's Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age 65 years or older
- able to walk with or without assistance
- living in the community (not long term care) prior to admission
- have an ambulation order
- admitted to hospital's general adult medical unit
- able to consent
- able to speak and understand English.
Exclusion Criteria:
- activated Power of Attorney
- lower extremity amputation
- terminal diagnosis (Comfort Care)
- on hospice
- bed rest order or activity restriction
- wheelchair bound
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Pre-intervention/control
160-200 older adult patients (age 65 or older) will be recruited on four units across two hospitals (two units per hospital) over 6 months prior to implementation of the unit-based MOVIN intervention.
|
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Experimental: Post-intervention
160-200 older adult patients (age 65 or older) will be recruited on four units across two hospitals (two units per hospital) over 6 months after MOVIN has been implemented on the unit.
|
MOVIN is a multi-component unit-based intervention comprised of five components that are implemented simultaneously in a hospital unit.
The five components are: 1) psychomotor skills training, 2) unit ambulation culture, 3) communication, 4) resources, 5) ambulation environment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in gait speed
Time Frame: Within 24 hours of hospital admission, Within 8 hours of hospital discharge, 3 months post-discharge; Up to 4 months total
|
Gait Speed is a physical performance measure identified as a sensitive clinical indicator of health, mortality, healthcare utilization, and independence in ambulation, and is feasible to test in hospitalized older adults.
A 4 meter walk test will be conducted on admission to the study, discharge from the hospital and at 3 months post discharge in the subjects home or the hospital or clinic.
A trained member of the research team will conduct the gait speed test.
Interrater reliability for the 4 meter walk test will be conducted between all members of the research team prior to collecting gait speed data on study participants.
Change scores will be calculated as the difference among gait speeds measured at each time points.
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Within 24 hours of hospital admission, Within 8 hours of hospital discharge, 3 months post-discharge; Up to 4 months total
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Change in self-report on Activities of Daily Living (ADL)
Time Frame: Within 24 hours of hospital admission, Within 8 hours of hospital discharge, 1 month post-discharge, 3 months post-discharge; 6 months post-discharge; Up to 7 months total
|
A trained member of the research team will collect patients self-report of ADLs on admission to the study, discharge from the hospital, by phone at 1 month post intervention, and in person at the 3 month post intervention visit using the Katz ADL Index.
The Katz ADL Index is a self-report scale that measures five ADL on three levels (independent, requiring assistance of another and unable to do).
A score of 0-6 is possible, with higher scores indicating higher independence with ADLs and lower scores indicating higher dependence on others to perform ADLs.
The scale demonstrates excellent reliability and predictive validity, and is sensitive to change in hospital settings.
Change scores will be calculated as the difference among ADL independence measured at each time point.
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Within 24 hours of hospital admission, Within 8 hours of hospital discharge, 1 month post-discharge, 3 months post-discharge; 6 months post-discharge; Up to 7 months total
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Change in Life Space Assessment
Time Frame: Within 24 hours of hospital admission, Within 8 hours of hospital discharge, 1 month post-discharge, 3 months post-discharge; 6 months post-discharge; Up to 7 months total
|
The UAB Life Space Assessment (LSA) is a self-report scale of ambulation that measures spaces patients' move in, the frequency of moving into those spaces, and dependency in moving into those spaces.
This scale has demonstrated reliability and predictive validity and sensitivity to change after hospital stay.
Level scores are calculated by multiplying the life-space level (higher numbers indicate farther distances moved, e.g., 1-inside the home to 5-places outside of the person's town), degree of independence (higher scores indicate greater independence), and frequency of movement (higher scores equal greater frequency).
Total scores range from 0 (totally bed-bound) to 120 (moved out of town every day without assistance).
A trained member of the research team will collect patients self-report on Life Space.
Change scores will be calculated as the difference among LSA ambulation measured at each time point.
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Within 24 hours of hospital admission, Within 8 hours of hospital discharge, 1 month post-discharge, 3 months post-discharge; 6 months post-discharge; Up to 7 months total
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Readmissions
Time Frame: 1 month post-discharge; 3 months post-discharge; 6 months post-discharge; Up to 7 months total
|
Hospital readmissions will be collected via patient medical record review by a nurse researcher from the study team.The nurse researcher from the study team will also collect patient self reports of hospital readmissions to account for any out of network visits that might be missed in medical record reviews.
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1 month post-discharge; 3 months post-discharge; 6 months post-discharge; Up to 7 months total
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Emergency Room Visits
Time Frame: 1 month post-discharge; 3 months post-discharge; 6 months post-discharge; Up to 7 months total
|
Emergency room visits Discharge destination (home, skilled nursing facility) will be collected via patient medical record review by a nurse researcher from the study team.
The nurse researcher from the study team will also collect patient self reports of emergency room visits to account for any out of network visits that might be missed in medical record reviews.
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1 month post-discharge; 3 months post-discharge; 6 months post-discharge; Up to 7 months total
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Length of Hospital Stay
Time Frame: Within 3 months post-discharge; Up to 4 months total
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Length of hospital stay will be collected via patient medical record review by a nurse researcher from the study team.
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Within 3 months post-discharge; Up to 4 months total
|
Discharge Destination
Time Frame: Within 3 months post-discharge; Up to 4 months total
|
Discharge destination (home, skilled nursing facility) will be collected via patient medical record review by a nurse researcher from the study team.
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Within 3 months post-discharge; Up to 4 months total
|
Patient Satisfaction
Time Frame: 6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total
|
Patient satisfaction will be measured at the hospital unit level using the nursing care sensitive questions from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS).
A report will be produced by the participant hospitals of HCAHPS responses from all patients who received care on the MOVIN participating units during the study period.
The HCAHPS uses "top box" scoring for measuring satisfaction, indicating how often patients selected positive response categories.
Higher scores on each item indicate higher levels of patient satisfaction.
Percentage of patients selecting the most positive "top box" response categories will be compared.
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6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Linsey M Steege, PhD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- 2020-0010
- A549000 (Other Identifier: UW Madison)
- NUR/FACULTY AFFAIRS/ADMIN (Other Identifier: UW Madison)
- 1R01HS026733-01A1 (U.S. AHRQ Grant/Contract)
- Protocol Version 03/22/2023 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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