- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03887572
Adaption of Mobilizing Older Adult Patients Via a Systems-based Intervention for a Non-Academic Hospital (MOVIN)
Getting Older Patients Walking: Adaption of MOVIN (Mobilizing Older Adult Patients Via a Systems-based INtervention) for Implementation in a Non-Academic Hospital
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, our research has identified multiple personal and organizational barriers that prevent nurses from walking patients. We 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. Our 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.
Our goal is to translate our positive research results into an actionable implementation package that can be used to disseminate MOVIN to hospitals nationwide and improve the quality of care and functional outcomes for older adult patients. In pursuit of this goal, our specific aims are to:
- Adapt MOVIN and develop and refine a MOVIN toolkit for implementation in a non-academic hospital.
- Implement MOVIN in an inpatient adult general medical unit in a non-academic hospital with an on-site clinical team leading the intervention and evaluate using the RE-AIM framework to collect preliminary data for a future dissemination study.
- Assess market demand for the intervention and develop a customer value statement in collaboration with the ICTR Dissemination and Implementation Program.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53215
- Aurora St. Luke's Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age 65 years or older
- able to walk with or without assistance
- absence of a medical order for bedrest or activity restriction
- have an ambulation order
- able to speak and understand English.
Exclusion Criteria:
- activated Power of Attorney
- a score of 11+ on Orientation Memory Cognition Test (OMCT)
- a score <2 on a Mini Cog
- lower extremity amputation
- terminal diagnosis (Comfort Care)
- on hospice
- bed rest order
- wheelchair bound
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pre-intervention/control
20 older adult patients (age 65 or older) will be recruited over 3 months prior to implementation of the unit-based MOVIN intervention.
|
|
Post-intervention
20 older adult patients (age 65 or older) will be recruited over 3 months after MOVIN has been implemented on the unit for a period of 12-14 weeks.
|
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: Hospital admission, hospital discharge, 3 months post-discharge; Up to 4 months total
|
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.
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.
Change scores will be calculated as the difference between gait speeds measured at each of these time points.
|
Hospital admission, hospital discharge, 3 months post-discharge; Up to 4 months total
|
Change in Self-report on Katz Activity of Daily Living (ADL) Index
Time Frame: Hospital admission, hospital discharge, 1 month post-discharge, 3 months post-discharge; Up to 4 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.
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).
The scale demonstrates excellent reliability and predictive validity, and is sensitive to change in hospital settings.
Change scores will be calculated as the difference between gait speeds measured at each of these time points.
|
Hospital admission, hospital discharge, 1 month post-discharge, 3 months post-discharge; Up to 4 months total
|
Change in Life Space Assessment
Time Frame: Hospital admission, hospital discharge, 1 month post-discharge, 3 months post-discharge; Up to 4 months total
|
A trained member of the research team will collect patients self-report on Life Space at 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.
The UAB Life Space Assessment: 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.
Change scores will be calculated as the difference between gait speeds measured at each of these time points.
|
Hospital admission, hospital discharge, 1 month post-discharge, 3 months post-discharge; Up to 4 months total
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Experience with Ambulation
Time Frame: 1 month post-discharge; Up to 2 months total
|
Brief interviews will be conducted to further examine and understand the patient experience with ambulation on the inpatient unit.
|
1 month post-discharge; Up to 2 months total
|
Age
Time Frame: Within 3 months post-discharge; Up to 4 months total
|
Age in years will be collected via patient medical record review by a nurse researcher from the study team.
|
Within 3 months post-discharge; Up to 4 months total
|
Gender
Time Frame: Within 3 months post-discharge; Up to 4 months total
|
Gender will be collected via patient medical record review by a nurse researcher from the study team
|
Within 3 months post-discharge; Up to 4 months total
|
Race
Time Frame: Within 3 months post-discharge; Up to 4 months total
|
Race will be collected via patient medical record review by a nurse researcher from the study team.
|
Within 3 months post-discharge; Up to 4 months total
|
Ethnicity
Time Frame: Within 3 months post-discharge; Up to 4 months total
|
Ethnicity will be collected via patient medical record review by a nurse researcher from the study team.
|
Within 3 months post-discharge; Up to 4 months total
|
Social support
Time Frame: Post-discharge; Up to 1 month
|
Social support (defined as: living alone, living with another, presence of a caregiver, use of home care services) will be collected via patient medical record review by a nurse researcher from the study team.
|
Post-discharge; Up to 1 month
|
Location admitted from
Time Frame: Within 3 months post-discharge; Up to 4 months total
|
Location admitted from (defined as: home, assisted living, nursing home, other hospital, other inpatient unit) will be collected via patient medical record review by a nurse researcher from the study team.
|
Within 3 months post-discharge; Up to 4 months total
|
Reason for admission
Time Frame: Within 3 months post-discharge; Up to 4 months total
|
Reason for admission will be collected via patient medical record review by a nurse researcher from the study team.
|
Within 3 months post-discharge; Up to 4 months total
|
Use of an ambulation assistive device
Time Frame: Within 3 months post-discharge; Up to 4 months total
|
Use of an ambulation assistive device (including, walker, cane, wheelchair) will be collected via patient medical record review by a nurse researcher from the study team.
|
Within 3 months post-discharge; Up to 4 months total
|
Presence of external lines
Time Frame: Within 3 months post-discharge; Up to 4 months total
|
Presence of external lines (Foley catheter, intravenous lines, supplemental oxygen, drainage tubes) will be collected via patient medical record review by a nurse researcher from the study team.
|
Within 3 months post-discharge; Up to 4 months total
|
Body Mass Index
Time Frame: Within 3 months post-discharge; Up to 4 months total
|
Body Mass Index will be collected via patient medical record review by a nurse researcher from the study team.
|
Within 3 months post-discharge; Up to 4 months total
|
Fall risk
Time Frame: Within 3 months post-discharge; Up to 4 months total
|
Documentation of fall risk status will be collected via patient medical record review by a nurse researcher from the study team.
|
Within 3 months post-discharge; Up to 4 months total
|
Fall reported
Time Frame: Within 3 months post-discharge; Up to 4 months total
|
Whether or not a fall was reported during the hospital stay will be collected via patient medical record review by a nurse researcher from the study team.
|
Within 3 months post-discharge; Up to 4 months total
|
Length of stay
Time Frame: Within 3 months post-discharge; Up to 4 months total
|
Length of hospital stay will be collected via patient medical record review by a nurse researcher from the study team.
|
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.
|
Within 3 months post-discharge; Up to 4 months total
|
Charlson Comorbidity Index
Time Frame: Within 3 months post-discharge; Up to 4 months total
|
This index will be calculated via chart review by a nurse researcher member of the study team.
|
Within 3 months post-discharge; Up to 4 months total
|
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 (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-1025
- A545000 (Other Identifier: UW Madison)
- 1UL1TR002373-01 (U.S. NIH Grant/Contract)
- NUR/FACULTY AFFAIRS/ADMIN (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.
Clinical Trials on Older Adults
-
KU LeuvenCompletedHealthy Older Adults | Ill Older AdultsBelgium
-
Georgia Institute of TechnologyUniversity of FloridaNot yet recruiting
-
University of GuelphOntario Bean GrowersRecruiting
-
University of JordanRecruiting
-
University of Illinois at ChicagoNational Institute on Aging (NIA)Recruiting
-
University of BathCompletedOlder AdultsUnited Kingdom
-
University of JaenCompletedOlder AdultsColombia
-
Metabolic Technologies Inc.National Institute on Aging (NIA); Vanderbilt UniversityCompleted
-
Riphah International UniversityCompleted
-
East Carolina UniversityCompleted
Clinical Trials on MOVIN
-
University of Wisconsin, MadisonAurora Health Care; Agency for Healthcare Research and Quality (AHRQ)RecruitingOlder Adults | Hospital Acquired Condition | Early MobilityUnited States
-
University of Vic - Central University of CataloniaNot yet recruitingPhysical Activity | Executive FunctionSpain
-
Women's College HospitalCompleted
-
Rush University Medical CenterRecruitingPhysical Function | Multiple Chronic ConditionsUnited States