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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03887572
Other study ID # 2018-1025
Secondary ID A545000NUR/FACUL
Status Completed
Phase
First received
Last updated
Start date March 4, 2019
Est. completion date February 4, 2020

Study information

Verified date April 2024
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This observational study is designed to adapt, create actionable implementation, and to access market demand of the Mobilizing Older adults Via a systems-based Intervention (MOVIN) toolkit. MOVIN is a program to increase ambulation while hospitalized at non-academic facilities. MOVIN is a unit-based intervention. Therefore all patients on this unit are exposed to the intervention once it is implemented regardless of whether or not they participate in the trial. The study will enroll 40 total hospitalized participants 65 years and older for the duration of their stay.


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: 1. Adapt MOVIN and develop and refine a MOVIN toolkit for implementation in a non-academic hospital. 2. 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. 3. Assess market demand for the intervention and develop a customer value statement in collaboration with the ICTR Dissemination and Implementation Program.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 4, 2020
Est. primary completion date February 4, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Intervention

Other:
MOVIN
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.

Locations

Country Name City State
United States Aurora St. Luke's Medical Center Milwaukee Wisconsin

Sponsors (3)

Lead Sponsor Collaborator
University of Wisconsin, Madison Aurora Health Care, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in gait speed 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
Primary Change in Self-report on Katz Activity of Daily Living (ADL) Index 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
Primary Change in Life Space Assessment 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 Patient Experience with Ambulation 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
Secondary Age 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
Secondary Gender 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
Secondary Race 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
Secondary Ethnicity 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
Secondary Social support 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
Secondary Location admitted from 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
Secondary Reason for admission 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
Secondary Use of an ambulation assistive device 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
Secondary Presence of external lines 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
Secondary Body Mass Index 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
Secondary Fall risk 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
Secondary Fall reported 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
Secondary Length of stay 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
Secondary Discharge destination 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
Secondary Charlson Comorbidity Index 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
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