Improving Patient Walking During Hospitalization

Older Adults Clinical Trial

Official title:

Preventing Hospital-Acquired Disability: An Intervention to Improve Older Adult Patient Ambulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04479943
• Other study ID #: 2020-0010
• Secondary ID: A549000NUR/FACUL
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2021
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: Linsey M Steege, PhD
• Phone: 608-263-5191
• Email: lsteege[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The MOVIN (Mobilizing Older adult patients Via a systems-based Intervention) randomized controlled trial is designed to evaluate the impact of the MOVIN intervention on improving the functional ability of older adult hospital patients and reducing their healthcare utilization post-hospitalization. MOVIN is a program to increase patient ambulation while hospitalized. The study's hypothesis is that MOVIN will improve functional outcomes for hospitalized older adult patients by producing a change in nursing practice and culture of ambulation on inpatient units. 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 360-420 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, 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: 1. Test the effectiveness of MOVIN to improve functional ability of older adult patients at discharge, and 1, 3 and 6 months post discharge; 2. Test the effectiveness of MOVIN to reduce healthcare utilization of older adults at discharge, and 1, 3 and 6 months post discharge; 3. Measure change in nurse behaviors and unit culture and identify ongoing systems barriers that impact translation of MOVIN across inpatient units and different hospitals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• 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
• 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
• at least 24h planned length of stay after initial study enrollment.

Exclusion Criteria:

• activated Power of Attorney
• lower extremity amputation
• on hospice
• bed rest order or activity restriction
• wheelchair bound

Related Conditions & MeSH terms

• Early Mobility
• Hospital Acquired Condition
• Iatrogenic Disease
• Older Adults

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	UW Health-University Hospital	Madison	Wisconsin
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Agency for Healthcare Research and Quality (AHRQ), Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gait speed	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.	Within 24 hours of hospital admission, Within 8 hours of hospital discharge, 3 months post-discharge; Up to 4 months total
Primary	Change in self-report on Activities of Daily Living (ADL)	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 6 months 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.	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
Primary	Change in Life Space Assessment	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.	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	Hospital Readmissions	Hospital readmissions will be collected via patient self-report and via medical record review by a trained researcher from the study team.	1 month post-discharge; 3 months post-discharge; 6 months post-discharge; Up to 7 months total
Secondary	Emergency Room Visits	Emergency room visits Discharge destination (home, skilled nursing facility) will be collected via patient self report.	1 month post-discharge; 3 months post-discharge; 6 months post-discharge; Up to 7 months total
Secondary	Length of Hospital 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	Patient Satisfaction	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.	6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total