Improving Patient Walking During Hospitalization

NCT04479943 | Completed Results

• 5 other identifiers: 2020-0010A549000NUR/FACULTY AFFAIRS/ADMINProtocol Version 08/19/20241R01HS026733-01A1
• Study Type: interventional
• Target: 765
• Locations: 1 country
• Sites: 1

Brief 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. It will also enroll any nurses 18 years and older who worked on the units during the study and are willing to fill out surveys.

Conditions

Early Mobility; Older Adults; Hospital Acquired Condition

Keywords

nursing care; hospitalization; aged; walking

Outcome Measures

Primary Outcomes (10)

• Aim 1: 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

• Aim 1: Change in Self-report on Activities of Daily Living (ADL)

  A trained member of the research team collected 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 six ADL on two levels (independent or requiring assistance of another). 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. For the primary analysis, patients with a score of 6 were converted to a binary score of 1=Independent; all others were scored as 0=Dependent.

  Within 24 hours of hospital admission, Within 8 hours of hospital discharge, 1 month post-discharge, 3 months post-discharge; 6 months post-discharge

• Aim 1: Change in Life Space Assessment

  The University of Alabama at Birmingham (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, 1 month post-discharge, 3 months post-discharge; 6 months post-discharge

• Aim 2: Hospital Readmissions

  Hospital readmissions were collected via patient self-report and via medical record review by a trained researcher from the study team. Patient readmission was coded as 0=not readmitted, 1=readmitted. Reported value for each cell reflects a model-based estimate of the probability of readmission, a type of least squares mean appropriate for a binary variable.

  1 month post-discharge; 3 months post-discharge; 6 months post-discharge; Up to 7 months total

• Aim 2: Emergency Department Visits

  Emergency department (ED) visits will be collected via patient self report. Patient ED usage was coded as 0=no ED visit, 1=any ED visit. Reported value for each cell reflects a model-based estimate of the probability of an ED visit, a type of least squares mean appropriate for a binary variable.

  1 month post-discharge; 3 months post-discharge; 6 months post-discharge; Up to 7 months total

• Aim 2: Length of Hospital Stay

  Length of hospital stay will be collected via patient medical record review by a nurse researcher from the study team.

  During hospital stay in the Pre-Intervention and Post-Intervention periods

• Aim 2: Discharge Destination

  Discharge destination (home, skilled nursing facility) was collected via patient medical record review by a nurse researcher from the study team. Patient discharge destination was coded as 1=discharged to home, 0=discharged to a skilled nursing facility. Reported value for each cell reflects a model-based estimate of the probability of discharge to home, a type of least squares mean appropriate for a binary variable.

  Within 3 months post-discharge; Up to 4 months total

• Aim 3: Distance of Patient Ambulation

  Unit level data on ambulation. Each week, the total distance walked on that unit by all patients on the unit was recorded. We report the average total weekly distance walked, using a model-based least squares mean. The number of participants analyzed is large because this measure is unit-level and includes all patients observed on the unit during the study period, not only those enrolled in the full study, and will double count patients who were observed during more than one week.

  6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total

• Aim 3: Barriers to Ambulation Survey

  Data collected from enrolled nursing staff via paper copies or online link before and after the intervention. The Barriers to Patient Ambulation Survey assesses the nurses opinions regarding ambulation of hospitalized patients within the past 2 weeks. It is scored from 0-100 with higher scores indicating increased barriers to ambulation.

  pre-intervention, post-intervention (up to about 20 weeks)

• Aim 3: Ambulation Culture Survey

  Data collected from enrolled nursing staff via paper copies or online link before and after the intervention. The Ambulation Culture Survey asks for opinions on ambulation culture. We report responses to the item, "How would you rate your unit/work area on patient care related to ambulation?" This item has a minimum score of 1 (Poor) and a maximum score of 5 (Excellent). Higher values represent a better outcome.

  pre-intervention, post-intervention (up to about 20 weeks)

Secondary Outcomes (7)

• Aim 3: Frequency of Patient Ambulation (Percent of Patients Ambulated by Nursing Staff)

  6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total

• Aim 3: Nurse Fatigue Survey: Chronic Fatigue Subscale

  pre-intervention, post-intervention (up to about 20 weeks)

• Aim 3: Nurse Fatigue Survey: Acute Fatigue Subscale

  pre-intervention, post-intervention (up to about 20 weeks)

• Aim 3: Nurse Fatigue Survey: Intershift Recovery Subscale

  pre-intervention, post-intervention (up to about 20 weeks)

• Aim 3: Professional Quality of Life Survey: Compassion Satisfaction

  pre-intervention, post-intervention (up to about 20 weeks)

Other Outcomes (9)

• Aim 3: Qualitative Assessment of Intervention Implementation

  post-intervention (approximately 3-5 months after active intervention launch)

• Aim 2: Physical Therapy (PT) Utilization

  6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total

• Patient Satisfaction: Participant Experience Scores From 1-5 on HCAHPS

  6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total

Study Arms (3)

Pre-intervention/control

NO INTERVENTION

160-200 older adult patients (age 65 or older) will be recruited on four units across two hospitals (two units per hospital) over 6-8 months prior to implementation of the unit-based MOVIN intervention.

Post-intervention

EXPERIMENTAL

160-200 older adult patients (age 65 or older) will be recruited on four units across two hospitals (two units per hospital) over 6-8 months after MOVIN has been implemented on the unit.

Other: MOVIN

Nurses

OTHER

Nurses will complete surveys and provide qualitative data to assess barriers to implementation. Nurses will be invited to enroll in the survey/qualitative data arm during both Pre-intervention and Post-intervention phases.

Other: Surveys and Focus groups

Interventions

MOVIN OTHER

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.

Post-intervention

Surveys and Focus groups OTHER

Nurses will answer surveys about nurse behavior, changes in self-efficacy, frequency and distance of patient ambulation, documentation of ambulation, qualitative data collected to determine barriers to implementation

Nurses

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

UW School of Medicine and Public Health

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Iatrogenic Disease

Interventions

Surveys and Questionnaires; Focus Groups

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Linsey Steege
• Organization: University of Wisconsin-Madison

lsteege@wisc.edu

608-263-5191

Study Officials

• Linsey M Steege, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses an incomplete stepped wedge cluster randomized controlled trial. In the incomplete stepped wedge design, inpatient units are randomly sequenced into the intervention. A baseline (control period) and 2 follow up data collection periods (intervention and post intervention period) occur for each unit. Incomplete stepped wedge cluster randomized trials are novel study designs that are particularly beneficial for evaluating service delivery interventions using a pragmatic design, when evaluations need to be completed at a system or population level, or it is impractical or cost prohibitive to roll out an intervention across multiple units simultaneously.

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 21, 2020
• Study Start: March 2, 2021
• Primary Completion: January 27, 2025
• Study Completion: January 27, 2025
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)