Improving Patient Walking During Hospitalization

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Recruiting
CT.gov ID
NCT04479943
Collaborator
Aurora Health Care (Other), Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
320
2
2
50.7
160
3.2

Study Details

Study Description

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 320 total hospitalized participants 65 years and older for the duration of their stay.

Condition or Disease Intervention/Treatment Phase
  • Other: MOVIN
N/A

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:

  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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
320 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
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.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.
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Preventing Hospital-Acquired Disability: An Intervention to Improve Older Adult Patient Ambulation
Actual Study Start Date :
Mar 10, 2021
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Pre-intervention/control

160 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.

Experimental: Post-intervention

160 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Change in gait speed [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.

  2. Change in self-report on Activities of Daily Living (ADL) [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.

  3. Change in Life Space Assessment [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.

Secondary Outcome Measures

  1. Hospital Readmissions [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.

  2. Emergency Room Visits [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.

  3. Length of Hospital Stay [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.

  4. Discharge Destination [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.

  5. Patient Satisfaction [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 speak and understand English.

Exclusion Criteria:
  • activated Power of Attorney

  • dementia diagnosis

  • lower extremity amputation

  • terminal diagnosis (Comfort Care)

  • on hospice

  • bed rest order or activity restriction

  • wheelchair bound

Contacts and Locations

Locations

Site City State Country Postal Code
1 UW Health-University Hospital Madison Wisconsin United States 53792
2 Aurora St. Luke's Medical Center Milwaukee Wisconsin United States 53215

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Linsey M Steege, PhD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT04479943
Other Study ID Numbers:
  • 2020-0010
  • A549000
  • NUR/FACULTY AFFAIRS/ADMIN
  • Protocol Version 1/23/2020
  • 1R01HS026733-01A1
First Posted:
Jul 21, 2020
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Wisconsin, Madison
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2022