Clinical trial NCT04479943: Improving Patient Walking During Hospitalization
Official title: Preventing Hospital-Acquired Disability: An Intervention to Improve Older Adult Patient Ambulation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Early Mobility
Older Adults
Hospital Acquired Condition
Keywords: nursing care
hospitalization
aged
walking
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-07-21
Enrollment: 387
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: PREVENTION

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.

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:

* Specific Aim 1:Test the effectiveness of MOVIN to improve functional ability of older adult patients at discharge, and 1, 3 and 6 months post discharge
* Specific Aim 2: Test the effectiveness of MOVIN to reduce healthcare utilization of older adults at discharge, and 1, 3 and 6 months post discharge

  * 2.A. To analyze a return on investment of MOVIN based on program costs and health utilization measures across different hospitals
* Specific Aim 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.

Eligibility criteria: 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

Primary outcomes:
measure: Aim 1: Change in gait speed
timeFrame: Within 24 hours of hospital admission, Within 8 hours of hospital discharge, 1 month post-discharge, 3 months post-discharge; Up to 4 months total
measure: Aim 1: Change in self-report on Activities of Daily Living (ADL)
timeFrame: 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
measure: Aim 1: Change in Life Space Assessment
timeFrame: 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
measure: Aim 2: Hospital Readmissions
timeFrame: 1 month post-discharge; 3 months post-discharge; 6 months post-discharge; Up to 7 months total
measure: Aim 2: Emergency Room Visits
timeFrame: 1 month post-discharge; 3 months post-discharge; 6 months post-discharge; Up to 7 months total
measure: Aim 2: Length of Hospital Stay
timeFrame: Within 3 months post-discharge; Up to 4 months total
measure: Aim 2: Discharge Destination
timeFrame: Within 3 months post-discharge; Up to 4 months total
measure: Aim 3: Distance of Patient Ambulation
timeFrame: 6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total
measure: Aim 3: Barriers to Ambulation Survey
timeFrame: pre-intervention, post-intervention (up to about 20 weeks)
measure: Aim 3: Ambulation Culture Survey
timeFrame: pre-intervention, post-intervention (up to about 20 weeks)
measure: Aim 3: Qualitative Assessment of Intervention Implementation
timeFrame: post-intervention (approximately 3-5 months after active intervention launch)
Secondary outcomes:
measure: Patient Satisfaction: Count of Participants With Satisfaction Responses to Never, Sometimes, Usually, Always Questions on HCAHPS
timeFrame: 6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total
measure: Patient Satisfaction: Count of Participants Answering Yes to items on the HCAPHS
timeFrame: 6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total
measure: Patient Satisfaction: Where Participants Went After Hospitalization
timeFrame: 6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total
measure: Patient Satisfaction: Hospital Experience Scores from 0-10 on HCAPHS
timeFrame: 6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total
measure: Patient Satisfaction: Count of Participants With Satisfaction Responses to Definitely no/Probably no/Probably yes/Definitely yes to the following question: Would you recommend this hospital to your friends and family?
timeFrame: 6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total
measure: Patient Satisfaction: Count of Participants With Responses to Strongly disagree/Disagree/Agree/Strongly agree questions on HCAHPS
timeFrame: 6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total
measure: Patient Satisfaction: Participant Experience Scores from 1-5 on HCAHPS
timeFrame: 6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total
measure: Aim 2: Physical Therapy (PT) Utilization
timeFrame: 6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total
measure: Aim 3: Frequency of Patient Ambulation (times per day)
timeFrame: 6 months pre-intervention, during the 14-week intervention period, and 6 months post-intervention; up to 16 months total
measure: Aim 3: Nurse Fatigue Survey
timeFrame: pre-intervention, post-intervention (up to about 20 weeks)
measure: Aim 3: Professional Quality of Life Survey
timeFrame: pre-intervention, post-intervention (up to about 20 weeks)
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Linsey M Steege, PhD
role: PRINCIPAL_INVESTIGATOR
References: