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临床试验/NCT04479943
NCT04479943已完成不适用

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

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 765 人开始时间: 2021年3月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
765
试验地点
1
主要终点
Aim 2: Hospital Readmissions

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

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.

干预措施: MOVIN (Other)

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.

干预措施: Surveys and Focus groups (Other)

结局指标

主要结局

Aim 2: Hospital Readmissions

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

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.

Aim 2: Discharge Destination

时间窗: Within 3 months post-discharge; Up to 4 months total

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.

Aim 3: Distance of Patient Ambulation

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

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.

Aim 3: Ambulation Culture Survey

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

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.

Aim 3: Barriers to Ambulation Survey

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

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.

Aim 1: Change in Gait Speed

时间窗: 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.

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

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

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.

Aim 1: Change in Life Space Assessment

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

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.

Aim 2: Emergency Department Visits

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

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.

Aim 2: Length of Hospital Stay

时间窗: During hospital stay in the Pre-Intervention and Post-Intervention periods

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

次要结局

  • 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))
  • Aim 3: Professional Quality of Life Survey: Burnout(pre-intervention, post-intervention (up to about 20 weeks))
  • Aim 3: Professional Quality of Life Survey: Secondary Traumatic Stress(pre-intervention, post-intervention (up to about 20 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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