Early MobilityMOVINNCT03887572
Adaption of Mobilizing Older Adult Patients Via a Systems-based Intervention for a Non-Academic Hospital
An observational study of Early Mobility and Older Adults, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This observational study is designed to adapt, create actionable implementation, and to access market demand of the Mobilizing Older adults Via a systems-based Intervention (MOVIN) toolkit. MOVIN is a program to increase ambulation while hospitalized at non-academic facilities. MOVIN is a unit-based intervention. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Early Mobility, Older Adults, Hospital Acquired Condition
- What is being tested?
- MOVIN
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2019to 4 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients admitted to the study intervention unit will be recruited to evaluate the implementation of MOVIN based on Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM framework). Patients (N=40) will be recruited during pre (n=20) and post (n=20)-intervention periods to provide an evaluation of effectiveness. Inclusion criteria for patients will consist of age 65 years or older, able to walk with or without assistance, have an ambulation order, and able to speak and understand English.
Who may be able to join
- age 65 years or older
- able to walk with or without assistance
- absence of a medical order for bedrest or activity restriction
- have an ambulation order
- able to speak and understand English.
Who cannot join
- activated Power of Attorney
- a score of 11+ on Orientation Memory Cognition Test (OMCT)
- a score <2 on a Mini Cog
- lower extremity amputation
- terminal diagnosis (Comfort Care)
- on hospice
- bed rest order
- wheelchair bound
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
About this study
Official title: Getting Older Patients Walking: Adaption of MOVIN (Mobilizing Older Adult Patients Via a Systems-based INtervention) for Implementation in a Non-Academic Hospital
This observational study is designed to adapt, create actionable implementation, and to access market demand of the Mobilizing Older adults Via a systems-based Intervention (MOVIN) toolkit. MOVIN is a program to increase ambulation while hospitalized at non-academic facilities. 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 40 total hospitalized participants 65 years and older for the duration of their stay.
Read the 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, our research has identified multiple personal and organizational barriers that prevent nurses from walking patients. We 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. Our 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.
Our goal is to translate our positive research results into an actionable implementation package that can be used to disseminate MOVIN to hospitals nationwide and improve the quality of care and functional outcomes for older adult patients. In pursuit of this goal, our specific aims are to:
- Adapt MOVIN and develop and refine a MOVIN toolkit for implementation in a non-academic hospital.
- Implement MOVIN in an inpatient adult general medical unit in a non-academic hospital with an on-site clinical team leading the intervention and evaluate using the RE-AIM framework to collect preliminary data for a future dissemination study.
- Assess market demand for the intervention and develop a customer value statement in collaboration with the ICTR Dissemination and Implementation Program.
- Conditions
- Early Mobility, Older Adults, Hospital Acquired Condition
- Being tested
- MOVIN
- Medical subject headings
- Iatrogenic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVINOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention/control | 20 older adult patients (age 65 or older) will be recruited over 3 months prior to implementation of the unit-based MOVIN intervention. | |
| Post-intervention | 20 older adult patients (age 65 or older) will be recruited over 3 months after MOVIN has been implemented on the unit for a period of 12-14 weeks. Receives: Other: MOVIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait speed
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. 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. Change scores will be calculated as the difference between gait speeds measured at each of these time points.
Measured: Hospital admission, hospital discharge, 3 months post-discharge; Up to 4 months total
Change in Self-report on Katz Activity of Daily Living (ADL) Index
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. 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). The scale demonstrates excellent reliability and predictive validity, and is sensitive to change in hospital settings. Change scores will be calculated as the difference between gait speeds measured at each of these time points.
Measured: Hospital admission, hospital discharge, 1 month post-discharge, 3 months post-discharge; Up to 4 months total
Change in Life Space Assessment
A trained member of the research team will collect patients self-report on Life Space at 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. The UAB Life Space Assessment: 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. Change scores will be calculated as the difference between gait speeds measured at each of these time points.
Measured: Hospital admission, hospital discharge, 1 month post-discharge, 3 months post-discharge; Up to 4 months total
Secondary outcomes (16)
Patient Experience with Ambulation
Brief interviews will be conducted to further examine and understand the patient experience with ambulation on the inpatient unit.
Measured: 1 month post-discharge; Up to 2 months total
Age
Age in years will be collected via patient medical record review by a nurse researcher from the study team.
Measured: Within 3 months post-discharge; Up to 4 months total
Gender
Gender will be collected via patient medical record review by a nurse researcher from the study team
Measured: Within 3 months post-discharge; Up to 4 months total
Race
Race will be collected via patient medical record review by a nurse researcher from the study team.
Measured: Within 3 months post-discharge; Up to 4 months total
Ethnicity
Ethnicity will be collected via patient medical record review by a nurse researcher from the study team.
Measured: Within 3 months post-discharge; Up to 4 months total
Social support
Social support (defined as: living alone, living with another, presence of a caregiver, use of home care services) will be collected via patient medical record review by a nurse researcher from the study team.
Measured: Post-discharge; Up to 1 month
Location admitted from
Location admitted from (defined as: home, assisted living, nursing home, other hospital, other inpatient unit) will be collected via patient medical record review by a nurse researcher from the study team.
Measured: Within 3 months post-discharge; Up to 4 months total
Reason for admission
Reason for admission will be collected via patient medical record review by a nurse researcher from the study team.
Measured: Within 3 months post-discharge; Up to 4 months total
Use of an ambulation assistive device
Use of an ambulation assistive device (including, walker, cane, wheelchair) will be collected via patient medical record review by a nurse researcher from the study team.
Measured: Within 3 months post-discharge; Up to 4 months total
Presence of external lines
Presence of external lines (Foley catheter, intravenous lines, supplemental oxygen, drainage tubes) will be collected via patient medical record review by a nurse researcher from the study team.
Measured: Within 3 months post-discharge; Up to 4 months total
Body Mass Index
Body Mass Index will be collected via patient medical record review by a nurse researcher from the study team.
Measured: Within 3 months post-discharge; Up to 4 months total
Fall risk
Documentation of fall risk status will be collected via patient medical record review by a nurse researcher from the study team.
Measured: Within 3 months post-discharge; Up to 4 months total
Fall reported
Whether or not a fall was reported during the hospital stay will be collected via patient medical record review by a nurse researcher from the study team.
Measured: Within 3 months post-discharge; Up to 4 months total
Length of stay
Length of hospital stay will be collected via patient medical record review by a nurse researcher from the study team.
Measured: Within 3 months post-discharge; Up to 4 months total
Discharge destination
Discharge destination (home, skilled nursing facility) will be collected via patient medical record review by a nurse researcher from the study team.
Measured: Within 3 months post-discharge; Up to 4 months total
Charlson Comorbidity Index
This index will be calculated via chart review by a nurse researcher member of the study team.
Measured: Within 3 months post-discharge; Up to 4 months total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start4 Mar 2019
- Primary completion4 Feb 2020
- Study completion4 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early MobilityStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Linsey M Steege, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887572
- Sponsor's protocol ID
- 2018-1025
- Other IDs
- A545000, NUR/FACULTY AFFAIRS/ADMIN, 1UL1TR002373-01
- Acronym
- MOVIN
- Status last verified
- Apr 2024
- First submitted
- 14 Mar 2019
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Getting Older Patients Walking: Adaption of MOVIN (Mobilizing Older Adult Patients Via a Systems-based INtervention) for Implementation in a Non-Academic Hospital
- ClinicalTrials.gov ID
- NCT03887572
- Acronym / sponsor ID
- MOVIN / 2018-1025
- Conditions
- Early Mobility, Older Adults, Hospital Acquired Condition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences, National Institutes of Health (NIH)
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study is designed to adapt, create actionable implementation, and to access market demand of the Mobilizing Older adults Via a systems-based Intervention (MOVIN) toolkit. MOVIN is a program to increase ambulation while hospitalized at non-academic facilities. 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 40 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, our research has identified multiple personal and organizational barriers that prevent nurses from walking patients. We 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. Our 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.
Our goal is to translate our positive research results into an actionable implementation package that can be used to disseminate MOVIN to hospitals nationwide and improve the quality of care and functional outcomes for older adult patients. In pursuit of this goal, our specific aims are to:
- Adapt MOVIN and develop and refine a MOVIN toolkit for implementation in a non-academic hospital.
- Implement MOVIN in an inpatient adult general medical unit in a non-academic hospital with an on-site clinical team leading the intervention and evaluate using the RE-AIM framework to collect preliminary data for a future dissemination study.
- Assess market demand for the intervention and develop a customer value statement in collaboration with the ICTR Dissemination and Implementation Program.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention/control | – | –20 older adult patients (age 65 or older) will be recruited over 3 months prior to implementation of the unit-based MOVIN intervention. |
| Post-intervention | – | Other: MOVIN20 older adult patients (age 65 or older) will be recruited over 3 months after MOVIN has been implemented on the unit for a period of 12-14 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients admitted to the study intervention unit will be recruited to evaluate the implementation of MOVIN based on Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM framework). Patients (N=40) will be recruited during pre (n=20) and post (n=20)-intervention periods to provide an evaluation of effectiveness. Inclusion criteria for patients will consist of age 65 years or older, able to walk with or without assistance, have an ambulation order, and able to speak and understand English.
Key inclusion criteria (5 listed)
- age 65 years or older
- able to walk with or without assistance
- absence of a medical order for bedrest or activity restriction
- have an ambulation order
- able to speak and understand English.
Key exclusion criteria (8 listed)
- activated Power of Attorney
- a score of 11+ on Orientation Memory Cognition Test (OMCT)
- a score <2 on a Mini Cog
- lower extremity amputation
- terminal diagnosis (Comfort Care)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOVINMOVIN 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. | Other | Post-intervention |
Primary outcome
Change in gait speed
Time frame: Hospital admission, hospital discharge, 3 months post-discharge; Up to 4 months total
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. 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. Change scores will be calculated as the difference between gait speeds measured at each of these time points.
Change in Self-report on Katz Activity of Daily Living (ADL) Index
Time frame: Hospital admission, hospital discharge, 1 month post-discharge, 3 months post-discharge; Up to 4 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. 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). The scale demonstrates excellent reliability and predictive validity, and is sensitive to change in hospital settings. Change scores will be calculated as the difference between gait speeds measured at each of these time points.
Change in Life Space Assessment
Time frame: Hospital admission, hospital discharge, 1 month post-discharge, 3 months post-discharge; Up to 4 months total
A trained member of the research team will collect patients self-report on Life Space at 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. The UAB Life Space Assessment: 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. Change scores will be calculated as the difference between gait speeds measured at each of these time points.
16 secondary outcomes
Patient Experience with Ambulation
Time frame: 1 month post-discharge; Up to 2 months total
Age
Time frame: Within 3 months post-discharge; Up to 4 months total
Gender
Time frame: Within 3 months post-discharge; Up to 4 months total
Race
Time frame: Within 3 months post-discharge; Up to 4 months total
Ethnicity
Time frame: Within 3 months post-discharge; Up to 4 months total
Social support
Time frame: Post-discharge; Up to 1 month
Location admitted from
Time frame: Within 3 months post-discharge; Up to 4 months total
Reason for admission
Time frame: Within 3 months post-discharge; Up to 4 months total
Use of an ambulation assistive device
Time frame: Within 3 months post-discharge; Up to 4 months total
Presence of external lines
Time frame: Within 3 months post-discharge; Up to 4 months total
Body Mass Index
Time frame: Within 3 months post-discharge; Up to 4 months total
Fall risk
Time frame: Within 3 months post-discharge; Up to 4 months total
Fall reported
Time frame: Within 3 months post-discharge; Up to 4 months total
Length of stay
Time frame: Within 3 months post-discharge; Up to 4 months total
Discharge destination
Time frame: Within 3 months post-discharge; Up to 4 months total
Charlson Comorbidity Index
Time frame: Within 3 months post-discharge; Up to 4 months total
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linsey M Steege, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Mobility and Older Adults, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait speed (time frame: Hospital admission, hospital discharge, 3 months post-discharge; Up to 4 months total). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.