ImmobilityAMP SWTNCT05021679
AMP Step Wedge Trial
A study testing AMP Implementation in people with Immobility and Disability, run by Johns Hopkins University at 1 site in United States.
Trial summary
Annually, more than 35 million patients are hospitalized in the United States. Many of these will experience hospital-acquired loss of physical functioning due to a lack of mobility during their in-patient stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immobility, Disability
- What is being tested?
- AMP Implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,676 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Apr 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients admitted to study hospital unit
- Analysis will only include those with lengths of stay >=3 days
Who cannot join
- Patients with active do-not-resuscitate (DNR) order
- <18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Activity and Mobility Promotion (AMP): Implementation and Impact of a Multifaceted Intervention to Increase Mobility in Hospital Patients
Annually, more than 35 million patients are hospitalized in the United States. Many of these will experience hospital-acquired loss of physical functioning due to a lack of mobility during their in-patient stay. Such loss includes difficulties performing basic activities, such as rising from a chair, toileting, or ambulating. This loss of function may increase hospital length of stay (LOS), nursing home placement, and decrease mobility and participation in community activities even years after hospitalization. Prevention of this hospital-acquired functional loss is critical. Even the sickest hospitalized patients (e.g., those in the intensive care unit [ICU]), can safely and feasibly benefit from early mobilization. In the non-ICU setting there is evidence that patient mobilization reduces LOS and hospital costs, while improving patient satisfaction and physical and psychological outcomes. The overall objective of this proposed project is to evaluate the implementation and impact of a transdisciplinary and multifaceted mobility program (Johns Hopkins Activity and Mobility Promotion - AMP) on clinical outcomes among hospitalized adults. In addition to clinical outcomes, we will identify barriers and facilitators to high-performance program adoption. Results of this project will provide critical new insights on the effectiveness of AMP and inform dissemination and implementation nationwide.
- Conditions
- Immobility, Disability
- Being tested
- AMP Implementation
- Keywords
- Activity, Mobility, Hospital-acquired disability
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMP ImplementationOther
Each study site will implement the Johns Hopkins AMP program at different times. The AMP program includes nursing staff training on the goals of AMP, how to complete mobility-focused outcome measures, set mobility goals, and to safely mobilize/ambulate patients. The AMP program also includes embedding these outcome measures and mobility goals into electronic medical records and producing weekly/monthly reports that show how often nursing staff score patient mobility and help patients meet daily activity goals.
| Study group | Role | What they receive |
|---|---|---|
| AMP Implementation | Experimental | Not described Receives: Other: AMP Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients meeting daily mobility goal
Mobility goal is set and measured using the Johns Hopkins Highest Level of Mobility (JH-HLM) Scale
Measured: 39 months
% of patients with mobility measurements documented daily
Mobility documentation to include Activity Measure for Post-Acute Care (AM-PAC) and JH-HLM
Measured: 39 months
% of patients receiving physical and/or occupational therapy consults
To be extracted from electronic medical record
Measured: 39 months
Secondary outcomes (6)
Hospital length of stay (days)
To be extracted from electronic medical record
Measured: 39 months
Discharge disposition status
Count of where patients are discharged to (e.g,. home, inpatient rehab unit) assessed by extraction from electronic medical record.
Measured: 39 months
Number of physical and occupational therapy visits received during inpatient stay
To be extracted from electronic medical record
Measured: 39 months
Number of hospital-acquired morbidities
Includes falls, pressure injury, and venous thromboembolism. To be extracted from electronic medical record
Measured: 39 months
Number of patients with 30-day readmissions
To be extracted from electronic medical record
Measured: 39 months
Employee injuries resulting from patient mobilization
Number of employee injuries from facilitating patient mobility as assessed by medical record extraction
Measured: 39 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Jan 2021
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmobilityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Step-wedge clinical trial
- Masking
- None (open label)
- Enrolment
- 16,676 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sapna Kudchadkar, MD, Principal investigator, Johns Hopkins UniversityErik Hoyer, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021679
- Sponsor's protocol ID
- IRB00270215
- Acronym
- AMP SWT
- Status last verified
- Apr 2024
- First submitted
- 16 Aug 2021
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity and Mobility Promotion (AMP): Implementation and Impact of a Multifaceted Intervention to Increase Mobility in Hospital Patients
- ClinicalTrials.gov ID
- NCT05021679
- Acronym / sponsor ID
- AMP SWT / IRB00270215
- Conditions
- Immobility, Disability
- Keywords
- Activity, Mobility, Hospital-acquired disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16,676 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 25 Aug 2021 (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.
Annually, more than 35 million patients are hospitalized in the United States. Many of these will experience hospital-acquired loss of physical functioning due to a lack of mobility during their in-patient stay. Such loss includes difficulties performing basic activities, such as rising from a chair, toileting, or ambulating. This loss of function may increase hospital length of stay (LOS), nursing home placement, and decrease mobility and participation in community activities even years after hospitalization. Prevention of this hospital-acquired functional loss is critical. Even the sickest hospitalized patients (e.g., those in the intensive care unit [ICU]), can safely and feasibly benefit from early mobilization. In the non-ICU setting there is evidence that patient mobilization reduces LOS and hospital costs, while improving patient satisfaction and physical and psychological outcomes. The overall objective of this proposed project is to evaluate the implementation and impact of a transdisciplinary and multifaceted mobility program (Johns Hopkins Activity and Mobility Promotion - AMP) on clinical outcomes among hospitalized adults. In addition to clinical outcomes, we will identify barriers and facilitators to high-performance program adoption. Results of this project will provide critical new insights on the effectiveness of AMP and inform dissemination and implementation nationwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Step-wedge clinical trial
| Arm | Type | Receives |
|---|---|---|
| AMP Implementation | Experimental | Other: AMP Implementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients admitted to study hospital unit
- Analysis will only include those with lengths of stay >=3 days
Key exclusion criteria (2 listed)
- Patients with active do-not-resuscitate (DNR) order
- <18 years old
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 |
|---|---|---|
| AMP ImplementationEach study site will implement the Johns Hopkins AMP program at different times. The AMP program includes nursing staff training on the goals of AMP, how to complete mobility-focused outcome measures, set mobility goals, and to safely mobilize/ambulate patients. The AMP program also includes embedding these outcome measures and mobility goals into electronic medical records and producing weekly/monthly reports that show how often nursing staff score patient mobility and help patients meet daily activity goals. | Other | AMP Implementation |
Primary outcome
% of patients meeting daily mobility goal
Time frame: 39 months
Mobility goal is set and measured using the Johns Hopkins Highest Level of Mobility (JH-HLM) Scale
% of patients with mobility measurements documented daily
Time frame: 39 months
Mobility documentation to include Activity Measure for Post-Acute Care (AM-PAC) and JH-HLM
% of patients receiving physical and/or occupational therapy consults
Time frame: 39 months
To be extracted from electronic medical record
6 secondary outcomes
Hospital length of stay (days)
Time frame: 39 months
Discharge disposition status
Time frame: 39 months
Number of physical and occupational therapy visits received during inpatient stay
Time frame: 39 months
Number of hospital-acquired morbidities
Time frame: 39 months
Number of patients with 30-day readmissions
Time frame: 39 months
Employee injuries resulting from patient mobilization
Time frame: 39 months
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 25 Apr 2024.
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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.
Sapna Kudchadkar, MD principal investigator
Johns Hopkins University
Erik Hoyer, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMP Implementation in people with Immobility and Disability, run by Johns Hopkins University 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 2 inclusion and 2 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 25 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?
% of patients meeting daily mobility goal (time frame: 39 months). 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 25 Apr 2024.