- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05021679
AMP Step Wedge Trial (AMP SWT)
April 23, 2024 updated by: Johns Hopkins University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16676
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- All adult patients admitted to study hospital unit
- Analysis will only include those with lengths of stay >=3 days
Exclusion Criteria:
- Patients with active do-not-resuscitate (DNR) order
- <18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AMP Implementation
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
% 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
|
39 months
|
|
% 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
|
39 months
|
|
% of patients receiving physical and/or occupational therapy consults
Time Frame: 39 months
|
To be extracted from electronic medical record
|
39 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital length of stay (days)
Time Frame: 39 months
|
To be extracted from electronic medical record
|
39 months
|
|
Discharge disposition status
Time Frame: 39 months
|
Count of where patients are discharged to (e.g,.
home, inpatient rehab unit) assessed by extraction from electronic medical record.
|
39 months
|
|
Number of physical and occupational therapy visits received during inpatient stay
Time Frame: 39 months
|
To be extracted from electronic medical record
|
39 months
|
|
Number of hospital-acquired morbidities
Time Frame: 39 months
|
Includes falls, pressure injury, and venous thromboembolism.
To be extracted from electronic medical record
|
39 months
|
|
Number of patients with 30-day readmissions
Time Frame: 39 months
|
To be extracted from electronic medical record
|
39 months
|
|
Employee injuries resulting from patient mobilization
Time Frame: 39 months
|
Number of employee injuries from facilitating patient mobility as assessed by medical record extraction
|
39 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sapna Kudchadkar, MD, Johns Hopkins University
- Principal Investigator: Erik Hoyer, PhD, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
April 1, 2024
Study Completion (Actual)
April 1, 2024
Study Registration Dates
First Submitted
August 16, 2021
First Submitted That Met QC Criteria
August 24, 2021
First Posted (Actual)
August 25, 2021
Study Record Updates
Last Update Posted (Actual)
April 25, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00270215
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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