AMP Step Wedge Trial

NCT05021679 | Completed

• 1 other identifier: IRB00270215
• Study Type: interventional
• Target: 16,676
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Activity; Mobility; Hospital-acquired disability

Outcome Measures

Primary Outcomes (3)

• % of patients meeting daily mobility goal

  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

  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

  To be extracted from electronic medical record

  39 months

Secondary Outcomes (6)

• Hospital length of stay (days)

  39 months

• Discharge disposition status

  39 months

• Number of physical and occupational therapy visits received during inpatient stay

  39 months

• Number of hospital-acquired morbidities

  39 months

• Number of patients with 30-day readmissions

  39 months

Study Arms (1)

AMP Implementation

EXPERIMENTAL

Other: AMP Implementation

Interventions

AMP Implementation OTHER

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.

AMP Implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients admitted to study hospital unit
• Analysis will only include those with lengths of stay \>=3 days

You may not qualify if:

• Patients with active do-not-resuscitate (DNR) order
• \<18 years old

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Sapna Kudchadkar, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Erik Hoyer, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Step-wedge clinical trial

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 25, 2021
• Study Start: January 1, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

US (1)