AMP Step Wedge Trial

NCT ID: NCT05021679

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16676 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-04-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AMP Implementation

Group Type: EXPERIMENTAL

AMP Implementation

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sapna Kudchadkar, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Erik Hoyer, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00270215

Identifier Type: -

Identifier Source: org_study_id