## Protocol Section
### Identification Module
**NCT ID:** NCT05021679

**Acronym:** AMP SWT

**Brief Title:** AMP Step Wedge Trial

**Official Title:** Activity and Mobility Promotion (AMP): Implementation and Impact of a Multifaceted Intervention to Increase Mobility in Hospital Patients

#### Organization Study ID Info
**ID:** IRB00270215
#### Organization
**Class:** OTHER
**Full Name:** Johns Hopkins University
### Status Module
#### Completion Date
**Date:** 2024-04-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-25

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-01

**Type:** ACTUAL

#### Start Date
**Date:** 2021-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2021-08-25
**Type:** ACTUAL
**Study First Submit Date:** 2021-08-16
**Study First Submit QC Date:** 2021-08-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Johns Hopkins University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Immobility

- Disability

**Keywords:**

- Activity

- Mobility

- Hospital-acquired disability

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Step-wedge clinical trial

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 16676

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: AMP Implementation

**Label:** AMP Implementation

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- AMP Implementation

**Description:** 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.

**Name:** AMP Implementation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Mobility goal is set and measured using the Johns Hopkins Highest Level of Mobility (JH-HLM) Scale

**Measure:** % of patients meeting daily mobility goal

**Time Frame:** 39 months

**Description:** Mobility documentation to include Activity Measure for Post-Acute Care (AM-PAC) and JH-HLM

**Measure:** % of patients with mobility measurements documented daily

**Time Frame:** 39 months

**Description:** To be extracted from electronic medical record

**Measure:** % of patients receiving physical and/or occupational therapy consults

**Time Frame:** 39 months

#### Secondary Outcomes

**Description:** To be extracted from electronic medical record

**Measure:** Hospital length of stay (days)

**Time Frame:** 39 months

**Description:** Count of where patients are discharged to (e.g,. home, inpatient rehab unit) assessed by extraction from electronic medical record.

**Measure:** Discharge disposition status

**Time Frame:** 39 months

**Description:** To be extracted from electronic medical record

**Measure:** Number of physical and occupational therapy visits received during inpatient stay

**Time Frame:** 39 months

**Description:** Includes falls, pressure injury, and venous thromboembolism. To be extracted from electronic medical record

**Measure:** Number of hospital-acquired morbidities

**Time Frame:** 39 months

**Description:** To be extracted from electronic medical record

**Measure:** Number of patients with 30-day readmissions

**Time Frame:** 39 months

**Description:** Number of employee injuries from facilitating patient mobility as assessed by medical record extraction

**Measure:** Employee injuries resulting from patient mobilization

**Time Frame:** 39 months

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Baltimore

**Country:** United States

**Facility:** Johns Hopkins Hospital

**State:** Maryland

**Zip:** 21287

#### Overall Officials

**Official 1:**

**Affiliation:** Johns Hopkins University

**Name:** Sapna Kudchadkar, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Johns Hopkins University

**Name:** Erik Hoyer, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
