NCT06089239

Brief Summary

This is a Hybrid II de-implementation study to reduce use of fall prevention alarms in hospitals. The intervention consists of tailored, site-specific approaches for three core implementation strategies: education, audit/feedback and opinion leaders. Hospital units will be randomized to low-intensity or high-intensity coaching for the implementation of the tailored strategies.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

24 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Oct 2023Aug 2026

First Submitted

Initial submission to the registry

September 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

2.3 years

First QC Date

September 18, 2023

Last Update Submit

July 14, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Fall Prevention Alarm Prevalence survey

    Number of Patients in a study unit with fall prevention alarm activated divided by the number of patients evaluated. This is assessed monthly and is expressed as the proportion of patients assessed with fall prevention alarm activated. This is not a time to event outcome. This measure will be recorded monthly for 30 months during both baseline and intervention periods.

    monthly for 30 months

  • Patient Falls

    Patients on participating units are monitored for falls beginning the date/time they are admitted to the date/time they are discharged from the study unit. Falls are determined using National Database of Nursing Quality Indicators (NDNQI) protocols. Patients may contribute one or more falls during their stay. This is expressed as the Number of Patients who fell/1000 bed days of care. This measure will be recorded monthly for 30 months during both baseline and intervention periods.

    monthly for 30 months

Study Arms (2)

High Intensity Coaching

ACTIVE COMPARATOR

In Quarter 1, high intensity initiation coaching will consist of a four-hour orientation session that will include: * comprehensive information on behavior and organizational change theory, * suggested approaches, and * in-depth training on behavioral and organization-focused change techniques to stimulate implementation efforts. Commencing in Quarter 2, high intensity sustainability coaching will consist of: * weekly virtual follow up sessions for the first month, followed by private monthly coaching follow up sessions via a virtual format. * Access to additional monthly web-based, synchronous "office hours" for group discussion on progress and customized troubleshooting to assist in navigating barriers. * Sites will also have access to "on call" assistance with coaches to assist with navigating challenges in real time.

Other: High Intensity Coaching

Low Intensity Coaching

SHAM COMPARATOR

In Quarter 1, low intensity initiation coaching will be conducted. It will consist of: * initial two-hour orientation session with introductory content on behavior change and organizational change theory and techniques, * an overview of implementation phases, and * selection of tailored de-implementation strategies for that site based on readiness for change, focus group data and local resources. Implementation coaches will provide the Fuld Toolkit for the site with suggestions for assigning strategies, local leaders, and development of timelines for de-implementation. Coaches will instruct site Team Leaders to establish the primary mechanism for sharing baseline and trended data in real time.

Other: Low Intensity Coaching

Interventions

External coaching is a commonly used strategy to change practice, especially for multi-site collaboratives where implementation requires customization to the site. Coaches serve as skill builders who train organizational personnel in quality improvement processes and develop proficiency in the targeted practice area (i.e., fall prevention).

High Intensity Coaching

External coaching is a commonly used strategy to change practice, especially for multi-site collaboratives where implementation requires customization to the site. Coaches serve as skill builders who train organizational personnel in quality improvement processes and develop proficiency in the targeted practice area (i.e., fall prevention).

Low Intensity Coaching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stakeholders in fall prevention at up to 30 participating NDNQI hospitals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

PIH Health Downey Hospital

Downey, California, 90241, United States

RECRUITING

El Camino Health - Los Gatos

Mountain View, California, 94040, United States

RECRUITING

University of California Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

Lakeland Regional Medical Center

Lakeland, Florida, 33809, United States

WITHDRAWN

OSF Saint Anthony's Health Center

Alton, Illinois, 62002, United States

WITHDRAWN

Central DuPage Hospital

Winfield, Illinois, 60190, United States

RECRUITING

Hendricks Regional Health

Danville, Indiana, 46122, United States

RECRUITING

IU Health North Hospital

Indianapolis, Indiana, 46256, United States

RECRUITING

UMass Memorial Health Harrington

Southbridge, Massachusetts, 01550, United States

RECRUITING

Henry Ford Hospital West Bloomfield

West Bloomfield, Michigan, 48322, United States

RECRUITING

Lahey Hospital & Medical Center

Derry, New Hampshire, 03038, United States

RECRUITING

Hunterdon Medical Center

Flemington, New Jersey, 08822, United States

RECRUITING

Raritan Bay Medical Center

New Brunswick, New Jersey, 08861, United States

RECRUITING

Greenwich Hospital

River Vale, New Jersey, 07675, United States

WITHDRAWN

St Peter's Health Samaritan Hospital

Albany, New York, 12208, United States

RECRUITING

Grant Medical Center

Columbus, Ohio, 43215, United States

RECRUITING

Barberton Hospital

Uniontown, Ohio, 44685, United States

RECRUITING

Kaiser Westside Medical Center

Hillsboro, Oregon, 97124, United States

RECRUITING

Kaiser Permanente - Sunnyside Medical Center

Woodburn, Oregon, 97071, United States

RECRUITING

Christiana Care

West Chester, Pennsylvania, 19382, United States

WITHDRAWN

Kent Hospital

Warwick, Rhode Island, 02886, United States

RECRUITING

Prisma Health

Irmo, South Carolina, 29063, United States

RECRUITING

St. David's Medical Center

Austin, Texas, 78703, United States

RECRUITING

Covenant Medical Center

Lubbock, Texas, 79410, United States

RECRUITING

Related Publications (1)

  • Turner K, McNett M, Potter C, Cramer E, Al Taweel M, Shorr RI, Mion LC. Alarm with care-a de-implementation strategy to reduce fall prevention alarm use in US hospitals: a study protocol for a hybrid 2 effectiveness-implementation trial. Implement Sci. 2023 Dec 5;18(1):70. doi: 10.1186/s13012-023-01325-9.

MeSH Terms

Conditions

Iatrogenic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ronald I Shorr, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronald I Shorr, MD, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2023

First Posted

October 18, 2023

Study Start

October 1, 2023

Primary Completion

February 2, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations