Choosing Wisely: De-implementing Fall Prevention Alarms in Hospitals
NCT ID: NCT06089239
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2023-10-01
2026-08-31
Brief Summary
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Detailed Description
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Alarm systems are designed to reduce falls by alerting staff when patients attempt to leave a bed or chair without assistance. There is now strong evidence that alarms are ineffective as a fall prevention maneuver in hospitals. Despite this, more than one-third of hospital patients are undergoing fall prevention alarm monitoring. In nursing homes, CMS regulates the use of fall prevention alarms as it does physical restraints. Instructions to nursing home surveyors state these devices should be used only when medically necessary and continuously reevaluated.
Guided by the Choosing Wisely De-implementation Framework, this project will generate a generalizable approach using coaching and tailored de-implementation strategies to reduce use of fall prevention alarms in hospitals. The investigators will conduct a hybrid II implementation study in 30 medical or medical-surgical units from US non-federal hospitals participating in the National Database of Nursing Quality Indicators. Findings from this study could also support future trials aimed at de-implementing low-quality alarm use in other care settings with known high fall rates (e.g., stroke care, cancer care). Evaluation of high versus low intensity coaching addresses an urgent need to evaluate use of tailored strategies and to establish effective thresholds for coaching within health service settings that have varying resources to support de-implementation efforts
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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High Intensity Coaching
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.
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
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.
Low 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).
Interventions
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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
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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Ronald I Shorr, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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PIH Health Downey Hospital
Downey, California, United States
El Camino Health - Los Gatos
Mountain View, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
OSF Saint Anthony's Health Center
Alton, Illinois, United States
Central DuPage Hospital
Winfield, Illinois, United States
Hendricks Regional Health
Danville, Indiana, United States
IU Health North Hospital
Indianapolis, Indiana, United States
UMass Memorial Health Harrington
Southbridge, Massachusetts, United States
Henry Ford Hospital West Bloomfield
West Bloomfield, Michigan, United States
Lahey Hospital & Medical Center
Derry, New Hampshire, United States
Hunterdon Medical Center
Flemington, New Jersey, United States
Raritan Bay Medical Center
New Brunswick, New Jersey, United States
Greenwich Hospital
River Vale, New Jersey, United States
St Peter's Health Samaritan Hospital
Albany, New York, United States
Grant Medical Center
Columbus, Ohio, United States
Barberton Hospital
Uniontown, Ohio, United States
Kaiser Westside Medical Center
Hillsboro, Oregon, United States
Kaiser Permanente - Sunnyside Medical Center
Woodburn, Oregon, United States
Christiana Care
West Chester, Pennsylvania, United States
Kent Hospital
Warwick, Rhode Island, United States
Prisma Health
Irmo, South Carolina, United States
St. David's Medical Center
Austin, Texas, United States
Covenant Medical Center
Lubbock, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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CED000000718
Identifier Type: -
Identifier Source: org_study_id
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