Choosing Wisely: De-implementing Fall Prevention Alarms in Hospitals

Not Applicable

Recruiting

• Conditions: Hospital Acquired Condition; Clinical Alarms; Accidental Fall; Patient Safety; Mentoring

• Registration Number: NCT06089239
• Lead Sponsor: University of Florida

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.

Detailed Description

Inpatient falls result in significant physical and economic burdens to patients (increased injury and mortality rates and decreased quality of life) as well as to medical organizations (increased lengths of stay, medical care costs, and litigation). The Centers for Medicare \& Medicaid Services (CMS) considers falls with injury a "never event"- an error in medical care that indicates a real problem in the safety and credibility of a health care institution. Hospitals are no longer reimbursed for extra costs incurred in the diagnosis and management of inpatient fall-related injuries. Thus, because patient falls are common, costly and interpreted as poor care quality, hospitals are highly incentivized to prevent them.

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

Study Timeline

• Study First Submitted: 2023-09-18
• Study Start: 2023-10-01
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-18
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-16
• Primary Completion: 2026-02-02
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Falls	monthly for 30 months	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.
Fall Prevention Alarm Prevalence survey	monthly for 30 months	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.

Trial Locations

Locations (24)

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

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