De-Implementing Fall Prevention Alarms in Hospitals

Patient Safety Clinical Trial

Official title:

De-Implementing Fall Prevention Alarms in Hospitals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06089239
• Other study ID #: CED000000718
• Secondary ID: R01AG073408-01A1
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: Ronald I Shorr, MD, MS
• Phone: 352-271-5001
• Email: rshorr[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 31, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Accidental Fall
• Clinical Alarms
• Hospital Acquired Condition
• Iatrogenic Disease
• Mentoring
• Patient Safety

Intervention

Other:
• 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).

Locations

Country	Name	City	State
United States	St Peter's Health Samaritan Hospital	Albany	New York
United States	OSF Saint Anthony's Health Center	Alton	Illinois
United States	St. David's Medical Center	Austin	Texas
United States	Grant Medical Center	Columbus	Ohio
United States	Hendricks Regional Health	Danville	Indiana
United States	Lahey Hospital & Medical Center	Derry	New Hampshire
United States	PIH Health Downey Hospital	Downey	California
United States	Hunterdon Medical Center	Flemington	New Jersey
United States	Kaiser Westside Medical Center	Hillsboro	Oregon
United States	IU Health North Hospital	Indianapolis	Indiana
United States	Prisma Health	Irmo	South Carolina
United States	Lakeland Regional Medical Center	Lakeland	Florida
United States	Covenant Medical Center	Lubbock	Texas
United States	El Camino Health - Los Gatos	Mountain View	California
United States	Raritan Bay Medical Center	New Brunswick	New Jersey
United States	Greenwich Hospital	River Vale	New Jersey
United States	University of California Davis Medical Center	Sacramento	California
United States	UMass Memorial Health Harrington	Southbridge	Massachusetts
United States	Barberton Hospital	Uniontown	Ohio
United States	Kent Hospital	Warwick	Rhode Island
United States	Henry Ford Hospital West Bloomfield	West Bloomfield	Michigan
United States	Christiana Care	West Chester	Pennsylvania
United States	Central DuPage Hospital	Winfield	Illinois
United States	Kaiser Permanente - Sunnyside Medical Center	Woodburn	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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