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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06089239
Other study ID # CED000000718
Secondary ID R01AG073408-01A1
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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: -

Study Design


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
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