Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
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.
  • 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).
Sham Comparator
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.
  • Other: 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).

Recruiting Locations

PIH Health Downey Hospital
Downey, California 90241
Contact:
Silvia Hernandez
silvia.hernandez@pihhealth.org

El Camino Health - Los Gatos
Mountain View, California 94040
Contact:
Ann Aquino
Ann_Aquino@elcaminohealth.org

University of California Davis Medical Center
Sacramento, California 95817
Contact:
Stacy Henever
srhevener@ucdavis.edu

Central DuPage Hospital
Winfield, Illinois 60190
Contact:
Mary Fran Oskvarek
maryfran.oskvarek@nm.org

Hendricks Regional Health
Danville, Indiana 46122
Contact:
Hannah Wyneken
hannah.wyneken@hendricks.org

IU Health North Hospital
Indianapolis, Indiana 46256
Contact:
Amy Leach
apollard4@iuhealth.org

UMass Memorial Health Harrington
Southbridge, Massachusetts 01550
Contact:
William Heckendorf
william.heckendorf@umassmemorial.org

Henry Ford Hospital West Bloomfield
West Bloomfield, Michigan 48322
Contact:
Kyle Bartley
KBartle1@hfhs.org

Lahey Hospital & Medical Center
Derry, New Hampshire 03038
Contact:
Danielle Ferreira
Danielle.N.Ferreira@lahey.org

Hunterdon Medical Center
Flemington, New Jersey 08822
Contact:
Marianne Sweeney
msweeney@hhsnj.org

Raritan Bay Medical Center
New Brunswick, New Jersey 08861
Contact:
Kathy Taylor
Kathy.Taylor@hmhn.org

St Peter's Health Samaritan Hospital
Albany, New York 12208
Contact:
Carole Wickham
Carole.Wickham@sphp.com

Grant Medical Center
Columbus, Ohio 43215
Contact:
Logan Griffith
logan.griffith@ohiohealth.com

Barberton Hospital
Uniontown, Ohio 44685
Contact:
Jenny Morgan
morganjen@summahealth.org

Kaiser Westside Medical Center
Hillsboro, Oregon 97124
Contact:
Audra Pfund
audra.k.pfund@kp.org

Kaiser Permanente - Sunnyside Medical Center
Woodburn, Oregon 97071

Kent Hospital
Warwick, Rhode Island 02886
Contact:
Julie Fierro
JFierro@KentRI.org

Prisma Health
Irmo, South Carolina 29063
Contact:
Whitney Smith
whitney.smith@prismahealth.org

St. David's Medical Center
Austin, Texas 78703
Contact:
Breanna Compian
Breanna.Compian@stdavids.com

Covenant Medical Center
Lubbock, Texas 79410
Contact:
Crystal Johnston
crystal.johnston@covhs.org

More Details

NCT ID
NCT06089239
Status
Recruiting
Sponsor
University of Florida

Study Contact

Ronald I Shorr, MD, MS
352-271-5001
rshorr@ufl.edu

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.