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De-Implementing Fall Prevention Alarms in Hospitals

Primary Purpose

Accidental Fall, Patient Safety, Hospital Acquired Condition

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Intensity Coaching
Low Intensity Coaching
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Accidental Fall

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Stakeholders in fall prevention at up to 30 participating NDNQI hospitals Exclusion Criteria: -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    High Intensity Coaching

    Low Intensity Coaching

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 18, 2023
    Last Updated
    October 17, 2023
    Sponsor
    University of Florida
    Collaborators
    National Institute on Aging (NIA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06089239
    Brief Title
    De-Implementing Fall Prevention Alarms in Hospitals
    Official Title
    De-Implementing Fall Prevention Alarms in Hospitals
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2025 (Anticipated)
    Study Completion Date
    August 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida
    Collaborators
    National Institute on Aging (NIA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Accidental Fall, Patient Safety, Hospital Acquired Condition, Clinical Alarms, Mentoring

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High Intensity Coaching
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Low Intensity Coaching
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    High Intensity Coaching
    Intervention Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Low Intensity Coaching
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Fall Prevention Alarm Prevalence survey
    Description
    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.
    Time Frame
    monthly for 30 months
    Title
    Patient Falls
    Description
    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.
    Time Frame
    monthly for 30 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Stakeholders in fall prevention at up to 30 participating NDNQI hospitals Exclusion Criteria: -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ronald I Shorr, MD, MS
    Phone
    352-271-5001
    Email
    rshorr@ufl.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ronald I Shorr, MD
    Organizational Affiliation
    University of Florida
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    De-Implementing Fall Prevention Alarms in Hospitals

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