Accidental FallNCT06089239
Choosing Wisely: De-implementing Fall Prevention Alarms in Hospitals
A study testing High Intensity Coaching and Low Intensity Coaching in people with Accidental Fall and Patient Safety, run by University of Florida at 20 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Accidental Fall, Patient Safety, Hospital Acquired Condition
- What is being tested?
- High Intensity Coaching and Low Intensity Coaching
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 365 participants
- Where
- 20 sitesUnited States
- Study dates
- 1 Oct 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stakeholders in fall prevention at up to 30 participating NDNQI hospitals
Who cannot join
- -
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
St Peter's Health Samaritan Hospital
Albany, New York, 12208
St. David's Medical Center
Austin, Texas, 78703
Grant Medical Center
Columbus, Ohio, 43215
Hendricks Regional Health
Danville, Indiana, 46122
Lahey Hospital & Medical Center
Derry, New Hampshire, 03038
PIH Health Downey Hospital
Downey, California, 90241
Hunterdon Medical Center
Flemington, New Jersey, 08822
Kaiser Westside Medical Center
Hillsboro, Oregon, 97124
IU Health North Hospital
Indianapolis, Indiana, 46256
Prisma Health
Irmo, South Carolina, 29063
Covenant Medical Center
Lubbock, Texas, 79410
El Camino Health - Los Gatos
Mountain View, California, 94040
Raritan Bay Medical Center
New Brunswick, New Jersey, 08861
University of California Davis Medical Center
Sacramento, California, 95817
UMass Memorial Health Harrington
Southbridge, Massachusetts, 01550
Barberton Hospital
Uniontown, Ohio, 44685
Kent Hospital
Warwick, Rhode Island, 02886
Henry Ford Hospital West Bloomfield
West Bloomfield, Michigan, 48322
Central DuPage Hospital
Winfield, Illinois, 60190
Kaiser Permanente - Sunnyside Medical Center
Woodburn, Oregon, 97071
About this study
Official title: De-Implementing Fall Prevention Alarms in Hospitals
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.
Read the 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
- Being tested
- High Intensity Coaching, Low Intensity Coaching
- Medical subject headings
- Iatrogenic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity CoachingOther
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 CoachingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Coaching | Active comparator | 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. Receives: Other: High Intensity Coaching |
| Low Intensity Coaching | Sham comparator | 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. Receives: Other: Low Intensity Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: monthly for 30 months
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.
Measured: monthly for 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Oct 2023
- Primary completion31 Mar 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Ronald I Shorr, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089239
- Sponsor's protocol ID
- CED000000718
- Other IDs
- R01AG073408-01A1
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turner K, McNett M, Potter C, Cramer E, Al Taweel M, Shorr RI, Mion LC. Alarm with care-a de-implementation strategy to reduce fall prevention alarm use in US hospitals: a study protocol for a hybrid 2 effectiveness-implementation trial. Implement Sci. 2023 Dec 5;18(1):70. doi: 10.1186/s13012-023-01325-9.
PubMed 38053114
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-Implementing Fall Prevention Alarms in Hospitals
- ClinicalTrials.gov ID
- NCT06089239
- Acronym / sponsor ID
- CED000000718
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Coaching | Active comparator | Other: High Intensity CoachingIn 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. |
| Low Intensity Coaching | Sham comparator | Other: Low Intensity CoachingIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stakeholders in fall prevention at up to 30 participating NDNQI hospitals
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity CoachingExternal 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). | Other | High Intensity Coaching |
| Low Intensity CoachingExternal 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). | Other | Low Intensity Coaching |
Primary outcome
Fall Prevention Alarm Prevalence survey
Time frame: 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.
Patient Falls
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 38053114Turner K, McNett M, Potter C, Cramer E, Al Taweel M, Shorr RI, Mion LC. Alarm with care-a de-implementation strategy to reduce fall prevention alarm use in US hospitals: a study protocol for a hybrid 2 effectiveness-implementation trial. Implement Sci. 2023 Dec 5;18(1):70. doi: 10.1186/s13012-023-01325-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald I Shorr, MD principal investigator
University of Florida
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Coaching and Low Intensity Coaching in people with Accidental Fall and Patient Safety, run by University of Florida at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall Prevention Alarm Prevalence survey (time frame: monthly for 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06089239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.