Falls-RiskNCT05810064
Effectiveness of an Automated Falls-Risk Screening and Referral Tool in the Emergency Department (ED)
An observational study of Falls-Risk, run by University of Wisconsin, Madison at 3 sites in United States.
Trial summary
The purpose of this retrospective cohort study is to evaluate the effectiveness of an EHR-based clinical decision support system (CDS) for automatically screening older adult ED patients for risk of future falls and providing ED clinicians opportunity to place referrals orders to the UW Health Mobility and Falls… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Falls-Risk
- What is being tested?
- Falls-Risk Clinical Decision Support (CDS) Tool
- How many people
- 36,205 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Feb 2022to 31 Aug 2026
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: ED patients age 65 or older who are not admitted.
Retrospective analysis will include data from:
- ED patients 65 years or older
- discharged from the ED (not admitted)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
East Madison Hospital
Madison, Wisconsin, 53718
UWHC Emergency Department
Madison, Wisconsin, 53792
Swedish American Emergency Department
Rockford, Illinois, 61008
About this study
Official title: Preventing Future Falls in Older Adult ED Patients: Evaluating the Implementation and Effectiveness of a Novel Automated Screening and Referral Intervention - Assessing Outcomes From Medical Records and Medicare Claims Data
The purpose of this retrospective cohort study is to evaluate the effectiveness of an EHR-based clinical decision support system (CDS) for automatically screening older adult ED patients for risk of future falls and providing ED clinicians opportunity to place referrals orders to the UW Health Mobility and Falls Clinic for those at highest risk prior to discharge.
This CDS tool has already been implemented at the UW Hospital ED, and as a QI initiative will be implemented in a staged process at two other UW Health-affiliated emergency departments (The American Center and Swedish American Hospital).
Read the detailed description
The specific aim of this retrospective cohort study is to test the effectiveness of the automated screening and referral intervention on completed referrals to the UW Health fall prevention clinic and rates of injurious falls, using a limited dataset created from EHR and Medicare claims data. The investigators hypothesize that ED patients referred using the falls risk CDS tool will have decreased healthcare use due to fall-related injuries, and that the intervention will have similar levels of effectiveness across different types of patient characteristics. The investigators will also systematically examine barriers to patients completing their clinic referrals, as well as clinic scheduling and pre-visit planning protocols that may have excluded patients from receiving Falls Clinic services.
Effectiveness will be assessed based on examination of a limited dataset consisting of EHR and Medicare claims data measuring rates of (1) patient referrals at each ED, (2) completed referrals to the Mobility and Falls Clinic (i.e., a completed clinic appointment), and (3) healthcare visits for fall-related causes occurring within the six months following the initial ED visit.
The primary analysis to evaluate effectiveness of the fall-risk CDS tool will include data from older adult patients (age ≥65) who visit study EDs during the intervention period at each site, have a UW Health System-affiliated primary care provider, and are discharged from the ED or ED observation unit (not admitted). Members of the UWH Applied Data Science team (not part of the study team) will extract data from patient EHR to create a limited dataset including: past falls and fall-related injuries (in the 12 months pre-visit, including the index ED visit), post-visit falls and fall-related injuries (in the 6 months following the index ED visit), patient demographics (age, gender, race/ethnicity, insurance), comorbidities, active medications, and utilization (e.g., primary and specialty care visits). Education and income levels will be approximated using census track data. Area Deprivation Index will also be employed based on patient address. These variables will be extracted retrospectively and stored on secure servers.
- Conditions
- Falls-Risk
- Being tested
- Falls-Risk Clinical Decision Support (CDS) Tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Falls-Risk Clinical Decision Support (CDS) ToolOther
CDS in the Electronic Health Record (EHR) to screen patients at high-risk for future falls enabling referrals to the UW Health Mobility and Falls clinic.
| Study group | Role | What they receive |
|---|---|---|
| Discharged ED Patients prior to Intervention | Patients aged 65 and older who are in the emergency department and subsequently discharged (not admitted) | |
| Discharged ED Patients after Intervention | Patients aged 65 and older who are in the emergency department and subsequently discharged (not admitted) Receives: Other: Falls-Risk Clinical Decision Support (CDS) Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Falls and Fall-Related Injuries
Comparison of data before and after implementation of CDS tool and before and after ED visit.
Measured: during the period 12 months prior to ED visit to 6 months post ED visit (18 month period)
Secondary outcomes (3)
Summary of Reasons Patients Did Not Schedule or Attend Appointments Based on Referral
Implementation outcome
Measured: during the period 12 months prior to ED visit to 6 months post ED visit (18 month period)
Percentage of Referred Patients Reached by Clinic Scheduler
Measured: during the period 12 months prior to ED visit to 6 months post ED visit (18 month period)
Percentage of Referred Patients Who Made Clinic Appointments
Measured: during the period 12 months prior to ED visit to 6 months post ED visit (18 month period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start22 Feb 2022
- Primary completion31 Aug 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 Falls-RiskStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 36,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Brian W Patterson, MD, MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810064
- Sponsor's protocol ID
- 2021-0776
- Other IDs
- 1K08HS024558, 1R18HS027735, SMPH/EMERG MED
- Status last verified
- Sep 2026
- First submitted
- 30 Mar 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hekman DJ, Cochran AL, Maru AP, Barton HJ, Shah MN, Wiegmann D, Smith MA, Liao F, Patterson BW. Effectiveness of an Emergency Department-Based Machine Learning Clinical Decision Support Tool to Prevent Outpatient Falls Among Older Adults: Protocol for a Quasi-Experimental Study. JMIR Res Protoc. 2023 Aug 3;12:e48128. doi: 10.2196/48128.
PubMed 37535416
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Future Falls in Older Adult ED Patients: Evaluating the Implementation and Effectiveness of a Novel Automated Screening and Referral Intervention - Assessing Outcomes From Medical Records and Medicare Claims Data
- ClinicalTrials.gov ID
- NCT05810064
- Acronym / sponsor ID
- 2021-0776
- Conditions
- Falls-Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36,205 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 12 Apr 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.
The purpose of this retrospective cohort study is to evaluate the effectiveness of an EHR-based clinical decision support system (CDS) for automatically screening older adult ED patients for risk of future falls and providing ED clinicians opportunity to place referrals orders to the UW Health Mobility and Falls Clinic for those at highest risk prior to discharge.
This CDS tool has already been implemented at the UW Hospital ED, and as a QI initiative will be implemented in a staged process at two other UW Health-affiliated emergency departments (The American Center and Swedish American Hospital).
Detailed description
The specific aim of this retrospective cohort study is to test the effectiveness of the automated screening and referral intervention on completed referrals to the UW Health fall prevention clinic and rates of injurious falls, using a limited dataset created from EHR and Medicare claims data. The investigators hypothesize that ED patients referred using the falls risk CDS tool will have decreased healthcare use due to fall-related injuries, and that the intervention will have similar levels of effectiveness across different types of patient characteristics. The investigators will also systematically examine barriers to patients completing their clinic referrals, as well as clinic scheduling and pre-visit planning protocols that may have excluded patients from receiving Falls Clinic services.
Effectiveness will be assessed based on examination of a limited dataset consisting of EHR and Medicare claims data measuring rates of (1) patient referrals at each ED, (2) completed referrals to the Mobility and Falls Clinic (i.e., a completed clinic appointment), and (3) healthcare visits for fall-related causes occurring within the six months following the initial ED visit.
The primary analysis to evaluate effectiveness of the fall-risk CDS tool will include data from older adult patients (age ≥65) who visit study EDs during the intervention period at each site, have a UW Health System-affiliated primary care provider, and are discharged from the ED or ED observation unit (not admitted). Members of the UWH Applied Data Science team (not part of the study team) will extract data from patient EHR to create a limited dataset including: past falls and fall-related injuries (in the 12 months pre-visit, including the index ED visit), post-visit falls and fall-related injuries (in the 6 months following the index ED visit), patient demographics (age, gender, race/ethnicity, insurance), comorbidities, active medications, and utilization (e.g., primary and specialty care visits). Education and income levels will be approximated using census track data. Area Deprivation Index will also be employed based on patient address. These variables will be extracted retrospectively and stored on secure servers.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discharged ED Patients prior to Intervention | – | –Patients aged 65 and older who are in the emergency department and subsequently discharged (not admitted) |
| Discharged ED Patients after Intervention | – | Other: Falls-Risk Clinical Decision Support (CDS) ToolPatients aged 65 and older who are in the emergency department and subsequently discharged (not admitted) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- ED patients age 65 or older who are not admitted.
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 |
|---|---|---|
| Falls-Risk Clinical Decision Support (CDS) ToolCDS in the Electronic Health Record (EHR) to screen patients at high-risk for future falls enabling referrals to the UW Health Mobility and Falls clinic. | Other | Discharged ED Patients after Intervention |
Primary outcome
Number of Falls and Fall-Related Injuries
Time frame: during the period 12 months prior to ED visit to 6 months post ED visit (18 month period)
Comparison of data before and after implementation of CDS tool and before and after ED visit.
3 secondary outcomes
Summary of Reasons Patients Did Not Schedule or Attend Appointments Based on Referral
Time frame: during the period 12 months prior to ED visit to 6 months post ED visit (18 month period)
Percentage of Referred Patients Reached by Clinic Scheduler
Time frame: during the period 12 months prior to ED visit to 6 months post ED visit (18 month period)
Percentage of Referred Patients Who Made Clinic Appointments
Time frame: during the period 12 months prior to ED visit to 6 months post ED visit (18 month period)
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 16 Sep 2026.
- Derived from this study: PubMed 37535416Hekman DJ, Cochran AL, Maru AP, Barton HJ, Shah MN, Wiegmann D, Smith MA, Liao F, Patterson BW. Effectiveness of an Emergency Department-Based Machine Learning Clinical Decision Support Tool to Prevent Outpatient Falls Among Older Adults: Protocol for a Quasi-Experimental Study. JMIR Res Protoc. 2023 Aug 3;12:e48128. doi: 10.2196/48128.
- 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.
Brian W Patterson, MD, MPH principal investigator
University of Wisconsin, Madison
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Falls-Risk, run by University of Wisconsin, Madison at 3 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?
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 16 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 3 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. 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?
Number of Falls and Fall-Related Injuries (time frame: during the period 12 months prior to ED visit to 6 months post ED visit (18 month period)). 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 NCT05810064, 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 16 Sep 2026.