From Screening to Safety: Implementing the AL-STEADI Initiative in Assisted Living Communities (AL-STEADI)

The goal of this trial is to test the real-world efficacy of AL-STEADI, a fall prevention program, in participating assisted living centers. The investigators will randomly assign residents from participating assisted living centers who screen at-risk of falling to either existing fall monitoring protocols or the enhanced AL-STEADI fall prevention program. The investigators will evaluate the effect of AL-STEADI on the rate of falls over 12 months. The investigators will also closely monitor implementation fidelity in these participating assisted living centers.

Study Overview

• Status: Not yet recruiting
• Conditions: Fall; Fall Prevention; Fall Injury Prevention
• Intervention / Treatment: Behavioral: AL-STEADI; Behavioral: Usual Care Group

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellen McCreedy, PhD, MPH; Phone Number: (401) 863-7345; Email: ellen_mccreedy@brown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Living in participating assisted living communities

Exclusion Criteria:

- Not living in participating assisted living communities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AL-STEADI	Behavioral: AL-STEADI; STEADI is an evidence-based falls prevention program developed by the CDC and tested in several community-based settings. STEADI involves universal fall screening, followed by personalized assessments and tailored interventions. Common, potentially modifiable causes of falls evaluated in STEADI include medication interactions or side effects, environmental hazards (e.g., floor rugs, thresholds), untreated visual impairment, low vitamin D, ill-fitting footwear, or low blood pressure. AL-STEADI is a modified version of STEADI for assisted living.
Active Comparator: Existing fall monitoring protocols	Behavioral: Usual Care Group; Typical fall prevention practices, including increased monitoring by assisted living staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall rate	Number of staff documented falls per 12 non-censored person-months, among individuals who screen at-risk for falls	12 person-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of fall-risk residents with any fall	Proportion of residents with any staff documented fall during follow-up, among individuals who screen at-risk for falls	12 person-months
Injurious fall rate among fall-risk residents	Number of staff documented injurious falls per 12 non-censored person-months, among individuals who screen at-risk for falls	12 person-months
Proportion of fall-risk residents with any injurious fall	Proportion of residents with any staff documented injurious fall during follow-up, among individuals who screen at-risk for falls	12 person-months
Hospital transfer rate among fall-risk residents	Number of hospital transfers per 12 non-censored person-months, among individuals who screen at-risk for falls	12 person-months
Proportion of fall-risk residents with any hospital transfer	Proportion of residents with any hospital transfers during follow-up, among individuals who screen at-risk for falls	12 person-months
Hospitalization rate among fall-risk residents	Number of in-patient hospitalizations per 12 non-censored person-months, among individuals who screen at-risk for falls	12 person-months
Proportion of fall-risk residents with any hospitalization	Proportion of residents with any in-patient hospitalization during follow-up, among individuals who screen at-risk for falls	12 person-months
Skilled nursing stay rate among fall-risk residents	Number of skilled nursing stays per 12 non-censored person-months, among individuals who screen at-risk for falls	12 person-months
Proportion of fall-risk residents with any skilled nursing stay	Proportion of residents with any skilled nursing stay during follow-up, among individuals who screen at-risk for falls	12 person-months

Collaborators and Investigators

• Sponsor: Brown University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): September 15, 2026
• Last Update Submitted That Met QC Criteria: September 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: fall prevention; assisted living; STEADI
• Other Study ID Numbers: U01CE003720 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Resident-level, electronic medical record data will be protected by Data Use Agreements and cannot be shared publicly. Summary tables may be made available; small cell restrictions and other measures to prevent re-identification would apply

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No