Prevention of Injury in Skilled Nursing Facilities Through Optimizing Medications

NCT06304428 | Enrolling By Invitation DMC

• 1 other identifier: Pro00114580
• Study Type: interventional
• Target: 3,780
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to compare three care models for optimizing medications and preventing falls with broken bones in patients receiving rehabilitation after a hospitalization for a broken bone. The primary outcome is injurious falls, with secondary outcomes measuring how the process of care is changed and capturing patient-reported outcomes valued by stakeholders. The main questions this study aims to answer are:

• Which of the three models is more effective in preventing falls with fractures?
• What are the differences in patient-centered outcomes amongst the three models? These include pain, depression, anxiety, sleep, medication side effect burden, and fear of falling.
• What are the differences in osteoporosis treatment and medication burden? The three care models are: a Deprescribing Care Model designed to reduce or stop fall-related medications, a Bone Heath Service Model designed to provide osteoporosis evaluation and management, and an Injury Prevention Service Model offering both services. 42 SNFs will participate in this study. The three models will be incorporated into the routine care of patients at these facilities who are receiving rehabilitation after a hospitalization for a fracture. All care models will be delivered remotely to patients in the SNF and after they transition home by a post-fracture nurse consultant supported by an interprofessional team. This study has three aims. See Detailed Description for more details. This ClinicalTrials.gov record represents the Comparative Effectiveness Aim of the protocol.

Conditions

Osteoporosis; Accidental Falls/Prevention and Control

Keywords

Osteoporosis; Deprescribing; Falls; Skilled Nursing Facilities

Outcome Measures

Primary Outcomes (1)

• Injurious falls

  Composite outcome of unique claims for emergency department, urgent care, or hospital visit for injurious fall or any fracture during follow-up (up to 3 years) (ICD 10 codes); to ensure complete ascertainment for participants with Medicare Advantage, researchers will also collect via self-report/proxy report at telephone calls 1, 3, 6, 12, 18 months, and 24 months following discharge from the SNF.

  Up to 3 years

Secondary Outcomes (10)

• Number of patients who initiate treatment for osteoporosis

  1 day of discharge from SNF and one year

• Medication Possession Ratio during follow-up, as measured by EHR and Medicare claims

  Up to 3 years

• Number of patients who had deprescribing ordered

  1 day of discharge from SNF and 90 days after SNF admission date

• Modified Drug Burden Index during follow-up, as measured by EHR and Medicare claims

  Up to 3 years

• Patient medication side effect burden, measured via Living with Medicines Questionnaire (LMQ3).

  90 days after SNF admission date

Study Arms (3)

Deprescribing Care Model

ACTIVE COMPARATOR

In this pragmatic, cluster randomized crossover trial 42 Skilled Nursing Facilities (SNF) will each receive 6 months of each care model in random sequence. All patients with OP fracture admitted to the SNF within the intervention time period will receive the full designated care model, even if their stay in the SNF extends into the next intervention period.

Other: Deprescribing Care Model

Bone Heath Service Model

ACTIVE COMPARATOR

In this pragmatic, cluster randomized crossover trial 42 Skilled Nursing Facilities (SNF) will each receive 6 months of each care model in random sequence. All patients with OP fracture admitted to the SNF within the intervention time period will receive the full designated care model, even if their stay in the SNF extends into the next intervention period.

Other: Bone Health Service Model

Injury Prevention Service Model

ACTIVE COMPARATOR

In this pragmatic, cluster randomized crossover trial 42 Skilled Nursing Facilities (SNF) will each receive 6 months of each care model in random sequence. All patients with OP fracture admitted to the SNF within the intervention time period will receive the full designated care model, even if their stay in the SNF extends into the next intervention period.

Other: Injury Prevention Service Model

Interventions

Injury Prevention Service Model OTHER

The Injury Prevention Service Model provides both the Deprescribing Care Model and the Bone Health Service Model.

Injury Prevention Service Model

Deprescribing Care Model OTHER

The Deprescribing Care Model is designed to deprescribe fall related medications (FRIDs)

Deprescribing Care Model

Bone Health Service Model OTHER

The Bone Health Service Model is designed to provide osteoporosis evaluation and management

Bone Heath Service Model

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 65 years or greater
• Admitted to an enrolled SNF after hospitalized fracture
• Completion of a medication optimization plan

You may not qualify if:

• Non-osteoporotic fracture (e.g. facial, digital, skull, at site of tumor or infection)
• Eligible for Hospice or palliative care
• Patient discharged or died prior to completion of a medication optimization plan

Sponsors & Collaborators

• Hebrew SeniorLife: collaborator
• Brown University: collaborator
• The American Health Care Association: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Duke University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Marcus Institute for Aging Research, Hebrew SeniorLife

Boston, Massachusetts, 02131, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Berry SD, Toles M, Travison TG, McConnell ES, Zullo AR, Little MO, Gwyther L, McDermott C, Lee R, Cary M, Syme M, Kissam S, Hecker E, MacLean KG, Colon-Emeric C. PReventing Injury in Skilled nursing facilities through optimizing Medications (PRISM), a protocol for a cluster randomized trial to reduce injurious falls in post-acute care. Trials. 2025 Sep 26;26(1):367. doi: 10.1186/s13063-025-09122-z.

  PMID: 41013714 DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Cathleen S Colon-Emeric, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)