Prevention of Injury in Skilled Nursing Facilities Through Optimizing Medications

NCT ID: NCT06304428

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 3780 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2028-07-01

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.

Detailed Description

After hospitalization for fracture, approximately 60% of older adults receive post-acute care in Skilled Nursing Facilities (SNFs), but fewer than 20% of these individuals receive medication optimization, which is evidence-based care known to prevent additional injurious falls, fractures, and mortality. Therefore, there is an opportunity to substantially improve care and patient outcomes in this setting. The purpose of this study is to determine the comparative efficacy of a Deprescribing Care Model designed to deprescribe fall related medications (FRIDs), a Bone Heath Service Model designed to provide osteoporosis evaluation and management, or an Injury Prevention Service Model offering both services. 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. 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.

Our Specific aims are to:

1. Conduct a randomized cluster crossover trial in fracture patients comparing the effectiveness of the Deprescribing Care Model, Bone Health Service Model, or Injury Prevention Service Model in 42 SNFs, with each SNF receiving 6 months of each intervention in random sequence. We will test for clinically important differences in patient-centered outcomes (living with medicines survey, PHQ-8 depression scale, anxiety, sleep, and pain scales) at 90 days and implementation measures osteoporosis prescriptions, drug burden) at the time of discharge.

2. Compare the effectiveness of the Deprescribing Care Model, Bone Health Service Model, or Injury Prevention Service Model on subsequent injurious fall and fractures for patients treated within the 42 randomized SNFs with those in 168 matched concurrent control SNFs. We will use data from the National Institute on Aging-funded Long-Term Care Data Cooperative which includes Minimum Data Set (MDS), Electronic Health Record (EHR), and Medicare (CMS) claims. To address decisional dilemmas, we will examine differences in efficacy by baseline estimated life expectancy and cognitive status.

3. Identify SNF characteristics associated with measures of effective model implementation. We hypothesize that organizational factors captured by SNF staff responses to surveys capturing organizational readiness for change will explain additional variance in implementation measures beyond factors known to be associated with care quality (staff turnover rates, for profit-status, region, case mix, and proportion of patients from racial and ethnic minority groups).

Study Design: In the Comparative Effectiveness Aim (Aim 1), we will conduct a pragmatic, cluster randomized crossover trial in 42 SNFs comparing the effectiveness of a Bone Health Service Model, a Deprescribing Care Model, or an Injury Prevention Service Model, all delivered remotely by a post-fracture nurse consultant supported by an interprofessional team. Every SNF will receive 6 months of each care model in random sequence. Follow-up for delivery of the care models will begin on the date that the first eligible patient from the facility is included in the study. All patients with osteoporotic (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. One primary post-fracture nurse consultant will be assigned to each facility for the life of the study. To prevent contamination between models, the nurse consultant will double check the care model assigned before every patient/proxy encounter. Medication utilization (measured using EHR data) will be assessed at discharge and 90 days after SNF admission date, and Patient Reported Outcomes (PROs) (measured via survey) will be assessed at 90 days after SNF admission date, regardless of whether they have discharged home or remain in the SNF. We will therefore be able to compare the effectiveness of the models on important PROs, osteoporosis treatment rates, and FRID medication burden. Patients will be followed for injurious falls and fractures using administrative data and self-report during post-fracture nurse consultant calls until the end of the study period (up to 3 years, mean 2 years) censoring at death.

In the Overall Effectiveness Aim, we will compare rates of injurious falls and fractures for patients treated with the Deprescribing Care Model, Bone Health Service Model, or Injury Prevention Service Model to patients treated in 168 matched concurrent control SNFs, identified through the Long Term Care Data Cooperative. No new data will be collected for this aim.

In the Implementation Evaluation Aim, we will identify facility characteristics associated with high levels of intervention implementation. This aim will require the collection of surveys from facility leadership.

Conditions

Accidental Falls/Prevention and Control; Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Deprescribing Care Model

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.

Group Type: ACTIVE_COMPARATOR

Deprescribing Care Model

Intervention Type: OTHER

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

Bone Heath Service Model

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.

Group Type: ACTIVE_COMPARATOR

Bone Health Service Model

Intervention Type: OTHER

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

Injury Prevention Service Model

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.

Group Type: ACTIVE_COMPARATOR

Injury Prevention Service Model

Intervention Type: OTHER

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

Interventions

Deprescribing Care Model

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

Intervention Type: OTHER

Bone Health Service Model

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

Intervention Type: OTHER

Injury Prevention Service Model

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Hebrew SeniorLife

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: collaborator

The American Health Care Association

UNKNOWN

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cathleen S Colon-Emeric, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Marcus Institute for Aging Research, Hebrew SeniorLife

Boston, Massachusetts, United States

Duke University School of Medicine

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 41013714 (View on PubMed)

Other Identifiers

Pro00114580

Identifier Type: -

Identifier Source: org_study_id