Injury Prevention Care Models for Osteoporosis
(PRISM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to compare three care models to determine which best prevents falls and broken bones in individuals recovering from a fracture. Participants will receive one of the following: a model that stops medications potentially causing falls (Deprescribing Care Model), a model focused on treating osteoporosis (a condition that weakens bones) through a Bone Health Service Model, or a model that combines both approaches (Injury Prevention Service Model). It is ideal for those who recently experienced a fracture, are in a skilled nursing facility for rehabilitation, and have completed a medication review plan. The goal is to identify which method best improves outcomes such as pain, anxiety, and fear of falling, while also managing medication side effects. As an unphased trial, this study provides participants the opportunity to contribute to valuable research that could enhance recovery strategies for future patients.
Will I have to stop taking my current medications?
The trial includes a Deprescribing Care Model, which is designed to reduce or stop medications that may increase the risk of falls. This suggests that some participants might need to stop or adjust their current medications.
What prior data suggests that these care models are safe for patients with osteoporosis?
Research has shown that the care models under study for osteoporosis are safe. The Bone Health Service Model evaluates and manages osteoporosis, using methods that reliably provide treatments to prevent future falls. Past studies report no major safety concerns, indicating it is well-tolerated.
The Deprescribing Care Model aims to reduce or stop medications that might cause falls. This approach is already standard in osteoporosis care after a fracture, demonstrating its safety and benefits. No specific safety issues have been reported with this model in osteoporosis care.
The Injury Prevention Service Model combines both approaches, supported by evidence of reduced death rates among patients. This suggests it has been used safely without significant adverse effects.
Overall, these models are based on established care practices that are generally safe and effective in various settings. There is no indication of serious risks, as they focus on improving patient safety and outcomes.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative care models for preventing injuries in individuals with osteoporosis. Unlike standard treatments that often focus on medication management, these models aim to integrate comprehensive service approaches in skilled nursing facilities. The Bone Health Service Model enhances bone strength, the Deprescribing Care Model optimizes medication use by reducing unnecessary drugs, and the Injury Prevention Service Model focuses on reducing fall risks. By testing these models in a real-world setting, researchers hope to find effective ways to improve patient outcomes and quality of life for those with osteoporosis.
What evidence suggests that this trial's care models could be effective for preventing falls with fractures?
Research has shown that the Bone Health Service Model, a care model in this trial, can lower the risk of future bone fractures. In several studies, patients who received osteoporosis care through similar programs experienced fewer additional fractures. The Deprescribing Care Model, another care model tested in this trial, focuses on reducing medications that can cause falls, potentially preventing injuries by minimizing medication side effects that increase fall risk. The Injury Prevention Service Model, also part of this trial, combines these strategies, offering both osteoporosis care and medication reduction. It aims to provide comprehensive care to reduce the chances of falls that cause injuries.35678
Who Is on the Research Team?
Cathleen S Colon-Emeric, MD, MHS
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for individuals aged 65 or older who are in skilled nursing facilities (SNFs) after being hospitalized for a fracture. It aims to prevent further injuries by optimizing medications and care.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Implementation of one of the three care models: Deprescribing Care Model, Bone Health Service Model, or Injury Prevention Service Model, each for 6 months in a randomized sequence
Follow-up
Participants are monitored for injurious falls, fractures, and patient-reported outcomes such as pain, depression, anxiety, and sleep disturbances
Data Analysis
Analysis of data collected from SNFs and matched control SNFs to compare the effectiveness of the care models
What Are the Treatments Tested in This Trial?
Interventions
- Bone Health Service Model
- Deprescribing Care Model
- Injury Prevention Service Model
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
The American Health Care Association
Collaborator
Hebrew SeniorLife
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
Brown University
Collaborator
University of North Carolina, Chapel Hill
Collaborator