Injury Prevention Care Models for Osteoporosis

(PRISM Trial)

Enrolling by invitation at 1 trial location

Overseen By Emily J Hecker, MSN, RN

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Non-osteoporotic fracture, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

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. ^{1 2 3 4 5}

Why 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. ^{3 5 6 7 8}

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

I was admitted to a skilled nursing facility after a hospital stay for a fracture.

I am 65 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

6 months per model

Remote delivery by a post-fracture nurse consultant

Follow-up

Participants are monitored for injurious falls, fractures, and patient-reported outcomes such as pain, depression, anxiety, and sleep disturbances

Up to 3 years

Regular follow-up calls at 1, 3, 6, 12, 18, and 24 months

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

Trial Overview

The study compares three care models: Deprescribing Care Model (reducing fall-related meds), Bone Health Service Model (osteoporosis management), and Injury Prevention Service Model (combines both). The effectiveness of preventing falls with fractures is measured.

How Is the Trial Designed?

Group I: Injury Prevention Service Model Active Control 1 Intervention

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 II: Deprescribing Care Model Active Control 1 Intervention

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 III: Bone Heath Service Model Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

The American Health Care Association

Collaborator

Trials

1

Recruited

3,800+

Hebrew SeniorLife

Collaborator

Trials

52

Recruited

273,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

A systematic review of osteoporosis treatments indicates that while these medications generally have a good tolerance profile, clinicians must be aware of potential rare serious adverse events associated with their use.

The review emphasizes the importance of balancing the benefits of fracture risk reduction against the risks of adverse events, highlighting the need for careful evaluation in pharmacological management of osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of drugs used in the treatment of osteoporosis: a systematical review of the literature. Varenna, M., Bertoldo, F., Di Monaco, M., et al.[2022]

Preventing osteoporosis-related fractures, especially hip fractures, is crucial as they significantly reduce quality of life and have a high mortality rate, particularly in older adults, with a 51% mortality rate within a year for nonagenarians after a hip fracture.

Effective prevention strategies should start in childhood to build peak bone mass and promote a healthy lifestyle, while also addressing modifiable risk factors like falls, to reduce the increasing prevalence of osteoporotic fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors and prevention of osteoporosis-related fractures. Dontas, IA., Yiannakopoulos, CK.[2022]

Women have a 50% lifetime risk of fractures by age 50, while men have a 20% risk, highlighting the significant impact of osteoporosis, especially in older adults.

Effective prevention of osteoporotic fractures is essential, and several medications have been proven effective in controlled trials, with long-term data supporting their safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term strategy in the management of postmenopausal osteoporosis. Rizzoli, R.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11211169/

Effectiveness of fracture liaison service in reducing the risk ...

This review found clinically important moderate certainty evidence showing that the risk of secondary fragility fracture was lower in the FLS intervention at ≥ ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589537021003023

Models of care for osteoporosis: A systematic scoping ...

Fracture reduction was reported by 65 studies, with 16 (37%) graded as high quality, and 19 / 47 studies with a comparator group found a reduction in fractures.

3.

bonehealthresources.com

bonehealthresources.com/osteoporosis-and-bone-health

Understand the gap in Post-Fracture Care

Following an initial osteoporosis-related fracture, postmenopausal women are 5 times more likely to fracture again within a year · Subsequent fractures are ...

4.

osteoporosis.foundation

osteoporosis.foundation/health-professionals/fragility-fractures/models-of-care

Models of care

Models of care have been developed to ensure that fracture patients reliably receive osteoporosis management and interventions to prevent future falls.

5.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2829239

Screening for Osteoporosis to Prevent Fractures: A ...

Two systematic reviews and 25 cohort studies reported in 40 articles reported on calibration outcomes for 6 risk assessment models (FRAX, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8319463/

Models of care for osteoporosis: A systematic scoping ...

Models of care for improving outcomes for people with, or at risk of, osteoporosis include fracture liaison, screening, education and exercise programs.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4242696/

A systematic review of the outcomes of osteoporotic ...

Vertebral fracture caused the greatest health burden, but hip fracture patients were the main users of informal care after hospital discharge.

8.

uspreventiveservicestaskforce.org

uspreventiveservicestaskforce.org/uspstf/document/final-evidence-summary/osteoporosis-screening

Evidence Summary: Osteoporosis to Prevent Fractures

Pooled RRs ranged from 0.33 to 0.81 across drugs and outcomes, with corresponding ARDs from 3 to 44 fewer events (fractures or deaths) per 1000 ...