Injury Prevention Care Models for Osteoporosis

(PRISM Trial)

Recruiting 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

3780 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is the Injury Prevention Care Model for Osteoporosis safe for humans?

The treatments for osteoporosis, including those used in various care models, generally have a good safety profile with rare serious side effects. While some concerns exist, such as atypical fractures with bisphosphonates, the overall risk of serious adverse effects is small compared to the benefits of reducing fracture risk. ^{1 2 3 4 5}

How does the Injury Prevention Care Models for Osteoporosis treatment differ from other treatments?

The Injury Prevention Care Models for Osteoporosis treatment is unique because it integrates multiple care models, including a Bone Health Service Model, Deprescribing Care Model, and Injury Prevention Service Model, to address both the prevention of osteoporosis and the circumstances leading to fractures. This comprehensive approach aims to improve patient outcomes by focusing on bone health, reducing unnecessary medications, and preventing injuries, which is different from traditional treatments that may focus solely on medication or bone density. ^{5 6 7 8 9}

What data supports the effectiveness of the Injury Prevention Care Models for Osteoporosis treatment?

Research shows that using a team-based approach and coordinator-based systems in osteoporosis care can significantly improve the identification and management of patients at risk of fractures. These models help ensure patients receive necessary screenings and follow-up care, which can prevent further fractures and improve overall bone health. ^{5 7 10 11 12}

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

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Models of care for osteoporosis: A systematic scoping review of efficacy and implementation characteristics. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Development of an integrated-care delivery model for post-fracture care in Ontario, Canada. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Subsequent Fracture Prevention in Patients 50 Years and Older With Fragility Fractures: A Quality Improvement Initiative. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Coordinator-based systems for secondary prevention in fragility fracture patients. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A team approach: implementing a model of care for preventing osteoporosis related fractures. [2022]

6. France pubmed.ncbi.nlm.nih.gov

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

7. Italy pubmed.ncbi.nlm.nih.gov

Safety profile of drugs used in the treatment of osteoporosis: a systematical review of the literature. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The safety and tolerability profile of therapies for the prevention and treatment of osteoporosis in postmenopausal women. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A model for estimating the potential costs and savings of osteoporosis prevention strategies. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Can we prevent fractures? [2019]

11. Greece pubmed.ncbi.nlm.nih.gov

Risk factors and prevention of osteoporosis-related fractures. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Models of care for the secondary prevention of osteoporotic fractures: a systematic review and meta-analysis. [2022]