PREVENT Program for Hip Fractures

(PREVENT Trial)

Overseen By Lauren Kane, MSc, BSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: End-stage disease, Comatose, Hospice, others

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

Compensation: Varies

Number of Visits: Unknown

3060 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called PREVENT, designed to reduce hip fractures in long-term care homes. The program uses a tool to identify residents at high risk of fractures due to weak bones and falls. Healthcare teams receive training on the latest care methods to help prevent these fractures. Some homes will implement the PREVENT program, while others will continue with their usual care to determine which approach is more effective. This trial is suitable for long-term care homes in Ontario, Canada, with at least 50 residents, excluding those with residents in hospice or expected to stay less than 90 days. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could enhance resident safety and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It seems likely that participants can continue their current medications, as the program focuses on training healthcare teams to make treatment decisions.

What prior data suggests that the PREVENT Program is safe for use in long-term care homes?

Research has shown that the PREVENT program effectively reduces hip fractures in older adults living in long-term care homes. This program trains healthcare teams to prevent falls and fractures by using a tool that calculates fracture risk, identifying residents most at risk due to weak bones or a history of falls.

The PREVENT program, based on educational outreach, has been tested in various long-term care settings. Notably, no negative effects have been reported related to the educational and procedural components of the program. The focus remains on improving management and prevention strategies rather than introducing new medications or physical treatments, which often carry more risk.

Since the program uses existing healthcare practices, it is considered safe and easy to adopt. It primarily involves training and support for healthcare providers, integrating smoothly into current care routines without adding unnecessary risk to patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PREVENT Program because it offers a proactive approach to reducing hip fractures, especially in older adults. Unlike traditional treatments that focus on recovery after a fracture occurs, the PREVENT Program is designed to minimize the risk of fractures happening in the first place. It incorporates elements like tailored exercise regimens, dietary adjustments, and environmental modifications to strengthen bones and improve balance. This preventive strategy could significantly reduce the incidence of hip fractures, which are often associated with severe health declines and loss of independence in the elderly.

What evidence suggests that the PREVENT Program is effective for decreasing hip fractures?

Research shows that the PREVENT Program, which participants in this trial may receive, might help reduce hip fractures in older adults living in long-term care facilities. This program uses a tool to identify residents most at risk of fractures and trains healthcare teams on effective prevention methods. Although direct evidence of the program's success is still being collected, it is based on proven methods to reduce fracture risk. These methods include creating personalized care plans and providing tools to help healthcare providers stay on track. Early signs suggest that identifying at-risk residents and using customized prevention strategies could lead to fewer hip fractures. ^{1 2 3 5 6}

Who Is on the Research Team?

Alexandra Papaioannou, MD, MSc

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

The PREVENT trial is for older adults in long-term care homes in Ontario and Alberta who are at risk of hip fractures due to osteoporosis and falls. Homes must have at least 70 residents to join. The study will use health records to identify eligible participants.

Inclusion Criteria

It seems like you've provided a criterion that is not related to clinical trial exclusion criteria. Could you please provide more details or clarify?

Residents who are eligible for the study will be identified using the RAI-MDS 2.0 database.

My home has at least 70 residents.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the PREVENT program in long-term care homes, including training healthcare teams and using a fracture risk calculator

12 months

Regular visits as per care plan

Control

Homes in the control group receive usual care without the PREVENT program

12 months

Regular visits as per usual care

Follow-up

Participants are monitored for safety and effectiveness after the intervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

• PREVENT Program

Trial Overview This trial tests the PREVENT program, which uses a fracture risk calculator and trains healthcare teams on fracture prevention strategies. It compares homes using this program with those that provide usual care to see if it reduces hip fractures.

How Is the Trial Designed?

Group I: PREVENT Program Experimental Treatment 1 Intervention

PREVENT model

Group II: Control Group Active Control 1 Intervention

Residents in homes allocated to the control group will receive usual care as provided within their home.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

Patients in long-term care institutions (LTCI) are at high risk for osteoporotic fractures due to factors like immobility and poor nutrition, yet osteoporosis is often underdiagnosed and undertreated in these settings.

The guide recommends comprehensive management strategies, including vitamin D and calcium supplementation, exercise programs, and pharmacological treatment for high-risk patients to prevent and treat osteoporotic fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To treat or not to treat, that is the question: proceedings of the Quebec symposium for the treatment of osteoporosis in long-term care institutions, Saint-Hyacinthe, Quebec, November 5, 2004. Duque, G., Mallet, L., Roberts, A., et al.[2018]

Effective interventions for reducing hip fracture risk include vitamin D and calcium supplementation, antiresorptive agents like bisphosphonates, and fall prevention strategies, highlighting the importance of a multi-faceted approach to prevention.

Despite advancements in understanding and managing hip fracture risks, current clinical practices are inadequate, emphasizing the need for primary care physicians and specialists to better identify and treat high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients with hip fracture: what can be improved? Siris, ES.[2018]

A fall screening program integrated into routine osteoporosis care was found to be feasible, with 68% of patients screened meeting the criteria, and the screening process taking significantly less time than traditional evaluations.

The program revealed that a large number of patients with osteoporosis are at risk of falling, with 40% reporting falls in the past year, highlighting the need for fall prevention strategies in osteoporosis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a fall screening program in a high risk of fracture population. Ritchey, K., Olney, A., Shofer, J., et al.[2018]

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]

Patients in long-term care institutions (LTCI) are at high risk for osteoporotic fractures due to factors like immobility and poor nutrition, yet osteoporosis is often underdiagnosed and undertreated in these settings.

The guide recommends comprehensive management strategies, including vitamin D and calcium supplementation, exercise programs, and pharmacological treatment for high-risk patients to prevent and treat osteoporotic fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To treat or not to treat, that is the question: proceedings of the Quebec Symposium for the Treatment of Osteoporosis in Long-term Care Institutions, Saint-Hyacinthe, Quebec, November 5, 2004. Duque, G., Mallet, L., Roberts, A., et al.[2013]

A fall and fracture prevention program implemented in 256 nursing homes in Bavaria, Germany, significantly reduced the incidence of femoral fractures, with rates of 33.6 fractures per 1000 person-years in the intervention group compared to 41.0 in the control group.

Residents exposed to the prevention program had a 18% lower relative risk of femoral fractures (adjusted relative risk of 0.82) compared to those in the control group, demonstrating the program's efficacy in enhancing safety for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of femoral fractures in long-term care facilities: the Bavarian fracture prevention study. Becker, C., Cameron, ID., Klenk, J., et al.[2021]

A survey of 120 Canadian physicians revealed strong support for secondary prevention strategies to reduce hip fractures in long-term care, particularly recommending calcium, vitamin D, oral aminobisphosphonates, physical therapy, and environmental modifications like handrails.

Barriers to implementing these strategies included a lack of strong evidence for some treatments, side effects, poor compliance, and costs associated with certain medications, highlighting the need for further research to address these challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hip fracture prevention strategies in long-term care: a survey of Canadian physicians' opinions. Sawka, AM., Ismaila, N., Raina, P., et al.[2021]

The fall and fracture prevention program was successfully implemented in 942 out of 1150 long-term care facilities, reaching around 62,000 residents, and led to an 18% reduction in femoral fracture rates during the first year.

Despite initial success, the program did not maintain a long-term impact on femoral fracture rates, possibly due to staff turnover and reduced adherence to training components over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term evaluation of the implementation of a large fall and fracture prevention program in long-term care facilities. Roigk, P., Becker, C., Schulz, C., et al.[2019]

A study of 244 hip fracture patients revealed that many are over 80 years old and face barriers to osteoporosis treatment, such as dementia and multiple medical conditions, highlighting the need for tailored care.

Implementing coordinator-facilitated programs in hospitals can effectively identify and treat osteoporosis in hip fracture patients, ensuring they receive necessary medications and education to improve adherence and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming barriers to osteoporosis care in vulnerable elderly patients with hip fractures. Switzer, JA., Jaglal, S., Bogoch, ER.[2022]

Efficient hip protective systems can significantly reduce the risk of hip fractures in the elderly, with the potential to prevent over 90% of such fractures, especially in nursing home residents.

The design improvements in hip protectors have made them more comfortable, which may enhance their effectiveness in preventing fractures among those at risk, including home dwellers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevention with hip protectors. Biomechanical aspects in falls and hip fractures]. Lauritzen, JB.[2013]

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 study involving 67 nursing homes and 606 residents with osteoporosis or recent hip fractures found that a multi-modal quality improvement intervention did not significantly improve the prescription of osteoporosis therapies or hip protectors.

Although the intervention showed a slight increase in therapy use (8.0% in the intervention group vs. 0.6% in the control group), the low participation rates in the intervention activities likely limited its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial to improve fracture prevention in nursing home residents. Colón-Emeric, CS., Lyles, KW., House, P., et al.[2021]

Citations

1. gerascentre.ca gerascentre.ca/our-research/prevent/

Person-centred Routine Fracture Prevention in LTC The study will examine if this program is effective for decreasing hip fractures by assigning some homes to receive the PREVENT program.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04947722

Study Details | NCT04947722 | The PREVENT Trial: a ... The study will examine if this program is effective for decreasing hip fractures by assigning some homes to receive the PREVENT program (intervention group) and ...

3. withpower.com withpower.com/trial/prevent-program-for-hip-fractures-82789

PREVENT Program for Hip Fractures (PREVENT Trial) The study will examine if this program is effective for decreasing hip fractures by assigning some homes to receive the PREVENT program (intervention group) and ...

4. rgpc.ca rgpc.ca/news/clinical-trial-prevent/

Clinical Trial: PREVENT To address this problem the PREVENT (Person-centered Routine Fracture PrEVENTion ... (LTC)) program was designed for use in long-term care homes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11588276/

A longitudinal study PREVENT (Person-centred Routine Fracture PreEVENTion) is an educational outreach model for delivering routine assessments on fall and fracture ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525861020305922

Preventing Fractures in Long-Term Care: Translating ... Province-wide over a 10-year period, hip fracture rates in LTC decreased from 2.3% to 1.9%, and any fracture rates decreased from 4% to 3.6%. This body of work ...