PREVENT Program for Hip Fractures

Recruiting in Palo Alto (17 mi)

Overseen by Alexandra Papaioannou, MD, MSc

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: McMaster University

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

Hip fractures occur nearly twice as often for older adults residing in long-term care as they do in older adults of a similar age still living in other settings. Hip fractures are the leading cause of hospitalization and often result in loss of independence, problems with walking and sometimes death. To address this problem the PREVENT (Person-centered Routine Fracture PrEVENTion in LTC) program was designed for use in long-term care homes. PREVENT uses a tool ("fracture risk calculator") based on a residents electronic health record to capture who is most at risk of fracture due to osteoporosis and falls. The program then trains the health care team including doctors, pharmacists and nurses on the latest recommendations on how to best assist residents and their families in making treatment decisions. The healthcare teams are also given tools that help them stay on track such as templates for ordering medications, strategies to reduce falls and fractures and making care plans. 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 some homes to usual care (control group) and comparing the results.

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 data supports the effectiveness of the PREVENT Program treatment for hip fractures?

The PREVENT Program treatment for hip fractures in long-term care facilities is supported by research indicating that interventions, including both non-drug and drug strategies, are needed to prevent fractures in these settings. Additionally, effective osteoporosis care, which is crucial for preventing hip fractures, involves early initiation and coordination of treatment, including calcium and vitamin D supplementation, and has shown benefits in improving patient outcomes. ^{1 2 3 4 5}

Is the PREVENT Program for Hip Fractures safe for humans?

The PREVENT Program, which includes strategies like exercise, medication reviews, and hip protectors, has been implemented in long-term care facilities and is generally considered safe for preventing falls and fractures in the elderly. ^{2 6 7 8 9}

How is the PREVENT Program treatment for hip fractures different from other treatments?

The PREVENT Program is unique because it focuses on person-centered care specifically in long-term care facilities, addressing the unique needs of residents who have different access to medical services compared to those living independently. It emphasizes fall and fracture prevention strategies tailored to this setting, which is not typically the focus of standard treatments like medication or supplements. ^{2 9 10 11 12}

Research Team

Alexandra Papaioannou, MD, MSc

Principal Investigator

McMaster University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• PREVENT Program (Behavioral Intervention)

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.

Participant Groups

Group I: PREVENT Program Experimental Treatment 1 Intervention

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+

Evan Stein

McMaster University

Chief Medical Officer since 2015

MD, PhD

Sam

McMaster University

Chief Executive Officer since 2023

MBA from McMaster University

Findings from Research

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]

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]

References

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

Randomized trial to improve fracture prevention in nursing home residents. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Hip fracture prevention strategies in long-term care: a survey of Canadian physicians' opinions. [2021]

3. United States 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. [2018]

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

Overcoming barriers to osteoporosis care in vulnerable elderly patients with hip fractures. [2022]

5. United States 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. [2013]

6. Sweden pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Long-term evaluation of the implementation of a large fall and fracture prevention program in long-term care facilities. [2019]

8. France pubmed.ncbi.nlm.nih.gov

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

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

Patients with hip fracture: what can be improved? [2018]

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

Reduction of femoral fractures in long-term care facilities: the Bavarian fracture prevention study. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Implementation of a fall screening program in a high risk of fracture population. [2018]

12. Greece pubmed.ncbi.nlm.nih.gov

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