An observational study in Osteoporosis, Frailty and Chronic Conditions, Multiple, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by McMaster University · Observational
A large proportion of older adults living in long term care homes are frail and have osteoporosis. With age, there is a gradual and progressive decline in bone quality and quantity and an increase in frailty, which is associated with increased fracture risk. Additionally, fractures pose a significant burden to the health and quality of life of long term care residents and contribute to high healthcare costs. Despite the high prevalence of osteoporosis, falls, and fractures in long term care, the management of osteoporosis is not optimal among long term care residents at risk of fracture. The aim of this study is to co-design a service provision (i.e., PREVENT - Person-centred Routine Fracture PreEVENTion) with healthcare providers in long term care and to determine the feasibility of implementing PREVENT in long term care settings.
Fractures pose a significant burden on health, quality of life, and mortality of older adults in long term care (LTC) and contribute to high health care costs. PREVENT (Person-centred Routine Fracture PreEVENTion) is a scalable model for delivering routine assessments and interventions on diet and supplements, multifactorial fall and fracture prevention strategies, and medications to long term care teams to treat residents at high risk of fracture. The purpose of the iCARE study is to create a fall and fracture educational program (i.e., PREVENT) for LTC healthcare providers to deliver routine assessments for the management and treatment of osteoporosis. The benefit of such a guide may help to reduce the devastating impact of fractures in older adults residing in LTC homes. The aim of this pilot study is to: 1) determine feasibility and 2) adaptations through facilitators and barriers. Before a larger trial can be implemented to determine the effectiveness of the PREVENT Program in practice, the iCARE study seeks to determine the feasibility of implementing PREVENT in practice and identify strategies to tailor the program to the individual long term care home and care team through design thinking solutions.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's enrollment of 40 is below the median of 160 across 455 observational studies indexed under Osteoporosis.
Browse Osteoporosis studies →McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Care planning in long term care is a collaborative effort between the resident, the long term care healthcare provider, and the resident's family/caregiver. An internal champion will be identified to represent several long term care homes and who will help identify the five Professional Advisory Committees care teams who are the end-users of the PREVENT program. The Professional Advisory Committee may consist of a Director of Care/Nursing Director, Medical Director, Clinical Consultant Pharmacist, and other participating members who may include dietitians, rehabilitation staff, nurses, physicians, and personal support workers.
Organizational Level Inclusion Criteria:
Five long LTC homes in Ontario that
Individual Level Inclusion Criteria:
The internal champion and LTC leadership team of each LTC home will attend two virtual focus group sessions to help co-design the PREVENT Program educational material. The internal champion will receive training on how to deliver the PREVENT program to the leadership team. The internal champion/pharmacist/data analyst will receive training on how to develop an audit and feedback report on fall and fracture management. All participants will attend an educational meeting facilitated by the internal champion who will use a combination of didactic and interactive activities. After the educational meeting, the leadership team will complete an action and care planning report for each LTC resident at high risk of fracture. Lastly, all participants will attend two virtual focus group sessions to discuss the successes and challenges of implementing the PREVENT program in practice.
Behavioral: PREVENT Program
The internal champion and LTC leadership team of each LTC home will attend two virtual focus group sessions to help co-design the PREVENT Program educational material. The internal champion will receive training on how to deliver the PREVENT program to the leadership team. The internal champion/pharmacist/data analyst will receive training on how to develop an audit and feedback report on fall and fracture management. All participants will attend an educational meeting facilitated by the internal champion who will use a combination of didactic and interactive activities. After the educational meeting, the leadership team will complete an action and care planning report for each LTC resident at high risk of fracture. Lastly, all participants will attend two virtual focus group sessions to discuss the successes and challenges of implementing the PREVENT program in practice.
Behavioral: PREVENT Program
The internal champion and LTC leadership team of each LTC home will attend two virtual focus group sessions to help co-design the PREVENT Program educational material. The internal champion will receive training on how to deliver the PREVENT program to the leadership team. The internal champion/pharmacist/data analyst will receive training on how to develop an audit and feedback report on fall and fracture management. All participants will attend an educational meeting facilitated by the internal champion who will use a combination of didactic and interactive activities. After the educational meeting, the leadership team will complete an action and care planning report for each LTC resident at high risk of fracture. Lastly, all participants will attend two virtual focus group sessions to discuss the successes and challenges of implementing the PREVENT program in practice.
Behavioral: PREVENT Program
PREVENT (Person-centred Routine Fracture PreEVENTion) is a scalable model for delivering routine assessments and interventions on diet and supplements, multifactorial fall and fracture prevention strategies, and medications to long term care teams to treat residents at high risk of fracture.
Feasibility - Recruitment Rate
Number of long term care homes (LTCs) in Ontario recruited within two months. Criteria for success: recruit 5 LTC homes in Ontario within 2 months
Time frame: 2 months
Feasibility - LTC home readiness and capacity
Determine long term care home readiness and capacity to participate in the iCARE study based on a Readiness Checklist Survey. Criteria for success: at least 75% of homes approached are ready and have the capacity to participate in the study
Time frame: 1 month
Feasibility - Length of time to complete PREVENT Program
Length of time for participants to implement the PREVENT Program
Time frame: 4 months
Feasibility - Logistics of linking data (Yes/No format)
Determine the logistics of linking MDS 2.0 data with pharmaceutical database data at the resident level. This will be assessed by a "yes" or "no" (i.e., Feasible - Yes vs. Feasible - No)
Time frame: 4 months
Fidelity of delivering the PREVENT program
Determine the fidelity of delivering the PREVENT program. Criteria for success: ≥ 80% on the fidelity checklist.
Time frame: 4-6 months
Feasibility - Number of Questions Completed
The number of questions answered by the participants for each questionnaire. Criteria for success is 80% of questions are completed.
Time frame: 4 months
Changes in Prescribing Habits
To determine if appropriate prescribing habits change after the educational session. The criteria for success is a 10% improvement in prescribing habits. This will be measured by the number of prescriptions per number of residents at high risk of fracture pre- vs. post-intervention.
Time frame: 4-6 months
Adaptations to PREVENT Program
To determine adaptations to the PREVENT program by facilitating two 1.5-hour focus group sessions (semi-structured interviews) with the leadership team to 1) discuss facilitators of and barriers to implementing the PREVENT program and 2) make necessary changes to the PREVENT program/educational material catered to the individual LTC home.
Time frame: 4-6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2022 to primary completion in Aug 2023, 12 months.
Of 114 non-industry observational studies under Osteoporosis, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 113. This study's 12 months is below that.
Counting every sponsor, half of 125 studies reached it within 51 months; a quarter within 24 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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