FracturePREVENTNCT04947722
The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care
A study testing PREVENT Program in people with Fracture and Fractures, Hip, run by McMaster University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fracture, Fractures, Hip, Osteoporosis
- What is being tested?
- PREVENT Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,060 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jun 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Both profit and non-profit long-term care homes in Ontario, Canada.
- Homes must have a minimum of 50 occupied beds to participate; there is no maximum home size for participation.
- For both control and intervention homes, resident eligibility (and study cohorts) will be determined via the RAI-MDS 2.0 database.
Who cannot join
- Residents identified as having end-stage disease, who are comatose, receiving hospice or respite care and who have an expected short stay (90 days or less).
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster University - St. Peter's Hospital
Hamilton, Ontario, L8M 1W9
About this study
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.
- Conditions
- Fracture, Fractures, Hip, Osteoporosis
- Being tested
- PREVENT Program
- Keywords
- Long-Term Care, Fracture Risk, Falls, Knowledge Translation, Osteoporosis
- Medical subject headings
- Fractures, Bone, Hip Fractures, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREVENT ProgramBehavioural
A standardized PREVENT educational program will be offered to each intervention LTC home and health-care staff. The curricula includes video modules with fracture-prevention care recommendations and an orientation to the Fracture Prevention Toolkit. Using the Fracture Risk Scale (i.e., a clinical decision support tool embedded in the RAI-MDS 2.0), the LTC team will identify residents at high-risk for fracture and will implement the fracture prevention recommendations into care plans on an individual resident basis.
| Study group | Role | What they receive |
|---|---|---|
| PREVENT Program | Experimental | PREVENT model Receives: Behavioral: PREVENT Program |
| Control Group | No intervention | Residents in homes allocated to the control group will receive usual care as provided within their home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hip-fractures
Data extracted from the Discharge Abstract Database (DAD) and National Ambulatory Care Reporting System (NACRS). Scored as occurred: yes, no.
Measured: One year
Secondary outcomes (10)
Number of non-hip fractures (wrist, spine, pelvis, humerus)
Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Measured: One year
Number of hospital transfers (emergency department and admissions)
Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Measured: One year
Number of deaths
Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.
Measured: One year
Change in number of falls
Assessed by the Minimum Data Set (MDS) (standardized assessment) 2.0. Scored as occurred: yes, no and number of falls.
Measured: Baseline, 3, 6, 9 and 12 months
Change in level of pain
Assessed by the MDS 2.0 Pain Scale. Scored on a scale from 0-4 where higher scores indicate more severe pain.
Measured: Baseline, 3, 6, 9 and 12 months
Change in mobility
Assessed by the MDS 2.0 Activities of Daily Living (ADL) Hierarchy Scale. Scored on a scale from 0-6 where higher scores indicate more impairment in ADL performance.
Measured: Baseline, 3, 6, 9 and 12 months
Change in responsive behaviours
Assessed by the MDS 2.0 Aggressive Behaviour Scale. Scored on a scale from 0-12 where higher scores indicate greater frequency and diversity of aggressive behaviour.
Measured: Baseline, 3, 6, 9 and 12 months
Change in health related quality of life
Assessed by the MDS 2.0 Health Status Index. Scored on a scale from 0-1 where a score of 1 indicates full health.
Measured: Baseline, 3, 6, 9 and 12 months
Change in medications
Data extracted from the pharmacy database. Recorded as number of LTC residents receiving osteoporosis medication(s).
Measured: Baseline, 3, 6, 9 and 12 months
Health quality indicators
Assessed by the Minimum Data Set (MDS) (standardized assessment) 2.0 or health quality indicators for falls, pressure ulcers, pain, physical function and depression.
Measured: Baseline, 3, 6, 9 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start19 Jun 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Papaioannou, McMaster University
- Investigators
- Alexandra Papaioannou, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947722
- Sponsor's protocol ID
- 13622
- Acronym
- PREVENT
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2021
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papaioannou A, Feldman S, Katz P, Costa AP, Kennedy CC, Adachi JD, Boyd H, Giangregorio L, Heckman G, Hewston P, Hirdes J, Holroyd-Leduc J, Howard M, Ho J, Jaglal S, Kaasalainen S, Kristof L, Lau A, Lee J, McArthur C, Marr S, O'Donnell D, Rodrigues IB, Shankardass K, Siu H, Straus S, Thrall S, Tarride JE, Thabane L, Hafid S, Tung J, Hillier LM, Kane LL, Azizudin AM, Desinghe TD, Ioannidis G. Study protocol for a pragmatic, cluster, randomized controlled trial of a multifaceted fracture prevention model for long-term care: the PREVENT trial. Trials. 2026 Jan 9;27(1):111. doi: 10.1186/s13063-025-09398-1.
PubMed 41507969
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care
- ClinicalTrials.gov ID
- NCT04947722
- Acronym / sponsor ID
- PREVENT / 13622
- Conditions
- Fracture, Fractures, Hip, Osteoporosis
- Keywords
- Long-Term Care, Fracture Risk, Falls, Knowledge Translation, Osteoporosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,060 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PREVENT Program | Experimental | Behavioral: PREVENT ProgramPREVENT model |
| Control Group | No intervention | –Residents in homes allocated to the control group will receive usual care as provided within their home. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Both profit and non-profit long-term care homes in Ontario, Canada.
- Homes must have a minimum of 50 occupied beds to participate; there is no maximum home size for participation.
- For both control and intervention homes, resident eligibility (and study cohorts) will be determined via the RAI-MDS 2.0 database.
Key exclusion criteria (1 listed)
- Residents identified as having end-stage disease, who are comatose, receiving hospice or respite care and who have an expected short stay (90 days or less).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREVENT ProgramA standardized PREVENT educational program will be offered to each intervention LTC home and health-care staff. The curricula includes video modules with fracture-prevention care recommendations and an orientation to the Fracture Prevention Toolkit. Using the Fracture Risk Scale (i.e., a clinical decision support tool embedded in the RAI-MDS 2.0), the LTC team will identify residents at high-risk for fracture and will implement the fracture prevention recommendations into care plans on an individual resident basis. | Behavioural | PREVENT Program |
Primary outcome
Number of hip-fractures
Time frame: One year
Data extracted from the Discharge Abstract Database (DAD) and National Ambulatory Care Reporting System (NACRS). Scored as occurred: yes, no.
10 secondary outcomes
Number of non-hip fractures (wrist, spine, pelvis, humerus)
Time frame: One year
Number of hospital transfers (emergency department and admissions)
Time frame: One year
Number of deaths
Time frame: One year
Change in number of falls
Time frame: Baseline, 3, 6, 9 and 12 months
Change in level of pain
Time frame: Baseline, 3, 6, 9 and 12 months
Change in mobility
Time frame: Baseline, 3, 6, 9 and 12 months
Change in responsive behaviours
Time frame: Baseline, 3, 6, 9 and 12 months
Change in health related quality of life
Time frame: Baseline, 3, 6, 9 and 12 months
Change in medications
Time frame: Baseline, 3, 6, 9 and 12 months
Health quality indicators
Time frame: Baseline, 3, 6, 9 and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Derived from this study: PubMed 41507969Papaioannou A, Feldman S, Katz P, Costa AP, Kennedy CC, Adachi JD, Boyd H, Giangregorio L, Heckman G, Hewston P, Hirdes J, Holroyd-Leduc J, Howard M, Ho J, Jaglal S, Kaasalainen S, Kristof L, Lau A, Lee J, McArthur C, Marr S, O'Donnell D, Rodrigues IB, Shankardass K, Siu H, Straus S, Thrall S, Tarride JE, Thabane L, Hafid S, Tung J, Hillier LM, Kane LL, Azizudin AM, Desinghe TD, Ioannidis G. Study protocol for a pragmatic, cluster, randomized controlled trial of a multifaceted fracture prevention model for long-term care: the PREVENT trial. Trials. 2026 Jan 9;27(1):111. doi: 10.1186/s13063-025-09398-1.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Papaioannou, MD, MSc principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREVENT Program in people with Fracture and Fractures, Hip, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hip-fractures (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04947722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.