OsteoporosisGOALNCT01887392
Gaining Optimal Osteoporosis Assessments in Long-Term Care (GOAL)
A study testing Knowledge Translation Education Sessions in people with Osteoporosis, run by McMaster University at 1 site in Canada.
Trial summary
The aim of this study is to disseminate the 2010 Osteoporosis Canada clinical practice guidelines, using a multi-faceted Knowledge Translation (KT) model, as KT aims to close the gap between knowledge generated from research and practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Knowledge Translation Education Sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,800 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A minimum of 2 physicians for each LTC home served by a Pharmacy provider
Who cannot join
- LTC homes that have only one prescribing physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of a Multifaceted, Knowledge Translation Education Intervention in Long-Term Care and Its Ability to Facilitate the Uptake of Osteoporosis Canada 2010 Clinical Practice Guidelines, Across Ontario LTC Homes
The aim of this study is to disseminate the 2010 Osteoporosis Canada clinical practice guidelines, using a multi-faceted Knowledge Translation (KT) model, as KT aims to close the gap between knowledge generated from research and practice. The investigators' primary objective is to evaluate if this intervention can increase the percent of long-term care (LTC) residents receiving appropriate treatment for osteoporosis (i.e. treatment is considered appropriate for an individual over age 50 who has had a diagnosis of osteoporosis or a fragility fracture of the hip or vertebrae and those who have had more than one fragility fracture and is therefore considered high-risk). A secondary objective is to examine whether the intervention increases the percent of all LTC residents receiving Vitamin D equivalent to ≥800 IU/day.
Read the detailed description
Individuals who live in LTC are at high risk for osteoporosis and fractures, particularly hip fractures, which lead to pain and transfer to acute care. The investigators' previous work in LTC has shown that awareness and use of clinical practice guidelines in LTC are low. To successfully transfer knowledge, it is imperative to understand the needs of the LTC teams and to tailor KT interventions appropriately.
Interventions which focus on strategies to overcome barriers and on new ways to deliver and promote the uptake of best practices that are specific to both the learning needs of LTC health care providers and the operational/organizational culture in LTC are greatly needed. Interdisciplinary teams who participated in the Vitamin D and Osteoporosis Study (ViDOS) indicated several process barriers that may hinder the proper identification and treatment of fractures in LTC. There is a need to educate Ontario LTC practitioners on the osteoporosis guidelines. The investigators' aim is to facilitate the uptake of Osteoporosis Canada 2010 Clinical Practice Guidelines, across Ontario LTC homes using the ViDOS multi-faceted KT model. Furthermore, the investigators will have a greater emphasis on the implementation of guidelines which includes risk assessment and appropriate medication use.
- Conditions
- Osteoporosis
- Being tested
- Knowledge Translation Education Sessions
- Keywords
- Long-term Care, Knowledge Translation
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge Translation Education SessionsOther
Two interactive sessions will be delivered to the interprofessional team at Month 1 and Month 6 and are 1 hour in length. The Clinical Consultant Pharmacist at each LTC home will lead the Knowledge Translation Sessions. Participants will watch an educational video, developed by the co-investigators with expertise in osteoporosis and geriatrics and members of the Ontario College of Family Physicians. Accompanying materials that support the topics in the video will be provided. Following the educational video, one of the experts from the video will phone the LTC home to address questions and provide the home with direct access to an expert.
| Study group | Role | What they receive |
|---|---|---|
| Wave A | Experimental | LTC Homes randomized into Wave A will receive the intervention first. The intervention includes Knowledge Translation Education Sessions. Receives: Other: Knowledge Translation Education Sessions |
| Wave B | Experimental | LTC Homes randomized into Wave B will receive the intervention after Wave A. The intervention includes Knowledge Translation Education Sessions. Receives: Other: Knowledge Translation Education Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the percentage of residents appropriately prescribed an osteoporosis medication before and after the intervention.
Difference in the percentage of residents appropriately prescribed an osteoporosis medication before and after the intervention will be measured. Medications to be included in the baseline and post data download are in accordance with the current Osteoporosis Canada guidelines. Treatment is considered appropriate for an individual over age 50 who has had a diagnosis of osteoporosis or a fragility fracture of the hip or vertebra and those who have had more than one fragility fracture (i.e. high risk).
Measured: 18 months
Secondary outcomes (1)
Difference in the percentage of residents prescribed Vitamin D (equivalent to ≥800 IU/day) before and after the intervention.
Vitamin D will be included in the baseline and post data download to compare the two results and see if more residents have been prescribed vitamin D.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,800 participants (actual)
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
- NCT01887392
- Sponsor's protocol ID
- REB 13-229
- Acronym
- GOAL
- Status last verified
- Dec 2016
- First submitted
- 24 Jun 2013
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a Multifaceted, Knowledge Translation Education Intervention in Long-Term Care and Its Ability to Facilitate the Uptake of Osteoporosis Canada 2010 Clinical Practice Guidelines, Across Ontario LTC Homes
- ClinicalTrials.gov ID
- NCT01887392
- Acronym / sponsor ID
- GOAL / REB 13-229
- Conditions
- Osteoporosis
- Keywords
- Long-term Care, Knowledge Translation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,800 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 26 Jun 2013 (estimated)
- 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.
The aim of this study is to disseminate the 2010 Osteoporosis Canada clinical practice guidelines, using a multi-faceted Knowledge Translation (KT) model, as KT aims to close the gap between knowledge generated from research and practice. The investigators' primary objective is to evaluate if this intervention can increase the percent of long-term care (LTC) residents receiving appropriate treatment for osteoporosis (i.e. treatment is considered appropriate for an individual over age 50 who has had a diagnosis of osteoporosis or a fragility fracture of the hip or vertebrae and those who have had more than one fragility fracture and is therefore considered high-risk). A secondary objective is to examine whether the intervention increases the percent of all LTC residents receiving Vitamin D equivalent to ≥800 IU/day.
Detailed description
Individuals who live in LTC are at high risk for osteoporosis and fractures, particularly hip fractures, which lead to pain and transfer to acute care. The investigators' previous work in LTC has shown that awareness and use of clinical practice guidelines in LTC are low. To successfully transfer knowledge, it is imperative to understand the needs of the LTC teams and to tailor KT interventions appropriately.
Interventions which focus on strategies to overcome barriers and on new ways to deliver and promote the uptake of best practices that are specific to both the learning needs of LTC health care providers and the operational/organizational culture in LTC are greatly needed. Interdisciplinary teams who participated in the Vitamin D and Osteoporosis Study (ViDOS) indicated several process barriers that may hinder the proper identification and treatment of fractures in LTC. There is a need to educate Ontario LTC practitioners on the osteoporosis guidelines. The investigators' aim is to facilitate the uptake of Osteoporosis Canada 2010 Clinical Practice Guidelines, across Ontario LTC homes using the ViDOS multi-faceted KT model. Furthermore, the investigators will have a greater emphasis on the implementation of guidelines which includes risk assessment and appropriate medication use.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wave A | Experimental | Other: Knowledge Translation Education SessionsLTC Homes randomized into Wave A will receive the intervention first. The intervention includes Knowledge Translation Education Sessions. |
| Wave B | Experimental | Other: Knowledge Translation Education SessionsLTC Homes randomized into Wave B will receive the intervention after Wave A. The intervention includes Knowledge Translation Education Sessions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- A minimum of 2 physicians for each LTC home served by a Pharmacy provider
Key exclusion criteria (1 listed)
- LTC homes that have only one prescribing physician
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 |
|---|---|---|
| Knowledge Translation Education SessionsTwo interactive sessions will be delivered to the interprofessional team at Month 1 and Month 6 and are 1 hour in length. The Clinical Consultant Pharmacist at each LTC home will lead the Knowledge Translation Sessions. Participants will watch an educational video, developed by the co-investigators with expertise in osteoporosis and geriatrics and members of the Ontario College of Family Physicians. Accompanying materials that support the topics in the video will be provided. Following the educational video, one of the experts from the video will phone the LTC home to address questions and provide the home with direct access to an expert. | Other | Wave A, Wave B |
Primary outcome
Difference in the percentage of residents appropriately prescribed an osteoporosis medication before and after the intervention.
Time frame: 18 months
Difference in the percentage of residents appropriately prescribed an osteoporosis medication before and after the intervention will be measured. Medications to be included in the baseline and post data download are in accordance with the current Osteoporosis Canada guidelines. Treatment is considered appropriate for an individual over age 50 who has had a diagnosis of osteoporosis or a fragility fracture of the hip or vertebra and those who have had more than one fragility fracture (i.e. high risk).
1 secondary outcome
Difference in the percentage of residents prescribed Vitamin D (equivalent to ≥800 IU/day) before and after the intervention.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
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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 Knowledge Translation Education Sessions in people with Osteoporosis, 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 1 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: finished, as of the sponsor's last update on 1 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in the percentage of residents appropriately prescribed an osteoporosis medication before and after the intervention. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2025.