- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01887392
Gaining Optimal Osteoporosis Assessments in Long-Term Care (GOAL) (GOAL)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8M 1W9
- St. Peter's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A minimum of 2 physicians for each LTC home served by a Pharmacy provider
Exclusion Criteria:
- LTC homes that have only one prescribing physician
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Wave A
LTC Homes randomized into Wave A will receive the intervention first.
The intervention includes Knowledge Translation Education Sessions.
|
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.
|
Experimental: Wave B
LTC Homes randomized into Wave B will receive the intervention after Wave A. The intervention includes Knowledge Translation Education Sessions.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in the percentage of residents prescribed Vitamin D (equivalent to ≥800 IU/day) before and after the intervention.
Time Frame: 18 months
|
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.
|
18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alexandra Papaioannou, MD, MSc, McMaster University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB 13-229
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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