- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8M 1W9
- St. Peter's Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Difference in the percentage of residents appropriately prescribed an osteoporosis medication before and after the intervention.
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Difference in the percentage of residents prescribed Vitamin D (equivalent to ≥800 IU/day) before and after the intervention.
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Alexandra Papaioannou, MD, MSc, McMaster University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- REB 13-229
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