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Vitamin D Osteoporosis Long-Term Care Study (ViDOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexandra Papaioannou, McMaster University
ClinicalTrials.gov Identifier:
NCT01398527
First received: July 19, 2011
Last updated: May 2, 2013
Last verified: May 2013

July 19, 2011
May 2, 2013
July 2009
February 2013   (final data collection date for primary outcome measure)
Number of LTC residents on vitamin D [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01398527 on ClinicalTrials.gov Archive Site
  • Number of falls and fractures [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Vitamin D dose [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Bisphosphonate use by LTC residents [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vitamin D Osteoporosis Long-Term Care Study
An Interdisciplinary Knowledge Translation Intervention in Long-term Care: The Vitamin D and Osteoporosis Study (ViDOS) Pilot Cluster Randomized Controlled Trial

The research question is, does a multifaceted, multidisciplinary intervention including small groups, chart audits and point of care tools, increase the number of people receiving optimal vitamin D therapy in the long term care (LTC) setting? Secondary outcomes include the number of falls and fractures experienced by the residents in each LTC home and the number of residents receiving appropriate bisphosphonate therapy.

This is a cluster randomized controlled trial. In the long-term care (LTC) setting, more research is needed on how health care professionals can be kept up to date on the latest medical evidence for providing care to elderly residents. The LTC environment differs from other health care settings. We need to examine what types of strategies can be used to effectively educate LTC physicians, nurses, and other care professionals about the best care practices.

In this study, we will deliver and evaluate a multi-component educational strategy that builds on research in LTC by our team. In order to evaluate its success, 20 homes will receive the intervention and 20 homes will receive usual care. In the intervention homes, a team of experts will give educational sessions at the LTC home, delivering key messages about "best practices", helping LTC professionals to plan changes for delivering better care, giving feedback about performance, and providing materials (e.g., DVD, treatment plans). We will also train a professional in the home to "champion" the cause after the experts are gone.

The specific "best practices" topic we have chosen to test our model is osteoporosis and fractures. These conditions are very common in the elderly living in LTC and negatively impact quality of life. For example, an individual with a hip or other fracture may experience unnecessary pain and suffering and even pre-mature death. There are effective treatments that can be used to reduce fractures, including vitamin D, which is a low-cost, well-tolerated and easy treatment to deliver. Unfortunately our previous studies have shown that most LTC residents are not receiving effective fracture-prevention treatments. To determine our intervention's success, we will examine whether the rate of vitamin D use and other treatments increases, and whether fewer LTC residents fall and fracture. We are also interested in studying the strategy's format and feasibility and what future changes should be made.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Osteoporosis
Other: Educ sessions & LTC Osteoporosis toolkit
Three points of contact to be made. The first being a 1-hour personal visit at each intervention LTC home from an osteoporosis expert with the homes professional or health advisory committee (PAC or HAC). The second and third contact points will be made through webinars between the osteoporosis expert and the group from the first meeting.
Other Name: Knowledge translation
  • No Intervention: LTC Osteoporosis Toolkit Only
    Homes will receive the LTC osteoporosis toolkit only and will be required to attend an online webinar to outline the toolkit contents.
  • Active Comparator: Educ sessions & LTC Osteoporosis toolkit
    LTC homes will receive the LTC osteoporosis toolkit, on line webinar. Three educational sessions lead by an osteoporosis expert will also take place, 1 on-site visit and 2 webinars.
    Intervention: Other: Educ sessions & LTC Osteoporosis toolkit
Kennedy CC, Ioannidis G, Giangregorio LM, Adachi JD, Thabane L, Morin SN, Crilly RG, Marr S, Josse RG, Lohfeld L, Pickard LE, King S, van der Horst ML, Campbell G, Stroud J, Dolovich L, Sawka AM, Jain R, Nash L, Papaioannou A. An interdisciplinary knowledge translation intervention in long-term care: study protocol for the vitamin D and osteoporosis study (ViDOS) pilot cluster randomized controlled trial. Implement Sci. 2012 May 24;7:48. doi: 10.1186/1748-5908-7-48.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • LTC homes in Ontario that are serviced by MPGI
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01398527
REB 09-215
No
Alexandra Papaioannou, McMaster University
Canadian Institutes of Health Research (CIHR)
Not Provided
Principal Investigator: Alexandra Papaioannou, MD, MSc McMaster University
McMaster University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP