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
  Purpose

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.


Condition Intervention
Osteoporosis
Other: Educ sessions & LTC Osteoporosis toolkit

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: An Interdisciplinary Knowledge Translation Intervention in Long-term Care: The Vitamin D and Osteoporosis Study (ViDOS) Pilot Cluster Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Number of LTC residents on vitamin D [ Time Frame: 16 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: July 2009
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LTC homes in Ontario that are serviced by MPGI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398527

Locations
Canada, Ontario
McMaster University - St. Peter's Hospital
Hamilton, Ontario, Canada, L8M1W9
Sponsors and Collaborators
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Alexandra Papaioannou, MD, MSc McMaster University
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alexandra Papaioannou, Dr. Alexandra Papaioannou, McMaster University
ClinicalTrials.gov Identifier: NCT01398527     History of Changes
Other Study ID Numbers: REB 09-215
Study First Received: July 19, 2011
Last Updated: May 2, 2013
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario
Canada: Ethics Review Committee

Keywords provided by McMaster University:
Long-Term Care
Vitamin D

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 20, 2014