Gaining Optimal Osteoporosis Assessments in Long-Term Care (GOAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by McMaster University
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
Alexandra Papaioannou, McMaster University
ClinicalTrials.gov Identifier:
NCT01887392
First received: June 24, 2013
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Osteoporosis
Other: Knowledge Translation Education Sessions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Difference in the percentage of residents appropriately prescribed an osteoporosis medication before and after the intervention. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Difference in the percentage of residents prescribed Vitamin D (equivalent to ≥800 IU/day) before and after the intervention. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wave A
LTC Homes randomized into Wave A will receive the intervention first. The intervention includes Knowledge Translation Education Sessions.
Other: 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.
Other: 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.

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.

  Eligibility

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

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
  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: NCT01887392

Contacts
Contact: Alyssa Higginson, MHSc 905-521-2100 ext 77714 higginson@hhsc.ca
Contact: Carly Skidmore, MSc 905-521-2100 ext 74161 skidmorec@hhsc.ca

Locations
Canada, Ontario
St. Peter's Hospital Recruiting
Hamilton, Ontario, Canada, L8M 1W9
Contact: Alyssa Higginson, MHSc    905-521-2100 ext 77714    higginson@hhsc.ca   
Principal Investigator: Alexandra Papaioannou, MD, MSc         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
McMaster University
Investigators
Principal Investigator: Alexandra Papaioannou, MD, MSc McMaster University
  More Information

No publications provided

Responsible Party: Alexandra Papaioannou, Hamilton Health Sciences, McMaster University
ClinicalTrials.gov Identifier: NCT01887392     History of Changes
Other Study ID Numbers: REB 13-229
Study First Received: June 24, 2013
Last Updated: June 26, 2013
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by McMaster University:
Long-term Care
Knowledge Translation

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 31, 2014