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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Knowledge Translation Education Sessions
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoporosis focused on measuring Long-term Care, Knowledge Translation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Peter's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Wave A

Wave B

Arm Description

LTC Homes randomized into Wave A will receive the intervention first. The intervention includes Knowledge Translation Education Sessions.

LTC Homes randomized into Wave B will receive the intervention after Wave A. The intervention includes Knowledge Translation Education Sessions.

Outcomes

Primary Outcome Measures

Difference in the percentage of residents appropriately prescribed an osteoporosis medication before and after the intervention.
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.
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.

Full Information

First Posted
June 24, 2013
Last Updated
December 13, 2016
Sponsor
Hamilton Health Sciences Corporation
Collaborators
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT01887392
Brief Title
Gaining Optimal Osteoporosis Assessments in Long-Term Care (GOAL)
Acronym
GOAL
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
McMaster University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Long-term Care, Knowledge Translation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wave A
Arm Type
Experimental
Arm Description
LTC Homes randomized into Wave A will receive the intervention first. The intervention includes Knowledge Translation Education Sessions.
Arm Title
Wave B
Arm Type
Experimental
Arm Description
LTC Homes randomized into Wave B will receive the intervention after Wave A. The intervention includes Knowledge Translation Education Sessions.
Intervention Type
Other
Intervention Name(s)
Knowledge Translation Education Sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in the percentage of residents appropriately prescribed an osteoporosis medication before and after the intervention.
Description
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).
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Difference in the percentage of residents prescribed Vitamin D (equivalent to ≥800 IU/day) before and after the intervention.
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Papaioannou, MD, MSc
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Peter's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1W9
Country
Canada

12. IPD Sharing Statement

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

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