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ISRCTN
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ISRCTN07170460
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ClinicalTrials.gov identifier
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Public title
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Building on Existing Tools to Improve Chronic Disease Prevention in Family Practice: The Better Project
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Scientific title
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The use of patient- and practice-level interventions to improve chronic disease prevention in family practice: A pragmatic randomised controlled trial
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Acronym
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BETTER
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Serial number at source
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2.0
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Study hypothesis
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1. In a family practice group setting, to determine if a patient-centred prevention and screening intervention by a well-trained health professional, for adults aged 40 to 65, is effective.
2. In a family practice group setting, to determine if a practice-centred intervention is effective.
3. To determine if either the patient-centred or practice-centred interventions are cost-effective.
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Lay summary
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Ethics approval
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1. University of Alberta Research Ethics Board approved on the 8th of April 2010
2. Ontario Cancer Research Ethics Board approved on the 31st of May 2010 (ref: #10-024)
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Study design
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Pragmatic randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Chronic disease prevention - specifically cancer, diabetes and cardiovascular diseases
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Participants - inclusion criteria
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1. Strata 1:
1.1. Adult patients of the participating Family Physicians who are between the ages of 40 and 65, inclusive
1.2. Written informed consent to participate in the trial
2. Strata 2: Adults with moderate mental illness aged 40 to 65
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Participants - exclusion criteria
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1. Patients who are unable to give written informed consent for reasons of language, literacy or competence
2. Patients who are not able to come to the family practice office
3. Off-site patients or non-active patients (no visit in the last 3 years) of the family physician
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Anticipated start date
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01/07/2010
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Anticipated end date
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01/03/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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1120
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Interventions
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1. Patient-level intervention with a trained health care professional during which a plan will be developed for the patient. All recommendations and discussions will be based on the 'BETTER' prevention and screening manoeuvers that are evidence-based best practice manoeuvers.
2. Practice-Level Intervention will involve a trained Practice Facilitator who will develop a plan for the practice that will focus on how to optimise the use of existing information tools and resources.
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Primary outcome measure(s)
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The Summary Quality Index (SQUID), measured at 6 months
A reliable and valid composite measure to track quality of care among primary care practice patients that use an electronic medical record (EMR). The primary analysis will be a comparison between the SQUID of the intervention group and the SQUID of the control group.
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Secondary outcome measure(s)
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1. Assessment of the impact of the intervention in improving the quality of care, comparison made from baseline to 6 months follow-up (intervention group only)
2. Economic evaluation to examine the cost-effectiveness of the interventions
Outcomes will be measured at 12 months.
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Sources of funding
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1. Canadian Partnership Against Cancer (Canada)
2. Heart and Stroke Foundation (Canada)
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Trial website
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Publications
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Contact name
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Dr
Eva
Grunfeld
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Address
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263 McCaul St. #329
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City/town
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Toronto
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Zip/Postcode
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M5T 1W7
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Country
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Canada
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Sponsor
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Canadian Partnership Against Cancer (Canada)
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Address
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1 University Ave.
#300
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City/town
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Toronto
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Zip/Postcode
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M5J 2P1
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Country
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Canada
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Sponsor website:
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http://www.partnershipagainstcancer.ca/
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Date applied
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23/03/2010
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Last edited
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16/09/2010
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Date ISRCTN assigned
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07/04/2010
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