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ISRCTN
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ISRCTN24808514
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ClinicalTrials.gov identifier
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Public title
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Decision Analysis in Routine Treatment II: a randomised controlled trial (efficacy study) of a decision aid to support shared decision making for patients with atrial fibrillation
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Scientific title
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Acronym
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DARTS II
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Serial number at source
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065131
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Study hypothesis
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To determine the efficacy of implicit and explicit decision support tools in reducing decision conflict under ideal circumstances.
To support design of a subsequent multi-centre pragmatic randomised controlled trial.
The initial study design was a three arm open randomised controlled trial comparing explicit and implicit decision support tools with paper based guidelines. The explicit arm was discontinued in October 2003.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Multicentre, randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Atrial fibrillation
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Participants - inclusion criteria
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Patients aged over 60 with non-valvular atrial fibrillation on aspirin, warfarin or no anti-thrombotic treatment
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Participants - exclusion criteria
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1. Acute onset requiring cardiological referral for consideration of cardioversion
2. Had a previous stroke or Transient Ischaemic Attack (TIA)
3. Have absolute contraindications to warfarin
4. Suffer from dementia or cognitive impairment sufficient to hinder shared decision making
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Anticipated start date
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01/11/2001
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Anticipated end date
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30/11/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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109
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Interventions
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Patients randomised to one of three interventions:
1. Explicit DARTS tool - full shared decision making tool
2. Implicit DARTS tool - shortened version of shared decision making tool
3. Evidence based guidelines group - control arm
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Primary outcome measure(s)
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The primary outcome measure is the decision conflict scale. Prior to clinic attendance patients will complete scales on decision conflict, their choice predisposition, knowledge, decision making preference, general anxiety and risk factors/demographic information.
Immediately following the clinic, patients will complete scales on decision conflict, knowledge, decision making role experienced, and anxiety.
At three months, patients will be sent follow-up postal questionnaires including the decision conflict scale, decision making preference scale and the knowledge scale.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 065131)
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Trial website
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Publications
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1. 2007 Results in http://www.ncbi.nlm.nih.gov/pubmed/17545350
2. 2007 Results of qualitative process evaluation in http://www.ncbi.nlm.nih.gov/pubmed/17545351
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Contact name
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Prof
Richard
Thomson
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Address
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School of Population and Health Sciences
Epidemiology & Public Health
University of Newcastle upon Tyne
Medical School
Framlington Place
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE2 4HH
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Country
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United Kingdom
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Tel
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+44 (0)191 222 8760
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Fax
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+44 (0)191 222 8211
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Email
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richard.thomson@ncl.ac.uk
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Sponsor
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Newcastle upon Tyne Hospitals NHS Trust (UK)
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Address
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Research and Development Department
Room 3, The Bridge, Peacock Hall
Royal Victoria Infirmary
Queen Victoria Road
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE1 4LP
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Country
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United Kingdom
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Tel
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+44 (0)191 232 5131
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Fax
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+44 (0)191 201 0155
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Email
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craig.mackerness@trvi.nuth.northy.nhs.uk
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Sponsor website:
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http://www.newcastle-hospitals.org.uk/
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Date applied
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06/11/2002
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Last edited
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06/01/2011
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Date ISRCTN assigned
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06/11/2002
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