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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
ISRCTN ISRCTN24808514
DOI 10.1186/ISRCTN24808514
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym DARTS II
Serial number at source 065131
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Multicentre, randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Atrial fibrillation
Participants - inclusion criteria Patients aged over 60 with non-valvular atrial fibrillation on aspirin, warfarin or no anti-thrombotic treatment
Participants - exclusion criteria 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
Anticipated start date 01/11/2001
Anticipated end date 30/11/2004
Status of trial Completed
Patient information material
Target number of participants 109
Interventions 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
Primary outcome measure(s) 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.
Secondary outcome measure(s) No secondary outcome measures
Sources of funding The Wellcome Trust (UK) (grant ref: 065131)
Trial website
Publications 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
Contact name Prof  Richard  Thomson
  Address School of Population and Health Sciences
Epidemiology & Public Health
University of Newcastle upon Tyne
Medical School
Framlington Place
  City/town Newcastle upon Tyne
  Zip/Postcode NE2 4HH
  Country United Kingdom
  Tel +44 (0)191 222 8760
  Fax +44 (0)191 222 8211
  Email richard.thomson@ncl.ac.uk
Sponsor Newcastle upon Tyne Hospitals NHS Trust (UK)
  Address Research and Development Department
Room 3, The Bridge, Peacock Hall
Royal Victoria Infirmary
Queen Victoria Road
  City/town Newcastle upon Tyne
  Zip/Postcode NE1 4LP
  Country United Kingdom
  Tel +44 (0)191 232 5131
  Fax +44 (0)191 201 0155
  Email craig.mackerness@trvi.nuth.northy.nhs.uk
  Sponsor website: http://www.newcastle-hospitals.org.uk/
Date applied 06/11/2002
Last edited 27/11/2012
Date ISRCTN assigned 06/11/2002
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