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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 |
| Source of record | UK Trials |
| ISRCTN | ISRCTN24808514 |
| Date ISRCTN assigned | 06/11/2002 |
| Local reference number(s) | 065131 |
| 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 |
| Disease/condition/study domain | Atrial fibrillation |
| 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. |
| Design/methodology | Multicentre, randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material | |
| Anticipated start date | 01/11/2001 |
| Anticipated end date | 30/11/2004 |
| Status of trial | Completed |
| 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 outcomes. |
| Publications | 1. Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17545350 2. Results of qualitative process evaluation in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17545351 |
| Sources of funding | The Wellcome Trust (UK) (grant ref: 065131) |
| Sponsor name | Newcastle upon Tyne Hospitals NHS Trust (UK) |
| Sponsor details | Research and Development Department Room 3, The Bridge, Peacock Hall Royal Victoria Infirmary Queen Victoria Road Newcastle upon Tyne United Kingdom NE1 4LP |
| Sponsor telephone | +44 (0)191 232 5131 |
| Sponsor fax | +44 (0)191 201 0155 |
| Sponsor email | craig.mackerness@trvi.nuth.northy.nhs.uk |
| Sponsor website | http://www.newcastle-hospitals.org.uk/ |
| Contact name | Prof Richard Thomson |
| Contact details | School of Population and Health Sciences Epidemiology & Public Health University of Newcastle upon Tyne Medical School Framlington Place Newcastle upon Tyne United Kingdom NE2 4HH |
| Contact telephone | +44 (0)191 222 8760 |
| Contact fax | +44 (0)191 222 8211 |
| Contact email | richard.thomson@ncl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN24808514 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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