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	https://doi.org/10.1186/ISRCTN24808514
Protocol serial number	065131
Sponsor	Newcastle upon Tyne Hospitals NHS Trust (UK)
Funder	The Wellcome Trust (UK) (grant ref: 065131)

Submission date: 06/11/2002
Registration date: 06/11/2002
Last edited: 27/11/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Richard Thomson
Scientific

School of Population and Health Sciences
Epidemiology & Public Health
University of Newcastle upon Tyne
Medical School
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom

Phone	+44 (0)191 222 8760
Email	richard.thomson@ncl.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre, randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	DARTS II
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Atrial fibrillation
Intervention	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
Intervention type	Other
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.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/11/2004

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	109
Key inclusion criteria	Patients aged over 60 with non-valvular atrial fibrillation on aspirin, warfarin or no anti-thrombotic treatment
Key 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
Date of first enrolment	01/11/2001
Date of final enrolment	30/11/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

School of Population and Health Sciences

Newcastle upon Tyne
NE2 4HH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/06/2007		Yes	No
Results article	Results of qualitative process evaluation	01/06/2007		Yes	No