Contact information
Type
Scientific
Primary contact
Prof Richard Thomson
ORCID ID
Contact details
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
+44 (0)191 222 8760
richard.thomson@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
065131
Study information
Scientific title
Acronym
DARTS II
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.
Ethics approval
Not provided at time of registration
Study design
Multicentre, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
No secondary outcome measures
Overall trial start date
01/11/2001
Overall trial end date
30/11/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients aged over 60 with non-valvular atrial fibrillation on aspirin, warfarin or no anti-thrombotic treatment
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
109
Participant 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
Recruitment start date
01/11/2001
Recruitment end date
30/11/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Population and Health Sciences
Newcastle upon Tyne
NE2 4HH
United Kingdom
Sponsor information
Organisation
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
NE1 4LP
United Kingdom
+44 (0)191 232 5131
craig.mackerness@trvi.nuth.northy.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 065131)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
-
Results
Thomson RG, Eccles MP, Steen IN, Greenaway J, Stobbart L, Murtagh MJ, May CR, A patient decision aid to support shared decision-making on anti-thrombotic treatment of patients with atrial fibrillation: randomised controlled trial., Qual Saf Health Care, 2007, 16, 3, 216-223, doi: 10.1136/qshc.2006.018481.
-
Results of qualitative process evaluation
Murtagh MJ, Thomson RG, May CR, Rapley T, Heaven BR, Graham RH, Kaner EF, Stobbart L, Eccles MP, Qualitative methods in a randomised controlled trial: the role of an integrated qualitative process evaluation in providing evidence to discontinue the intervention in one arm of a trial of a decision support tool., Qual Saf Health Care, 2007, 16, 3, 224-229, doi: 10.1136/qshc.2006.018499.