Condition category
Circulatory System
Date applied
06/11/2002
Date assigned
06/11/2002
Last edited
27/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.newcastle-hospitals.org.uk/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes