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 |
| Secondary identifying numbers | 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
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 |
|---|---|
| richard.thomson@ncl.ac.uk |
Study information
| Study design | Multicentre, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Not Specified |
| 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 | 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 study start date | 01/11/2001 |
| Completion date | 30/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
School of Population and Health Sciences
Newcastle upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
Room 3, The Bridge, Peacock Hall
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
| Phone | +44 (0)191 232 5131 |
|---|---|
| craig.mackerness@trvi.nuth.northy.nhs.uk | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 065131)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
