None listed
Conditions
Brief summary
The burden of stroke due to atrial fibrillation (AF; a common irregular heart rhythm) is high, especially in older persons in whom AF is most common. To prevent stroke in this high-risk population antithrombotic (anti-clotting) medicines must be used. Warfarin is currently the recommended therapy, however, it requires careful monitoring & management to avoid side-effects (eg bleeding), leading some clinicians to choose less effective therapies (aspirin) for their patients. This clinical trial will test the use of a novel computerised clinical tool (CARAT) to assist GPs in assessing their patients risk of stroke versus side-effects from treatment, and recommended treatment based on ‘risk assessment’.
Interventions
General Practitioners (GPs) in the intervention arm will utilise an online computerised antithrombotic risk assessment tool (CARAT) during routine clinical practice to support their decision-making processes in selecting and/or reviewing antithrombotic (anti-clotting) therapy in their elderly patients with atrial fibrillation. Administration of CARAT will take 15-20 minutes. The intervention will be trialled by GPs over 12 months. CARAT will be applied at 0 and 12 months, and involves a combinat
General Practitioners (GPs) in the intervention arm will utilise an online computerised antithrombotic risk assessment tool (CARAT) during routine clinical practice to support their decision-making processes in selecting and/or reviewing antithrombotic (anti-clotting) therapy in their elderly patients with atrial fibrillation. Administration of CARAT will take 15-20 minutes. The intervention will be trialled by GPs over 12 months. CARAT will be applied at 0 and 12 months, and involves a combination of questions that assess stroke risk, bleeding risk and medication safety issues. CARAT will then quantify the patient’s estimated risk of stroke versus bleeding, flag pertinent medication management issues, and generate a recommendation for therapy (warfarin, aspirin, none, other).The GP will consider the CARAT output and make a final treatment decision to initiate, cease, or maintain current therapy. Where the GP may disagree with CARAT, the rationale for the decision will be documented in the data collection process. Reviewed patients will be followed-up for up to 12 months (0, 1, 6, 12 months) to document key clinical outcomes (i.e., strokes, bleeds).
Sponsors
University of Technology, Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
GPs: 1. must be practicing in one site (i.e., general practice surgery), not across multiple sites or surgeries 2. must practice in the specified Divisions of General Practice 3. must provide informed written consent to participate in the study Patients: 1. aged >= 65 years (older persons) 2. have a diagnosis of chronic (persistent) AF, whether new or pre-existing, irrespective of the antithrombotic therapy prescribed at the time of recruitment 3. provide informed written consent to participate in the study, including telephone follow-up
Exclusion criteria
GPs: 1. not practicing in one site (i.e., general practice surgery across multiple sites or surgeries) 2. not practicing in the specified Divisions of General Practice 3. do not provide informed written consent to participate in the study Patients: 1. aged < 65 years 2. do not have a diagnosis of chronic (persistent) AF 3. do not provide informed written consent to participate in the study, including telephone follow-up
Outcome results
None listed