N/A
N=1,186
SDM for Stroke Prevention in Atrial Fibrillation
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02905032 ↗Enrolled (actual)
1,186
Serious AEs
8.9%
Results posted
Jan 2022
Primary outcome: Primary: Number of Clinician Satisfied Encounters — 277; 400 encounters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Decision Aid (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Clinician Satisfied Encounters |
277; 400 | — |
| PRIMARY Number of Clinician Recommendation |
199; 396 | — |
| SECONDARY Number of Participants With Anticoagulant Medication Use |
391; 399 | — |
| SECONDARY Patient Involvement |
29.1; 33.0 | — |
| SECONDARY Encounter Duration |
31; 32 | — |
Summary
The objective of this project is to evaluate a treatment decision aid for patients with atrial fibrillation.
Eligibility Criteria
Clinician Inclusion Criteria:
- All clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible AF patients at participating sites, without exclusion
Patient Inclusion Criteria:
- ≥ 18 years of age
- Chronic nonvalvular atrial fibrillation deemed at high risk of thromboembolic strokes (CHA2D2-VASc Score ≥ 1, or 2 in women)
- Able to read and understand (despite cognitive, sensorial, hearing or language challenges) the informed consent document as determined by the study coordinator during consent
Patient Exclusion Criteria:
- Clinician indicates that patient is not a candidate for a discussion about anticoagulation medication
Data sourced from ClinicalTrials.gov (NCT02905032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.