Clinical trial NCT05900414: RAPID AFib Decision Aid for Stroke Prevention in Atrial Fibrillation
Official title: Pilot Clinical Trial of the Risk Assessment and Personal Preference to Improve Decisions in Atrial Fibrillation Patient Decision Aid for Stroke Prevention in Atrial Fibrillation: the RAPID AFib Pilot Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: patient decision aid
stroke
shared decision aid
anticoagulant therapy
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Servier
First posted: 2023-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this pilot clinical trial is to evaluate the utility of a new electronic patient decision aid for stroke prevention therapy in patients with atrial fibrillation. The main questions it aims to answer are:

Is the patient decision aid acceptable to both patients and physicians? Does the patient decision aid lead to more effective shared decision-making than standard care among patients with atrial fibrillation who are considering stroke prevention therapy? Participants with a recent diagnosis of atrial fibrillation will be enrolled before an upcoming specialist physician visit. Researchers will compare a pre-visit intervention consisting of standard educational materials plus use of the patient decision aid to educational materials alone to see if using the decision aid results in improved shared decision making during the clinic visit.

Detailed description: Background:

Atrial fibrillation (AF) leads to a 4-fold increased risk of stroke, accounting for 15-20% of the 50,000 strokes suffered by Canadians each year. The annual stroke risk in untreated patients is 4.5%, but varies 10-fold based on risk factors captured in clinical prediction tools. Given that oral anticoagulation (OAC) reduces stroke risk by 65%, the majority of AF-associated strokes are potentially preventable. All current Canadian and international AF guidelines strongly recommend use of clinical prediction rules to assess stroke risk, and anticoagulation of high-risk patients. However, population-based studies continue to document significant rates of risk-discordant stroke prevention therapy. Addressing this care gap is a major knowledge translation challenge.

Patient decision aids are knowledge translation tools that can facilitate a process of shared decision-making to improve patient knowledge and decision quality. These tools have the potential to improve both initial therapy selection and adherence, ultimately reducing the risks of AF-associated stroke and unnecessary bleeding. We have developed and performed initial user testing for a new, web-based decision aid, called Risk Assessment and Personal preferences to Improve Decisions for Atrial Fibrillation (RAPID AFib). The tool has 3 sequential functions: (1) it estimates an individual's risk for stroke and for bleeding using published risk scores; (2) it allows them to interactively compare OACs to select one or more therapies that best matches their risk profile and individual preferences ; and (3) it summarizes the risk information and their selected therapy to facilitate discussion with their physician in a Summary Report. This study represents the next step in this program of research, by performing a formal evaluation of the performance of this tool in a real-world clinical setting.

Primary Objective:

To conduct a pilot study to establish the acceptability of the RAPID AFib tool and its impact on the process of shared decision-making for stroke prevention therapy in patients with recent onset AF

Hypothesis:

The RAPID Afib decision aid will be acceptable for both patients and clinicians, and will lead to more effective shared decision-making than standard care among patients with AF who are considering OAC.

Methods:

Study Design: Prospective, randomized pilot study.

Study procedures:

Clinic staff will screen referred patients, then the research team will approach them to confirm eligibility, request informed consent for participation, and collect baseline demographic and clinical data. Consenting patients will be randomized 1:1 using a web-based application linked to the study database to receive the study intervention or control. Randomization will be stratified by clinic site.

All patients will be invited to review an evidence-based website providing information about AF and its management.

Intervention group: Patients randomized to the RAPID AFib intervention will be sent a link to the decision aid website and asked to complete the decision aid before their upcoming visit. They will also be asked to bring the Summary Report to their upcoming clinic visit. A copy of the Summary Report will be added to the patient chart for clinician review.

Control group: Patients randomized to the control group will attend their clinic visit as scheduled, with no further direction from the study team.

Follow-up: Study participation will end after completion of a post-visit survey.

Eligibility criteria: Inclusion Criteria:

* Non-valvular AF diagnosed within 12 months, with any level of stroke risk assessed by CHA2DS2-VASc score.
* Age 18 or older
* Either no OAC treatment or treated for less than 90 days.
* Initial specialist AF visit scheduled in 7-30 days.

Exclusion Criteria:

* Valvular AF, defined, per Canadian Cardiovascular Society Guidelines, as AF in the presence of mechanical heart valves, rheumatic mitral stenosis, or moderate to severe nonrheumatic mitral stenosis.
* Currently prescribed dual antiplatelet therapy (ASA plus either clopidogrel, ticagrelor, or prasugrel) for an indication other than AF.
* Has an independent, non-AF indication for oral anticoagulation.
* Has a non-modifiable impediment to effective use of web-based tools. Examples include lack of internet access, lack of English literacy (Grade 5 level).

Primary outcomes:
measure: The 9-Item Shared Decision Making Questionnaire (SDM-Q-9: patient version).
timeFrame: Immediately after clinic visit
Secondary outcomes:
Other outcomes:
measure: OPTION 5: Objective assessment of shared decision-making
timeFrame: Immediately after clinic visit
measure: Physician version of the 9-Item Shared Decision Making Questionnaire (SDM-Q-Doc)
timeFrame: Immediately after clinic visit
measure: Therapy decision
timeFrame: Immediately after clinic visit
measure: Decisional conflict
timeFrame: Immediately after clinic visit
measure: Visit Duration
timeFrame: Immediately after clinic visit
Locations:
city: Calgary
country: Canada
facility: Calgary Zone, Alberta Health Services
state: Alberta
city: Calgary
country: Canada
facility: Vita Diagnostics
state: Alberta
Study officials:
affiliation: University of Calgary
name: Stephen B Wilton, MD
role: PRINCIPAL_INVESTIGATOR
References: