Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05900414 |
| Other study ID # |
REB22-1737 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2023 |
| Est. completion date |
March 2025 |
Study information
| Verified date |
June 2023 |
| Source |
University of Calgary |
| Contact |
Stephen B Wilton, MD |
| Phone |
403-210-7102 |
| Email |
sbwilton[@]ucalgary.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
