Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05900414
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-12
First Post:
2023-06-04
Brief Title:
Pilot Study of the RAPID AFib Decision Aid for Stroke Prevention in Atrial Fibrillation
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 50000 strokes suffered by Canadians each year The annual stroke risk in untreated patients is 45 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 individuals 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 11 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
Atrial fibrillation AF leads to a 4-fold increased risk of stroke accounting for 15-20 of the 50000 strokes suffered by Canadians each year The annual stroke risk in untreated patients is 45 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 individuals 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None