Ignite Creation Date:
2024-05-06 @ 2:33 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04357288
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-29
First Post:
2020-04-13
Brief Title:
Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
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:
RED-AF
Brief Summary:
This study will compare the effectiveness of the use of a Patient Decision Aid PDA and an Encounter Decision Aid EDA on Shared Decision Making SDM and health outcomes for at-risk participants with Atrial Fibrillation AF at 6 study sites We hypothesize the combination of the PDA and EDA will be more effective in promoting high-quality SDM and in adoption of and adherence to anticoagulation than either tool alone
Detailed Description:
Background Information
Atrial fibrillation AF is the most common cardiac arrhythmia worldwide and it continues to grow in prevalence afflicting an estimated 3 million Americans While treatment of AF symptoms can be resource-intensive another source of physical social and economic burden is thromboembolic stroke the major cause of morbidity and mortality for both symptomatic and asymptomatic people with AF People with AF must decide on a stroke prevention medication typically Warfarin or Oral Anti-Coagulants OACs
Shared Decision Making SD is particularly useful when decisions such as this are value laden and complex Models of SDM stress clear communication of the risks and benefits of all treatment options including no treatment to patients who in turn need opportunities to share their treatment preferences relevant values and goals of care
Decision aids are tools designed to support both people with AF and clinicians in SDM by 1 providing accurate balanced information 2 clarifying patients values and 3 improving SDM skills
Two types of decision aids will be evaluated in the study a patient-centered Patient Decision Aid PDA and an Encounter Decision Aid for collaborative use by the clinician and patient The PDA is intended to help people with AF prepare for the medical visit with foundational understanding and questions The EDA is intended to promote SDM between the clinician and person with AF
Research Design Methods
Through a randomized controlled trial our study will address whether the use of a PDA and EDA a combination of the 2 or usual care achieves the best SDM process and health outcomes We will assess the comparative effectiveness of those 4 approaches in terms of their ability to affect the following outcomes 1 SDM outcomes including decisional conflict knowledge and quality of patient-clinician communication and 2 health outcomes including adoption rates of anticoagulation therapy adherence to anticoagulation therapy regimen bleeding strokesystemic embolism and death Data collection will include medical record review survey completion and videoaudio recording of the clinician encounter
Study sites
Recruitment is planned to occur from 6 sites within the US
Data Collection
Self-reported outcomes from people with AF and clinicians will be collected at the end of each clinical encounter In addition clinicians will complete a survey that collects data on their demographics and practice characteristics
Data from the medical record will be abstracted for all enrolled participants with AF to capture demographic clinical and medication prescription data
Atrial fibrillation AF is the most common cardiac arrhythmia worldwide and it continues to grow in prevalence afflicting an estimated 3 million Americans While treatment of AF symptoms can be resource-intensive another source of physical social and economic burden is thromboembolic stroke the major cause of morbidity and mortality for both symptomatic and asymptomatic people with AF People with AF must decide on a stroke prevention medication typically Warfarin or Oral Anti-Coagulants OACs
Shared Decision Making SD is particularly useful when decisions such as this are value laden and complex Models of SDM stress clear communication of the risks and benefits of all treatment options including no treatment to patients who in turn need opportunities to share their treatment preferences relevant values and goals of care
Decision aids are tools designed to support both people with AF and clinicians in SDM by 1 providing accurate balanced information 2 clarifying patients values and 3 improving SDM skills
Two types of decision aids will be evaluated in the study a patient-centered Patient Decision Aid PDA and an Encounter Decision Aid for collaborative use by the clinician and patient The PDA is intended to help people with AF prepare for the medical visit with foundational understanding and questions The EDA is intended to promote SDM between the clinician and person with AF
Research Design Methods
Through a randomized controlled trial our study will address whether the use of a PDA and EDA a combination of the 2 or usual care achieves the best SDM process and health outcomes We will assess the comparative effectiveness of those 4 approaches in terms of their ability to affect the following outcomes 1 SDM outcomes including decisional conflict knowledge and quality of patient-clinician communication and 2 health outcomes including adoption rates of anticoagulation therapy adherence to anticoagulation therapy regimen bleeding strokesystemic embolism and death Data collection will include medical record review survey completion and videoaudio recording of the clinician encounter
Study sites
Recruitment is planned to occur from 6 sites within the US
Data Collection
Self-reported outcomes from people with AF and clinicians will be collected at the end of each clinical encounter In addition clinicians will complete a survey that collects data on their demographics and practice characteristics
Data from the medical record will be abstracted for all enrolled participants with AF to capture demographic clinical and medication prescription data
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