Clinical trial NCT04357288: Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation
Official title: Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Shared Decision Making
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Patient-Centered Outcomes Research Institute
name: Mayo Clinic
name: Northwestern University
name: Vanderbilt University
name: University of Michigan
name: University of Alabama at Birmingham
First posted: 2020-04-22
Enrollment: 1117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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, stroke/systemic embolism, and death. Data collection will include medical record review, survey completion, and video/audio 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.

Eligibility criteria: Patient Participants -

Inclusion Criteria:

1. Adults (18 and older)
2. Are diagnosed with Atrial Fibrillation
3. Are aware they have been diagnosed with Atrial Fibrillation
4. Participants with additional risk of thromboembolic events (CHA2DS2-VASc scores ≥ 1 in men and ≥ 2 in women)

Exclusion Criteria:

1. Participants deemed by their clinician or research personnel to be ineligible for consideration of taking or of foregoing anticoagulation
2. Have deficits in cognitive abilities or sensory input
3. Have a language barrier significant enough to impede shared decision making and/or the provision of written informed consent.

Clinician Participants -

Inclusion Criteria:

1. All clinicians (MDs, NP/PAs, PharmDs, APPs, etc.) that are responsible for the modality of Anticoagulation in eligible AF patients at participating sites, without exclusion.

Primary outcomes:
measure: Decisional Conflict Scale
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit
measure: Patient Knowledge
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit
measure: Shared Decision Making
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit
Secondary outcomes:
measure: Decision Regret
timeFrame: Survey will be given at 6 months after enrollment and again at 12 months after enrollment
measure: Preparation for Decision Making
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit
measure: Quality of Communication
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit
measure: 9-item Shared Decision Making Questionnaire (SDMQ9)
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit
measure: Control Preference Scale
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit
measure: Patient Satisfaction with the Decision Aid
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months
measure: Collaborative Agreement
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit
measure: Anticoagulation Adherence 1 - Visual Analogue Scale
timeFrame: Survey will be given at 6 months after enrollment and again at 12 months after enrollment
measure: Anticoagulation Adherence 2 - Self-Report
timeFrame: Survey will be given at 6 months after enrollment and again at 12 months after enrollment
measure: Anticoagulation Adherence 3 - Warfarin Use
timeFrame: We gather this information throughout the length of the participant's enrollment (approximately 12 months)
measure: Anticoagulation Adherence 4 - Time in Therapeutic Range
timeFrame: We gather this information throughout the length of the participant's enrollment (approximately 12 months)
measure: Treatment Choice
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months
measure: Fidelity of Decision Aids
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit
measure: Clinical Events
timeFrame: Survey will be given and data will be collected at 12 months after enrollment
measure: Encounter Length
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit
measure: Min/Max Scale
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit
measure: Anticoagulation Persistence
timeFrame: Approximately 12 months after enrollment
measure: Medical History
timeFrame: We gather medical information at the time of enrollment; again at 6 months; and again at 12 months after enrollment.
measure: Adapted Illness Intrusiveness Ratings
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months
measure: Values Trade-off
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit
measure: Clinician Satisfaction
timeFrame: Post encounter surveys will be given or sent within 1 week after each visit
measure: Choice of Anticoagulant
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months
measure: Predicting Mortality and Healthcare Utilization (Quality of Life)
timeFrame: Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: The Mayo Clinic
state: Minnesota
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
affiliation: University of Utah
name: Elissa Ozanne, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Angela Fagerlin, PhD
role: STUDY_DIRECTOR
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