Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,117
- 试验地点
- 12
- 主要终点
- Patient Knowledge
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 and older)
- •Are diagnosed with Atrial Fibrillation
- •Are aware they have been diagnosed with Atrial Fibrillation
- •Participants with additional risk of thromboembolic events (CHA2DS2-VASc scores ≥ 1 in men and ≥ 2 in women)
排除标准
- •Participants deemed by their clinician or research personnel to be ineligible for consideration of taking or of foregoing anticoagulation
- •Have deficits in cognitive abilities or sensory input
- •Have a language barrier significant enough to impede shared decision making and/or the provision of written informed consent.
- •Clinician Participants -
- •Inclusion Criteria:
- •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.
结局指标
主要结局
Patient Knowledge
时间窗: Post encounter surveys will be given or sent within 1 week after the visit
An 8-question survey assesses a participant's knowledge about atrial fibrillation and anticoagulation use after the intervention. Participants not in the intervention arm will also take this survey for comparison. Each question uses a response format of "true / false / do not know". All questions are answered with full access to the decision aid(s) (if not in standard care arm) since they are not meant to test recall. "Better" scores will be measured by how many questions that a participant answers correctly.
Shared Decision Making
时间窗: Post encounter surveys will be given or sent within 1 week after the visit
The extent of shared decision making between the participant and provider that took place during the encounter will be assessed by study team members using the Observing Patient Involvement scale (OPTION12). The scale consists of 12 items scored from 0, "the behavior is not observed," to 4, "the behavior is observed and executed to a high standard." The more shared decision making behaviors observed the better, so a higher score is "better" for this scale.
Decisional Conflict Scale
时间窗: Post encounter surveys will be given or sent within 1 week after the visit
Validated scale of 16 questions that evaluates 1) uncertainty in making a healthcare decision, 2) factors contributing to the uncertainty, and 3) the participant's perceived effective decision making. Answers range in a 5 point Likert scale from 0=strongly agree to 4=strongly disagree. Clarity and understanding are indicated if the participant "strongly agrees" to the statements, so smaller scores are better.
次要结局
- Quality of Communication(Post encounter surveys will be given or sent within 1 week after the visit)
- Collaborative Agreement(Post encounter surveys will be given or sent within 1 week after the visit)
- Clinical Events(Survey will be given and data will be collected at 12 months after enrollment)
- Medical History(We gather medical information at the time of enrollment; again at 6 months; and again at 12 months after enrollment.)
- Anticoagulation Adherence 2 - Self-Report(Survey will be given at 6 months after enrollment and again at 12 months after enrollment)
- Decision Regret(Survey will be given at 6 months after enrollment and again at 12 months after enrollment)
- Control Preference Scale(Post encounter surveys will be given or sent within 1 week after the visit)
- Min/Max Scale(Post encounter surveys will be given or sent within 1 week after the visit)
- Preparation for Decision Making(Post encounter surveys will be given or sent within 1 week after the visit)
- 9-item Shared Decision Making Questionnaire (SDMQ9)(Post encounter surveys will be given or sent within 1 week after the visit)
- Patient Satisfaction with the Decision Aid(Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months)
- Anticoagulation Adherence 3 - Warfarin Use(We gather this information throughout the length of the participant's enrollment (approximately 12 months))
- Anticoagulation Persistence(Approximately 12 months after enrollment)
- Predicting Mortality and Healthcare Utilization (Quality of Life)(Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months)
- Anticoagulation Adherence 1 - Visual Analogue Scale(Survey will be given at 6 months after enrollment and again at 12 months after enrollment)
- Anticoagulation Adherence 4 - Time in Therapeutic Range(We gather this information throughout the length of the participant's enrollment (approximately 12 months))
- Encounter Length(Post encounter surveys will be given or sent within 1 week after the visit)
- Adapted Illness Intrusiveness Ratings(Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months)
- Values Trade-off(Post encounter surveys will be given or sent within 1 week after the visit)
- Clinician Satisfaction(Post encounter surveys will be given or sent within 1 week after each visit)
- Choice of Anticoagulant(Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months)
- Treatment Choice(Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months)
- Fidelity of Decision Aids(Post encounter surveys will be given or sent within 1 week after the visit)
研究者
Elissa Ozanne
Associate Professor
University of Utah