Comparative Effectiveness of a Decision Aid for Therapeutic Options in Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Acceptability of Decision Aid Education Assessed by the Acceptability Survey
研究概览
简要总结
Sickle cell disease (SCD) is an inherited disorder with chronic multi-system manifestations affecting 100,000 individuals in the US, largely of minority origin and associated with substantial morbidity, premature mortality, individual suffering, healthcare costs and loss of productivity. Disease modifying treatments such as hydroxyurea, chronic blood transfusion and curative bone marrow transplantation are offered to patients based on physician preference and current practice informed by clinical trials. Decision aids are tools that could help translate evidence from these sources into practice by helping clinicians involve patients in making deliberate choices based on accessible information about the options available and their outcomes and to help them make decisions based on their values and preferences.
The overarching goal of this project is to implement a web based decision aid individualized to patient characteristics to help patients with SCD achieve more accurate perception of risks and benefits of treatment options and make decisions in congruence with their values and preferences. Investigators will use a randomized controlled trial of the effectiveness of a web-based decision aid to give patients accurate information about risks and benefits of therapies that enable patients to make decisions based on their individual values and preferences.
详细描述
Sickle cell disease (SCD) is an inherited disorder with chronic multi-system manifestations affecting 100,000 individuals in the US, largely of minority origin and associated with substantial morbidity, premature mortality, individual suffering, healthcare costs and loss of productivity. Disease modifying treatments such as hydroxyurea, chronic blood transfusion and curative bone marrow transplantation are offered to patients based on physician preference and current practice informed by clinical trials. Decision aids are tools that could help translate evidence from these sources into practice by helping clinicians involve patients in making deliberate choices based on accessible information about the options available and their outcomes and to help them make decisions based on their values and preferences.
There are minimal data about patient-related barriers to and attitudes towards, the use of curative therapies in SCD. Thus significant gaps remain in the understanding of patient perspectives, in the provision of accurate information about risks and benefits of therapies and of incorporating patients' values and preferences in offering treatment options. There is a need for research that helps to understand patient values and preferences and determines how to help patients make informed treatment decision in congruence with their values and preferences.
The overarching goal of this project is to implement a web based decision aid individualized to patient characteristics to help patients with SCD achieve more accurate perception of risks and benefits of treatment options and make decisions in congruence with their values and preferences. Investigators will use a randomized controlled trial of the effectiveness of a web-based decision aid to give patients accurate information about risks and benefits of therapies that enable patients to make decisions based on their individual values and preferences.
Investigators hypothesize that a web based decision aid individualized to patient characteristics can improve knowledge and help patients with SCD achieve more accurate perception of risks and benefits of treatment options and is associated with lower decisional conflict than standard care.
The aims of the study are to estimate the effectiveness of the decision aid tailored to individual patient characteristics on patient knowledge, patient involvement in decision-making and decision-making quality, when compared with usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals with sickle cell disease ages 8 to 80 years, inclusive OR
- •Parent/legal guardian of patients (age < 18 years) with sickle cell disease who are directly involved in decision making regarding sickle cell disease healthcare treatment OR
- •Health care provider directly involved in care of individuals with sickle cell disease, including child of parent/legal guardian enrolled in study
- •Patients/parents/caregivers who have made a past decision to not obtain treatment of the considered option or who have not obtained treatment of the chosen option in past 12 months.
- •All participants will be able to comprehend English
- •Patients/Parent/Legal guardian will have access to the internet from iPad, smart phone or personal computer
排除标准
- •Family Members/Individuals/Caregivers not directly involved in decision-making regarding sickle cell disease healthcare.
- •Patient/parent/legal guardian who has already made a decision to begin and has started the treatment option.
- •Child < 18 years of parent/legal guardian who is participating in Cohort A of this study and randomized to the control arm and not the decision aid arm.
- •Spouse, significant other, or other family member involved in decision making for child <18 years if parent/legal guardian of child already enrolled into this study.
研究组 & 干预措施
Standard Practice
Participants will receive education regarding treatment consideration from their healthcare provider/team as per standard practice (usual care).
干预措施: Standard Practice (Other)
Standard Practice + Decision Aid
Participants will receive standard of care teaching and discussion in addition to web-based decision aid tool access.
干预措施: Decision Aid Tool (Other)
Standard Practice + Decision Aid
Participants will receive standard of care teaching and discussion in addition to web-based decision aid tool access.
干预措施: Standard Practice (Other)
结局指标
主要结局
Acceptability of Decision Aid Education Assessed by the Acceptability Survey
时间窗: Post Visit 1 (Up to 2 Weeks)
Subjects will take an acceptability of education questionnaire which is a 8-item survey to assess the comprehension of education received for the decision aid tool. Each item will be scored on a scale from 1-4 where 1=poor, 2=fair, 3=good, and 4=excellent. Scores will be rated individually 1-4 according to each item. There is no overall total score.
次要结局
- Mean Difference in Decisional Conflict Scale Scores(Baseline, Month 6)
- Mean Decisional Self-Efficacy Scale Score(Month 3, Month 6)
- Mean Values Survey Score(Post Visit 1 (Up to 2 Weeks))
- Mean Change in Preparation for Decision Making Scale Score(Month 3, Month 6)
- Mean Decisional Regret Scale Score(Visit 3)
- Mean Knowledge Survey Scores(Baseline, Month 3, Month 6)
研究者
Lakshmanan Krishnamurti
Professor
Emory University