Enhancing Patient Ability to Understand and Utilize Complex Information Concerning Medication Self-management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Percentage of Participants Classified as Having Made an Informed Decision at 6 Months
研究概览
简要总结
The aim of the proposed project is to compare the effectiveness of two strategies designed to enhance patient understanding of medication risks/benefits: (1) Medication Guides, mandated for many medications by the Food and Drug Administration and (2) Drug Facts Boxes, developed by Woloshin and Schwartz to enhance the usability of consumer medication information. The investigators will also assess whether the effectiveness of these communication strategies can be increased by Gist Reasoning Training, which is designed to enhance patients' ability to extract meaningful gist from complex information.The investigators anticipate enrolling 300 individuals with rheumatoid arthritis. The study will use a randomized controlled trial design with four study arms. Data will be collected primarily via self-administered, Internet-based surveys using REDCap. All participants will be followed for 6 months after the completion of baseline data collection.
详细描述
Rheumatoid arthritis (RA) is a systemic, autoimmune disorder affecting 0.5% to 1% of the adult population in developed countries worldwide. Current guidelines underscore the importance of aggressive treatment of RA with disease modifying antirheumatic drugs (DMARDS) to control inflammation. Aggressive treatment has been shown to improve patient-centered outcomes, including better symptom control, functional status, and health-related quality of life and reduce the risk of premature death. A major issue in implementing aggressive therapy in practice, however, involves patient reluctance to escalate therapy when they believe that their symptoms are tolerable, despite the presence of active disease, due to concerns about medications risks. Moreover, patients often find it difficult to obtain accurate and personally-relevant information about medication risks and benefits that is written in language they can understand. There is a clear gap between the information patients want about medication risks and benefits and the information they currently receive as part of routine care.
The aim of the proposed project is to compare the effectiveness of two strategies designed to enhance patient understanding of medication risks/benefits: (1) Medication Guides, mandated for many medications by the Food and Drug Administration and (2) Drug Facts Boxes, developed by Woloshin and Schwartz to enhance the usability of consumer medication information. The investigators will also assess whether the effectiveness of these communication strategies can be increased by Gist Reasoning Training, which is designed to enhance patients' ability to extract meaningful gist from complex information.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Able to speak and read in English
- •Physician confirmed RA define by 1987 American College of Rheumatology criteria
- •Moderate or highly active rheumatoid arthritis (assess by Routine Assessment of Patient Index Data 3 (RAPID3) score > 2.0) and
- •Physician indicates patient is a candidate for initiation or escalation of Disease-modifying antirheumatic drug (DMARD) therapy
排除标准
- •Hearing or visually impaired
研究组 & 干预措施
Other CMI Only
Approximately 75 participants will be assigned to this study group. Participants will ONLY receive medication guides, or other comparable Consumer Medication Information (CMI), for rheumatoid arthritis medications.
干预措施: Medication Guides (Behavioral)
Other CMI & SMART Program
Approximately 75 participants will be assigned to this study group. Participants will receive medication guides, or other comparable Consumer Medication Information (CMI), for rheumatoid arthritis medications AND will be enrolled into the Strategic Memory Advanced Reasoning Training (SMART) Program.
干预措施: Medication Guides (Behavioral)
Other CMI & SMART Program
Approximately 75 participants will be assigned to this study group. Participants will receive medication guides, or other comparable Consumer Medication Information (CMI), for rheumatoid arthritis medications AND will be enrolled into the Strategic Memory Advanced Reasoning Training (SMART) Program.
干预措施: SMART Program (Behavioral)
Drug Facts Boxes Only
Approximately 75 participants will be assigned to this study group. Participants will ONLY receive Drug Facts Boxes for rheumatoid arthritis medications.
干预措施: Drug Facts Boxes (Behavioral)
Drug Facts Boxes & SMART Program
Approximately 75 participants will be assigned to this study group. Participants will receive Drug Facts Boxes for rheumatoid arthritis medicationsAND will be enrolled into the Strategic Memory Advanced Reasoning Training (SMART) Program.
干预措施: SMART Program (Behavioral)
Drug Facts Boxes & SMART Program
Approximately 75 participants will be assigned to this study group. Participants will receive Drug Facts Boxes for rheumatoid arthritis medicationsAND will be enrolled into the Strategic Memory Advanced Reasoning Training (SMART) Program.
干预措施: Drug Facts Boxes (Behavioral)
结局指标
主要结局
Percentage of Participants Classified as Having Made an Informed Decision at 6 Months
时间窗: Month 6 Follow-up
Informed decision making is characterized by making a value-consistent decision based on accurate knowledge. Knowledge will be assessed as described under Outcome 2. Values will be assessed using a 10-item scale developed by Fraenkel et al. Scores on this scale can range from 0 to 10, with lower scores reflecting a reluctance to use medications to control disease activity. Participants will be classified as having made an informed choice if they: (1) answered at least 85% of the knowledge items correctly, scored 6 or more on the values scale, and are currently taking one or more DMARDS OR (2) answered 85% of the knowledge items correctly, scored 5 or less on the values measure, and are not currently taking a DMARD. Otherwise, individuals will be classified as not having made an informed choice.
次要结局
- Mean Arthritis Self-Efficacy at 6-Month Follow-up Adjusted for Baseline(Month 6 Follow-up)
- Mean Satisfaction With Medication Information at 6-Month Follow-up Adjusted for Baseline(Month 6 Follow-up)
- Mean Overall Treatment Satisfaction at 6-Month Follow-up Adjusted for Baseline(Month 6 Follow-up)
- Mean Illness Intrusiveness at 6-Month Follow-up Adjusted for Baseline(Month 6 Follow-up)
- Mean Knowledge of the Risks and Benefits Associated With DMARD Therapy at 6 Months Adjusted for Baseline(Month 6 Follow-up)
- Mean Gist Reasoning Ability, Complex Abstraction at 6-Month Follow-up Adjusted for Baseline(Month 6 Follow-up)
- Mean Health Distress at 6-Month Follow-up Adjusted for Baseline(Month 6 Follow-up)
- Mean Fatigue at 6-Month Follow-up Adjusted for Baseline(Month 6 Follow-up)
- Mean Health Literacy at 6-Month Follow-up Adjusted for Baseline(Month 6 Follow-up)
- Mean Visual Selective Learning at 6-Month Follow-up Adjusted for Baseline(Month 6 Follow-up)
- Mean Values at 6-Months Adjusted for Baseline(Month 6 Follow-up)
- Mean Gist Reasoning Ability, Lesson Quality at 6 Month Follow-up Adjusted for Baseline(Month 6 Follow-up)
- Mean Medication Adherence at 6-Month Follow-up Adjusted for Baseline(Month 6 Follow-up)
- Information Seeking: Use of RA Self-Management Website(6 months)
- Mean Verbatim Recall of Information Concerning Medication Benefits and Risks(6 weeks)
- Mean Global Health Status at 6-Month Follow-up Adjusted for Baseline(Month 6 Follow-up)
- Mean Disease Activity at 6-Month Follow-up Adjusted for Baseline(Month 6 Follow-up)
- Mean Depression at 6-Month Follow-up Adjusted for Baseline(Month 6 Follow-up)
- Information Seeking: Participating in BetterChoices, BetterHealth(6 months)
- Mean Medication Self-Management Knowledge(6 months)