Enhancing Patient Ability to Understand and Utilize Complex Information Concerning Medication Self-management
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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
Exclusion criteria
- Hearing or visually impaired
Trial design
Primary purpose
Allocation
Interventional model
Masking
286 participants in 4 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal