Enhancing Patient Ability to Understand and Utilize Complex Information Concerning Medication Self-management
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): Medication Guides; SMART Program; Drug Facts Boxes
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The investigators will compare the effectiveness of two types of written prescription drug information targeted for patients: (1) Medication Guides mandated by the Food and Drug Administration, and (2) Drug Facts Boxes, developed by Woloshin and Schwartz.; The investigators will determine if the effectiveness of written medication information can be increased by Gist Reasoning Training, delivered via the SMART Program, which is designed to enhance patients' ability to extract meaningful gist from complex information.; The investigators will compare the effectiveness of two types of written prescription drug information targeted for patients: (1) Medication Guides mandated by the Food and Drug Administration, and (2) Drug Facts Boxes, developed by Woloshin and Schwartz.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other