Enhancing Patient Ability to Understand and Utilize Complex Information Concerning Medication Self-management



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 99
Updated:2/9/2019
Start Date:September 2016
End Date:December 31, 2018

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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.

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.

Inclusion Criteria:

1. Age 18 years or older

2. Able to speak and read in English

3. Physician confirmed RA define by 1987 American College of Rheumatology criteria

4. Moderate or highly active rheumatoid arthritis (assess by RAPID3 score > 2.0) and

5. Physician indicates patient is a candidate for initiation or escalation of DMARD
therapy

Exclusion Criteria:

1. Hearing or visually impaired
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Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-962-0080
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