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

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.

Conditions

• Rheumatoid Arthritis

Interventions

BEHAVIORAL

Medication Guides

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.

BEHAVIORAL

SMART Program

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.

BEHAVIORAL

Drug Facts Boxes

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.

Sponsors & Collaborators

• The University of Texas at Dallas

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• University of Pittsburgh Medical Center

  collaborator OTHER

• Global Healthy Living Foundation

  collaborator OTHER

• Dartmouth College

  collaborator OTHER

• Cornell University

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Susan J Blalock, PhD · UNC

• Caprice Hunt, MPH · UNC

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2018-12-31

Completion

2018-12-31

Countries

• United States

Study Locations