Clinical trial NCT02820038: Enhancing Patient Ability to Understand and Utilize Complex Information Concerning Medication Self-management
Official title: Enhancing Patient Ability to Understand and Utilize Complex Information Concerning Medication Self-management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: The University of Texas at Dallas
name: University of Alabama at Birmingham
name: University of Texas Southwestern Medical Center
name: University of Pittsburgh Medical Center
name: Global Healthy Living Foundation
name: Dartmouth College
name: Cornell University
name: Patient-Centered Outcomes Research Institute
First posted: 2016-06-30
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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 Routine Assessment of Patient Index Data 3 (RAPID3) score \> 2.0) and
5. Physician indicates patient is a candidate for initiation or escalation of Disease-modifying antirheumatic drug (DMARD) therapy

Exclusion Criteria:

1. Hearing or visually impaired

Primary outcomes:
measure: Percentage of Participants Classified as Having Made an Informed Decision at 6 Months
timeFrame: Month 6 Follow-up
Secondary outcomes:
measure: Mean Knowledge of the Risks and Benefits Associated With DMARD Therapy at 6 Months Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Mean Values at 6-Months Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Mean Gist Reasoning Ability, Lesson Quality at 6 Month Follow-up Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Mean Gist Reasoning Ability, Complex Abstraction at 6-Month Follow-up Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Mean Satisfaction With Medication Information at 6-Month Follow-up Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Mean Overall Treatment Satisfaction at 6-Month Follow-up Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Mean Arthritis Self-Efficacy at 6-Month Follow-up Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Mean Medication Adherence at 6-Month Follow-up Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Mean Illness Intrusiveness at 6-Month Follow-up Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Mean Health Distress at 6-Month Follow-up Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Mean Global Health Status at 6-Month Follow-up Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Mean Disease Activity at 6-Month Follow-up Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Mean Depression at 6-Month Follow-up Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Mean Fatigue at 6-Month Follow-up Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Mean Health Literacy at 6-Month Follow-up Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Information Seeking: Participating in BetterChoices, BetterHealth
timeFrame: 6 months
measure: Information Seeking: Use of RA Self-Management Website
timeFrame: 6 months
measure: Mean Visual Selective Learning at 6-Month Follow-up Adjusted for Baseline
timeFrame: Month 6 Follow-up
measure: Mean Medication Self-Management Knowledge
timeFrame: 6 months
measure: Mean Verbatim Recall of Information Concerning Medication Benefits and Risks
timeFrame: 6 weeks
Other outcomes:
measure: Patient Interest in Information About Treatment Options: Viewed at Least One Webpage
timeFrame: 6 months
measure: Patient Interest in Information About Treatment Options: Number of Pages Viewed
timeFrame: 6 months
measure: Percentage of Participants Using a DMARD (Disease-Modifying Antirheumatic Drug) at 6-Month Follow-up
timeFrame: Month 6 Follow-up
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC
name: Susan J Blalock, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC
name: Caprice Hunt, MPH
role: STUDY_DIRECTOR
References:
citation: Blalock SJ, Solow EB, Reyna VF, Keebler M, Carpenter D, Hunt C, Hickey G, Curtis JR, O'Neill K, Chapman SB. Enhancing Patient Understanding of Medication Risks and Benefits. Arthritis Care Res (Hoboken). 2022 Jan;74(1):142-150. doi: 10.1002/acr.24421. Epub 2021 Dec 22.