Comparing Two Programs for Helping Patients Make Informed Decisions about Rheumatoid Arthritis Treatment
Year: 2020
Type: report
Abstract: This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final. What is the research about? Rheumatoid arthritis, or RA, is a health problem in which the immune system attacks healthy tissue. RA can affect many parts of the body and can cause swelling in and damage to the joints, especially in the hands and feet. RA can cause pain and limit people’s ability to complete daily activities. Medicine can help, but it can be hard for patients to choose a course of treatment. Some patients may want to take strong medicines now to keep RA from getting worse in the future. Other patients may want to avoid side effects of strong medicines. To make an informed choice, patients must understand the benefits and risks of these medicines and weigh the trade-offs between them. Knowing the risks and benefits can help patients talk with their doctor about what treatment to choose. There are proven ways to give patients information on medicines and help patients understand and use this information. For example, the U.S. Food and Drug Administration requires that drug companies include a paper handout called a Medication Guide with many medicines. Medication Guides provide directions on how to take a medicine and list possible side effects. However, these guides can be hard to understand. To address this issue, researchers developed DrugFactsBox®, a simple one-page summary of a medicine’s benefits and harms for patients. Another way to help patients make decisions about medicines is to train them to quickly get the main ideas, or gist, of the information they are reading. In this study, the research team wants to know how well Medication Guides and the DrugFactsBox® work to help patients with RA decide which medicine is best for them. The team is also looking to see if training patients in gist thinking can help patients decide about medicines using Medication Guides and DrugFactsBox®. Who can this research help? Findings from this study can help hospital and clinic administrators decide what information or training to offer patients to help them work with doctors to pick an RA medicine. Findings may help people with RA understand information about and choose a medicine. What is the research team doing? The research team is enrolling 300 patients with RA through clinics and an online patient support community. The research team is assigning patients by chance to one of four groups, each of which gets information about medicine using a different approach: Medication Guides Medication Guides plus training in gist thinking DrugFactsBoxes® DrugFactsBoxes® plus training in gist thinking The team is looking to see whether these approaches help patients work with their doctors to make an informed choice about RA medicine. To figure out if patients make an informed choice, the team is surveying patients about their knowledge of RA medicines and seeing if the treatment patients choose fits their values. Three patients on the research team help plan and conduct the study. The research team also includes RA experts who make sure that information on RA is up to date. Research methods at a glance Design Element Description Design Randomized controlled trial Population Adults ages 18 or older who have moderate or highly active rheumatoid arthritis and who are candidates to begin treatment with disease-modifying antirheumatic drugs Interventions/ Comparators Medication Guides Medication Guides plus training in gist thinking DrugFactsBoxes® DrugFactsBoxes® plus training in gist thinking Outcomes Primary: change in the percentage of participants classified as having made an informed decision (knowledge of RA medications and concordance of medication choice with expressed values) Secondary: interest in information about treatment options, interest in obtaining information about illness self-management, and average change in: knowledge of the risks and benefits associated with rheumatoid arthritis medicines, gist reasoning ability, satisfaction with medication information, arthritis self-efficacy, illness intrusiveness, health distress, overall treatment satisfaction, disease activity, depression, fatigue, health literacy, and medication adherence Timeframe 6-month follow-up for primary outcome
Authors: Susan J. Blalock, Caprice Hunt, Genevieve Hickey, Delesha Carpenter, Sandra Bond Chapman, Molly Keebler, Elizabeth Solow, Valerie Reyna, Jeffery Curtis, Cynthia Carol Edmonds, Cynthia Johnson, Kimberlee O’Neill
Institution: University of North Carolina at Chapel Hill
Language: English
Subfield: General Health Professions
Field: Health Professions
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W3109280315