An interventional study of US-ANSWER-2 decision aid and Control group (Online medication guide) in Rheumatoid Arthritis, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
This proof-of-concept randomized trial evaluates the effectiveness of using an online decision aid (US-ANSWER-2) in the decision-making to start or switch biologic therapy in US patients with rheumatoid arthritis.
The proposed project aims to improve the process of making evidence-informed treatment decisions by patients with rheumatoid arthritis (RA) and ultimately empower patient self-management. Current RA treatment emphasizes: 1) the need for early and aggressive treatment, and 2) the use of a treat-to-target approach. However, patients often struggle with treatment decisions, especially when the options have both benefits and risks. To address this challenge, investigators based at Arthritis Research Canada have previously developed an online decision aid called ANSWER-2 (ANimated, Self-serve, WEb-based, Research Tool: Version 2) for RA patients who are considering a biologic, and this tool has been recently adapted for the US healthcare setting (called US-ANSWER-2).
Objectives: 1) To evaluate the effectiveness of US-ANSWER-2 in reducing patients' decisional conflict. 2) To assess the extent to which US-ANSWER-2 improves patients' knowledge about RA medications and confidence in managing their health. 3) To examine the experiences of patients and rheumatologists in using US-ANSWER-2.
The investigators will conduct a proof-of-concept randomized controlled trial with 80 patients with RA. Eligible individuals are those: 1) with a diagnosis of RA from a rheumatologist, 2) whose rheumatologists have recommended initiating a biologic or switching to another biologic, and 3) who have internet access and email. The Intervention Group will receive simple instructions to access the US-ANSWER-2 decision aid and complete the program on their own within two days. At the end of the session, a one-page summary will be produced to help them discuss their questions, concerns, and preferred choices with their health care providers. The Control Group will receive a standard online medication guide, reflective of usual practice. Participants will complete the Decisional Conflict Scale (primary outcome) before and after the intervention (US-ANSWER-2 or standard online medication guide). The following secondary outcome measures will be collected at baseline, Month 1, and Month 2: 1) Medication Education Impact Questionnaire, and 2) Partners in Health Scale. In addition, the use of healthcare resources will be collected at baseline and Month 2, and the use of biologics will be collected at Month 6. All participants and their rheumatologists will be invited to participate in a qualitative interview about their experience with the patient decision aid.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's planned enrollment of 80 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The inclusion criteria are as follows:
Exclusion Criteria:
The intervention group will receive simple instructions to access the US-ANSWER-2 decision aid and complete the program on their own computers within two days. At the end of the session, US-ANSWER-2 will produce a one-page summary with the participant's questions, concerns, and preferred medication option.
Behavioral: US-ANSWER-2 decision aid
The control group will receive the online medication guide, reflective of usual practice. The online medication guide contains standard information about biologics, including an introduction about biologic options, dosages, and effects.
Behavioral: Control group (Online medication guide)
US-ANSWER-2 will consist of: 1) an Information Module that presents effectiveness and side effects of each treatment option, and 2) an interactive Value Clarification Module that guides patients to consider what matter to them the most, and the pros and cons of each treatment option. Within the Information Module, the decision support information (i.e., the benefits and harms of treatment options) will be presented in narrated text, graphics, and a series of animated patient stories demonstrating attributes required for effective communication with doctors and significant others.
Standard online medication guide.
Decisional Conflict Scale (DCS)
The Decisional Conflict Scale (short version) measures personal perceptions of uncertainty in choosing options, factors contributing to uncertainty, and effective decision-making. It is one-dimensional and has 10 questions and three response categories (yes/no/unsure) used to compute one score.
Time frame: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1)
Medication Education Impact Questionnaire (MeiQ)
The MeiQ consists of 6 subscales and a total of 29 items. MeiQ was developed and tested in three different samples of patients with rheumatic conditions on their knowledge of medications.
Time frame: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1 and at Month 2
Partners in Health Scale (PHS)
The Partners in Health Scale is an 11-item measure designed to assess self-efficacy, knowledge of RA and treatment, and self-management behaviours such as taking medication appropriately and adopting a healthy lifestyle.
Time frame: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1 and at Month 2
Health Resource Utilization (HRU) Questionnaire
The HRU questionnaire was developed for both self and interviewer administration in people with arthritis and other chronic conditions. It consists of a series of open-ended questions about individuals' visits to health professionals, use of investigative tests, hospital visits, use of medications, purchases of adaptive aids, and estimable productivity loss incurred by the individual and their caregivers due to his/her health.
Time frame: Change measure (baseline score compared to after using the US-ANSWER-2 at Month 2)
Use of biologics
Patients will be asked whether they started or switched a biologic, and the name, since using the US-ANSWER-2.
Time frame: 6 months from baseline
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts General Hospital