Supporting Patient Care With Electronic Resources in the United States

Rheumatoid Arthritis Clinical Trial

— SuPER-US  

Official title:

Supporting Patient Care With Electronic Resources in the United States (SuPER-US): Effectiveness of an Online Decision Aid for Patients Considering Biologic Therapy for Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02787538
• Other study ID #: 2015P002116
• Status: Recruiting
• Phase: N/A
• First received: May 26, 2016
• Last updated: May 31, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: May 2016
• Source: Massachusetts General Hospital
• Contact: Sharan K Rai, BSc
• Email: srai1[@]mgh.harvard.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The inclusion criteria are as follows:

1. with a diagnosis of RA from a rheumatologist

2. whose rheumatologists have recommended initiating a biologic or switching to another biologic

3. who have internet access and email.

Exclusion Criteria:

• Patients who do not meet the inclusion criteria.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• US-ANSWER-2 decision aid
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.
• Control group (Online medication guide)
Standard online medication guide.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Arthritis Research Centre of Canada, Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Use of biologics	Patients will be asked whether they started or switched a biologic, and the name, since using the US-ANSWER-2.	6 months from baseline	No
Primary	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.	Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1)	No
Secondary	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.	Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1 and at Month 2	No
Secondary	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.	Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1 and at Month 2	No
Secondary	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.	Change measure (baseline score compared to after using the US-ANSWER-2 at Month 2)	No