Supporting Patient Care With Electronic Resource (SuPER)

Arthritis, Rheumatoid Clinical Trial

— SuPER  

Official title:

Supporting Patient Care With Electronic Resource (SuPER): Efficacy of an Online Decision Aid for Patients Considering Biologic Therapy for Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02540044
• Other study ID #: H15-02046
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2015
• Last updated: June 27, 2017
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: June 2017
• Source: University of British Columbia
• Contact: Jasmina Geldman, MS
• Phone: 604-207-4007
• Email: jgeldman[@]arthritisresearch.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This proof-of-concept randomized trial evaluates the effectiveness of using an on-line decision aid (ANSWER-2) in the decision making to start or switch biologic therapy in Canadian 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. Patients often struggle with treatment decisions, however, especially when the options have both benefits and risks. To address this challenge, the investigators have developed a new online decision aid called ANSWER-2 (ANimated, Self-serve, WEb-based, Research Tool: Version 2) for RA patients who are considering a biologic or other new therapy. A unique feature of ANSWER-2 is its ability to individualize how treatment options are presented based on the patient's preferences.

Objective: 1) To evaluate the effectiveness of ANSWER-2 in reducing patients' decisional conflict. 2) To assess the extent to which 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 the ANSWER-2.

The investigators will conduct a proof-of-concept randomized controlled trial with 148 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 other new therapy or switching to another agent, and 3) who have internet access. The Intervention Group will receive simple instructions to access ANSWER-2 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 The Arthritis Society's online education booklet "Arthritis Medications: A Consumer's Guide". Participants will complete the Decisional Conflict Scale (primary outcome) before and after the intervention (ANSWER-2 or booklet). The following secondary outcome measures will be collected at baseline, 1 month and 2 months: 1) Medication Education Impact Questionnaire (MeIQ), and 2) Partners in Health Scale (PHS). In addition, use of healthcare resources will be collected at 2 months. Participants will also be asked about their medication preferences at Month 1, as well as the shared decision making process in their last appointment, (using the 3-item CollaboRATE scale), at Month 1. Participants who received the ANSWER-2 decision aid and their rheumatologists will be invited to participate in an interview about their experience with the patient decision aid. The investigators will use analysis of variance (ANOVA) to compare between the Intervention Group and Control Group, using the baseline measure as a covariate. An iterative content analysis will be conducted for the qualitative interviews.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 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/subsequent entry biologic or switching to another biologic agent, and 3) who have internet access and email.

Exclusion Criteria:

• Patients who do not meet the inclusion criteria.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Behavioral:
• ANSWER-2 decision aid
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 (TAS Consumer Guide)
The Arthritis Society Consumer guide pdf.

Locations

Country	Name	City	State
Canada	Arthritis Research Canada	Richmond	British Columbia

Sponsors (5)

Lead Sponsor	Collaborator
University of British Columbia	Arthritis Research Centre of Canada, Simon Fraser University, University of Alberta, Vancouver General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CollaboRATE Scale	a 3-item measure of the shared decision making process	Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1)
Primary	Decisional Conflict Scale	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 ANSWER-2 intervention at month 1)
Secondary	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 ANSWER-2 intervention at month 1, and at month 2)
Secondary	Partners in Health Scale	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 ANSWER-2 intervention at month 1, and at month 2)
Secondary	Health Resource Utilization	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 the his/her health.	Change measure (baseline score compared to after using the ANSWER-2 at month 2)

External Links

•   University of BC Study Website