Supporting Patient Care With Electronic Resources in the United States



Status:Recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:6/2/2016
Start Date:January 2016
End Date:December 2018
Contact:Sharan K Rai, BSc
Email:srai1@mgh.harvard.edu

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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

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.

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.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Hyon K Choi, MD, DrPH
?
mi
from
Boston, MA
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