Clinical trial NCT02787538: Supporting Patient Care With Electronic Resources in the United States
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Decision Aids
Biologics
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Arthritis Research Centre of Canada
name: Brigham and Women's Hospital
First posted: 2016-06-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Decisional Conflict Scale (DCS)
timeFrame: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1)
Secondary outcomes:
measure: Medication Education Impact Questionnaire (MeiQ)
timeFrame: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1 and at Month 2
measure: Partners in Health Scale (PHS)
timeFrame: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1 and at Month 2
measure: Health Resource Utilization (HRU) Questionnaire
timeFrame: Change measure (baseline score compared to after using the US-ANSWER-2 at Month 2)
Other outcomes:
measure: Use of biologics
timeFrame: 6 months from baseline
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Hyon K Choi, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
References: