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Clinical Trials/NCT02787538
NCT02787538
Completed
N/A

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

Massachusetts General Hospital1 site in 1 country80 target enrollmentJanuary 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
Massachusetts General Hospital
Enrollment
80
Locations
1
Primary Endpoint
Decisional Conflict Scale (DCS)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
December 31, 2019
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyon Choi

Professor of Medicine

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • The inclusion criteria are as follows:
  • with a diagnosis of RA from a rheumatologist
  • whose rheumatologists have recommended initiating a biologic or switching to another biologic
  • who have internet access and email.

Exclusion Criteria

  • Patients who do not meet the inclusion criteria.

Outcomes

Primary Outcomes

Decisional Conflict Scale (DCS)

Time Frame: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1)

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.

Secondary Outcomes

  • Partners in Health Scale (PHS)(Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1 and at Month 2)
  • Medication Education Impact Questionnaire (MeiQ)(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(Change measure (baseline score compared to after using the US-ANSWER-2 at Month 2))

Study Sites (1)

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