跳至主要内容
临床试验/NCT02787538
NCT02787538已完成不适用

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 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Decisional Conflict Scale (DCS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •Patients who do not meet the inclusion criteria.

研究组 & 干预措施

US-ANSWER-2 decision aid

Experimental

The intervention group will receive simple instructions to access the US-ANSWER-2 decision aid and complete the program on their own computers within two days. At the end of the session, US-ANSWER-2 will produce a one-page summary with the participant's questions, concerns, and preferred medication option.

干预措施: US-ANSWER-2 decision aid (Behavioral)

Control group (Online medication guide)

Active Comparator

The control group will receive the online medication guide, reflective of usual practice. The online medication guide contains standard information about biologics, including an introduction about biologic options, dosages, and effects.

干预措施: Control group (Online medication guide) (Behavioral)

结局指标

主要结局

Decisional Conflict Scale (DCS)

时间窗: 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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyon Choi

Professor of Medicine

Massachusetts General Hospital

研究点 (1)

Loading locations...

相似试验