The Effect of Review of a Decision Aid Prior to the Appointment on Decisional Conflict Compared to Usual Care in the Treatment of Trapeziometacarpal (TMC) Arthritis
2019年8月13日 更新者：Neal Chung-Jen Chen、Massachusetts General Hospital
A Randomized Trial Measuring the Effect of Review of a Decision Aid Prior to the Appointment on Decisional Conflict Compared to Usual Care in the Treatment of Trapeziometacarpal (TMC) Arthritis
The investigators plan a prospective randomized controlled study that compares whether the use of a decision aid results in different scores on variables reflective of the decision-making process, behavior, health outcomes, communication, and healthcare system.
研究概览
详细说明
Decision aids (shared decision making tools-websites, videos, or pamphlets) are interventions to prepare patients to make more informed decisions and satisfying decisions that match their preferences and values. With greater understanding of the risks and benefits of the treatment options patients may make a more informed choice.
Decision aids - delivered online, on paper, or on video - increase patient participation in the decision-making process,1 and can result in a decrease in discretionary surgery for knee osteoarthritis, herniated disk, and benign prostatic hypertrophy.2-4 They also reduce decisional conflict. Relatively few studies have investigated the influence of decision aids in orthopedic or hand surgery. Decision aids might affect decisional conflict, satisfaction, and outcomes in hand surgery where many treatments are discretionary and address quality of life.
Utilizing the Ottawa Decision Support Framework- an evidence-based, practical theory used to guide the development of decision aids - and the International Patient Decision Aid Standards criteria the investigators developed a decision aid for trapeziometacarpal arthritis.
研究类型
介入性
注册 (实际的)
90
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- at least 18 years of age
- English-speaking
- Diagnosis of trapeziometacarpal (TMC) arthritis
Exclusion Criteria:
- Prior surgical intervention for trapeziometacarpal (TMC) arthritis
- Previously accessed or used the online TMC arthritis Decision Aid (DA)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Decision Aid
Cohort that will receive a decision aid.
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队列 I 将使用决策辅助工具（以下简称“DA”）进行管理，而队列 II 将在没有决策辅助工具的情况下进行管理。
队列 I 中的患者将收到 DA，他们可以在单独的房间内完成并带回家。
决策辅助工具包括有关疾病/病症、治疗方案、益处、风险、科学不确定性以及根据患者健康风险因素量身定制的潜在结果概率的信息。
此外，它还包括价值观澄清，例如以功能术语描述结果，要求患者考虑哪些利益和风险对他们最重要，以及在决策制定步骤和与家人/朋友讨论他们的决定时提供指导。
它具有互动性和动态性，可帮助患者明确他们的偏好并做出最适合他们的决定。
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无干预：No Decision Aid (control)
One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Decision Conflict Scale (DCS)
大体时间：Day 1
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This scale measures patients' perception of uncertainty in making health-related decisions and consists of 3 subscales: (1) uncertainty choosing between different options, (2) modifiable factors contributing to this uncertainty-feeling uninformed, unclear about personal values, and feeling unsupported, and (3) perceived effectiveness of the decision-making an informed and values-based choice and expressing satisfaction with the decision.
We used the validated statement format Decisional Conflict Scale, consisting of 16 items with 5 response options.
Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
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Day 1
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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QuickDASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire
大体时间：Day 1
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The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability.
The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.
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Day 1
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Patient Health Questionnaire-2 (PHQ-2)
大体时间：Day 1
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The PHQ-2 screens for depressive mood over the past 2 weeks.
The score ranges from 0-6, where 0 is not at all depressed and 6 is major depression.
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Day 1
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Consultation and Relational Empathy (CARE) Measure
大体时间：Day 1
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The CARE measure is a 10-item questionnaire capturing patient perception of the physician's empathetic understanding under the office visit.
Each item is rated on a 5-point Likert scale, yielding a total score from 0-50.
A higher score indicates greater empathy.
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Day 1
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11-point Ordinal Satisfaction Scale
大体时间：Day 1
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The patient satisfaction scale measures how satisfied a patient is with their treatment for their thumb arthritis.
Patients score satisfaction on a scale of 0 to 10, where 0 is not satisfied and 10 is extremely satisfied.
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Day 1
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Change in Decision Regret Scale After 6 Weeks and 6 Months
大体时间：6 week and 6 month follow up
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Change in the Decision Regret Scale, which measures distress or remorse after a health care decision.
The scale consists of 5 questions, which range from strongly agree to strongly disagree, scoring 0-100 with higher scores indicating more regret.
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6 week and 6 month follow up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.
- Deyo RA, Cherkin DC, Weinstein J, Howe J, Ciol M, Mulley AG Jr. Involving patients in clinical decisions: impact of an interactive video program on use of back surgery. Med Care. 2000 Sep;38(9):959-69. doi: 10.1097/00005650-200009000-00009.
- Jayadev C, Khan T, Coulter A, Beard DJ, Price AJ. Patient decision aids in knee replacement surgery. Knee. 2012 Dec;19(6):746-50. doi: 10.1016/j.knee.2012.02.001. Epub 2012 Mar 2.
- Murray E, Davis H, Tai SS, Coulter A, Gray A, Haines A. Randomised controlled trial of an interactive multimedia decision aid on benign prostatic hypertrophy in primary care. BMJ. 2001 Sep 1;323(7311):493-6. doi: 10.1136/bmj.323.7311.493.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年5月13日
初级完成 (实际的)
2017年11月1日
研究完成 (实际的)
2017年11月1日
研究注册日期
首次提交
2017年6月2日
首先提交符合 QC 标准的
2017年6月7日
首次发布 (实际的)
2017年6月9日
研究记录更新
最后更新发布 (实际的)
2019年8月14日
上次提交的符合 QC 标准的更新
2019年8月13日
最后验证
2019年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
决策辅助的临床试验
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University of Alabama at BirminghamNational Cancer Institute (NCI)主动，不招人
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Universitat de LleidaInstitut de Recerca Biomèdica de Lleida; Hospital Universitari de Santa María (Lleida - Spain).尚未招聘
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Fondazione Poliambulanza Istituto Ospedaliero完全的
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Medtronic MiniMed, Inc.招聘中