Teaching Improved Communication To Adolescents and Clinicians (TicTac)
2018年12月7日 更新者:Duke University
The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention aimed at improving how adolescent patients and their clinicians communicate about behavior change.
研究概览
地位
完全的
详细说明
The investigators propose a randomized pilot trial across two health systems, Duke University and University of Michigan to evaluate the effect of Feedback Guides on clinician-adolescent communication about high-risk behaviors.
- The investigators consent clinicians prior to any patient recruitment.
- When a patient aged 12-21 years arrives for an annual visit and is a patient of a consented clinician, the front desk staff will provide the teen with an iPad tablet.
- As part of standard clinical care, all teens will complete the Rapid Assessment for Adolescent Preventive Services (RAAPS) questionnaire on the tablet privately (either in waiting room or in clinic room while waiting for the provider).
- The patient and parent will then review a study explanation and informed consent on the tablet and sign electronically if they agree to participate. The study clinician will review the informed consent with the patient and answer any questions.
- Participating teens will then complete a brief baseline survey and those randomized to the intervention arm will print the visit conversation guides using a wireless study printer connected to the tablet. The guides will print in a designated nursing area and clinic staff will add the printed guides to visit-related paperwork for the patient and clinician to use during the visit.
- The teen patient audio records the encounter on the tablet.
- The patient completes post-visit patient survey on tablet.
- The clinician completes a post-visit survey on paper.
- The patient returns tablet to clinic staff.
- The iPad will be connected to a study workstation, where the iTunes application will be used to transfer the audio file from the Voice Memos app to the workstation and then to it's final destination on the file server. Once the transfer has been confirmed, using iTunes, the audio file will be deleted from both the iPad and the workstation, including any residual versions of the audio file.
- Three months after the encounter, staff will provide participating patients a link to a REDCap survey (not the survey itself). The link will be sent using the preferred method selected by the patient through a question in the baseline survey - email or short message service (SMS). To protect the confidentiality of the responses, we will also provide the participant a code to access the REDCap follow-up survey. This will prevent others from accessing the survey results.
研究类型
介入性
注册 (实际的)
36
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
-
-
North Carolina
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Durham、North Carolina、美国、27705
- Duke University Medical Center
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Durham、North Carolina、美国、27710
- Duke University Medical Center - Cancer Prevention, Detection and Control
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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
12年 至 21年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- All English-speaking adolescent patients
- cognitively able to participate
Exclusion Criteria:
- Adolescents less than 12 years of age
- Adolescents over 21 years of age
- cognitively unable to participate.
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:其他
- 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 |
|---|---|
|
实验性的:Communication Intervention
Investigators are testing the feasibility, acceptability, and preliminary efficacy of a systems intervention that asks adolescents to report their risk behaviors before their encounter.
Both clinicians and patients will receive a Feedback Guide that gives them tips on effective ways to communicate about these behaviors.
|
In this study, Investigators are testing the feasibility, acceptability, and preliminary efficacy of a systems intervention that asks adolescents to report their risk behaviors before their encounter.
Both clinicians and patients will receive a Feedback Guide that gives them tips on effective ways to communicate about these behaviors.
|
|
无干预:Standard Of Care
Investigators will compare patients randomized into the intervention group to those who receive standard of care.
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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 |
|---|---|---|
|
Feasibility as measured by recruitment number
大体时间:9 months
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We will consider the intervention feasible if we recruit 20 adolescent patients and up to 10 clinicians per site.
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9 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acceptability
大体时间:9 months
|
To determine acceptability, we will examine patients' reports of rated helpfulness of the intervention.
To be deemed acceptable, 75% would have to rate it as a "4" or "5" on the 5-point scale
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9 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient perceived provider empathy as measure by a summed 10-question scale
大体时间:10 minutes
|
We will assess patient perceived provider empathy with a summed 10-question scale (α=0.95;
e.g., "Thinking about your visit with your doctor, how was your doctor at fully understanding your concerns?"
(1= Not at all good and 5= Extremely good)).
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10 minutes
|
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Patient perceived autonomy support using a 15 question scale
大体时间:10 minutes
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We will assess patient autonomy support using a 15 question scale (a=0.95;e.g., "I feel that my physician has provided me choices and potions" (1=Strongly disagree and 5=Strongly agree).
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10 minutes
|
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Patient's self rated participation in the encounter
大体时间:10 minutes
|
We will assess patient's self rated participation in the encounter using a five-point Likert-type scale (i.e., 1 "Not at all good" - 5 "Extremely good")
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10 minutes
|
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。
有用的网址
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)
2017年9月25日
初级完成 (实际的)
2018年10月29日
研究完成 (实际的)
2018年10月29日
研究注册日期
首次提交
2017年5月2日
首先提交符合 QC 标准的
2017年5月11日
首次发布 (实际的)
2017年5月12日
研究记录更新
最后更新发布 (实际的)
2018年12月11日
上次提交的符合 QC 标准的更新
2018年12月7日
最后验证
2018年10月1日
更多信息
与本研究相关的术语
其他研究编号
- Pro00078439
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
De-identified web-based surveys from the University of Michigan will be available to Duke researchers through REDCap.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
Communication Intervention的临床试验
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Ege Miray Topcu完全的
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University完全的
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人