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临床试验/NCT03152045
NCT03152045已完成不适用

Teaching Improved Communication To Adolescents and Clinicians

Duke University4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年9月25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
发起方
入组人数
36
试验地点
4
主要终点
Feasibility as measured by recruitment number

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
12 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All English-speaking adolescent patients
  • cognitively able to participate

排除标准

  • Adolescents less than 12 years of age
  • Adolescents over 21 years of age
  • cognitively unable to participate.

研究组 & 干预措施

Communication Intervention

Experimental

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.

干预措施: Communication Intervention (Behavioral)

Standard Of Care

No Intervention

Investigators will compare patients randomized into the intervention group to those who receive standard of care.

结局指标

主要结局

Feasibility as measured by recruitment number

时间窗: 9 months

We will consider the intervention feasible if we recruit 20 adolescent patients and up to 10 clinicians per site.

次要结局

  • Acceptability(9 months)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (4)

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