跳至主要内容
临床试验/NCT04633616
NCT04633616已完成不适用

Tailored Patient-Provider Communication (TPPC): A Pragmatic Single-Blinded Trial Evaluating the Impact of TPPC in Dermatology Patients Compared to Standard Patient-Provider Communication.

University of Southern California2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2020年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
134
试验地点
2
主要终点
Patient Response Rates

研究概览

简要总结

The impact of tailored patient-provider communication to improve clinical trial recruitment, patient knowledge, and patient engagement will be studied. Tailored patient-provider communication refers to the individualization of patient-provider communication using patients' preferred methods of communication. This involves the utilization of social messaging such as e-mail or text and/or social media platforms. These communication methods purport to and meet individual patient needs whilst ensuring that information is received and in a format that is familiar to each patient. The primary outcomes of the proposed research is to evaluate the impact of tailored patient-provider communication on patient response rates (speed and number), clinical trial recruitment rates, patient knowledge, and patient engagement.

详细描述

This is a 3-month, pragmatic, single-blinded randomized controlled trial evaluating the impact of tailored patient-provider communication on patient engagement and clinical outcomes of adult dermatology patients compared to non-tailored patient-provider communication. The pragmatic trial will compare patient engagement and clinical outcomes between the two models. The rationale for proposing a pragmatic trial is to test whether tailored patient-provider communication works in real life. This design allows for a large spectrum of everyday clinical settings in order to maximize applicability and generalizability. The pragmatic approaches are especially pronounced along the inclusive eligibility criteria, experimental intervention flexibility, and primary outcome being highly relevant to patients and providers alike.

The investigators will recruit from approximately 32,310 adult patients from target populations, southern California to enroll 134 participants in the study. In addition to recruiting from the general population, the investigators will place a specific emphasis on recruiting patients living in rural and underserved communities; the investigators will also recruit from a full range of dermatological diseases.

Patient recruitment and enrollment will begin the first month of year one and continue through the fourth month of year one. The expected duration of this pragmatic, single-blinded randomized controlled equivalency trial for each participant will be a maximum of 3 months, including an initial baseline visit. No additional follow-up visits beyond this are expected for this research study.

Patients will be randomized to receive patient education via tailored or non-tailored patient-provider communication. The study team will know which form of communication each patient will receive while study participants will not know the different types of communication being studied. Patients randomized to either study population groups can be assessed remotely or in-person at the screening/baseline visit. At month 3, all patients will take high-quality photographs of their skin and submit these pictures to our dermatologist online. Any additional in-person or remote visits will be determined by providers and patients just as they would occur in the real-world. Primary and secondary outcomes will be monitored at months 0, 1.5, and 3.

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
Double (Care Provider, Investigator)

盲法说明

Single-blinded

入排标准

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

入选标准

  • Provide signed and dated informed consent form
  • Speak English or Spanish
  • Male or female, at least 18 years of age
  • Have an active, physician-diagnosed dermatological condition
  • Have access to an electronic device that is capable of capturing images with a minimum resolution of 1024x768 pixels
  • Have access to at least one form of social messaging (e-mail, SMS, WhatsApp, or Facebook) which can connect online

排除标准

  • Does not have an active dermatological condition at the beginning of the study
  • Does not live in southern California
  • Unable to fulfill the required tasks of the study

结局指标

主要结局

Patient Response Rates

时间窗: 3 months

Patient response rate will determine the first step of patient engagement and assesses a patients willingness to 'interact' with the weblink delivered. Patient response rates will be measured by click rates. Click rates will be calculated using the proportions of patients in both study populations who choose to click on the weblinks delivered throughout the study, regardless of whether or not questionnaires are completed. The time elapsed from when the weblink is sent and when the weblink is clicked will also be recorded.

次要结局

  • Patient Drop-out Rate(3 months)
  • Patient Activation(3 months)
  • Patient Experience(3 months)

研究者

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

April Armstrong

Doctor/Professor

University of Southern California

研究点 (2)

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