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临床试验/NCT01233388
NCT01233388已完成不适用

Real-time Influenza Vaccine Surveillance: FLUNET

Columbia University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
1
主要终点
Number of participants who report a health symptom within 6 weeks of vaccination

研究概览

简要总结

The aim of this proposal is to pioneer the implementation and evaluation of a novel patient centered text messaging vaccine adverse event surveillance network.

详细描述

The proposal will be conducted at six clinical sites of Columbia University Medical Center (CUMC), using a customized version of our already operational technology platform. Our proposed 12 month project will entail three phases: (a) 3 months of preparatory work, (b) 6 months of intervention rollout and (c) 3 months of data analysis and dissemination.

Preparatory work will include 3 areas:

Indepth interviews: We will conduct a series of interviews with patients and parents to understand their perspective on vaccine safety and Flunet. We will also interview a sample of providers to understand the most effective way for service promotion among providers. Design of registration process and messages: We will use patient/parental feedback to refine critical parts of the implementation, such as the registration process and the messages (content, frequency, format) to maximize response rates and the quality of information collected, which will be piloted in the next phase.

Technology set up and testing will occur prior to roll out in a HIPAA compliant data center. The intervention rollout will begin with a 6week refinement period. The primary goals of the refinement period are to: (1) validate/improve the methodology (e.g. registration, logic and content of the interactive menus, data collection process (2) test the application and infrastructure required for the full roll out (3) refine logistic details, such as printed materials for patients and providers. We will interview 25 patients to learn about their experience using Flunet. We will also evaluate the operations, technology and clinical findings from the intervention and incorporate any adjustments needed. After the refinement period, we will continue to monitor the systems and operations on an ongoing basis. All patients receiving a vaccine(vaccinees) will be offered the service. For children <18 years of age, a parent or guardian (parent) will be offered the service. By calling a registration number vaccinees/parents will agree to receive a series of text messages following up on the vaccinee's health.

Participating locations will include five community health centers and one hospital-based clinic, affiliated with New York Presbyterian Hospital Ambulatory Care Network (ACN) and Columbia University. These clinics include general pediatric, general medicine, Obstetric Gynecology(OBGYN)and family medicine patients. These sites are all in Health Professional Shortage Areas (HPSA).

研究设计

研究类型
Observational
时间视角
Prospective

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

  • Have an active cell phone with text messaging capability
  • Presents for care at participating sites
  • Fluent in English or Spanish

排除标准

  • 未提供

结局指标

主要结局

Number of participants who report a health symptom within 6 weeks of vaccination

时间窗: 6 weeks

As this is a pilot study, we want to first determine if people will report health problems. Therefore, we will assess the number of participants who report a health problem within 6 weeks of vaccination.

次要结局

  • Sensitivity of the patient reporting compared to medical record(6 weeks)
  • Specificity of the patient reporting compared to medical record(6 weeks)

研究者

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

Melissa Stockwell, MD, MPH

Asst Prof of Pediatrics

Columbia University

研究点 (1)

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