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临床试验/NCT02705365
NCT02705365已完成不适用

Patient Navigation for Lung Screening at MGH Community Health Centers

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2016年2月1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
入组人数
1,200
试验地点
2
主要终点
Chest CT Completion

研究概览

简要总结

To develop and implement a patient navigator (PN) program for lung screening and smoking cessation in community health center primary care practices. This program will be evaluated in a randomized controlled trial of primary care patients who currently smoke.

详细描述

The specific aims of this study are:

Specific Aim 1: To develop a patient navigator (PN) program for lung screening for patients who are current smokers, aged 55-77 years, potentially eligible for lung screening and are receiving care at community health centers (CHCs) affiliated with MGH.

Specific Aim 2: To evaluate the effectiveness of the new lung screening PN program in improving screening rates and increasing use of tobacco cessation services in a randomized controlled trial.

Specific Aim 3: To demonstrate that equity is maintained in rates of lung screening and in follow up of abnormal chest CT results, comparing eligible smokers from CHCs with eligible smokers from other practices within the MGH primary care network.

研究设计

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

入排标准

年龄范围
55 Years 至 77 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients aged 55-77 years who are current cigarette smokers (according to an algorithm using electronic medical record data), and
  • receive care at one of the five Massachusetts General Hospital community health centers.

排除标准

  • patients who have previously received a diagnosis of lung cancer,
  • have undergone a chest CT within 18 months before enrollment,
  • are subsequently identified as having died prior to the study intervention,
  • deemed by their primary care provider as not eligible for lung screening.

研究组 & 干预措施

Patient Navigation

Experimental

Patients assigned to the patient navigator (PN) arm will be sent a letter about the program with lung screening educational materials. The PN will educate eligible patients about lung screening, explore barriers to screening, coordinate scheduling an appointment with a provider, and possibly attend the visit with the patient. The PN will further coordinate scheduling the CT scan, help the patient obtain the test, and access any required follow-up. The PN will assess the patient's interest in quitting smoking and if so, offer and help to connect the smoker to existing cessation resources in the community and provide follow-up contacts to monitor adherence to treatments.

干预措施: Patient Navigation (Other)

Usual Care

Active Comparator

The control group will receive usual care during the 1-year study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results as well as smoking cessation guidance.

干预措施: Usual Care (Other)

结局指标

主要结局

Chest CT Completion

时间窗: Up to 1 year

Percentage of patients assigned to the intervention and control groups who had at least one chest CT (according to billing and EMR data) during the 1-year study period.

次要结局

  • Tobacco Treatment Use(Up to 1 year)

研究者

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

Sanja Percac-Lima, MD

Assistant Professor

Massachusetts General Hospital

研究点 (2)

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