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临床试验/NCT05181722
NCT05181722已完成不适用

Evaluating the Use of Patient Navigation to Promote Timely Diagnostic Evaluation During the COVID-19 Pandemic

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2022年7月18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
126
试验地点
1
主要终点
Diagnostic follow-up rates

研究概览

简要总结

The primary objective of this project is to evaluate the role of patient navigation in promoting timely follow-up of abnormal breast imaging findings in patient populations that have been most severely impacted by the novel coronavirus (COVID-19) pandemic. This project aims to assess the impact of patient navigation as an intervention tool in patient populations that are most at risk for delayed follow-up. The investigators hypothesize that patient navigation services may be an effective way to mitigate the impact of the pandemic by decreasing the risk of a delayed breast cancer diagnosis and promoting timely diagnostic follow-up.

详细描述

Patients who meet the study selection criteria will be randomized into two groups in a 1:1 ratio: the usual care group and the intervention group. Initially, patients will be invited to participate in the study via a brief statement included in the patient result letter informing patients of their abnormal screening mammogram result. The patient navigator will then follow up with each patient who expresses interest in the study via telephone to reiterate the details of the project, answer any questions that the patients might have, and invite the patients to participate in the project if the patients meet the study inclusion criteria. Informed consent will be obtained from the study participants.

The primary role of the patient navigator will be to identify and address barriers to accessing timely diagnostic care. The patient navigator's duties will also include providing an array of services aimed at improving health care access and engagement, including appointment reminder phone calls, health education, assistance with scheduling appointments, providing information about available transportation options to the clinic sites (e.g., shuttle service provided by the institution), helping patients to connect with language interpretation services, providing assistance with resolving insurance issues, and motivating and coaching patients on the importance of timely follow-up of abnormal breast imaging results. The services provided by the patient navigator will be tailored to the specific needs of each patient and will be aimed at helping patients to overcome personal, cultural and systemic barriers to successfully completing follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Care Provider, Investigator)

盲法说明

The patient navigator and statistician will be unblinded to the patient groups.

入排标准

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

入选标准

  • •Patients who have an abnormal screening mammogram (i.e. given a Breast Imaging-Reporting and Data System [BI-RADS] assessment category of 0) at the investigators' institution during the study period and have not yet undergone diagnostic evaluation

排除标准

  • •Any study participant who is unable to provide consent to participate in the study will be excluded.

研究组 & 干预措施

Intervention group

Active Comparator

The study participants in this group will receive support from the patient navigator as part of this study.

干预措施: Patient navigator support (Other)

Usual care group

No Intervention

The study participants in this group will receive the usual care per the institutional protocol.

结局指标

主要结局

Diagnostic follow-up rates

时间窗: 30 days after the screening mammogram

The follow-up rates for patients with an abnormal screening mammogram will be calculated. This will be expressed as the percentage of patients who follow-up within 30 days after the abnormal screening mammogram.

次要结局

  • Anxiety level as assessed by the Spielberger State-Trait Anxiety Inventory(1 day prior to the scheduled diagnostic appointment)
  • Breast cancer worry as assessed by the Lerman Breast Cancer Worry Scale(1 day prior to the scheduled diagnostic appointment)

研究者

发起方
Johns Hopkins University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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