跳至主要内容
临床试验/NCT02270021
NCT02270021已完成不适用

Randomized Trial to Increase Adherence to Cervical Cancer Screening Guidelines for Young Women

University of California, San Francisco4 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2014年7月24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
42
试验地点
4
主要终点
Rate of Cervical Cancer Screening

研究概览

简要总结

The goal of this study is to prevent over screening and over treatment of young women for cervical precancers, which can result in psychological distress and has been associated with future risk of premature deliveries. Current national guidelines recommend that routine screening be performed at less-frequent intervals and that excisional cervical therapies are discouraged in young women. The objectives of this study are to examine physician- and patient-based interventions designed to decrease over screening and over treatment by increasing adherence to US guidelines for women under 30 years.

详细描述

In this study, we compare two different intervention arms that are designed to prevent over screening and over treatment by increasing adherence to the new US cervical cancer screening guidelines and the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. Specifically, the interventions will focus on the newly recommended cervical cancer screening intervals and decreasing the number of colposcopy procedures and cervical procedures for abnormal cytology.

This is a cluster randomized trial with individual clinics serving as the clusters. Clinics from the California Family PACT provider network who serve at least 200 female clients per year under 30 years of age will be randomized to one of two arms: 1) ASCCP mobile application (ProvAPP)-based intervention for providers, or 2) ProvAPP + Patient education Tool (Tab) intervention. These groups will be compared to a control comparison group of 28 clinics chosen using propensity score matching based on clinic characteristics such as county and private versus public from the Family PACT claims data. The ProvAPP intervention is for clinicians' mobile phones and will help them maneuver through current guidelines based on patient age and condition. An existing application from the ASCCP will be updated to include screening guidelines and to be more user-friendly. The patient-based Tab intervention will be a patient education tool accessible via URL on a tablet device at the time of check-in to assist in asking questions and evaluating treatment options. The tool will be developed with input from women age 21-29 as well as other stakeholders including Latinas Contra Cancer and the National Cervical Cancer Coalition. It is hypothesized that the ProvAPP+Tab approach will be most successful; all interventions will be more successful than no intervention.

Family PACT serves predominantly uninsured women and 40% of clients are Latina. We plan to enroll 7 sites (ProvAPP) and 7 sites (ProvAPP+Tab) into the other intervention arm with an average of 2,800 women to 3,500 women aged 21-29 years per arm (14 sites) with a similar number of sites and women randomly chosen for the comparison arm (28 sites) resulting in a total of 39 sites and 8,400-10,500 women. We will use Family PACT claims data to examine, by age, the number of and average interval between cytology specimens, colposcopy examinations, and the number of excisional procedures.

研究设计

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

入排标准

年龄范围
21 Years 至 29 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Provider Mobile Application (ProvAPP)

Experimental

Mobile phone application for providers.

干预措施: Provider Mobile Application (ProvAPP) (Other)

ProvAPP + Patient Educational Tool (Tab)

Experimental

Patient educational tool; plus the Mobile phone application for providers.

干预措施: ProvAPP + Patient Educational Tool (Tab) (Other)

ProvAPP Control Group

No Intervention

Clinics in this group are those NOT randomized - receiving no intervention. These clinics will be chosen at random for comparison using Family PACT claims data.

ProvAPP+Tab Control Group

No Intervention

Clinics in this group are those NOT randomized - receiving no intervention. These clinics will be chosen at random for comparison using Family PACT claims data.

结局指标

主要结局

Rate of Cervical Cancer Screening

时间窗: Change from baseline screening rate (3 months prior to intervention) to 15-18 months after start of intervention

Rate of women 21-29 years who received cervical cytology tests.

次要结局

  • Rate of Colposcopy(Change from baseline colposcopy rate (3 months prior to intervention) to 15-18 months after start of intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验