Decreasing Over Screening and Treatment of Cervical Precancers in Young Women
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Provider Mobile Application (ProvAPP); ProvAPP + Patient Educational Tool (Tab)
Intervention type(s): Other; Other
Intervention description(s): Mobile phone application to maneuver clinicians through the cervical cancer screening and treatment guidelines based on patient age and condition.; Patient Educational Tool (Tab): A patient educational tool (mobile tablet) will educate women on cervical cancer screening and treatment. Patients' self-assessment using a tablet at the time of clinic check-in will help them to understand current guidelines and their choices for treatment if they have abnormal cytology. It will allow them to assess the risks and benefits of screening intervals and of treatment choices.
ProvAPP: Mobile phone application to maneuver clinicians through the cervical cancer screening and treatment guidelines based on patient age and condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: clinic sites were randomized not subjects
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Pap smear; Screening; Women; Human papillomavirus; Cervical precancer; Guideline adherence