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| ID | Type | Description | Link |
|---|---|---|---|
| CD-1304-6551 | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Latinas Contra Cancer | UNKNOWN |
| National Cervical Cancer Coalition | UNKNOWN |
| California Department of Health Services |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Provider Mobile Application (ProvAPP) | Experimental | Mobile phone application for providers. |
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| ProvAPP + Patient Educational Tool (Tab) | Experimental | Patient educational tool; plus the Mobile phone application for providers. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provider Mobile Application (ProvAPP) | Other | Mobile phone application to maneuver clinicians through the cervical cancer screening and treatment guidelines based on patient age and condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Cervical Cancer Screening | Rate of women 21-29 years who received cervical cytology tests. | Change from baseline screening rate (3 months prior to intervention) to 15-18 months after start of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Colposcopy | Rate of women 21-29 years who receive colposcopy for cervical cancer screening over the total number of women 21-29 years. | Change from baseline colposcopy rate (3 months prior to intervention) to 15-18 months after start of intervention |
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Inclusion Criteria - Patients:
Exclusion Criteria - Patients:
Inclusion Criteria - Clinics:
Exclusion Criteria - Clinics:
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| Name | Affiliation | Role |
|---|---|---|
| Anna-Barbara Moscicki, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| University of California, San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33632649 | Derived | Moscicki AB, Chang C, Vangala S, Zhou X, Elashoff DA, Dehlendorf C, Sawaya GF, Kuppermann M, Duron Y, Wyand FL, Navarro SK, Thiel de Bocanegra H. Effect of 2 Interventions on Cervical Cancer Screening Guideline Adherence. Am J Prev Med. 2021 May;60(5):666-673. doi: 10.1016/j.amepre.2020.11.015. Epub 2021 Feb 23. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2015 | Aug 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| OTHER |
| American College of Obstetricians and Gynecologists | OTHER |
| American Society for Colposcopy and Cervical Pathology | OTHER |
clinic sites were randomized not subjects
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| ProvAPP + Patient Educational Tool (Tab) | Other | 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. |
|
| San Francisco |
| California |
| 94143 |
| United States |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011230 | Precancerous Conditions |