NCT02265120

Brief Summary

Significant developments have led to a dramatic change in recommendations for cervical cancer screening. The understanding that the Human Papilloma Virus (HPV) is the cause of nearly 100% of cervical cancer cases and the development of new technologies for detection of HPV DNA at time of cervical cancer screening, has produced changes in preventive healthcare policy for this condition. In an unprecedented event, the American College of Obstetrics and Gynecology, the American Cancer Society and the U.S. Preventive Services Task Force recommended dramatic and unified changes in screening utilizing this new framework. No studies of significance have evaluated (since guideline change in 2013), whether primary care providers find the new recommendations authoritative and believe in them, or whether providers understand implementation of these new guidelines given the many decades of contradictory and differing recommendations. For this study, the opinions of primary care providers who care for patients in the 194 federally designated regions of Primary Care provider shortage within California will be studied. Using the California Medical Board database of licensed providers, a questionnaire will be mailed to a random subset. It is anticipated that the analysis will show varying contempt, confusion and compliance with new guidelines exists. Understanding these factors will have beneficial health policy implications in terms of overcoming barriers to these cost-effective, less intrusive, and more accurate health policy guidelines in the prevention and early detection of cervical cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

5 months

First QC Date

September 30, 2014

Last Update Submit

November 30, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary Health Care Providers Beliefs Regarding Current Cervical Cancer Screening Guidelines

    Questionnaire responses to clinical scenarios and assessments of current published clinical guidelines by ACOG, ACS or USPSTF

    5 months

Study Arms (1)

primary care providers by region

EXPERIMENTAL

A questionnaire will be given to a randomized sample of primary care providers who care for patients in the 194 federally designated regions of Primary Care provider shortage within California will be studied.

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

The Questionnaire aims to evaluate based on the responses if providers don't uniformly agree with the new guidelines, if they can't interpret them correctly, and or if they have personal biases towards the older guidelines based upon prior training, personal experience, financial incentives, etc.

primary care providers by region

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary care providers who care for patients within the 194 federally designated regions of Primary Care provider shortage within California

You may not qualify if:

  • Outside of federally designated region of Primary Care provider shortage within California

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Sol Price School of Public Policy

Los Angeles, California, 90007, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Emily J Boone

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Professor of Public Policy and Director of Undergraduate Programs

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 15, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations