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Primary Care Providers' Views and Understanding of Current Recommended Guidelines for Cervical Cancer Screening

2015년 11월 30일 업데이트: Lavona Lewis, University of Southern California
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.

연구 개요

상태

완전한

개입 / 치료

상세 설명

Cervical cancer remains a common cause of death and disability among women both within the United States and world-wide. Potential exists for significant prevention and early detection if cervical cancer screening is performed at the correct frequencies, with correct methods, on the appropriate women. Since the development of the Papanicolaou smear (Pap smear), cervical cancer screening has been recommended as a component of preventative healthcare for women. The tradition of an annual pap smear remains a common component of American medicine. For over four decades, controversy has existed as to the optimal method and timing of cervical cancer screening. The result has been great confusion amongst providers.

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 technology: In healthy women, A: do not start screening prior to age 21, B: screen every 3 years between ages 21-29, C: screen only every 5 years between ages 30-65, and D: stop any further screening for cervical cancer after 65. This significant reduction in the number of cervical cancer screenings is the result of these new technologies for the detection of the HPV virus, as well as evidence-based findings on the lack of risk for cancer in women who test negative for HPV. From a public health policy standpoint, the new recommendations are revolutionary. Whereas a women previously might have received 62 "Pap Smears" between the ages of 18-79, with new recommendations, only 6 cervical cancer screenings would be required over her lifetime.

Understanding these new recommendations and complying with these new unified recommendations would have a dramatic effect on health policy. The current multi-billion dollar cost of annual cervical cancer screening would be dramatically reduced. The time and physical inconvenience of this examination would be lessened. At a time when there is a great shortage of primary care providers (MD's, PA's and NP's) in many parts of the U.S., these dramatically reduced needs for cervical cancer screening might allow primary care providers greater time for more important health policy. 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.

The implications for health policy are significant:

  1. To the extent that primary care providers don't believe in the new guidelines, then providers should be educated on the evidence-based rationale from which they were constructed. In other words: to overcome whatever misgivings providers might harbor as to the new recommendations.
  2. To the extent that primary care providers believe in the new guidelines, but can't correctly apply them, then health policy would suggest an educational campaign to indicate correct application.
  3. To the extent that primary care providers harbor biases, further research to understand and develop strategies to overcome these biases would be indicated.

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. The sample will be randomized to include providers in both urban and rural areas of provider shortages, with a spectrum of patients of differing ethnic and economic status. It is anticipated that approximately 5,000 questionnaires will be mailed out with the goal of 1,000 responses.

The study will investigate the following issues: 1) Do primary care providers in these regions believe in these new and dramatically different guidelines? 2) Are the providers able to correctly apply these guidelines in four different clinical vignettes? 3) Do the providers hold a bias which may influence their willingness to follow these new guidelines? 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.

연구 유형

중재적

등록 (예상)

1000

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • California
      • Los Angeles, California, 미국, 90007
        • USC Sol Price School of Public Policy

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

20년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

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

Exclusion Criteria:

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: primary care providers by region
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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Primary Health Care Providers Beliefs Regarding Current Cervical Cancer Screening Guidelines
기간: 5 months
Questionnaire responses to clinical scenarios and assessments of current published clinical guidelines by ACOG, ACS or USPSTF
5 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Emily J Boone, University of Southern California

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2014년 10월 1일

기본 완료 (실제)

2015년 3월 1일

연구 완료 (실제)

2015년 3월 1일

연구 등록 날짜

최초 제출

2014년 9월 30일

QC 기준을 충족하는 최초 제출

2014년 10월 9일

처음 게시됨 (추정)

2014년 10월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 12월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 11월 30일

마지막으로 확인됨

2015년 11월 1일

추가 정보

이 연구와 관련된 용어

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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