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Colorectal Cancer Screening Among Primary Care Physicians of the Swiss Sentinel Surveillance Network

2019年6月18日 更新者:University of Bern

Colorectal Cancer Testing in Swiss Primary Care: A Cluster Randomized Controlled Trial Among Primary Care Physicians of the Swiss Sentinel Surveillance Network

Colorectal cancer (CRC) is the third leading cause of cancer mortality in Switzerland, and kills 1600 people annually. Most deaths could be prevented by screening, but the 2012 Swiss national health survey found that only 40% of 50-75-year-olds had been tested within recommended intervals (26% with colonoscopy in the last 10 year, 7% with fecal occult blood test [FOBT] in the last 2 years, and 7% with both). If screening starts at age 50, in the average risk population absolute risk of dying from CRC at age 80 can be cut from 2% to 1%, reducing relative risk by 50%. Since 2013, Switzerland has reimbursed screening by colonoscopy every 10 years or FOBT every 2 years for adults 50-69 years old. Conforming to current recommendations, the Federal Office of Public Health (FOPH) officially recognizes both screening modalities.

When patients are offered a choice of screening test (colonoscopy vs. FOBT), they are as likely to opt for one as the other. Patient preferences are unlikely to vary much between PCP practices, so distribution of colonoscopy and FOBT within each practice should also be roughly equal. Family physicians are recognized as the most trusted professional to discuss CRC screening in Switzerland. However, many primary care physicians (PCPs) prefer prescribing colonoscopy over FOBT, but physician preference for method seems to vary widely between regions. If physician preferences and local medical culture currently influence choice of method more strongly than patient preferences, encouraging PCPs to diagnose patient preferences for screening method may reduce the number of PCPs who prescribe only one method. An earlier study in Switzerland showed that training PCPs and giving them educational support and decision aids raised the number who intend to prescribe colonoscopy and FOBT in equal proportions. A randomized controlled trial in the US showed that when patients were offered both FOBT and colonoscopy rather than only colonoscopy alone, more patients were screened for CRC. Offering choice of method may thus increase overall screening rates.

The Swiss Sentinel Surveillance Network (Sentinella) is a cooperative surveillance project including the Federal Office of Public Health (FOPH), PCPs representatives and the five Swiss institutes of family medicine. A sample of 150 to 250 general practitioners, internists and pediatricians in private practices from all regions of Switzerland report weekly morbidity data to the network using irreversibly anonymized patient data collected during consultations. In 2017, 91 out of 129 eligible PCPs of the Sentinella network participated in a cross-sectional data collection on CRC screening. The Sentinella network appears ideally suited to perform an intervention in order to modify screening practices and measure outcomes using the same collection form as in 2017.

This study will test the benefits of a prepackaged training program in participatory medicine sent by post to PCPs in Switzerland. The package is designed to improve their diagnoses of patient preferences for screening and screening method (colonoscopy or FOBT). The study begins with the hypothesis that giving PCPs evidence summaries on CRC screening, decision aids for patients, and performance feedback on the 2017 data collection will increase the number of PCPs whose patients include at least one screened with FOBT, and who will prescribe at least one FOBT/FIT (Fecal Immunochemical Test) instead of prescribing only colonoscopy. This might reduce variation in care between PCP practices by increasing variation in methods of screening prescribed within each PCP practices. Analyses from the 2017 data collection suggest that fewer patients refused CRC testing in practices that offered both methods than in practices that offered only colonoscopy. This intervention might increase screening rates overall, while respecting patient's autonomy to refuse the test and to be prescribed the test they prefer.

The study will compare outcomes among PCPs allocated to the intervention group to those in the control group, and will be measured by collecting anonymous structured patient data on 40 consecutive patients by PCPs and questionnaires filled by PCPs.

The study is designed to fit within the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework for structuring data collection. RE-AIM ensures that a study's outcomes for future implementation and dissemination works are collected. The RE-AIM criteria will be used to identify the translatability and public health impact of this intervention, and for making clear to future stakeholders the internal and external validity of study results.

調査の概要

状態

完了

条件

研究の種類

介入

入学 (実際)

109

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Bern、スイス、3012
        • Institute of Primary Health Care (BIHAM), University of Bern

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

50年~75年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Physician-level: PCPs participating in the Swiss Sentinel Surveillance Network (Sentinella) willing to participate in the study
  • Patient-level: Each PCP will collect data on 40 consecutive patients aged 50 to 75 years old seen in PCP offices over a 2 weeks to 2 months period. Patients will be included if there is a face-to-face consultation billed for at least 5 minutes at the practice.

Exclusion Criteria:

  • None except criteria which do not respect inclusion criteria

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ふるい分け
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
介入なし:対照群
実験的:介入群

PCPs from the intervention group will be mailed an intervention package that includes:

  1. 2-page structured evidence summary on CRC screening and information about Colonoscopy & FIT ("Decision box")
  2. patient decision aid (20-page booklet) on CRC screening for distribution to patients (Decision Aid)
  3. video example for the PCP, which illustrates a participatory approach to discussing CRC screening with a patient
  4. 4-page abridged version of the booklet to support PCPs when they discuss CRC screening with patients during a clinical visit ("Decision Board")
  5. individualized 1-page summary of PCP screening practices comparing their individual prescription patterns to group patterns, based on the data collected in 2017 ("Performance card")
  6. 2-page document that encourages PCPs still using the inferior guaiac-based FOBT to switch to FIT and includes list of laboratories from which they can order FIT
  7. sample FIT for PCPs who may not be familiar with its contents and use

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of PCPs who have at least one patient ever tested with FOBT, or who prescribe at least one FOBT to eligible patients (patients not already tested within recommended intervals, with no contra-indication for screening).
時間枠:At 3 months after intervention
PCPs systematically collect data from 40 consecutive patients, aged 50-75 years
At 3 months after intervention

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of PCPs whose proportion of patients previously tested or planning to be tested with FOBT/colonoscopy is at least 40% (the PCP must have discussed screening with these patients, who have no symptoms or risk factors for CRC
時間枠:At 3 months after intervention
PCPs systematically collect data from 40 consecutive patients, aged 50-75 years
At 3 months after intervention
Number of PCPs who discussed CRC with >50% of their eligible patients (patients not tested within recommended intervals, with no contra-indications for CRC screening)
時間枠:At 3 months after intervention
PCPs systematically collect data from 40 consecutive patients, aged 50-75 years
At 3 months after intervention
Change in PCPs' future intentions to prescribe CRC screening tests
時間枠:At 3 months after intervention
A questionnaire completed by participating PCPs
At 3 months after intervention
Change in PCPs' future intentions to prescribe colonoscopy vs. FOBT over the next 6 months
時間枠:At 3 months after intervention
A questionnaire completed by participating PCPs
At 3 months after intervention

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Reto Auer, MD, MAS、Institute of Primary Health Care (BIHAM), University of Bern

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年4月26日

一次修了 (実際)

2019年4月1日

研究の完了 (実際)

2019年4月1日

試験登録日

最初に提出

2018年5月25日

QC基準を満たした最初の提出物

2018年6月8日

最初の投稿 (実際)

2018年6月12日

学習記録の更新

投稿された最後の更新 (実際)

2019年6月19日

QC基準を満たした最後の更新が送信されました

2019年6月18日

最終確認日

2019年6月1日

詳しくは

本研究に関する用語

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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