The Magnitude of Effect of PCP Counseling on Participation Rate and Sedation Rate in Colonoscopy-based Screening Program
The Magnitude of Effect of Physician's Counseling on Participation Rate and Utilization of Sedation in Colonoscopy-based Colorectal Cancer Screening Program
調査の概要
詳細な説明
Participation rate is one of the major factors influencing the effectiveness of screening programs. Participation rates in CRC screening, including primary colonoscopy programs, remain suboptimal. It is known that one of the strongest predictors of CRC screening participation rate is a physician, especially primary care physician (PCP), recommendation. Engaging a PCP tends to improve participation rate in organized and opportunistic cancer screening programs.
To our best knowledge there are no randomized controlled trials, dedicated specifically to assess the effect of physician's counseling on participation rate in primary colonoscopy CRC screening programs. There is also no data on the impact of physician's counseling on patient's decision to choose unsedated (not in sedation) or sedated colonoscopy.
In this study we aimed to quantitatively estimate the impact of a PCP's counseling on screening participation rate and utilization of sedation in the opportunistic primary CRC screening program when compared to the effect obtained by using a standardized information leaflet only.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 50-65 years of age
Exclusion Criteria:
- colonoscopy within last 10 years
- change in bowel habits in the previous six months
- a visible blood in stool (unless related to known hemorrhoids)
- anemia or weight loss of unknown cause
- severe comorbid conditions making subject ineligible for screening colonoscopy
研究計画
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：ヘルスサービス研究
- 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 |
|---|---|
|
他の：Physician's counseling
|
Colorectal cancer (CRC) screening was recommended to a patient personally by a PCP.
The issue was discussed during a routine medical visit according to a standardized scheme.
PCP provided a patient with a rationale for CRC screening in asymptomatic individuals and benefits of early treatment of the disease.
A patient was told about colonoscopy-based screening program.
A PCP provided patient with information on how colonoscopy is performed and how to prepare a bowel for the examination, and informed a patient about possible adverse events related to the procedure including post-polypectomy bleeding and bowel perforation.
According to the scheme of the discussion screening modalities other than colonoscopy were not debated, unless a patient specifically asked about them.
|
|
アクティブコンパレータ：Information leaflet
|
Patients were given leaflet on primary colonoscopy colorectal cancer screening program.
A leaflet provided rationale for colorectal cancer screening and information on colonoscopy-based colorectal cancer screening program.
|
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 |
時間枠 |
|---|---|
|
Effect of primary care physician's (PCP) counseling on participation rate in primary colonoscopy screening program
時間枠：Six months after intervention
|
Six months after intervention
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Effect of primary care physician's (PCP) counseling on a patient's decision to choose unsedated colonoscopy (not in sedation).
時間枠：Six months after intervention
|
Six months after intervention
|
協力者と研究者
捜査官
- スタディディレクター：Jaroslaw Regula, MD, PhD、The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
- スタディチェア：Michal F. Kaminski, MD, PhD、The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
- 主任研究者：Michal Wiszniewski, MD、The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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