Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Michigan
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Detroit、Michigan、アメリカ、48202
- Henry Ford Health System
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New Mexico
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Albuquerque、New Mexico、アメリカ、87106
- ABQ Health Partners/Lovelace Clinic Foundation
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Washington
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Seattle、Washington、アメリカ、98109
- Battelle Centers for Public Health Research and Evaluation
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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:
Inclusion Criteria for the Patient-focused Intervention
- Average risk
- Male or female
- 50-75 years
- Scheduled for non-acute ambulatory care visit at one of the study sites
- Due for CRC screening including no record of FOBT in the past year, no record of flexible sigmoidoscopy in the past 5 years, no record of colonoscopy in the past 10 years, and no record of double contrast barium enema in the past 5 years
Inclusion Criteria for the Clinic-focused Intervention
- Primary care clinicians, to include the following specialties: Family Practice/General Practice Physicians, General Internal Medicine Physicians, Nurse Practitioners in Family/General Practice, Physician Assistants who conduct non-acute ambulatory medical exams in study clinics
- Primary care clinical staff, to include nurses, medical assistants, and appointment schedulers
Exclusion Criteria (Patients):
- Prior diagnosis of CRC
- Prior diagnosis of colorectal polyps
- Prior diagnosis of ulcerative colitis
- Prior diagnosis of Crohn's Disease
- Prior diagnosis of hereditary nonpolyposis or polyposis
- Medical records contain an International Classification of Diseases (ICD-9) code for family history of CRC
- Younger than 50 years of age
- Older than 80 years of age.
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:防止
- 割り当て:ランダム化
- 介入モデル:階乗代入
- 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 |
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他の:1
普段のお手入れ
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No intervention will be conducted in this arm of the study.
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実験的:2
Clinic-focused intervention: The clinicians and clinical staff in each of the clinics will be scheduled for training sessions.
The provider trainings will be designed for clinicians and clinical staff and will be conducted in at least two separate sessions of approximately 3 hours total duration.
The sessions will be scheduled to accommodate the clinic schedule, but will be held with no more than 1 month between them.
Participants in clinic training sessions will receive continuing education credit.
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The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff.
The provider training sessions will include the presentation of CRC screening statistics and information, and will be heavily interactive and skills-based.
The provider training sessions will also focus on the provision of tools for improving clinical staff- and clinician-patient interactions about CRC screening and for office system changes/improvements to identify eligible patients and to track screening.
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実験的:3
Clinic-focused and patient focused intervention: The clinic focused-intervention as described in Arm 2 will be combined with a patient-focused intervention. Patient focused intervention: CRC education packets, based upon previously developed CDC CRC patient education materials, have been adapted for each study site. These CRC educational packets will be mailed to average-risk patients aged 50-80 years who are due for CRC screening (based on electronic records) and who schedule a non-acute ambulatory care visit in clinics assigned to the patient-focused intervention. A cover letter signed by the patient's physician will be included with each packet. The packets will be mailed approximately 1 week before the medical appointment. |
This arm will combine the clinic-focused intervention and the patient-focused intervention.
The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff as described in Arm 2. The patient-focused intervention includes sending a CRC screening education packet (CDC-developed educational text tailored for use within the study sites), accompanied by a letter from the patient's physician, to patients meeting study inclusion criteria.
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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 |
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Changes in colorectal cancer screening rates (4 modalities)
時間枠:One year post initiation of intervention
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One year post initiation of intervention
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二次結果の測定
結果測定 |
時間枠 |
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Changes in the frequency of secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening)
時間枠:One year post initiation in intervention
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One year post initiation in intervention
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Changes in measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff.
時間枠:One year post initiation of intervention
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One year post initiation of intervention
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協力者と研究者
捜査官
- 主任研究者:Judith Lee Smith, PhD、Centers for Disease Control and Prevention
出版物と役立つリンク
一般刊行物
- Coughlin SS, Costanza ME, Fernandez ME, Glanz K, Lee JW, Smith SA, Stroud L, Tessaro I, Westfall JM, Weissfeld JL, Blumenthal DS. CDC-funded intervention research aimed at promoting colorectal cancer screening in communities. Cancer. 2006 Sep 1;107(5 Suppl):1196-204. doi: 10.1002/cncr.22017.
- Shires DA, Divine G, Schum M, Gunter MJ, Baumer DL, Kasprzyk D, Montano DE, Smith JL, Elston-Lafata J. Colorectal cancer screening use among insured primary care patients. Am J Manag Care. 2011;17(7):480-8.
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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