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This study is a three-arm randomized controlled trial to implement and evaluate the relative effects of: 1) clinic-focused intervention; 2) combined patient- and clinic-focused intervention, and 3) usual care on the provision of colorectal cancer (CRC) screening in primary care clinics. The study will also examine the relative effects of the intervention conditions on secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening) and on intermediate outcome measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff. The target population includes average-risk patients aged 50-75 years, clinicians, and clinical staff within the primary care setting. The intervention will be implemented within primary care clinics in two managed care organizations (MCOs). The intervention targets the following CRC screening modalities: fecal occult blood test (FOBT), flexible sigmoidoscopy, colonoscopy, and double contrast barium enema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Usual care |
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| 2 | Experimental | 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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| 3 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care | Behavioral | No intervention will be conducted in this arm of the study. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in colorectal cancer screening rates (4 modalities) | One year post initiation of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the frequency of secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening) | One year post initiation in intervention | |
| Changes in measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff. |
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Inclusion Criteria:
Inclusion Criteria for the Patient-focused Intervention
Inclusion Criteria for the Clinic-focused Intervention
Exclusion Criteria (Patients):
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| Name | Affiliation | Role |
|---|---|---|
| Judith Lee Smith, PhD | Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States | ||
| ABQ Health Partners/Lovelace Clinic Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16802326 | Background | 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. | |
| 21819168 | Background |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000554 | Ambulatory Care Facilities |
| ID | Term |
|---|---|
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
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| Clinic-focused intervention |
| Behavioral |
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. |
|
| Clinic- and patient-focused | Behavioral | 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. |
|
| One year post initiation of intervention |
| Albuquerque |
| New Mexico |
| 87106 |
| United States |
| Battelle Centers for Public Health Research and Evaluation | Seattle | Washington | 98109 | United States |
| 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. |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |