Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Usual care
* Behavioral: Clinic-focused intervention
* Behavioral: Clinic- and patient-focused


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Usual care | Behavioral: Usual care<br>* No intervention will be conducted in this arm of the study.<br>|
| Experimental: 2<br>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. | Behavioral: Clinic-focused intervention<br>* 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.<br>|
| Experimental: 3<br>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. | Behavioral: Clinic- and patient-focused<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in colorectal cancer screening rates (4 modalities) |  | One year post initiation of intervention | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | One year post initiation of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Colorectal cancer, Patient education, Physician education