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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Usual care; Behavioral: Clinic-focused intervention; Behavioral: Clinic- and patient-focused

• Registration Number: NCT00737646
• Lead Sponsor: Centers for Disease Control and Prevention

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-18
• Study First Posted: 2008-08-19
• Study Start: 2009-07
• Primary Completion: 2010-06
• Study Completion: 2011-12
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-14
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5066

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Usual care	Usual care
2	Clinic-focused intervention	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.
3	Clinic- and patient-focused	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.

Primary Outcome Measures

Name	Time	Method
Changes in colorectal cancer screening rates (4 modalities)	One year post initiation of intervention

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Battelle Centers for Public Health Research and Evaluation; 🇺🇸 Seattle, Washington, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

ABQ Health Partners/Lovelace Clinic Foundation; 🇺🇸 Albuquerque, New Mexico, United States