Colorectal Cancer
Conditions
Keywords
Cancer, Colorectal cancer, Patient education, Physician education
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.
Interventions
BEHAVIORALUsual care
No intervention will be conducted in this arm of the study.
BEHAVIORALClinic-focused intervention
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.
BEHAVIORALClinic- and patient-focused
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.
Sponsors
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in colorectal cancer screening rates (4 modalities) | One year post initiation of intervention |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed