Clinical trial NCT00737646: Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics
Official title: Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Cancer
Colorectal cancer
Patient education
Physician education
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2008-08-19
Enrollment: 5066
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in colorectal cancer screening rates (4 modalities)
timeFrame: One year post initiation of intervention
Secondary outcomes:
measure: Changes in the frequency of secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening)
timeFrame: One year post initiation in intervention
measure: Changes in measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff.
timeFrame: One year post initiation of intervention
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Albuquerque
country: United States
facility: ABQ Health Partners/Lovelace Clinic Foundation
state: New Mexico
city: Seattle
country: United States
facility: Battelle Centers for Public Health Research and Evaluation
state: Washington
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Judith Lee Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.