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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737646
• Other study ID #: CDC-NCCDPHP-4555
• Status: Completed
• Phase: N/A
• First received: August 15, 2008
• Last updated: December 14, 2012
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5066
• Est. completion date: December 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Usual care
No intervention will be conducted in this arm of the study.
• Clinic-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.
• Clinic- 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.

Locations

Country	Name	City	State
United States	ABQ Health Partners/Lovelace Clinic Foundation	Albuquerque	New Mexico
United States	Henry Ford Health System	Detroit	Michigan
United States	Battelle Centers for Public Health Research and Evaluation	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in colorectal cancer screening rates (4 modalities)		One year post initiation of intervention	No
Secondary	Changes in the frequency of secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening)		One year post initiation in intervention	No
Secondary	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	No