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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00737646
First received: August 15, 2008
Last updated: December 14, 2012
Last verified: December 2012

August 15, 2008
December 14, 2012
July 2009
June 2010   (final data collection date for primary outcome measure)
Changes in colorectal cancer screening rates (4 modalities) [ Time Frame: One year post initiation of intervention ] [ Designated as safety issue: No ]
Increase in colorectal cancer screening rates (4 modalities) [ Time Frame: One year post initiation of intervention ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00737646 on ClinicalTrials.gov Archive Site
  • Changes in the frequency of secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening) [ Time Frame: One year post initiation in intervention ] [ Designated as safety issue: No ]
  • Changes in measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff. [ Time Frame: One year post initiation of intervention ] [ Designated as safety issue: No ]
  • Increase in secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening) [ Time Frame: One year post initiation in intervention ] [ Designated as safety issue: No ]
  • Intermediate outcome measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff. [ Time Frame: One year post initiation of intervention ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics
Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Colorectal Cancer
  • Behavioral: Usual care
    No intervention will be conducted in this arm of the study.
  • Behavioral: 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.
  • Behavioral: 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.
  • 1
    Usual care
    Intervention: Behavioral: Usual care
  • Experimental: 2
    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.
    Intervention: Behavioral: Clinic-focused intervention
  • Experimental: 3

    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.

    Intervention: Behavioral: Clinic- and patient-focused

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5066
December 2011
June 2010   (final data collection date for primary outcome measure)

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.
Both
50 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00737646
CDC-NCCDPHP-4555
No
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
Not Provided
Principal Investigator: Judith Lee Smith, PhD Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP