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
  Purpose

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.


Condition Intervention
Colorectal Cancer
Behavioral: Usual care
Behavioral: Clinic-focused intervention
Behavioral: Clinic- and patient-focused

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Changes in colorectal cancer screening rates (4 modalities) [ Time Frame: One year post initiation of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5066
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Usual care
Behavioral: Usual care
No intervention will be conducted in this arm of the study.
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737646

Locations
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New Mexico
ABQ Health Partners/Lovelace Clinic Foundation
Albuquerque, New Mexico, United States, 87106
United States, Washington
Battelle Centers for Public Health Research and Evaluation
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Investigators
Principal Investigator: Judith Lee Smith, PhD Centers for Disease Control and Prevention
  More Information

Publications:
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00737646     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-4555
Study First Received: August 15, 2008
Last Updated: December 14, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Cancer
Colorectal cancer
Patient education
Physician education

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 17, 2014