Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00737646|
Recruitment Status : Completed
First Posted : August 19, 2008
Last Update Posted : December 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Behavioral: Usual care Behavioral: Clinic-focused intervention Behavioral: Clinic- and patient-focused||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5066 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||December 2011|
Behavioral: Usual care
No intervention will be conducted in this arm of the study.
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.
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.
- Changes in colorectal cancer screening rates (4 modalities) [ Time Frame: One year post initiation of intervention ]
- Changes in the frequency of secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening) [ Time Frame: 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. [ Time Frame: One year post initiation of intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737646
|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|
|Principal Investigator:||Judith Lee Smith, PhD||Centers for Disease Control and Prevention|