Back to resultsEvaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual care
Clinic-focused intervention
Clinic- and patient-focused
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring Cancer, Colorectal cancer, Patient education, Physician education
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.
Sites / Locations
- Henry Ford Health System
- ABQ Health Partners/Lovelace Clinic Foundation
- Battelle Centers for Public Health Research and Evaluation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Usual care
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.
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.
Outcomes
Primary Outcome Measures
Changes in colorectal cancer screening rates (4 modalities)
Secondary Outcome Measures
Changes in the frequency of secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening)
Changes in measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff.
Full Information
NCT ID
NCT00737646
First Posted
August 15, 2008
Last Updated
December 14, 2012
Sponsor
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT00737646
Brief Title
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
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Cancer, Colorectal cancer, Patient education, Physician education
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5066 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Usual care
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Arm Title
3
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
No intervention will be conducted in this arm of the study.
Intervention Type
Behavioral
Intervention Name(s)
Clinic-focused intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Clinic- and patient-focused
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in colorectal cancer screening rates (4 modalities)
Time Frame
One year post initiation of intervention
Secondary Outcome Measure Information:
Title
Changes in the frequency of secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening)
Time Frame
One year post initiation in intervention
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Lee Smith, PhD
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
ABQ Health Partners/Lovelace Clinic Foundation
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Battelle Centers for Public Health Research and Evaluation
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16802326
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.
Results Reference
background
PubMed Identifier
21819168
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.
Results Reference
background
Learn more about this trial
Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics
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