Promoting CRC Screening in an Urban Minority Population
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Printed Education Material
Academic Detailing
Academic Detailing+Telephone Education
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring colorectal cancer screening
Eligibility Criteria
Inclusion Criteria:
- out of compliance with recommended CRC screening
- having a 'regular doctor' (for women, could be gynecologist)
- stated intention to remain in benefit fund for at least one year
- age 50 to 75
- reachable by telephone
- able to communicate in English
- ability to grant informed consent
Exclusion Criteria:
- colonoscopy in past 10 years
- flexible sigmoidoscopy, barium enema or CT colonography in past 5 years
- stool DNA in past 3 years
- 3 day FOBT or FIT within past year
- history of colorectal polyps, inflammatory bowel disease, irritable bowel syndrome, Crohn's disease, ulcerative colitis, or current treatment for any type of cancer
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Printed Education Material
Academic Detailing
Academic Detailing+Telephone Education
Arm Description
Participants received printed education materials (PEM) sent by first class mail.
Participants' primary care physicians (PCPs) received academic detailing (AD) to improve colorectal cancer screening referral and follow-up practices.
Participants' primary care physicians (PCPs) received academic detailing (AD) to improve colorectal cancer screening referral and follow-up practices and participants received tailored telephone education (TTE).
Outcomes
Primary Outcome Measures
Colorectal Cancer Screening
defined as colonoscopy, flexibile sigmoidoscopy, barium enema, CT colonography or DNA stool test based on medical claims paid by benefit fund
Secondary Outcome Measures
Full Information
NCT ID
NCT02392143
First Posted
March 12, 2015
Last Updated
March 17, 2015
Sponsor
Teachers College, Columbia University
Collaborators
Columbia University, 1199SEIU Benefit and Pension Funds
1. Study Identification
Unique Protocol Identification Number
NCT02392143
Brief Title
Promoting CRC Screening in an Urban Minority Population
Official Title
Promoting CRC Screening in a Hard-To-Reach, Low-Income Minority Population
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teachers College, Columbia University
Collaborators
Columbia University, 1199SEIU Benefit and Pension Funds
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study (Healthy Colon Project II) is to evaluate different educational approaches for increasing rates of colorectal cancer (CRC) screening in a hard-to-reach urban minority population with health insurance.
Detailed Description
This project is an extension of the investigators' earlier study (Healthy Colon Project I) in which the investigators demonstrated that telephone outreach to individuals had a significant effect on CRC screening in a hard-to-reach, working class, urban minority population (~27.0% screened who received telephone outreach vs. ~6.1% screened who received printed educational materials). Additional investigation suggested the possible benefits of intervening with primary care physicians (PCPs) regarding their CRC screening referral and follow-up practices.
In the current project, the investigators conducted a 3-group randomized trial. The aims are as follows: Aim 1: Evaluate the incremental effect of tailored telephone education (TTE), over and above the effect of academic detailing (AD), for increasing rates of CRC screening 12-months post-randomization; Aim 2: Evaluate the effect of academic detailing alone (AD) over minimal intervention (control group), for increasing rates of CRC screening 12-months post-randomization; Aim 3: Identify factors that mediate the effectiveness of the interventions; and Aim 4: Identify factors that moderate the effectiveness of the interventions among subgroups.
In one group, participants received printed education materials. In a second group, participants' PCPs received academic detailing (AD) to improve CRC screening referral and follow-up practices. And in a third group, PCPs received AD and participants received tailored telephone education (TTE). Participants were members of a union-based, self-administered and self-insured benefit fund in the NYC metropolitan area.
The educational intervention approaches were informed by the investigators' earlier study among this population, with the goal of helping participants to make an informed choice about screening. The CRC PEM described the importance of early detection and prevention, risk factors, and the importance of talking to the subject's doctor about CRC screening. The PEM highlighted colonoscopy as being the only test that can identify and prevent CRC and described how to prepare for a colonoscopy beginning seven days prior to the test. The PEM also described other CRC screening tests, including the FOBT, FIT, sigmoidoscopy, barium enema and virtual colonoscopy. Academic detailing (AD) involved an in-person visit from a member of the research team who attempted to communicate strategies for improving CRC screening uptake in the practice's patient panel. In cases where the PCP was unavailable, an office staff member was approached. A brief description of the RCT was followed by a semi-structured interview assessing usual practice regarding CRC screening referral and follow up. The direction of the discussion was guided by PCP responses. A variety of resources were provided: a binder with up-to-date scientific evidence about CRC screening recommendations and printed patient education materials, and order forms for refilling supplies. Specific directives were following up to make sure patients had made appointments with a gastroenterologist and offering 3-day FOBT. The detailer attempted to elicit a verbal commitment to do at least one new thing to strengthen the probability that patients would be screened. The TTE was based on the investigators' previously tested model and involved a semi-structured protocol in which the first goals were to build rapport and assess level of knowledge and readiness to be screened. In contrast to the earlier RCT, the current study's TTE clearly represented colonoscopy as the screening method of choice, while encouraging alternative screening methods as well. This emphasis was consistent with goals of the New York City Department of Health and Mental Hygiene and the American Cancer Society at the time of the study. Rapport established, the TTE dialogue focused on identifying and addressing barriers that might impede receipt of screening. Verbal commitments were elicited: to speak with the PCP and make an appointment for a colonoscopy, or request a home stool test, as appropriate. Follow up calls assessed progress towards achieving goals.
Three types of data were collected. Baseline survey data assessed eligibility and measured a variety of demographic and other variables. Implementation data monitored the extent to which the AD and TTE interventions had been conducted as planned. And outcome data (CRC screening one year post-randomization) was based on medical claims data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
564 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Printed Education Material
Arm Type
Active Comparator
Arm Description
Participants received printed education materials (PEM) sent by first class mail.
Arm Title
Academic Detailing
Arm Type
Active Comparator
Arm Description
Participants' primary care physicians (PCPs) received academic detailing (AD) to improve colorectal cancer screening referral and follow-up practices.
Arm Title
Academic Detailing+Telephone Education
Arm Type
Active Comparator
Arm Description
Participants' primary care physicians (PCPs) received academic detailing (AD) to improve colorectal cancer screening referral and follow-up practices and participants received tailored telephone education (TTE).
Intervention Type
Other
Intervention Name(s)
Printed Education Material
Other Intervention Name(s)
Print education
Intervention Description
The printed education material described the importance of early detection and prevention, risk factors, and the importance of talking to your doctor about CRC screening. The PEM highlighted colonoscopy as being the only test that can identify and prevent CRC and described how to prepare for a colonoscopy beginning seven days prior to the test [18]. The PEM also described other CRC screening tests, including the FOBT, FIT, sigmoidoscopy, barium enema and virtual colonoscopy.
Intervention Type
Other
Intervention Name(s)
Academic Detailing
Intervention Description
Academic detailing (AD) involved an in-person visit from a member of the research team who attempted to communicate strategies for improving CRC screening uptake in the practice's patient panel. A brief description of the RCT was followed by a semi-structured interview assessing usual practice regarding CRC screening referral and follow up. The direction of the discussion was guided by PCP responses. A variety of resources were provided. Specific directives were following up to make sure patients had made appointments with a gastroenterologist and offering home stool tests. The detailer attempted to elicit a verbal commitment to do at least one new thing to strengthen the probability that patients would be screened.
Intervention Type
Other
Intervention Name(s)
Academic Detailing+Telephone Education
Other Intervention Name(s)
Academic Detailing+Tailored Telephone Education
Intervention Description
PCPs received AD as described in the Academic Detailing arm. In addition, participants received tailored telephone education (TTE) which focused on identifying and addressing barriers that might impede screening. Verbal commitments were elicited to speak with their PCP and make an appointment for a colonoscopy, or request a home stool test, as appropriate. Follow-up calls assessed progress towards achieving goals.
Primary Outcome Measure Information:
Title
Colorectal Cancer Screening
Description
defined as colonoscopy, flexibile sigmoidoscopy, barium enema, CT colonography or DNA stool test based on medical claims paid by benefit fund
Time Frame
one year
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:
out of compliance with recommended CRC screening
having a 'regular doctor' (for women, could be gynecologist)
stated intention to remain in benefit fund for at least one year
age 50 to 75
reachable by telephone
able to communicate in English
ability to grant informed consent
Exclusion Criteria:
colonoscopy in past 10 years
flexible sigmoidoscopy, barium enema or CT colonography in past 5 years
stool DNA in past 3 years
3 day FOBT or FIT within past year
history of colorectal polyps, inflammatory bowel disease, irritable bowel syndrome, Crohn's disease, ulcerative colitis, or current treatment for any type of cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles E Basch, PhD
Organizational Affiliation
Teachers College, Columbia University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
27098522
Citation
Basch CH, Basch CE, Zybert P, Wolf RL. Failure of Colonoscopy Knowledge to Predict Colonoscopy Uptake. J Community Health. 2016 Oct;41(5):1094-9. doi: 10.1007/s10900-016-0194-6.
Results Reference
derived
PubMed Identifier
26831486
Citation
Basch CH, Basch CE, Zybert P, Wolf RL. Fear as a Barrier to Asymptomatic Colonoscopy Screening in an Urban Minority Population with Health Insurance. J Community Health. 2016 Aug;41(4):818-24. doi: 10.1007/s10900-016-0159-9.
Results Reference
derived
PubMed Identifier
26585609
Citation
Wolf RL, Basch CE, Zybert P, Basch CH, Ullman R, Shmukler C, King F, Neugut AI. Patient Test Preference for Colorectal Cancer Screening and Screening Uptake in an Insured Urban Minority Population. J Community Health. 2016 Jun;41(3):502-8. doi: 10.1007/s10900-015-0123-0.
Results Reference
derived
PubMed Identifier
25850386
Citation
Basch CE, Zybert P, Wolf RL, Basch CH, Ullman R, Shmukler C, King F, Neugut AI, Shea S. A Randomized Trial to Compare Alternative Educational Interventions to Increase Colorectal Cancer Screening in a Hard-to-Reach Urban Minority Population with Health Insurance. J Community Health. 2015 Oct;40(5):975-83. doi: 10.1007/s10900-015-0021-5.
Results Reference
derived
Learn more about this trial
Promoting CRC Screening in an Urban Minority Population
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