Promoting CRC Screening in an Urban Minority Population

Colorectal Cancer Clinical Trial

Official title:

Promoting CRC Screening in a Hard-To-Reach, Low-Income Minority Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392143
• Other study ID #: 542376
• Status: Completed
• Phase: N/A
• First received: March 12, 2015
• Last updated: March 17, 2015
• Start date: January 2009
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: Teachers College, Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 564
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Printed Education Material
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.
• Academic Detailing
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.
• Academic Detailing+Telephone Education
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Teachers College, Columbia University	1199SEIU Benefit and Pension Funds, Columbia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colorectal Cancer Screening	defined as colonoscopy, flexibile sigmoidoscopy, barium enema, CT colonography or DNA stool test based on medical claims paid by benefit fund	one year	No