Interventions to Improve Colon Cancer Screening in Poor Rural Iowa Counties

Colorectal Cancer Clinical Trial

Official title:

Randomized Clinical Trial to Improve Colon Cancer Screening in Poor Rural Iowa Counties

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477814
• Other study ID #: 200805728
• Status: Completed
• Phase: N/A
• First received: November 18, 2011
• Last updated: April 20, 2017
• Start date: July 2008
• Est. completion date: July 16, 2015

Study information

• Verified date: April 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the study is to conduct a randomized clinical trial to test several office-based strategies for improving colon cancer screening among individuals who are regular patients at 16 family practice physician offices in the state of Iowa. These offices are members of the Iowa Research Network (IRENE), a rural practice-based research network. The interventions to be tested are increasing in intensity from the usual care provided in the office, to physician chart reminders, mailed educational materials to patients, a fecal immunochemical test with postage-paid return envelope, and a telephone call designed to determine attitudes and barriers to screening, and to motivate subjects to get screened. Our main research questions are: 1)do attitudes toward CRC screening change after providing educational materials about CRC screening? 2)do mailed educational materials and a FIT, with or without a telephone reminder, result in increased rates of CRC testing with the FIT?

Description:

Colorectal cancer is the second leading cause of cancer death in the U.S. yet approximately half of eligible adults are not up-to-date with colon cancer screening and the rates of screening are lower among those with lower incomes and who lack insurance. A physician's recommendation for screening has consistently been show to be one of the most powerful predictors of CRC screening. Relatively few studies of CRC screening have been conducted in primary care. Disparities in CRC screening rates are seen in low socioeconomic and rural individuals who often lack resources and access to screening. Most intervention studies have been conducted in managed care settings, community health centers, Veteran's Administration or academic practices. Few studies have looked at interventions in rural medical practices. This research will address screening issues for rural patients and those residing in communities designated as medically underserved. The interventions tested in the study will focus on two key areas: educating the patient about the importance of screening, and reminding the physician about the need to discuss screening during the patient's visit.

The original goal of the study was to enroll 1500 unscreened patients aged 52 to 79 years from 16 family physician practices located in poor, rural Iowa counties. This study will test a combination of patient and physician reminder strategies designed to ensure that the patient is educated about CRC screening and receives a recommendation for CRC screening from their physician. The main outcome is colorectal cancer screening by any of the accepted methods. Rates of screening will be compared across intervention groups. We will also determine how much the interventions cost per person screened.

Patients due for screening within each practice (based on their self-report) (never screened or not up to date with screening) will be randomized to one of four groups that will receive office reminder system strategies of increasing intensity: 1) Usual care, 2) Physician chart reminder alone, 3) Physician chart reminder plus multifaceted mailed patient education, including a postage paid fecal immunochemical test, a reminder magnet, and returnable CRC screening test preference sheet, or 4) Physician chart reminder + multifaceted mailed patient education/FIT/magnet/preference sheet + telephone reminder to encourage screening and address barriers.

Our central hypothesis is that providing offices with one or more CRC screening support systems based on the Chronic Care Model will significantly increase CRC screening rates in comparison with usual care, and that such interventions will be cost-effective and accepted in practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 743
• Est. completion date: July 16, 2015
• Est. primary completion date: April 27, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 52 Years to 79 Years

Eligibility

Inclusion Criteria:

• patients not up-to-date with CRC screening guidelines based on their responses to baseline survey

• patients with a positive personal history of CRC

Exclusion Criteria:

• patients with personal history of CRC or inflammatory bowel disease

• patients with a family history of hereditary conditions that put them at high risk for CRC (familial adenomatous polyposis or hereditary, nonpolyposis CRC)

• inability to read and comprehend the Informed Consent or written survey

• patients who are up-to-date with CRC screening guidelines based on their response to the baseline survey

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Physician chart reminder
Subjects randomized to this intervention will have paper or electronic chart reminders placed on their medical records alerting their physicians to the need for colorectal cancer screening
• chart reminder, educational mat'ls, FIT
Subjects randomized to this group will have a physician chart reminder, mailed educational packet which includes the CDC Screen for Life materials, a FIT with return envelope, a magnet to remind the subject about CRC screening and a CRC screening preference sheet
• CR,ed mat'ls, FIT, phone call
Subjects randomized to this group will have a physician chart reminder, mailed educational packet which includes the CDC Screen for Life materials, a FIT with return envelope, a magnet to remind the subject about CRC screening and a CRC screening preference sheet. Subjects will also receive a telephone call from project staff to assess barriers to screening and to encourage CRC screening

Locations

Country	Name	City	State
United States	Iowa Research Network, University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Barcey T. Levy	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Daly JM, Xu Y, Levy BT. Patients whose physicians recommend colonoscopy and those who follow through. J Prim Care Community Health. 2013 Apr 1;4(2):83-94. doi: 10.1177/2150131912464887. Epub 2012 Nov 4. — View Citation

Ely JW, Levy BT, Daly J, Xu Y. Patient Beliefs About Colon Cancer Screening. J Cancer Educ. 2016 Mar;31(1):39-46. doi: 10.1007/s13187-015-0792-5. — View Citation

Levy BT, Daly JM, Xu Y, Ely JW. Mailed fecal immunochemical tests plus educational materials to improve colon cancer screening rates in Iowa Research Network (IRENE) practices. J Am Board Fam Med. 2012 Jan-Feb;25(1):73-82. doi: 10.3122/jabfm.2012.01.110055. — View Citation

Levy BT, Xu Y, Daly JM, Ely JW. A randomized controlled trial to improve colon cancer screening in rural family medicine: an Iowa Research Network (IRENE) study. J Am Board Fam Med. 2013 Sep-Oct;26(5):486-97. doi: 10.3122/jabfm.2013.05.130041. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	colorectal cancer screening	The main outcome measure is the percentage of subjects who complete colorectal cancer screening by any of the accepted methods	15 months
Secondary	cost-effectiveness of various strategies for screening	cost-effectiveness of the various interventions for colorectal cancer screening	15 months