Interventions to Improve Colon Cancer Screening in Poor Rural Iowa Counties

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

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?

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Physician chart reminder; Behavioral: chart reminder, educational mat'ls, FIT; Behavioral: CR,ed mat'ls, FIT, phone call

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 743
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242-1097
      • Iowa Research Network, University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 52 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: physician chart reminder; either a paper or an electronic reminder placed on the subject's medical record to remind the physician to screen for colorectal cancer	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; Other Names: chart reminder
Active Comparator: chart reminder, educational mat'ls, FIT; physician chart reminder plus mailed educational materials, including the Centers for Disease Control CRC Screen for Life, the ACS DVD on CRC screening, a fecal immunochemical test with postage-paid return mailer, a magnet reminding individuals to get screened, and a CRC screening preference sheet where subjects could indicate their preferred CRC test	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; Other Names: chart reminder; Behavioral: 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; Other Names: chart reminder, mailed education, FIT
Active Comparator: CR, ed mat'ls, FIT, phone call; physician chart reminder (CR) plus mailed educational materials, including the Centers for Disease Control CRC Screen for Life, the ACS DVD on CRC screening, a fecal immunochemical test with postage-paid return mailer, a magnet reminding individuals to get screened, and a CRC screening preference sheet where subjects could indicate their preferred CRC test, and a motivational telephone call designed to elicit barriers and preferences and motivate individuals to complete a CRC screening test.	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; Other Names: chart reminder; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
cost-effectiveness of various strategies for screening	cost-effectiveness of the various interventions for colorectal cancer screening	15 months

Collaborators and Investigators

• Sponsor: Barcey T. Levy
• Collaborators: American Cancer Society, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Daly JM, Xu Y, Ely JW, Levy BT. A randomized colorectal cancer screening intervention trial in the Iowa Research Network (IRENE): study recruitment methods and baseline results. J Am Board Fam Med. 2012 Jan-Feb;25(1):63-72. doi: 10.3122/jabfm.2012.01.110054.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): April 27, 2010
• Study Completion (Actual): July 16, 2015

Study Registration Dates

• First Submitted: November 18, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (Estimate): November 23, 2011

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 20, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: colorectal cancer; colonoscopy; screening; clinical guidelines; fecal immunochemical test
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 200805728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Written request from an appropriate researcher to the PI