search
Back to results

Interventions to Improve Colon Cancer Screening in Poor Rural Iowa Counties

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physician chart reminder
chart reminder, educational mat'ls, FIT
CR,ed mat'ls, FIT, phone call
Sponsored by
Barcey T. Levy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring colorectal cancer, screening, colonoscopy, fecal immunochemical test, clinical guidelines

Eligibility Criteria

52 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Iowa Research Network, University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

physician chart reminder

chart reminder, educational mat'ls, FIT

CR, ed mat'ls, FIT, phone call

Arm Description

either a paper or an electronic reminder placed on the subject's medical record to remind the physician to screen for colorectal cancer

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

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.

Outcomes

Primary Outcome Measures

colorectal cancer screening
The main outcome measure is the percentage of subjects who complete colorectal cancer screening by any of the accepted methods

Secondary Outcome Measures

cost-effectiveness of various strategies for screening
cost-effectiveness of the various interventions for colorectal cancer screening

Full Information

First Posted
November 18, 2011
Last Updated
April 20, 2017
Sponsor
Barcey T. Levy
Collaborators
American Cancer Society, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01477814
Brief Title
Interventions to Improve Colon Cancer Screening in Poor Rural Iowa Counties
Official Title
Randomized Clinical Trial to Improve Colon Cancer Screening in Poor Rural Iowa Counties
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
April 27, 2010 (Actual)
Study Completion Date
July 16, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Barcey T. Levy
Collaborators
American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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?
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.

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, colonoscopy, fecal immunochemical test, clinical guidelines

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
743 (Actual)

8. Arms, Groups, and Interventions

Arm Title
physician chart reminder
Arm Type
Active Comparator
Arm Description
either a paper or an electronic reminder placed on the subject's medical record to remind the physician to screen for colorectal cancer
Arm Title
chart reminder, educational mat'ls, FIT
Arm Type
Active Comparator
Arm Description
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
Arm Title
CR, ed mat'ls, FIT, phone call
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physician chart reminder
Other Intervention Name(s)
chart reminder
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
chart reminder, educational mat'ls, FIT
Other Intervention Name(s)
chart reminder, mailed education, FIT
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
CR,ed mat'ls, FIT, phone call
Intervention Description
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
Primary Outcome Measure Information:
Title
colorectal cancer screening
Description
The main outcome measure is the percentage of subjects who complete colorectal cancer screening by any of the accepted methods
Time Frame
15 months
Secondary Outcome Measure Information:
Title
cost-effectiveness of various strategies for screening
Description
cost-effectiveness of the various interventions for colorectal cancer screening
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
52 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barcey T Levy, PhD, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa Research Network, University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1097
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Written request from an appropriate researcher to the PI
Citations:
PubMed Identifier
24004700
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.
Results Reference
background
PubMed Identifier
23799714
Citation
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.
Results Reference
background
PubMed Identifier
22218627
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.
Results Reference
background
PubMed Identifier
25619196
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.
Results Reference
background
PubMed Identifier
22218626
Citation
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.
Results Reference
derived

Learn more about this trial

Interventions to Improve Colon Cancer Screening in Poor Rural Iowa Counties

We'll reach out to this number within 24 hrs