Simultaneous Improvement in Colon Cancer Screening Rates and Patient-Centered Care

NCT ID: NCT02377232

Last Updated: 2017-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-07-31

Brief Summary

Several screening methods exist to screen patients for CRC ranging from invasive (i.e., colonoscopy) to less invasive (i.e., testing the stool for blood). Although choice between screening methods is recommended, patients are not currently offered an unbiased choice and physicians generally recommend only colonoscopy. In this project, the investigators will answer the following questions: 1) Is it feasible to incorporate a DA in the AHP protocol?; 2) Is it feasible to incorporate mailing patients a stool blood test?; 3) Does the DA change CRC screening decision quality, using proxy measures such as knowledge and intent; and 4) Does the DA change the proportion of participants that complete a CRC screening test? To answer these questions the investigators will compare survey responses and CRC test type completed between two AHP CRC surveillance patients groups - those that received usual care versus those that received the DA.

Detailed Description

At the University of Colorado Hospital primary care clinics, only 59% of eligible patients are up to date with current colorectal cancer (CRC) screening. This is below the national average of 65% and well below the healthy people 2020 goal of 70.5%. Several screening methods exist to screen patients for CRC ranging from invasive (i.e., colonoscopy) to less invasive (i.e., testing the stool for blood). Although choice between screening methods is recommended, patients are not currently offered an unbiased choice and physicians generally recommend only colonoscopy. Further, the investigators know from research that choice increases screening rates. Unfortunately, many people do not follow through when only colonoscopy is offered. However, participants in one study were nearly twice as likely to be screened if they were offered a choice between colonoscopy and fecal occult blood testing rather than being offered colonoscopy alone. Thus, in this project, the investigators aim to examine the feasibility of incorporating a patient decision aid (DA) for patients in CRC screening surveillance with the Ambulatory Health Promotion (AHP) using a pre/post design. The investigators will answer the following questions: 1) Is it feasible to incorporate a DA in the AHP protocol?; 2) Is it feasible to incorporate mailing patients a stool blood test?; 3) Does the DA change CRC screening decision quality, using proxy measures such as knowledge and intent; and 4) Does the DA change the proportion of participants that complete a CRC screening test? To answer these questions the investigators will compare survey responses and CRC test type completed between two AHP CRC surveillance patients groups - those that received usual care versus those that received the DA.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

Usual Care Outreach for Colon Cancer Screening

Receives standard of care outreach concerning colon cancer screening.

Group Type: ACTIVE_COMPARATOR

Usual Care Outreach for Colon Cancer Screening

Intervention Type: BEHAVIORAL

Patients overdue for colon cancer screening are contacted and outreach is performed in an effort to schedule colonoscopy

Decision Aid for Colon Cancer Screening

Receives colon cancer screening decision aid intervention in addition to outreach.

Group Type: ACTIVE_COMPARATOR

Decision Aid for Colon Cancer Screening

Intervention Type: BEHAVIORAL

Paper decision aid describing different screening options for colon cancer

Interventions

Decision Aid for Colon Cancer Screening

Paper decision aid describing different screening options for colon cancer

Intervention Type: BEHAVIORAL

Usual Care Outreach for Colon Cancer Screening

Patients overdue for colon cancer screening are contacted and outreach is performed in an effort to schedule colonoscopy

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Individuals that fall within the age range for CRC screening surveillance (age 50 to < = 75 years) from AHP
• Are eligible for CRC screening surveillance from AHP
• Were seen in the last 18 months by a provider at one of the primary medical care clinics from the University of Colorado General Internal Medicine, Family Medicine, or the Women's Integrated Services in Health clinic, and the individual's primary medical care provider has provided approval for AHP CRC outreach to an AHP staff person
• Have no record of a colonoscopy within the last 10 years,
• Have no record of flexible sigmoidoscopy or double-contrast barium enema within the past 5 years, or
• Have no record of FOBT within the past year.

Exclusion Criteria

• Individuals that do not speak English
• Individuals that have limited cognitive function/developmental disabilities
• Individuals that have a personal or family history of CRC (previous adenomatous polyp), and/or, have a signs and symptoms colonoscopy order from their primary care physician
• Not eligible for CRC screening surveillance from AHP
• Have a terminal medical illness that would otherwise categorize them as inappropriate candidates for CRC screening as noted in their EPIC EMR:
• The individual exhibits any of the following:

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmen L Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Other Identifiers

14-1976

Identifier Type: -

Identifier Source: org_study_id