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

NCT02377232 | Completed

• 1 other identifier: 14-1976
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Colon Cancer Screening Intent

  Measured using a survey instrument to assess intent

  6 months

Secondary Outcomes (1)

• Colon Cancer Screening Completed

  6 Months

Study Arms (2)

Usual Care Outreach for Colon Cancer Screening

ACTIVE COMPARATOR

Receives standard of care outreach concerning colon cancer screening.

Behavioral: Usual Care Outreach for Colon Cancer Screening

Decision Aid for Colon Cancer Screening

ACTIVE COMPARATOR

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

Behavioral: Decision Aid for Colon Cancer Screening

Interventions

Decision Aid for Colon Cancer Screening BEHAVIORAL

Paper decision aid describing different screening options for colon cancer

Decision Aid for Colon Cancer Screening

Usual Care Outreach for Colon Cancer Screening BEHAVIORAL

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

Usual Care Outreach for Colon Cancer Screening

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Carmen L Lewis, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 3, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: June 26, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)