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

Primary Purpose

Colon Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid for Colon Cancer Screening
Usual Care Outreach for Colon Cancer Screening
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colon Cancer

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

    • personal history of CRC, colectomy, colostomy, or ileostomy; currently prescribed anti-coagulation medications (ReoPro (abciximab), Aggrenox (aspirin plus dipyridamole), Persantine (dipyridamole), Integrilin (eptifibatide), Ticlid (ticlopidine), Aggrastat (tirofiban), Heparin, Coumadin (warfarin), Pradaxa (dabigatran), Xarelto (rivaroxaban)); currently prescribed plavix (clopidogrel); on chronic oxygen; have end-stage renal disease; have unstable angina; have arrhythmia/atrial fibrillation; have cardiomyopathy; currently weighs >350 pounds; have cystic fibrosis; and/or, are insured by the Colorado indigent care program (CICP) or Medicaid-Old age pension, AARP Medicare/Secure Horizons (except PFFS), Denver Health Managed Medicaid, Evercare; Kaiser (not the prescriber of origin), Medicare Complete, New Medicaid, New CICP. Furthermore, dependent on the severity of the condition, the following are gauged for exclusion criteria and noted in the AHP CRC screening surveillance test notes to then inquire about appropriate candidacy for a colonoscopy: diabetes mellitus (insulin, oral, or both), chronic obstructive pulmonary disease, emphysema, reactive airway disease; chronic renal disease; multiple sclerosis; seizure disorder; murmurs; hepatitis; human immunodeficiency virus /acquired immunodeficiency syndrome ; congestive heart failure; coronary artery disease; aortic aneurysm; history of coronary artery bypass graft; heart valve issues (prolapse, regurgitation, etc.); tachycardia; bradycardia; history of myocardial infarction.

Sites / Locations

  • University of Colorado Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Usual Care Outreach for Colon Cancer Screening

Decision Aid for Colon Cancer Screening

Arm Description

Receives standard of care outreach concerning colon cancer screening.

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

Outcomes

Primary Outcome Measures

Colon Cancer Screening Intent
Measured using a survey instrument to assess intent

Secondary Outcome Measures

Colon Cancer Screening Completed
Measured through retrospective chart reviews to check for completed screening

Full Information

First Posted
February 25, 2015
Last Updated
June 22, 2017
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02377232
Brief Title
Simultaneous Improvement in Colon Cancer Screening Rates and Patient-Centered Care
Acronym
CRCSreening
Official Title
Simultaneous Improvement in Colon Cancer Screening Rates and Patient-Centered Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
424 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Outreach for Colon Cancer Screening
Arm Type
Active Comparator
Arm Description
Receives standard of care outreach concerning colon cancer screening.
Arm Title
Decision Aid for Colon Cancer Screening
Arm Type
Active Comparator
Arm Description
Receives colon cancer screening decision aid intervention in addition to outreach.
Intervention Type
Behavioral
Intervention Name(s)
Decision Aid for Colon Cancer Screening
Intervention Description
Paper decision aid describing different screening options for colon cancer
Intervention Type
Behavioral
Intervention Name(s)
Usual Care Outreach for Colon Cancer Screening
Intervention Description
Patients overdue for colon cancer screening are contacted and outreach is performed in an effort to schedule colonoscopy
Primary Outcome Measure Information:
Title
Colon Cancer Screening Intent
Description
Measured using a survey instrument to assess intent
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Colon Cancer Screening Completed
Description
Measured through retrospective chart reviews to check for completed screening
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: personal history of CRC, colectomy, colostomy, or ileostomy; currently prescribed anti-coagulation medications (ReoPro (abciximab), Aggrenox (aspirin plus dipyridamole), Persantine (dipyridamole), Integrilin (eptifibatide), Ticlid (ticlopidine), Aggrastat (tirofiban), Heparin, Coumadin (warfarin), Pradaxa (dabigatran), Xarelto (rivaroxaban)); currently prescribed plavix (clopidogrel); on chronic oxygen; have end-stage renal disease; have unstable angina; have arrhythmia/atrial fibrillation; have cardiomyopathy; currently weighs >350 pounds; have cystic fibrosis; and/or, are insured by the Colorado indigent care program (CICP) or Medicaid-Old age pension, AARP Medicare/Secure Horizons (except PFFS), Denver Health Managed Medicaid, Evercare; Kaiser (not the prescriber of origin), Medicare Complete, New Medicaid, New CICP. Furthermore, dependent on the severity of the condition, the following are gauged for exclusion criteria and noted in the AHP CRC screening surveillance test notes to then inquire about appropriate candidacy for a colonoscopy: diabetes mellitus (insulin, oral, or both), chronic obstructive pulmonary disease, emphysema, reactive airway disease; chronic renal disease; multiple sclerosis; seizure disorder; murmurs; hepatitis; human immunodeficiency virus /acquired immunodeficiency syndrome ; congestive heart failure; coronary artery disease; aortic aneurysm; history of coronary artery bypass graft; heart valve issues (prolapse, regurgitation, etc.); tachycardia; bradycardia; history of myocardial infarction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen L Lewis, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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