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

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ClinicalTrials.gov Identifier: NCT02377232
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE February 25, 2015
First Posted Date  ICMJE March 3, 2015
Last Update Posted Date June 26, 2017
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2015)
Colon Cancer Screening Intent [ Time Frame: 6 months ]
Measured using a survey instrument to assess intent
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
Colon Cancer Screening Intent [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT02377232 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2015)
Colon Cancer Screening Completed [ Time Frame: 6 Months ]
Measured through retrospective chart reviews to check for completed screening
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
Colon Cancer Screening Completed [ Time Frame: 6 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simultaneous Improvement in Colon Cancer Screening Rates and Patient-Centered Care
Official Title  ICMJE Simultaneous Improvement in Colon Cancer Screening Rates and Patient-Centered Care
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Screening
Condition  ICMJE Colon Cancer
Intervention  ICMJE
  • Behavioral: Decision Aid for Colon Cancer Screening
    Paper decision aid describing different screening options for colon cancer
  • 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
Study Arms  ICMJE
  • Active Comparator: Usual Care Outreach for Colon Cancer Screening
    Receives standard of care outreach concerning colon cancer screening.
    Intervention: Behavioral: Usual Care Outreach for Colon Cancer Screening
  • Active Comparator: Decision Aid for Colon Cancer Screening
    Receives colon cancer screening decision aid intervention in addition to outreach.
    Intervention: Behavioral: Decision Aid for Colon Cancer Screening
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2017)
424
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2015)
500
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02377232
Other Study ID Numbers  ICMJE 14-1976
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carmen L Lewis, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP