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Promoting Colorectal Cancer Screening in Rural Emergency Departments

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ClinicalTrials.gov Identifier: NCT03473587
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Hatcher, University of Kentucky

Tracking Information
First Submitted Date  ICMJE January 18, 2018
First Posted Date  ICMJE March 22, 2018
Last Update Posted Date March 22, 2018
Actual Study Start Date  ICMJE November 7, 2014
Estimated Primary Completion Date May 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
Change in colorectal cancer screening rate [ Time Frame: 6 months ]
Number of participants that seek out colorectal cancer screening after a motivational interview with a lay health advisor compared to standard of care (being provided a screening brochure)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Promoting Colorectal Cancer Screening in Rural Emergency Departments
Official Title  ICMJE Promoting Colorectal Cancer Screening in Rural Emergency Departments
Brief Summary This trial will compare the effects of a culturally targeted intervention designed to assist participants to identify and overcome individual barriers to colorectal cancer (CRC) and to promote CRC screenings using motivational interviewing (Ml) delivered by a lay health advisor (LHA) compared to the current standard-of-care (distribution of a brochure describing CRC screening services offered by the hospital) on CRC screening compliance.
Detailed Description The specific aim of this project is to adapt and pilot a tailored intervention to promote CRC screenings in a rural Appalachian Kentucky emergency department (ED) in order to: (a) evaluate the feasibility of providing a cancer screening promotion intervention in an emergency department (ED) that serves a rural Appalachian community; and (b) assess the effects of the intervention on barriers to CRC screening, stage of readiness to screen and CRC screening engagement. The first phase of the project will involve the adaptation and pretesting of the intervention. This phase will take approximately 6 months. The second phase of the project will involve piloting the intervention and evaluating its efficacy and feasibility and will take place over the following 18 months. We will conduct a randomized controlled trial to examine the efficacy and feasibility of delivering the LHA delivered MI intervention to promote CRC screening in persons waiting in a rural Appalachian emergency department (ED) for non urgent complaints. We will evaluate efficacy by measurement of CRC screening status at baseline and three and six months post intervention.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Behavioral: Motivational interview
    A lay health advisor will engage the subject in a motivational interview to promote the importance of colorectal cancer screening
  • Behavioral: Standard of care
    A lay health advisor will provide the subject with a brochure promoting the importance of colorectal cancer screening
Study Arms  ICMJE
  • Experimental: Motivational Interview
    Subjects will engage in a brief motivational interview to establish an action plan and discuss follow-up interviews a 3 and 6 months post ED visit
    Intervention: Behavioral: Motivational interview
  • Active Comparator: Standard of Care
    Subjects will be provided a standard of care colorectal cancer screening brochure at the time of ED visit
    Intervention: Behavioral: Standard of care
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2018)
191
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2018
Estimated Primary Completion Date May 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 50+ years of age
  2. Rural Appalachian resident
  3. No personal history of colorectal cancer
  4. No cognitive impairment
  5. Ability to speak and understand English
  6. Has not had one of the following colorectal cancer screening tests--

    1. Fecal Occult Blood Test within the past year
    2. Flexible sigmoidoscopy within the past five years, or
    3. Colonoscopy within the past ten years

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jennifer Hatcher, RN, PhD 859-257-5263 jennifer.hatcher@uky.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03473587
Other Study ID Numbers  ICMJE MCC-14-0681-P1H
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Jennifer Hatcher, University of Kentucky
Study Sponsor  ICMJE University of Kentucky
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jennifer Hatcher, RN, PhD University of Kentucky
PRS Account University of Kentucky
Verification Date March 2018

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