Promoting Colorectal Cancer Screening in Rural Emergency Departments

NCT ID: NCT03473587

Last Updated: 2018-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-07

Study Completion Date

2018-05-30

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Motivational interview

Intervention Type BEHAVIORAL

A lay health advisor will engage the subject in a motivational interview to promote the importance of colorectal cancer screening

Standard of Care

Subjects will be provided a standard of care colorectal cancer screening brochure at the time of ED visit

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type BEHAVIORAL

A lay health advisor will provide the subject with a brochure promoting the importance of colorectal cancer screening

Interventions

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Motivational interview

A lay health advisor will engage the subject in a motivational interview to promote the importance of colorectal cancer screening

Intervention Type BEHAVIORAL

Standard of care

A lay health advisor will provide the subject with a brochure promoting the importance of colorectal cancer screening

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kentucky

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Hatcher

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Hatcher, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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St. Clair Regional Medical Center

Morehead, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer Hatcher, RN, PhD

Role: CONTACT

859-257-5263

Facility Contacts

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Jennifer Hatcher, RN, PhD

Role: primary

859-257-5263

Other Identifiers

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MCC-14-0681-P1H

Identifier Type: -

Identifier Source: org_study_id

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