The PRIME-CRC Trial to Promote CRC Screening in Rural Communities

January 27, 2025 updated by: Louisiana State University Health Sciences Center Shreveport

Patient-Centered Reminders to Inform, Motivate, and Engage Colorectal Cancer Screening Adherence in Rural Communities: the PRIME-CRC Trial

The investigators will expand an existing, patient-centered, health literacy strategy to promote longer-term adherence to colorectal cancer (CRC) screening in resource-limited, rural health clinics via colonoscopy or annual fecal immunochemical test (FIT). In the proposed 2-arm study, both PRIME-CRC and enhanced usual care (control) will incorporate health literacy evidence-based practices for delivering CRC patient information and counseling to aid patient decision making for selecting FIT or colonoscopy, including simplified test instructions. In addition, the PRIME-CRC arm will use a "stepped care" approach for reminding patients on proper CRC screening preparation for scheduled colonoscopy or completion of annual FIT. Patients in the PRIME-CRC arm will receive frequent follow-up contact from their health care provider via audio-recorded, automated call or SMS text, based on patient preference.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators will expand an existing, patient-centered, health literacy strategy to promote longer-term adherence to colorectal cancer (CRC) screening in resource-limited, rural health clinics via colonoscopy or annual fecal immunochemical test (FIT). Guided by recently completed trials, the investigators will leverage consumer technologies that are now available in rural areas and implement a multifaceted approach - designed for scale in resource-limited federally qualified health centers (FQHCs). While significant gains have been made to improve CRC screening, compliance with those guidelines is sub-optimal and disparities remain. In particular, adults who receive care at rural FQHCs that have limited resources struggle to initiate and maintain annual CRC screening via the most common method, FIT. Over the past decade, this team has studied the effectiveness of specific interventions to enhance initial and repeat CRC screening completion among lower income, lower health literate, racially/ethnically diverse adults in rural FQHC settings. The majority of patients will complete the initial test (67% - 69%), yet fewer (32% - 40%) complete an annual test in years 2 and 3. This indicates a "stepped care" approach is needed to promote long-term CRC screening. The investigators' rural health literacy interventions have until now been limited to the FIT due to restrictions of state Medicaid coverage and clinical bandwidth of colonoscopy services available to rural FQHCs. Changes to Medicaid have now expanded the availability of colonoscopy. The investigators propose a novel intervention guided by evidence learned from the investigators' previous studies and recent literature - the Patient-Centered Reminders to Inform, Motivate, and Engage-CRC Screening (PRIME-CRC). In this proposed 2-arm, randomized control trial (N=1200), both PRIME-CRC and enhanced usual care arms will at point of care receive CRC patient information and counseling to aid patient decision making for selecting FIT or colonoscopy utilizing core components including evidence-based Health Literacy education and counseling, along with printed, simplified CRC screening information and simplified test instructions. PRIME-CRC will additionally have a "stepped care" approach for reminding patients on proper CRC screening preparation for scheduled colonoscopy or completion of annual FIT. Patients in the PRIME-CRC arm will have frequent follow-up with tailored contact via automated call or SMS text (based on patient preference) from their healthcare provider (audio recorded or personalized text). The primary outcome will be completion of either colonoscopy or annual FIT over 3 years. The specific aims are to: test the effectiveness of the PRIME-CRC intervention to improve CRC screening completion rates in rural FQHCs compared to enhanced usual care; investigate whether the intervention can reduce CRC screening disparities by patient health literacy, race or sex; determine the fidelity of PRIME-CRC components, and explore patient, provider, and healthcare system barriers to implementation, and evaluate the cost associated with the intervention from a FQHC perspective. This study extends this team's longstanding collaboration on health literacy, health disparities, rural health and cancer screening.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
804

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Louisiana
      • Bastrop, Louisiana, United States, 71220-5013
        • CommuniHealth (dba Morehouse Community Medical Centers, Inc.)
      • Marion, Louisiana, United States, 71260-3653
        • CommuniHealth (dba Morehouse Community Medical Centers, Inc.)
      • St. Joseph, Louisiana, United States, 71366
        • Tensas Community Health Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. have been a patient at one of the participating FQHCs with at least one prior visit in the past 12 months;
  2. age 45 to 75 (based on USPSTF guidelines);
  3. English-speaking.

Exclusion Criteria:

  1. have a previous history of cancer other than non-melanoma skin cancer;
  2. are up-to-date with CRC screening according to USPSTF guidelines (FOBT in less than a year, sigmoidoscopy less than 5 years, or colonoscopy less than 10 years);
  3. a family history that requires a more complete history and possible colonoscopy because of their risk factor;
  4. have a documented or uncorrectable cognitive, hearing, or visual impairment;
  5. are too ill to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: PRIME CRC
Patients will receive a plain language, literacy appropriate, actionable printed CRC screening handout emphasizing the benefits of CRC screening and screening options; as well as plain language, literacy appropriate handouts on the CRC screening test they choose - colonoscopy or FIT. Patients will also receive automated reminder calls and texts for both screening options to encourage screening.
Behavioral: health literacy appropriate education and demonstration
If a patient chooses the Fecal Immunochemical Test (FIT), the Screening Coordinator (SC) will give the FIT kit, emphasize the necessity of annual completion, and distribute an additional plain language, literacy appropriate, actionable handout with simplified illustrated instructions on how to complete the test and mail to the central lab. The SC will review the handout and instructions with the patient and use the 'teach back' method to confirm understanding.
Behavioral: shared decision making
Screening Coordinator (SC) will give patients a plain language, literacy appropriate, actionable printed CRC screening handout emphasizing the benefits of CRC screening and screening options; using the low literacy handout as a teaching tool, the SC will briefly counsel patients on CRC screening options prior to seeing their healthcare provider, reviewing the benefits of each, as well as applicable costs. After reviewing the CRC screening pamphlets with a patient, the SC will use shared decision-making techniques using the study CRC materials to aid patients in selecting the test they prefer and that meets their needs - colonoscopy or FIT.
Behavioral: automated call reminders or automated texts

Colonoscopy year 1: Will receive an automated call recording by PCP 48 hours after the clinic visit to remind them of their choice of colonoscopy; then, one week before the test reminding them to pick up the preparation kit. Those who chose SMS will receive a text message from their PCP with content similar to the voice call. A 3rd reminder call/text will be sent 2 days prior to the test. If no colonoscopy with 3 months, the clinical manager (CCM) will call to determine if they want to switch screening options. The CCM will discuss barriers and option of choosing FIT for 3 years. If they opt to change, they will be mailed a FIT with simplified instructions and then follow the FIT follow-up protocol.

FIT year 1: Motivational reminders recorded by their PCP will be sent by automated call or text within 48 hours after the visit and again at 4, 8 and 12 weeks for those who have NOT completed the test. FIT will be mailed year 2 & 3 - follow-up will follow same procedure as year 1.
Active Comparator: Enhanced Usual Care
Patients will receive a plain language, literacy appropriate, actionable printed CRC screening handout emphasizing the benefits of CRC screening and screening options; as well as plain language, literacy appropriate handouts on the CRC screening test they choose - colonoscopy or FIT. Patients will receive no reminder calls.
Behavioral: health literacy appropriate education and demonstration
If a patient chooses the Fecal Immunochemical Test (FIT), the Screening Coordinator (SC) will give the FIT kit, emphasize the necessity of annual completion, and distribute an additional plain language, literacy appropriate, actionable handout with simplified illustrated instructions on how to complete the test and mail to the central lab. The SC will review the handout and instructions with the patient and use the 'teach back' method to confirm understanding.
Behavioral: shared decision making
Screening Coordinator (SC) will give patients a plain language, literacy appropriate, actionable printed CRC screening handout emphasizing the benefits of CRC screening and screening options; using the low literacy handout as a teaching tool, the SC will briefly counsel patients on CRC screening options prior to seeing their healthcare provider, reviewing the benefits of each, as well as applicable costs. After reviewing the CRC screening pamphlets with a patient, the SC will use shared decision-making techniques using the study CRC materials to aid patients in selecting the test they prefer and that meets their needs - colonoscopy or FIT.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CRC Screening
Time Frame: 3 years
completion of colonoscopy or 3 years of completion of FIT CRC screening
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Louisiana State University Health Sciences Center Shreveport

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
Northwestern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Connie L Arnold, PhD, LSU Health Sciences Center Shreveport

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LSUShreveport
  • 5R01CA240496 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators will provide and disseminate a complete IRB approved study protocol describing the study sample, all research questions, analysis methods, description of measures and procedures with the first progress report.

The investigators will maintain primary data in accordance with NIH regulations. The investigators will consider requests for primary study data from other researchers and from the public, in light of our intent to publish, and will make data available in accordance with institutional policies, IRB rules, and local/state/federal laws and regulations.

For interested researchers, the investigators will make anonymized, aggregated data available to researchers who complete a data sharing use agreement in compliance with the Louisiana State University Health Sciences Center - Shreveport.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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