Skip to main content
Clinical Trials/NCT03167125
NCT03167125
Completed
Not Applicable

Participatory Research to Advance Colon Cancer Prevention

Kaiser Permanente1 site in 1 country27,580 target enrollmentSeptember 5, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Kaiser Permanente
Enrollment
27580
Locations
1
Primary Endpoint
Increased colorectal cancer screening rates
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The overall goal of this study is to test strategies to raise rates of colorectal cancer screening among the Latino population in a federally qualified health center that operates multiple clinics. This intervention study will test automated and live prompts to a direct-mail fecal testing program in two phases.

In Phase I (Years 01 - 02), the investigators will tailor and define intervention components using a community-based participatory research approach called boot camp translation (BCT). The ultimate design of the intervention will be defined by patient and provider feedback from BCT. The investigators will then conduct a three-arm patient-randomized comparative effectiveness trial in two pilot clinics to compare 1) automated prompts (i.e., automated phone calls, text messages) to alert and remind patients to complete screening, 2) live prompts (i.e., live phone calls), and 3) a combination approach of automated plus live prompts.

In Phase II (Years 03 - 05), the investigators will spread and test the spread of the adapted intervention to additional clinics within the partnering health center using a two-arm main trial.

Both phases will be guided by an advisory group of clinicians, researchers, policy makers, and patients.

Detailed Description

The study will fulfill the following aims: Aim 1: Develop personalized messages (e.g., phone scripts, text messages, patient portal prompts) and define an intervention using boot camp translation to increase colon cancer screening among Latino populations. Aim 2: Assess the reach, effectiveness, and differences by subgroup (e.g., preferred language) of a three-arm colorectal cancer screening program among Latino FQHC patients, in 2 clinics, through a patient randomized-controlled trial. In addition to Usual Care, the arms are: * Automated Prompts-an automated data-driven program for delivering FIT kit prompts (using automated phone calls, text messages, and/or emails) to patients due for colorectal cancer screening. * Automated Plus Live Prompts-a higher-intensity program using automated, data-driven strategies for delivering FIT kit prompts plus linguistically and culturally tailored live prompts. Aim 3: Test the spread of the program across additional clinics using a two-arm randomized approach and develop an implementation guide that includes outreach materials, strategies for incorporating patient input, and resources.

Registry
clinicaltrials.gov
Start Date
September 5, 2017
End Date
June 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Persons aged 50-75 years and not up-to-date with colorectal cancer screening

Exclusion Criteria

  • Persons having colorectal disease (e.g., ulcerative colitis or colectomy), personal history of colorectal cancer or colorectal disease, end-stage or life threatening diseases or, those known to be under hospice care or living in a skilled nursing facility may be excluded.

Outcomes

Primary Outcomes

Increased colorectal cancer screening rates

Time Frame: Up to 4 years (study period)

Fecal testing completion

Study Sites (1)

Loading locations...

Similar Trials