Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03167125 |
Other study ID # |
1U01MD010665-01 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 5, 2017 |
Est. completion date |
June 30, 2021 |
Study information
Verified date |
April 2022 |
Source |
Kaiser Permanente |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.