Participatory Research to Advance Colon Cancer Prevention (PROMPT)
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|ClinicalTrials.gov Identifier: NCT03167125|
Recruitment Status : Recruiting
First Posted : May 25, 2017
Last Update Posted : December 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Other: Automated Prompts Other: Automated Plus Live Prompts||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15000 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||
Phase I: The investigators will conduct a three-arm patient-randomized trial to compare 1) usual care, 2) automated prompts, and 3) automated plus live prompts. (Number of Arms: 3)
Phase II: This spread trial will use a stepped-wedge design, which is a variant of a crossover randomized trial, where clinics cross over from usual practice to the best practices program. In the stepped-wedge design, a baseline period controls for the level and rate of change of the outcomes prior to program implementation and the staggered implementation minimizes confounding due to changes in the secular trend. By randomizing practices to when they receive an intervention instead of whether they receive it, the stepped wedge design ensures that all practices eventually receive the intervention, an important consideration for clinic leadership. Furthermore, the wedge-defined clusters act as their own controls as they each receive both intervention conditions. (Number of Arms: 2)
|Masking:||None (Open Label)|
|Official Title:||Participatory Research to Advance Colon Cancer Prevention|
|Actual Study Start Date :||September 5, 2017|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
Active Comparator: Automated Prompts
Patients randomized to this arm will receive automated prompts to complete and return the FIT kit.
Other: Automated Prompts
This intervention is an automated data-driven program, using automated phone calls, text messages, and/or emails, for delivering FIT kit prompts to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.
Active Comparator: Automated Plus Live Prompts
Patients randomized to this arm will receive automated prompts plus linguistically and culturally tailored live prompts to complete and return the FIT kit.
Other: Automated Plus Live Prompts
This intervention is a higher-intensity program, using automated data-driven prompts plus linguistically and culturally tailored live prompts, for delivering FIT kit messages to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.
No Intervention: Usual Care
Patients randomized to this arm will receive usual care screening opportunities per recommended colorectal cancer screening guidelines.
- Increased colorectal cancer screening rates [ Time Frame: Up to 4 years (study period) ]Fecal testing completion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167125
|Contact: Jamie Thompson, MPHfirstname.lastname@example.org|
|United States, California|
|AltaMed Health Services||Recruiting|
|Los Angeles, California, United States, 90040|
|Contact: Melissa Castillo|
|Principal Investigator:||Gloria Coronado, PhD||Kaiser Permanente|