PROMPT: Participatory Research to Advance Colon Cancer Prevention

Sponsor

Kaiser Permanente (Other)

Overall Status

Completed

CT.gov ID

NCT03167125

Collaborator

Oregon Health and Science University (Other), AltaMed Health Services (Other)

27,580

Enrollment

Location

Arms

45.8

Actual Duration (Months)

602.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Other: Automated Prompts Other: Automated Plus Live Prompts	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

27580 participants

Allocation:

Randomized

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)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)

Primary Purpose:

Screening

Official Title:

Participatory Research to Advance Colon Cancer Prevention

Actual Study Start Date :

Sep 5, 2017

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Increased colorectal cancer screening rates [Up to 4 years (study period)]
Fecal testing completion

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AltaMed Health Services	Los Angeles	California	United States	90040

Sponsors and Collaborators

Kaiser Permanente
Oregon Health and Science University
AltaMed Health Services

Investigators

Principal Investigator: Gloria Coronado, PhD, Kaiser Permanente

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kaiser Permanente

ClinicalTrials.gov Identifier:

NCT03167125

Other Study ID Numbers:

1U01MD010665-01

First Posted:

May 25, 2017

Last Update Posted:

Apr 5, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kaiser Permanente

colorectal cancer screening

cancer screening

pragmatic trial

boot camp translation

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Apr 5, 2022