Ignite Creation Date:
2024-05-06 @ 10:06 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03167125
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2017-05-24
Brief Title:
Participatory Research to Advance Colon Cancer Prevention
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Participatory Research to Advance Colon Cancer Prevention
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMPT
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 ie automated phone calls text messages to alert and remind patients to complete screening 2 live prompts ie 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
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 ie automated phone calls text messages to alert and remind patients to complete screening 2 live prompts ie 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 eg 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 eg 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 andor 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
Aim 1 Develop personalized messages eg 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 eg 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None