UH3 Project: Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC)
Overview
Principal Investigators:
Sponsoring Institution: Kaiser Permanente Center for Health Research
Collaborators:
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Federally qualified health centers in the Oregon Community Health Information Network (OCHIN)
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Group Health Cooperative
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The National Center for Complementary and Integrative Health (NCCIH)
NIH Institute Providing Oversight: National Cancer Institute (NCI)
Program Official: Erica Breslau, PhD, MPH (NCI)
Project Scientist: Jerry Suls, PhD (NCI)
ClinicalTrials.gov Identifier: NCT01742065
Study Locations: Affiliated clinics in California and Oregon
Trial Status: Completed
Trial Summary
Study question and significance: Federally qualified health centers have low rates of colorectal cancer screening. The objective of the study was to determine the effectiveness of an electronic health record (EHR)–embedded outreach program implemented in health centers as part of standard care to improve screening rates.
Design and setting: Cluster randomized trial in 26 federally qualified health center clinics in 8 health centers in Oregon and California with participants who were overdue for colorectal cancer screening. Of the 26 participating clinics, 13 received the intervention and 13 practiced usual care.
Intervention and methods: The intervention involved embedding a tool in the EHR to identify patients who were overdue for colorectal cancer screening, mailing a fecal immunochemical test (FIT) kit and reminder letter to eligible patients, and implementing a practice improvement process at participating clinics.
Findings: Compared with clinics that practiced usual care, intervention clinics had a significantly higher proportion of participants who completed a FIT (3.4 percentage points) and any colorectal cancer screening (3.8 percentage points). The improved screening rates occurred despite low and highly variable rates of implementation of the program.
Conclusions and relevance: An EHR-based mailed outreach program improved rates of colorectal cancer screening. Successful implementation of the outreach program was correlated with higher rates of FIT completion.
Data and Resource Sharing
- STOP CRC Clinic Materials
STOP CRC Clinic Materials
- Computable Phenotypes for outcome measures
STOP CRC Report Definitions
- STOP CRC Protocol
STOP CRC Protocol
- STOP-CRC_Coronado_UH3 follow-up
STOP CRC Ethics and Regulatory Documentation - UH3 project updates
- GloriaCoronado-StrategiesOpportunitiesStopColonCancerPriorityPopulations-StopCRC
Minutes from Ethics/Regulatory Call with Dr. Coronado’s Trial – STOP CRC
Featured Interviews
Drs. Coronado and Green discuss findings from the STOP CRC project.
News and Interviews
- News_Your Pragmatic Trial Has Ended Now What
January 22, 2024: Your Pragmatic Trial Has Ended. Now What?
- News_A Year of New Insights From the NIH Pragmatic Trials Collaboratory
December 12, 2023: A Year of New Insights From the NIH Pragmatic Trials Collaboratory
- News_Biostatistics Core Develops Tools and Strategies for Common Research Challenges
August 16, 2022: Biostatistics Core Develops Tools and Strategies for Common Research Challenges
- News_A Year of Results and New Insights From the NIH Collaboratory
December 15, 2020: A Year of Results and New Insights From the NIH Collaboratory
- News_Online NIH Course on Pragmatic and Group-Randomized Trials
January 24, 2017: New Online NIH Course on Pragmatic and Group-Randomized Trials
- News_Applying PRECIS Ratings to Collaboratory Pragmatic Trials
January 16, 2016: Applying PRECIS Ratings to Collaboratory Pragmatic Trials
- News_Collaboratory PIs Give Advice to New Pragmatic Trials
November 1, 2019: Collaboratory PIs Give Advice to New Pragmatic Trials
- News_PIs of Completed NIH Collaboratory Demonstration Projects Share Accomplishments
July 14, 2020: PIs of Completed NIH Collaboratory Trials Share Accomplishments
- News_Cost-Effectiveness Analysis of STOP CRC Trial Finds Wide Variation Across Health Centers
May 2, 2019: Cost-Effectiveness Analysis of STOP CRC Trial Finds Wide Variation Across Health Centers
- News_STOP CRC Trial Finds Higher Rates of CRC Screening in Community Clinics Using an EHR-Based Outreach Tool
August 10, 2018: STOP CRC Trial Finds Higher Rates of Colorectal Cancer Screening in Community Clinics Using an EHR-Based Outreach Tool
Publications
- Maleyeff et al Stat Med 2023
Sample size requirements for testing treatment effect heterogeneity in cluster randomized trials with binary outcomes
- O'Leary et al BMC Health Serv Res 2019
Colorectal cancer screening in newly insured Medicaid members: a review of concurrent federal and state policies
- Richesson et al J Am Med Inform Assoc 2021
Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory
- Petrik et al J Gen Intern Med 2020
Factors influencing implementation of a colorectal cancer screening improvement program in community health centers: an applied use of configurational comparative methods
- Living Textbook Chapter_Which PCTs Should Have a DMC
Living Textbook Chapter: Which PCTs Should Have a DMC?
- Living Textbook_The Embedded Pragmatic Trials Ecosystem
Living Textbook: The Embedded Pragmatic Clinical Trial Ecosystem
- O'Connor et al Sci Rep 2020
Prospective cohort study of predictors of follow-up diagnostic colonoscopy from a pragmatic trial of FIT screening
- O'Connor et al Trials 2020
Moderators of the effectiveness of an intervention to increase colorectal cancer screening through mailed fecal immunochemical test kits: results from a pragmatic randomized trial
- STOP CRC Study Snapshot
STOP CRC Study Snapshot
- Green et al Implement Sci 2019
Using a continuum of hybrid effectiveness-implementation studies to put research-tested colorectal screening interventions into practice
- Green et al Prev Med Rep 2019
Challenges in assessing population reach in a pragmatic trial
- Neilson et al J Gen Intern Med 2019
Factors affecting adherence in a pragmatic trial of annual fecal immunochemical testing for colorectal cancer
- Meenan et al Prev Med 2019
A cost-effectiveness analysis of a colorectal cancer screening program in safety net clinics
- Living Textbook Chapter_Analysis Plan_Case Study STOP CRC
Living Textbook Chapter: Analysis Plan: Case Study STOP CRC Trial
- Thompson et al 2019 J Prim Care Community Health
A survey of provider attitudes, beliefs, and perceived barriers regarding a centralized direct-mail colorectal cancer screening approach at community health centers
- Living Textbook Chapter_Deciding Who to Engage
Living Textbook Chapter: Building Partnerships to Ensure a Successful Trial - Deciding Who to Engage
- Living Textbook Chapter_Dissemination and Implementation_Legislative Changes
Living Textbook Chapter: Dissemination and Implementation: Legislative Changes
- Living Textbook Chapter_Data Sharing and Embedded Research
Living Textbook Chapter: Data Sharing Solutions for Embedded Research
- Coury et al Transl Behav Med 2018
Two Medicaid health plans' models and motivations for improving colorectal cancer screening rates
- Nielson et al Prev Med Rep 2018
Effectiveness of automated and live phone reminders after mailed-FIT outreach in a pilot randomized trial
- Coronado et al JAMA Intern Med 2018
STOP CRC Main Outcome Paper
- Nielson et al Cancer Med 2018
Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial
- Petrik et al J Community Health 2018
Predictors of colorectal cancer screening prior to implementation of a large pragmatic trial in Federally Qualified Health Centers
- Coronado et al J Gen Intern Med 2017
Effect of reminding patients to complete fecal immunochemical testing: a comparative effectiveness study of automated and live approaches
- Coronado et al Transl Behav Med 2017
Implementation successes and challenges in participating in a pragmatic study to improve colon cancer screening: perspectives of health center leaders
- Living Textbook Chapter_Assessing Feasibility
Living Textbook Chapter: Assessing Feasibility: Spotlight of Four NIH Collaboratory Trials
- Living Textbook_Alternative Approaches to Disclosure and Authorization
Living Textbook Chapter: Alternative Approaches to Disclosure and Authorization
- Living Textbook_Analysis Plan_Unanticipated Changes
Living Textbook Chapter: Analysis Plan: Unanticipated Changes
- Coury et al BMC Health Serv Res 2017
Applying the Plan-Do-Study-Act (PDSA) approach to a large pragmatic study involving safety net clinics
- Coronado et al EGEMS (Wash DC) 2017
Mapping multi-site clinic workflows to design systems-enabled interventions
Presentations
- 2022 NIH Workshop_Panel 4
2022 NIH Workshop Panel 4
- GR-Video-06-04-21
Inclusion of Diverse Participants in Pragmatic Clinical Trials: Planning for Diversity – Stakeholder Engagement and Site Selection to Maximize Diversity
- GR-Slides-06-04-21
Inclusion of Diverse Participants in Pragmatic Clinical Trials: Planning for Diversity – Stakeholder Engagement and Site Selection to Maximize Diversity
- SC-2019-Completed-STOP-CRC
Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC)
- Workshop on the Design and Analysis of PCTs_Panel 4_Unique Considerations
Workshop on the Design and Analysis of PCTs: Panel 4: Unique Considerations
- Presentation_STOPCRC_NCRC_2018_c
Making the Case for FIT: (CRC Forum 2018)
- Presentation_STOPCRC_OHSU_2018_c
How to Assure Follow-up to a Positive FIT in Safety Net Settings (OHSU 2018)
- 9.-Green_STOP-CRC_Barriers-Lessons_NEW
Top Barriers and Challenges in The Strategies and Opportunities to STOP Colon Cancer in Priority Populations
- Presentation_STOPCRC_KPCHR_2018_c
Applying Risk Prediction Modeling to Address Low Rates of Follow-up Colonoscopy (KPCHR 2018)
- Presentation_STOPCRC_NWTribal_2018_2_c
How to Improve CRC Screening Rates: Tips for Health Centers (NW Tribal CRC Summit 2018)
- Presentation_STOPCRC_NWTribal_2018_c
Colorectal Cancer Burden (NW Tribal CRC Summit 2018)
- Presentation_STOPCRC_DOH_2018_c
Designing a Colorectal Screening Training Plan (DOH 2018)
- Presentation_STOPCRC_NCI_2018_c
Presentation: Effectiveness and Implementation of a CRC Screening Program (NCI 2018)
- Poster_STOPCRC_NCI_2018_c
Comparing the Effectiveness of Automated and Live Reminders for a Direct-Mail Fecal Testing Program (HCSRN 2018)
- Presentation_STOPCRC_OCHIN_2018_c(1)
Direct Mail Programs Work…But Will Health Centers Implement Them? Findings From STOP CRC (OCHIN 2018)
- GR-Slides-2-23-18
Direct Mail Programs Work… But Will Health Centers Implement Them? Findings from STOP CRC (GR Slides 2018)
- GR-Video-02-23-18
Direct Mail Programs Work… But Will Health Centers Implement Them? Findings from STOP CRC (GR Video 2018)
- Introduction to Case Studies
Introduction to Case Studies
- Topic 1-Embedded PCTs
ePCT Workshop Topic 1-Embedded PCTs
- Presentation_STOPCRC_DCRI_2018_c
Direct Mail Programs Work…But Will Health Centers Implement Them? Findings From STOP CRC (Duke 2018)
- Poster_STOPCRC_AHR_2018_c
Variation in Quality of Approved Colorectal Cancer Screening Options: FIT Positivity From the STOP CRC Pragmatic Trial (AcademyHealtth 2018)
- Presentation_STOPCRC_NCRC_2018_2_c
Ensuring Screening Follow-up to Abnormal Fecal Testing (NCRC 2018)
- Poster_STOPCRC_DI_2017_2_c
Costs of Establishing a CRC Screening Program in Safety Net Clinics (D&I 2017)
- Presentation_STOPCRC_NCRC_2017_c
How to Assure Follow-up to a Positive FIT in Safety Net Settings (NCRC 2017)
- Poster_STOPCRC_DI_2017_3_c
Development of a Predictive Risk Model to Identify Patients Unlikely to Complete a Colonoscopy Following an Abnormal Fecal Test in Community Clinics (D&I 2017)
- Poster_STOPCRC_DI_2017_c
The Research to Practice Pipeline (D&I 2017)
- Presentation_STOPCRC_NAPCRG_2017_2_c
Predicting Follow-up Colonoscopy to an Abnormal Fecal Test in Safety-Net Clinics (NAPCRG 2017)
- Presentation_STOPCRC_NAPCRG_2017_c
Effectiveness and Implementation of a Pragmatic Direct-Mail Colorectal Cancer Screening Program in Safety Net Clinics (NAPCRG 2017)
- Poster_STOPCRC_AACR_2017_c
Implementing a Mailed CRC Screening Program: A Safety-Net Clinic Case Study (AACR 2017)
- Panel_STOPCRC_NCRC_2018_2_c
Getting Patients Screened for Colon Cancer (CRC Forum 2018)