Population Management Platform for Colorectal Cancer Screening

Recruiting at 3 trial locations

Overseen By Heidi Emerson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Not involved in CRC screening

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to improve colorectal cancer screenings at community health centers. Researchers test various strategies, including an Implementation Science Strategy, to enhance the screening process for patients and healthcare providers. The trial introduces and withdraws strategies to determine which are most effective. Staff involved in colorectal cancer screening at these centers are ideal participants. As an unphased trial, this study presents a unique opportunity to contribute to innovative approaches that could enhance cancer screening processes in community settings.

Do I need to stop my current medications for this trial?

The trial does not specify whether you need to stop taking your current medications.

What prior data suggests that this implementation science strategy is safe for colorectal cancer screening?

Research has shown that certain strategies can increase colorectal cancer screening rates. These strategies focus on effective ways to encourage screenings. Studies have found that methods like sending reminders or using health technology significantly boost the number of completed screenings.

These strategies are generally well-accepted regarding safety, as they mainly involve changes in healthcare provider communication or technology use. No reports of negative effects exist, as these are not medical treatments but improvements in healthcare services.

While specific data on side effects is lacking, the nature of these strategies suggests safety for participants. The focus on improving processes and communication does not pose direct health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve colorectal cancer screening through a novel implementation strategy. Unlike traditional methods that focus solely on screening tests themselves, this approach digs deeper into how these tests are introduced and managed at multiple levels—patient, provider, and system. By identifying and tackling barriers, the trial hopes to optimize screening strategies for each community health center, potentially leading to higher screening rates and early detection. This could transform how screening is conducted, making it more efficient and effective for diverse populations.

What evidence suggests that this implementation science strategy is effective for colorectal cancer screening?

Research has shown that specific strategies can improve colorectal cancer (CRC) screening rates. This trial will introduce and test various implementation strategies to enhance these rates. Studies have found that mailing fecal tests significantly increases screening rates across different groups. Proven methods in community health centers have also encouraged more people to participate in CRC screening. Additionally, screening for colorectal cancer can reduce the risk of developing the disease and dying from it by up to 50%. These methods are particularly effective in areas with historically low screening rates, offering a promising approach to early detection and treatment. ^{3 6 7 8 9}

Who Is on the Research Team?

Adjoa Anyane-Yeboa, MD, MPH

Principal Investigator

Mass General Hospital // Harvard Medical School

Are You a Good Fit for This Trial?

This pilot study is for staff members at partnering community health centers (CHCs) involved in colorectal cancer screening. Eligible participants include administrative leaders, population health managers, data analysts, quality improvement staff, nurses, and providers who are 18 years or older.

Inclusion Criteria

Staff members at partnering sites (see locations) who are administrative leaders, population health managers, data analysts, quality improvement staff, nurses, nurse managers, practice managers, medical assistants, and providers

Staff members at partnering sites ages 18+.

Exclusion Criteria

Staff members that are not involved in CRC screening practices at CHCs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection and Analysis

Data from EHR and DRVS platform is analyzed to understand demographics and screening needs

4 months

Data collection and analysis phase

Focus Groups

Conduct focus groups to identify barriers and facilitators to colorectal cancer screening

4 months

Multiple focus group sessions

Implementation Strategy Development and Testing

Develop and test intervention components using rapid cycle methods

4 months

Implementation strategy testing at CHCs

Follow-up

Participants are monitored for the effectiveness of implementation strategies

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Implementation Science Strategy

Trial Overview The study is testing an Implementation Science Strategy to remove obstacles from colorectal cancer screening processes. It involves focus groups with CHC staff and analysis of electronic health records (EHR) and data from a management platform.

How Is the Trial Designed?

Group I: Introduction of Implementation Strategies Experimental Treatment 1 Intervention

The investigators will determine the best intervention and strategy (and thus implementers) based on high ranking barriers/facilitators identified in focus groups. A minimum of 2 implementation strategies will be developed and implemented at each level (patient, provider, system) at each site that considers (1) implementation strategy; (2) mechanism in which the strategy impacts the identified determinant (3) the determinant; (4) moderators that may influence the impact of the strategy; (5) the preconditions necessary for successful implementation; and (6) implementation outcomes affected. Each community health center (CHC) will serve as its own separate subject, and individual strategies will be tested using single case experimental design (SCED) at each CHC using component analysis to rapidly test and optimize our strategies. In SCED each subject serves as their own control, an intervention is systematically introduced and withdrawn, and the effects of the intervention are measured.

Group II: Withdrawal of Implementation Strategies Active Control 1 Intervention

In SCED each subject serves as their own control, an intervention is systematically introduced and withdrawn, and the effects of the intervention are measured.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12239677/

Difference-making factors for successful implementation of a ... Rural disparities in colorectal cancer (CRC) screening persist despite the availability of effective, evidence-based interventions.

2. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-025-01448-1

protocol for a large cluster-randomized implementation study Use of evidence-based interventions and implementation strategies to increase colorectal cancer screening in federally qualified health centers.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827026

Centralized Colorectal Cancer Screening Outreach in ... The findings of this study suggest that centralized mailed fecal immunochemical testing outreach can substantially improve CRC screening in diverse patient ...

4. healthcaredelivery.cancer.gov healthcaredelivery.cancer.gov/accsis/

Accelerating Colorectal Cancer Screening and follow-up ... ACCSIS is improving colorectal cancer screening, follow-up, and referral for care among populations that have low colorectal cancer screening rates.

5. ysph.yale.edu ysph.yale.edu/cmips/research/projects/cost-effectiveness-colorectal-screening/

Cost-effectiveness of colorectal cancer screening Screening for colorectal cancer (CRC) in asymptomatic people can reduce the incidence and mortality of CRC by as much as 50%. Current guidelines for colonoscopy ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4311575/

Implementation Intentions and Colorectal Screening The 61% of participants who received a provider recommendation for CRC screening were not more likely to complete CRC screening (50.6% completed screening among ...

7. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/1748-5908-8-58

Systems intervention to promote colon cancer screening in ... This paper describes the study protocol for a trial designed to increase colorectal cancer screening in those 'safety-net' health centers that ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05524428

Eliminating Barriers to Colorectal Cancer Screening Using ... Outcomes: The outcome of this aim will be identified barriers and facilitators to colorectal cancer screening at health centers with a key focus on ...

9. cancer.jmir.org cancer.jmir.org/2024/1/e49002

Implementation of Health IT for Cancer Screening in US ... This scoping review aims to identify (1) HIT-based interventions that effectively support guideline concordance in breast, cervical, and colorectal cancer ...