Screening Tool Implementation for Colorectal Cancer
((PB-iCRC) Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Kansas Medical Center
Disqualifiers: Colorectal cancer history, Genetic risk, Cognitive incapacity
No Placebo Group
Trial Summary
What is the purpose of this trial?Although implementation intentions (I2)-based tools enhance colorectal cancer (CRC) screening uptake, prior studies have not tested their implementation into routine primary care delivery. In this study, investigators will conduct a cluster-randomized trial in 20 US primary care clinics. Specific aims for the project will be: 1) to test whether a Normalization Process Theory-informed Participatory Learning in Action (NPT-PLA intervention) implementation of a proven implementation Intentions-based colorectal cancer screening tool ("I2") improves screening uptake (i.e. screening order and completion) within 6 months of patient enrollment versus usual quality improvement (control) implementation; and 2) to evaluate the facilitators and barriers of each implementation arm using the 2022 expanded Normalization Process Theory (NPT) framework. Multi-disciplinary clinic 'implementation teams' that include clinic staff and patients whose preferred language is Spanish will meet monthly during the first 6 months of clinic participation and aim to integrate into routine primary care the "I2" CRC screening tool, using the NPT-PLA intervention or control approach. The I2 tool addresses the "when," "where" and "how" details of stool sample or colonoscopy screening. The I2 tool will be delivered via an on-line survey or (if patients prefer) by paper form customized for use in English or Spanish. At least 100 patients in each clinic will be enrolled in the first 6 months of clinic participation (2000 in total). All patients eligible for CRC screening will be offered the I2 tool. Their choices will be communicated automatically to clinics for order entry. Primary (Aim 1) outcomes will be CRC screening orders placed (by clinic staff); completion of the I2 tool and CRC screening completion (by patients) over 6 months of patient follow-up. For Aim 2, surveys based on the NPT domains (the "NOMAD") will be used to assess staff comprehension of their role in implementing the I2-based CRC screening tool, its salience, their buy-in, feasibility of altering workflows, and the potential impact of using the tool in their setting. Investigators will conduct summative qualitative focus group discussions in all participating clinics after 6 months of clinic participation. The study will provide important information on barriers and facilitators of embedding NPT-PLA interventions in "real-world" primary care clinical settings.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on colorectal cancer screening tools, so it's best to consult with the trial coordinators or your doctor for guidance.
What data supports the effectiveness of the treatment NPT-PLA, Usual Quality Improvement for colorectal cancer?
The research highlights that organized colorectal cancer screening can reduce cancer incidence and mortality, suggesting that effective screening interventions, like the one being studied, could improve outcomes by increasing screening rates.
12345Is the colorectal cancer screening tool safe for humans?
The safety of colorectal cancer screening tools, like colonoscopy and sigmoidoscopy, has been studied, and while they are generally safe, there can be some side effects or adverse reactions. It's important to weigh the benefits of early cancer detection against these potential risks.
15678Eligibility Criteria
This trial is for patients eligible for colorectal cancer screening at clinics participating in the American Academy of Family Physicians National Research Network. It aims to include individuals with limited English proficiency and will enroll at least 100 patients per clinic.Inclusion Criteria
I am a patient at the clinic, prefer Spanish, but can also speak English.
I am between 45 and 75 years old and due for a colon cancer screening but haven't had one recently.
Patients will be followed for 6 months after their initial invitation to complete I2
+4 more
Exclusion Criteria
I have been found to have decision-making difficulties after a cognitive test.
I or my close family do not have a history of colorectal cancer.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Active Intervention
Implementation of the I2 tool in clinics, with monthly meetings to plan and adapt workflows for CRC screening
6 months
Monthly meetings
Follow-up
Participants are monitored for CRC screening completion and tool usage
6 months
Summative Evaluation
Conduct qualitative focus group discussions to evaluate the implementation process
1 month
Focus group discussions
Participant Groups
The study compares two methods of implementing a colorectal cancer screening tool: Normalization Process Theory-Participatory Learning in Action (NPT-PLA) versus usual quality improvement strategies across different clinics. The effectiveness, staff comprehension, workflow integration, and sustainability are evaluated.
2Treatment groups
Experimental Treatment
Active Control
Group I: NPT-PLAExperimental Treatment1 Intervention
Clinics randomized to NPT-PLA will also define their CRC screening workflow via a checklist and preset I2 implementation protocol but will be trained initially then receive monthly support to facilitate a "Participatory Learning in Action" (PLA) session. NPT-PLA i-teams will identify barriers and supports to I2 implementation, and use Normalization Process Theory (NPT) constructs to guide identification, selection and ordering of action steps to progress implementation e.g. "(before taking the step) does everyone understand the step to be taken, does everyone who needs to act 'buy in', (during implementation of the step) is everyone who needs to act actually taking action to complete the step, (after the step is taken) did taking the step have the intended impact, if not what happened?" . NPT-PLA I-teams can adapt the I2 implementation protocol to fit their context, including when and how patients are presented with I2, to maximize I2 implementation and CRC screening completion.
Group II: Usual QIActive Control1 Intervention
I-teams in each Usual QI clinic will be provided a pre-set protocol to implement the I2 tool into routine clinic CRC screening workflow (which they will define via a provided checklist). The protocol instructs the clinic to provide access to I2 zero to two weeks before a clinic visit, review the patient's I2 screening intentions with the patient in the clinic visit, at which time staff will order and schedule CRC screening in the visit. I2 may be completed on-line or via a paper form. I-teams will meet monthly to make progress on their implementation of I2, and complete a report/meet a study staff member monthly (separately) to report on their meetings and progress but will not receive coaching or skill training.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
DARTNet InstituteAurora, CO
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Who Is Running the Clinical Trial?
University of Kansas Medical CenterLead Sponsor
DARTNet InstituteCollaborator
National Cancer Institute (NCI)Collaborator
References
Effects of Organized Colorectal Cancer Screening on Cancer Incidence and Mortality in a Large Community-Based Population. [2022]Little information is available on the effectiveness of organized colorectal cancer (CRC) screening on screening uptake, incidence, and mortality in community-based populations.
Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Test Kit on Colorectal Cancer Screening Rates: A Randomized Clinical Trial. [2022]Colorectal cancer (CRC) screening reduces CRC mortality; however, screening rates remain well below the national benchmark of 80%.
Effectiveness of a patient and practice-level colorectal cancer screening intervention in health plan members: the CHOICE trial. [2021]Colorectal cancer (CRC) screening reduces CRC incidence and mortality but is underused. Effective interventions to increase screening that can be implemented broadly are needed.
Toward standardizing and reporting colorectal cancer screening indicators on an international level: The International Colorectal Cancer Screening Network. [2022]The International Colorectal Cancer Screening Network was established in 2003 to promote best practice in the delivery of organized colorectal cancer screening programs. To facilitate evaluation of such programs, we defined a set of universally applicable colorectal cancer screening measures and indicators. To test the feasibility of data collection, we requested data on these variables and basic program characteristics from 26 organized full programs and 9 pilot programs in 24 countries. The size of the target population for each program varied considerably from a few thousand to 36 million. The majority of programs used fecal occult blood tests for primary screening, with more using guaiac than immunochemical tests. There was wide variation in the ability of screening programs to report the requested measures and in the values reported. In general, pilot programs were more likely to provide screening measure values than were full programs. As expected, detection rates for polyps and neoplasia were substantially higher in programs screening with endoscopy than in those using fecal occult blood tests. It is hoped that the screening measures and indicators, once revised in the light of this survey, will be adopted and used by existing programs and those in the early planning stages, allowing international comparison with the goal of improved colorectal cancer screening quality.
A stepped randomized trial to promote colorectal cancer screening in a nationwide sample of U.S. Veterans. [2022]Colorectal cancer (CRC) screening (CRCS) facilitates early detection and lowers CRC mortality.
Risk factors for adverse events related to polypectomy in the English Bowel Cancer Screening Programme. [2022]The English National Health Service Bowel Cancer Screening Programme (NHSBCSP) is one of the world's largest organized screening programs. Minimizing adverse events is essential for any screening program. Study aims were to determine rates and to examine risk factors for adverse events.
Acceptability and side-effects of colonoscopy and sigmoidoscopy in a screening setting. [2022]Quantitative information on adverse reactions associated with colorectal cancer (CRC) screening tests is useful to estimate the balance between benefit and risk in different strategies.
A community laboratory drop-off option for bowel screening test kits increases participation rates: results from an interrupted time series analysis. [2021]Countries with population-based colorectal cancer screening using faecal occult blood test kits performed in the home and posted to the laboratory struggle to achieve higher than 60% uptake. We measured the impact on participation of offering a community laboratory drop-off (CLD) alternative to postal return in New Zealand's Bowel Screening Pilot.