Screening Tool Implementation for Colorectal Cancer

((PB-iCRC) Trial)

Overseen By Joseph W LeMaster, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Colorectal cancer history, Genetic risk, Cognitive incapacity

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

Compensation: Varies

Number of Visits: Unknown

2200 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 5 6 7 8}

Research Team

Joseph W LeMaster, MD MPH

Principal Investigator

University of Kansas

Christina Hester, PhD

Principal Investigator

DARTNet Institute

Keith A Greiner, MD MPH

Principal Investigator

University of Kansas

Eligibility 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

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.

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

Treatment Details

Interventions

• NPT-PLA
• Usual Quality Improvement

Trial Overview 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.

Participant Groups

Group I: NPT-PLA Experimental Treatment 1 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 QI Active Control 1 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.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

DARTNet Institute

Collaborator

Trials

5

Recruited

13,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The implementation of organized colorectal cancer (CRC) screening significantly increased screening participation from 38.9% in 2000 to 82.7% in 2015, demonstrating effective outreach in a community-based population.

This increase in screening was associated with a 25.5% reduction in CRC incidence and a 52.4% reduction in cancer mortality, highlighting the program's effectiveness in early detection and prevention of advanced-stage cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Organized Colorectal Cancer Screening on Cancer Incidence and Mortality in a Large Community-Based Population. Levin, TR., Corley, DA., Jensen, CD., et al.[2022]

An electronic primer message sent through a patient portal significantly increased colorectal cancer (CRC) screening completion rates from 32.1% to 37.6% in a study of 2339 average-risk patients aged 50 to 75 years.

Patients who opened the electronic primer message had a 7.3% higher screening completion rate, and the time to complete screening was also shorter in the intervention group, indicating that digital reminders can effectively enhance participation in CRC screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Test Kit on Colorectal Cancer Screening Rates: A Randomized Clinical Trial. Goshgarian, G., Sorourdi, C., May, FP., et al.[2022]

A controlled trial involving 443 participants tested a combined intervention of a patient decision aid and practice-level support to increase colorectal cancer (CRC) screening rates, showing a modest increase in screening from 32.2% in usual care to 39% in the intervention group.

The intervention was particularly more effective for participants with higher incomes, suggesting that socioeconomic factors may influence the success of CRC screening interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a patient and practice-level colorectal cancer screening intervention in health plan members: the CHOICE trial. Pignone, M., Winquist, A., Schild, LA., et al.[2021]

The International Colorectal Cancer Screening Network evaluated 35 organized colorectal cancer screening programs across 24 countries, finding that most programs primarily used fecal occult blood tests, with significant variation in their ability to report screening measures.

Programs utilizing endoscopy for screening had much higher detection rates for polyps and neoplasia compared to those using fecal occult blood tests, highlighting the importance of screening method in identifying colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward standardizing and reporting colorectal cancer screening indicators on an international level: The International Colorectal Cancer Screening Network. Benson, VS., Atkin, WS., Green, J., et al.[2022]

In a study involving 60,332 Vietnam-era veterans, various delivery methods for colorectal cancer screening (CRCS) interventions showed a combined increase in screening rates by 7% compared to controls, indicating that stepped interventions can be effective overall.

While individual interventions (like letters and phone calls) did not show statistically significant differences in CRCS rates, the cumulative effect of the interventions demonstrated a significant improvement in screening participation, highlighting the potential of multi-faceted approaches in increasing CRCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A stepped randomized trial to promote colorectal cancer screening in a nationwide sample of U.S. Veterans. Vernon, SW., Del Junco, DJ., Coan, SP., et al.[2022]

In a study analyzing 130,831 colonoscopies, the overall bleeding rate was found to be 0.65%, with a very low rate of bleeding requiring transfusion (0.04%) and perforation (0.06%), indicating that the NHS bowel cancer screening program is relatively safe.

The study identified that larger polyp size and cecal location significantly increase the risk of adverse events, with cecal polypectomy showing a 13.5-fold increased risk of bleeding requiring transfusion and a 12.2-fold increased risk of perforation compared to distal colon procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events related to polypectomy in the English Bowel Cancer Screening Programme. Rutter, MD., Nickerson, C., Rees, CJ., et al.[2022]

In a study involving over 12,000 average-risk individuals undergoing colorectal cancer screening, total colonoscopy (TC) was associated with significantly higher levels of pain and serious reactions compared to flexible sigmoidoscopy (FS), indicating a greater discomfort for patients during TC procedures.

The bowel preparation for TC was poorly tolerated, leading to increased reports of severe pain and discomfort, which were predictive of post-procedural issues, highlighting the need for improved patient management strategies during this screening method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and side-effects of colonoscopy and sigmoidoscopy in a screening setting. Senore, C., Ederle, A., Fantin, A., et al.[2022]

Offering a community laboratory drop-off (CLD) option for returning bowel screening test kits led to a 26% uptake among invitees, with significant increases in participation among males, individuals under 60, and Māori and Pacific populations.

The CLD option resulted in small but significant increases in screening participation at little or no additional cost, suggesting it could be beneficial for other bowel screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community laboratory drop-off option for bowel screening test kits increases participation rates: results from an interrupted time series analysis. Sandiford, P., Buckley, A., Robinson, T., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Organized Colorectal Cancer Screening on Cancer Incidence and Mortality in a Large Community-Based Population. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Test Kit on Colorectal Cancer Screening Rates: A Randomized Clinical Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a patient and practice-level colorectal cancer screening intervention in health plan members: the CHOICE trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Toward standardizing and reporting colorectal cancer screening indicators on an international level: The International Colorectal Cancer Screening Network. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A stepped randomized trial to promote colorectal cancer screening in a nationwide sample of U.S. Veterans. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events related to polypectomy in the English Bowel Cancer Screening Programme. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Acceptability and side-effects of colonoscopy and sigmoidoscopy in a screening setting. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A community laboratory drop-off option for bowel screening test kits increases participation rates: results from an interrupted time series analysis. [2021]