Improving Colonoscopy Adherence for Colorectal Cancer

(IMPACTT Trial)

Overseen By Kristan Olazo, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Normal FIT result, Age under 18

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

Compensation: Varies

Number of Visits: Unknown

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Complete and timely colonoscopy after an abnormal stool-based colorectal cancer screening test results in early detection, cancer prevention, and reduction in mortality, but follow-up in safety-net health systems occurs in less than 50% at 6 months. The proposal will implement multi-level approach consisting of a stepped-wedge clinic-level intervention of team-based best practices co-developed with primary and specialty care, a patient-level technology intervention to provide enhanced instructions and navigation to complete diagnostic colonoscopy, and a mixed methods evaluation to explore multi-level factors contributing to intervention outcomes. Developing a solution to this high-risk and diverse population has the potential to translate to other health systems, support patient self-management, and address other patient conditions.

Will I have to stop taking my current medications?

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

Is colonoscopy generally safe for humans?

Colonoscopy is a common procedure with a low rate of adverse events, about 2.8 per 1000 screenings. Serious issues like bleeding and bowel perforation are more likely when removing polyps, but overall, the procedure is considered safe. ^{1 2 3 4 5}

How does capsule colonoscopy differ from other treatments for colorectal cancer screening?

Capsule colonoscopy is a minimally invasive procedure that involves swallowing a small camera capsule to examine the colon, which may improve adherence to colorectal cancer screening compared to traditional methods like optical colonoscopy, as it is less invasive and does not require sedation. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment BPB, No PIN, Colonoscopy, Diagnostic Colonoscopy, BPB, PIN, No BPB, No PIN, No BPB, PIN for improving colonoscopy adherence for colorectal cancer?

Research shows that improving bowel preparation instructions and methods can significantly enhance the quality of colonoscopy results, which may indirectly support better adherence to colonoscopy procedures. ^{2 6 8 10 11}

Who Is on the Research Team?

Urmimala Sarkar, MD, MPH

Principal Investigator

University of California, San Francisco

Ma Somsouk, MD, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults who speak English, Spanish, or Cantonese and have had an abnormal stool-based colorectal cancer screening test. It's not open to those under 18 or anyone with a normal screening result.

Inclusion Criteria

Patients with abnormal FIT result

Exclusion Criteria

I am under 18 years old.

Patients with normal FIT result

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of a multi-level approach with team-based best practices and patient-level technology intervention to improve colonoscopy completion

6 months

Ongoing visits as needed for intervention implementation

Follow-up

Participants are monitored for colonoscopy completion and quality of bowel preparation

6 months

Follow-up visits to assess colonoscopy completion

What Are the Treatments Tested in This Trial?

Interventions

• BPB, No PIN
• BPB, PIN
• No BPB, No PIN
• No BPB, PIN

Trial Overview The study tests a multi-level approach to improve colonoscopy follow-ups in safety-net health systems. This includes team-based best practices and patient-level technology interventions like enhanced instructions and navigation aids.

How Is the Trial Designed?

Group I: No BPB, PIN Experimental Treatment 1 Intervention

No BPB: Clinic's usual practice after a patient receives an abnormal FIT result. PIN: enhanced patient instructions and navigation (PIN).

Group II: No BPB, No PIN Experimental Treatment 1 Intervention

No BPB: Clinic's usual practice after a patient receives an abnormal FIT result. No PIN: Patients will receive usual communication from their care team.

Group III: Best Practices Bundle (BPB), No Patient Instructions and Navigation (PIN) Experimental Treatment 1 Intervention

BPB: patient tracking and lists, audit and feedback, standardized documentation, standardization of care team communication. No PIN: Patients will receive usual communication from their care team.

Group IV: BPB, PIN Experimental Treatment 1 Intervention

BPB: patient tracking and lists, audit and feedback, standardized documentation, standardization of care team communication. PIN: enhanced patient instructions and navigation (PIN).

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study involving over 45,000 patients revealed that a lack of understanding about fecal occult blood tests (FOBT) is the strongest predictor of not following up with a colonoscopy after a positive result, particularly among older adults, Arab ethnicity, and those with lower socioeconomic status.

Healthcare providers, including primary care physicians and gastroenterologists, have differing views on the effectiveness of FOBT for colorectal cancer detection, which contributes to low follow-up rates; addressing these discrepancies and improving patient education are crucial for enhancing screening program effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to completing colonoscopy after a positive fecal occult blood test. Azulay, R., Valinsky, L., Hershkowitz, F., et al.[2021]

In a survey of 308 participants, 49% of those who had previously declined conventional colonoscopy preferred capsule colonoscopy, compared to 24% of those who had undergone colonoscopy, indicating a strong interest in this alternative screening method.

Key attractive features of capsule colonoscopy included the convenience of not needing a ride and the ability to avoid time off work, suggesting that these factors could enhance adherence to colorectal cancer screening among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of potential adherence to capsule colonoscopy in patients who have accepted or declined conventional colonoscopy. Rex, DK., Lieberman, DA.[2022]

Improving patient instructions and pre-assessment for bowel preparation led to a significant increase in the quality of bowel prep for colonoscopies, rising from 80% to nearly 93%.

This enhancement not only improved diagnostic outcomes and reduced the need for repeat procedures but also resulted in estimated savings of around £150,000 for the hospital trust over a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving bowel preparation for colonoscopy in a cost effective manner. Gardezi, SA., Tibbatts, C.[2020]

In a study of 178 patients treated for colorectal cancer or polyps, only 54% adhered to the recommended surveillance colonoscopy at 1 year, indicating low compliance with follow-up care.

Among patients who participated in fecal occult blood testing (FOBT), those who returned their FOBT specimens were more likely to undergo colonoscopy, suggesting that willingness to participate in FOBT may correlate with better adherence to surveillance colonoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surveillance for colorectal neoplasia: is patient adherence following treatment a problem? Myers, RE., Bralow, SP., Goldstein, R., et al.[2007]

In a study of 474 colonoscopy outpatients with low health literacy, both WeChat-based education and automatic reminders significantly improved bowel preparation quality compared to a control group, with adequate preparation rates of 79.1% and 74.7% respectively versus 61.4%.

Patients receiving enhanced education reported lower anxiety levels and fewer adverse reactions, and the WeChat group had a higher polyp detection rate in the right hemi-colon, indicating that improved education can lead to better outcomes in colorectal cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing bowel preparation quality and tolerability in a low health literacy population in Western China: a multicenter randomized trial. Zhao, X., Yang, L., Hu, X., et al.[2023]

Colonoscopy is generally safe, with an adverse event rate of 2.8 per 1000 procedures, but serious complications like hemorrhage and perforation are more common when polypectomy is performed.

The article emphasizes the importance of preventing and managing adverse events specifically related to polypectomy and endoscopic mucosal resection of colonic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events related to colonic endoscopic mucosal resection and polypectomy. Sethi, A., Song, LM.[2022]

In a study of 345,546 patients undergoing therapeutic colonoscopy for colorectal neoplasia, the overall rates of adverse events such as bleeding (32.5 per 1000 patients) and bowel perforation (0.47 per 1000 patients) were found to be low, indicating that therapeutic colonoscopy is generally a safe procedure.

Factors associated with increased risk of bleeding and bowel perforation included male gender, larger tumor size (≥2 cm), and the use of certain medications like warfarin and NSAIDs, highlighting the importance of patient characteristics in assessing risk during these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors predicting adverse events associated with therapeutic colonoscopy for colorectal neoplasia: a retrospective nationwide study in Japan. Niikura, R., Yasunaga, H., Yamada, A., et al.[2022]

A study of 53,220 elderly Medicare beneficiaries found that those undergoing outpatient colonoscopy had a higher risk of serious gastrointestinal events, such as bleeding and perforation, compared to matched individuals who did not have the procedure.

The risk of adverse events increased with age and was notably higher in patients undergoing polypectomy, as well as in those with specific comorbid conditions like stroke or chronic obstructive pulmonary disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events after outpatient colonoscopy in the Medicare population. Warren, JL., Klabunde, CN., Mariotto, AB., et al.[2022]

A case was reported where a malfunctioning colonoscope caused mucosal injury during a screening colonoscopy due to a high-pressure water jet, highlighting a rare but serious device-related adverse event.

This incident emphasizes the importance of endoscopist awareness regarding potential equipment malfunctions, as the patient was found to have normal mucosa upon repeat colonoscopy with a functioning device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colon mucosal injury caused by water jet malfunction during a screening colonoscopy: A case report. Patel, P., Chen, CH.[2022]

Colon capsule endoscopy (CCE) shows high diagnostic accuracy for detecting colorectal polyps, with sensitivities of 87% for polyps ≥6 mm and ≥10 mm, and specificities of 87% and 95%, respectively, based on a systematic review of 13 studies.

Despite its effectiveness, patient preference for CCE over traditional optical colonoscopy remains unclear, indicating a need for further research to improve acceptance and adherence to CCE as a screening method for colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-generation colon capsule endoscopy for detection of colorectal polyps: Systematic review and meta-analysis of clinical trials. Möllers, T., Schwab, M., Gildein, L., et al.[2021]

Only 26% of individuals over 49 reported having a fecal occult blood test (FOBT) in the past 3 years, and 33% reported having a sigmoidoscopy, indicating that adherence to colorectal cancer screening is below the Healthy People 2000 goals of 50% and 40%, respectively.

Efforts to increase adherence to CRC screening have been varied, with community-wide public health campaigns and individual-targeted medical models, but many lacked systematic evaluation, highlighting the need for more effective strategies to promote long-term adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participation in colorectal cancer screening: a review. Vernon, SW.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Barriers to completing colonoscopy after a positive fecal occult blood test. [2021]

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

A survey of potential adherence to capsule colonoscopy in patients who have accepted or declined conventional colonoscopy. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Improving bowel preparation for colonoscopy in a cost effective manner. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Surveillance for colorectal neoplasia: is patient adherence following treatment a problem? [2007]

5. Germany pubmed.ncbi.nlm.nih.gov

Enhancing bowel preparation quality and tolerability in a low health literacy population in Western China: a multicenter randomized trial. [2023]

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

Adverse events related to colonic endoscopic mucosal resection and polypectomy. [2022]

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

Factors predicting adverse events associated with therapeutic colonoscopy for colorectal neoplasia: a retrospective nationwide study in Japan. [2022]

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

Adverse events after outpatient colonoscopy in the Medicare population. [2022]

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

Colon mucosal injury caused by water jet malfunction during a screening colonoscopy: A case report. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Second-generation colon capsule endoscopy for detection of colorectal polyps: Systematic review and meta-analysis of clinical trials. [2021]

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

Participation in colorectal cancer screening: a review. [2022]