Optimizing Timing of Follow-up Colonoscopy

NCT04889352 | Completed

• 1 other identifier: H2020:435
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

Overall Objective: To optimize timing of surveillance colonoscopy. Principal research question and specific aims: To assess the impact of access to a hand-held application on the timing of surveillance colonoscopy. To assess whether access to the tool improves adherence to recommended guidelines for follow-up colonoscopy intervals. Colonoscopy is commonly used for surveillance of patients with high risk of developing colorectal cancer, including those with family history of colorectal cancer and those with colorectal polyps. The recommended timing of surveillance colonoscopy varies by the estimated risk for development of colorectal cancer. The estimated risk varies by family history of colorectal cancer (number of affected individuals, age of the persons affected with CRC) and characteristics of the colorectal polyps (size, number, and histology of colorectal polyps (tubular or villous; high grade or low-grade dysplasia; sessile serrated polyp, sessile serrated polyp with dysplasia, hyperplastic polyp or traditional serrated adenomas). Guidelines take all of these factors into account in the recommendations for follow-up colonoscopy and hence are difficult to recall for the busy clinicians. Colonoscopy surveillance is frequently performed at shorter or longer than the recommended time intervals. The investigators have developed a smart phone application in which the characteristics of the patients can be inputted and the tool provides the recommended time interval for surveillance colonoscopy, based on North American guidelines. The investigators are proposing a pilot randomized trial to determine sample size estimates for a larger trial to assess the utility of this application in clinical practice.

Conditions

Colo-rectal Cancer; Colon Polyp; Colonic Polyp; Rectal Polyp; Polyp of Colon; Polyp Rectal; Polyps

Outcome Measures

Primary Outcomes (1)

• Proportion of cases where the colonoscopy physician recommendations matched with the guideline recommendation

  % of patients whose recommended colonoscopy frequency is in agreement with guideline recommendation based on patient factors and colonoscopy findings'

  7 months

Secondary Outcomes (11)

• Physicians' use of the application (tool reliable)

  7 months

• Physicians' use of the application (ease of use)

  7 months

• Physicians' use of the application (how familiar is the information in the tool)

  7 months

• Physicians' use of the application (how often used)

  7 months

• Physicians' use of the application (how often used in first month)

  7 months

Study Arms (2)

Access to colonoscopy web app

EXPERIMENTAL

Approximately half of the consenting individual endoscopy physicians in the city (gastroenterologists and surgeons) will be randomized (stratified by physician specialty) to the intervention group where they are provided access to an application which indicates recommended timing of follow-up colonoscopy given values for various entered factors. In the intervention group, the application can be downloaded to smart phones for portability which will allow access in an endoscopy suite or in clinic or used as a reference at other times. It can also be accessed online (all endoscopy rooms in Winnipeg have computers with internet access for the endoscopy physicians' use). Access to the application will be password-protected, thereby avoiding exposure of the non-intervention group to the application. The clusters of patients will be defined by the endoscopy physician providing the colonoscopy.

Other: Access to colonoscopy web app

Control

NO INTERVENTION

Approximately half of the consenting individual endoscopy physicians in the city (gastroenterologists and surgeons) will be randomized (stratified by physician specialty) to the group where they are not provided access to the application (control group).

Interventions

Access to colonoscopy web app OTHER

There is a very high utilization of colonoscopy at both shorter and longer time intervals than the recommended guidelines. Investigators have developed a clinical support tool in which the characteristics of the patients can be inputted and the guideline recommended time interval for surveillance colonoscopy is then provided. This tool uses the recommendations from the current North American national guidelines. The tool has been developed as a web-based application as well as a smart phone application.

Access to colonoscopy web app

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For physician participants, there are no age limits/parameters. All physicians performing colonoscopy on adult patients in Winnipeg will be eligible to participate (other than those involved in pilot testing and study investigators). Participating physicians will be informed that the introduced intervention will be an information tool to help improve care for individuals undergoing colonoscopy, and will be asked to consent to review of their patient records. Participating physicians will be informed that no individual-level information will be disclosed at any time and all analysis will be on anonymized data.
• For patient participants:
• Adequate bowel preparation defined by Boston Bowel Preparation Scale Score of ≥ 2 in each of segments of the colon (Boston bowel prep scale score recording is mandatory in the Winnipeg city-wide endoscopy reporting system);
• Colonoscopy completed to the cecum/ileocolonic anastomosis;
• Colonoscopy performed between 1 to 4 months before randomization of endoscopy physician (to determine baseline adherence) or between 3 to 7 months after randomization (to determine effect of the intervention).

You may not qualify if:

• Physicians will be excluded if they are away for more than six weeks continuously in the six months after randomization. In this situation, an alternate physician will be recruited and randomized. Thus there is no anticipated loss of follow-up.
• Patients will be excluded if any of the following criteria are met:
• History of inherited CRC predisposition (Lynch Syndrome, Familial adenomatous polyposis, others);
• Inflammatory bowel disease;
• Partially excised polyp or endoscopy physician recommending early colonoscopy to document complete excision;
• Endoscopy physician documenting a rationale for not repeating colonoscopy in future such as co-morbid conditions.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (2)

Health Sciences Center

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Winnipeg Regional Health Authority

Winnipeg, Manitoba, R3E 3P4, Canada

Location

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MeSH Terms

Conditions

Colonic Neoplasms; Colonic Polyps; Polyps

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Harminder Singh, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomization will be performed after the endoscopy physician consent and enrolment into the study. A computer generated randomization sequence will used in blocks of eight. Stratification for surgical and gastroenterology endoscopy physician will be performed as there might be differential adherence to recommendations by specialty of training.Randomization will be performed and the application distributed by study personnel different than those involved in data extraction from medical records so that the person extracting the data remains blinded to the randomized group assignment. Patients of participating physicians will not require blinding as they will not be approached by the study investigators and will get routine care decided by their physicians.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a cluster randomized controlled trial in which individual endoscopy physicians (gastroenterologists and surgeons) will be randomized (stratified by physician specialty) to one of two groups: A) provided access to the application (intervention group) or B) not provided access to the application (control group). The clusters of patients will be defined by the endoscopy physician providing the colonoscopy.

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: May 17, 2021
• Study Start: July 15, 2021
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)