Towards Painless Colonoscopy

NCT04093687 | Unknown

• 1 other identifier: MSCI
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

One of the major barriers to CRC screening participation is a negative perception of colonoscopy as a painful and unpleasant procedure. Previously, by monitoring patient-reported outcomes as one of the colonoscopy quality performance measures, the investigators identified the endoscopist as the single, most important risk factor for painful colonoscopy. Therefore, the investigators propose a randomized controlled trial to analyse the effectiveness of directed training on the endoscopists painful colonoscopy rate. The study will be conducted in two phases: endoscopist categorization and design of training (I) and randomized controlled trial evaluating training effectiveness (II). Phase I will include endoscopists from Polish Colonoscopy Screening Programme (PCSP) willing to participate. Volunteers will be divided into underperformers, average performers and overperformers, based on their painful colonoscopy rate (obtained from PCSP database records) and will be invited to take part in the initial workshop focused on pain reduction during colonoscopy (conducted in a similar fashion to Train Colonoscopy Leaders (TCL) workshop, aiming at ADR improvement). On the basis of the differences in performance between over- and underperformers, categories of importance, target scores and a questionnaire for the assessment of factors for improvement will be developed. In Phase II, endoscopists from PCSP screening centres previously categorized as underperformers and average performers will be randomized in 1:1 ratio either to control (no intervention) or intervention arm. The subjects in the control arm will not be trained or informed about study participation. The endoscopists assigned to the intervention arm will be invited to take part in one training session designed in Phase I of the study (according to the evaluation questionnaire from Phase I). Willing overperformers will be asked to participate in the training as teachers. The training session will be divided into two parts: theoretical - presentation of research on painless colonoscopy - and practical - colonoscopy performance with commentary. Subjects matched 1:1 with trainers will take part in such a session, supervised by the study coordinator. Each endoscopist who underwent training in the second phase of the study will be sent a written, customized feedback on changes after the intervention and information about factors to improve (as per evaluation questionnaire from Phase I of the study). All endoscopists enrolled into Phase II will be followed through PCSP database for the endpoint of painful colonoscopy rate; the intervention arm will be compared with the control group at 6 and 12 months after feedback in order to investigate whether the adjusted painful colonoscopy rate improved as a result of the intervention.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer Screening; Screening Colonoscopy; Pain During Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Endoscopist adjusted painful colonoscopy rate change

  Endoscopist adjusted painful colonoscopy rate change (pain during colonoscopy) assessed 6 and 12 months after training intervention.

  assessed 6 and 12 months after training intervention

Secondary Outcomes (4)

• Endoscopist adjusted painful colonoscopy rate change - pain after colonoscopy

  assessed 6 and 12 months after training intervention

• Adenoma detection rate (ADR)

  assessed 6 and 12 months after training intervention

• Cecum intubation rate (CIR)

  assessed 6 and 12 months after training intervention

• Adjusted painful colonoscopy rate for screening centres (in which assessed endoscopists are working)

  assessed 6 and 12 months after training intervention

Study Arms (2)

Intervention Arm

EXPERIMENTAL

The intervention will consist of one training session, focusing on technical and non-technical aspects identified in the study Phase I (according to the evaluation questionnaire). The training will be conducted by a team consisting of (i) supervisors (researchers) and (ii) teachers experienced in the previous trial (Train-Colonoscopy-Leaders course - TCL; this methodology has already been evaluated (citation)). There will be 7 trainees per session: 1 under-, 4 average and 2 overperformers. The training session will be divided into two parts: theoretical and practical. During the first, theoretical part of the training, the body of research on the phenomenon of colonoscopy pain will be presented. The second, practical part of the training, will consist of a one-day session of 7 colonoscopies. Each average and underperforming endoscopist who underwent training in the randomized phase will receive a written, customized feedback on his/her performance during the training session.

Other: Endoscopist's training

Control Arm

NO INTERVENTION

The endoscopists in the control arm will not be informed about participation in the study and will receive only tailored feedback on adjusted painful colonoscopy rate (practice as usual). They will receive a reminder, that dedicated report on painful colonoscopy rate is provided in the Polish Colonoscopy Screening Program database and they will be monitored for endpoints through Polish Colonoscopy Screening Program database.

Interventions

Endoscopist's training OTHER

The training session will be divided into two parts: theoretical and practical. Trainees will be blinded to the criterion of being chosen due to their performance status. During the first, theoretical part, the body of research on the phenomenon of colonoscopy pain will be presented. Aspects on how to deliver a painless colonoscopy (patient characteristics, insertion technique, endoscope characteristics, non-technical skills, additional manoeuvres) will be discussed. This part will be based on the findings from Phase I. The second, practical part of the training, will consist of a one-day session of 7 colonoscopies. Participants will be matched with each other. Each participant, will perform one colonoscopy with an oversight of a matched partner, then in turn oversee the colonoscopy of another participant. The rest of the participants will observe a live transmission of each colonoscopy in a separate room, with a commentary from study coordinator.

Intervention Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Endoscopists contributing to Polish Colonoscopy Screening Program
• Endoscopists classified as underperformers and average performers, i.e. endoscopists performing above the adjusted mean rate of painful colonoscopies (with high adjusted painful colonoscopy rate), outside of confidence interval of 99% based on the number of performed colonoscopies, and performing inside the confidence interval of 99%, respectively.

You may not qualify if:

• Endoscopists from the PCSP coordinating centre
• Endoscopists who have participated in the first phase of the study
• Endoscopists classified as overperformers, i.e. performing below the adjusted mean rate of painful colonoscopies (with high adjusted painful colonoscopy rate), outside of confidence interval of 99% based on the number of performed colonoscopies.

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• Centre of Postgraduate Medical Education: collaborator

Study Sites (1)

Maria Sklodowska-Curie Institute - Oncology Center

Warsaw, Poland

Location

Related Publications (1)

• Kaminski MF, Anderson J, Valori R, Kraszewska E, Rupinski M, Pachlewski J, Wronska E, Bretthauer M, Thomas-Gibson S, Kuipers EJ, Regula J. Leadership training to improve adenoma detection rate in screening colonoscopy: a randomised trial. Gut. 2016 Apr;65(4):616-24. doi: 10.1136/gutjnl-2014-307503. Epub 2015 Feb 10.

  PMID: 25670810 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Marek Bugajski, MD, PhD

CONTACT

22-5463-044; marek.bugajski@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 15, 2019
• First Posted: September 18, 2019
• Study Start: November 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2021
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)