Towards Painless Colonoscopy

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

Interventions

OTHER

Endoscopist's training

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.

Sponsors & Collaborators

• Centre of Postgraduate Medical Education

  collaborator OTHER

• Maria Sklodowska-Curie National Research Institute of Oncology

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-30

Primary Completion

2020-06-30

Completion

2021-07-31

Countries

• Poland

Study Locations