NCT05466292: Val_CEC

Evaluating a Clinical Ethics Committee (CEC) Implementation Process

Active, enrolled Last updated 24 June 2025

What this trial tests

trial testing Survey1 in Service Evaluation in 20 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

4 July 2022

Primary endpoint
30 April 2023

30 December 2025

Quick facts

Lead sponsor	Azienda USL Reggio Emilia - IRCCS
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	20
Start date	4 July 2022
Primary completion	30 April 2023
Estimated completion	30 December 2025
Sites	1 location across Italy

Drugs / interventions tested

• Survey1
• semi-structured interview_1
• semi-structured interview_2
• semi-structured interview_3
• survey_2

Conditions studied

• Service Evaluation — all drugs for Service Evaluation →

Sponsor

Azienda USL Reggio Emilia - IRCCS — full company profile →

Who can join

Adults 18 to 75, any sex, with Service Evaluation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Mixed-method study with retrospective quantitative assessment and prospective qualitative evaluation focused on the development and implementation of a multidisciplinary Clinical Ethics Committee (CEC), 16 months from its implementation.

A CEC is a multi-professionals service that aims to support healthcare professionals (HPs) and healthcare organizations in dealing with ethical issues of clinical practice, providing also ethics consultations (EC) for complex clinical cases, characterized by conflicting ethical perspectives.

In 2020, a CEC was established in an Oncology Research Hospital in the North of Italy. It was developed and implemented according to the Medical Research Council (MRC) framework for developing and evaluating complex interventions.

The purpose of this study is to evaluate the CEC's development and implementation process, after 16 months it entered into force.

Study's hypothesis: the investigators expect to identify the relevant components that contribute to the CEC's successful implementation and integration into everyday practice. Findings would also identify required modifications to improve the service and develop practical strategies for enabling and sustaining the CEC delivery in clinical settings.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluating a clinical ethics committee (CEC) implementation process in an oncological research hospital: protocol for a process evaluation study using normalisation process theory (EvaCEC).
   Perin M, Magelssen M, Ghirotto L, De Panfilis L. · · 2023 · cited 2× · PMID 36894200 · DOI 10.1136/bmjopen-2022-067335
2. How to implement a clinical ethics committee in an oncological research hospital: Qualitative results from a process evaluation study using normalization process theory (EVACEC).
   Perin M, Magelssen M, Crico C, Ghirotto L, et al · · 2025 · PMID 40327687 · DOI 10.1371/journal.pone.0318870