Evaluating a Clinical Ethics Committee (CEC) Implementation Process

NCT05466292 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-07-17

No results posted yet for this study

Summary

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.

Conditions

  • Service Evaluation

Interventions

OTHER

Survey1

Closed-ended survey on the level of knowledge, use, and dissemination of the CEC.

OTHER

semi-structured interview_1

the semi-structured interview concerns participants'motivations/expectations for implementing CEC, personal attitude towards the service, experience with CEC in terms of facilitators, problems, and critical evaluation on the service delivered

OTHER

semi-structured interview_2

semi-structured interview concerns participants motivations and expectations to be a member of the CEC, personal attitude towards the service, experience with CEC in terms of facilitators, problems, and critical evaluation on the service delivered.

OTHER

semi-structured interview_3

semi-structured interview concerns participants' experiences with the ethics consultation service provide by the Clinical Ethics Committee

OTHER

survey_2

survey of 20 multiple-choice questions and supplemented by free-text questions.

Sponsors & Collaborators

  • Azienda USL Reggio Emilia - IRCCS

    lead OTHER_GOV

Principal Investigators

  • Marta Perin, MA · Azienda USL - IRCCS di Reggio Emilia

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-16
Primary Completion
2023-07-05
Completion
2023-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05466292 on ClinicalTrials.gov