Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05466292

Evaluating a Clinical Ethics Committee (CEC) Implementation Process

Sponsor: Azienda USL Reggio Emilia - IRCCS

View on ClinicalTrials.gov

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.

Official title: Evaluation of a Clinical Ethics Committee (CEC) Implementation Process in an Oncological Research Hospital. A Process Evaluation Study Using Normalization Process Theory

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2022-07-04

Completion Date

2025-12-30

Last Updated

2025-06-24

Healthy Volunteers

No

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.

Locations (1)

Azienda USL-IRCCS di Reggio Emilia

Reggio Emilia, Italia, Italy