CompletedNot Applicable

Evaluating a Clinical Ethics Committee (CEC) Implementation Process

Italy20 participantsStarted 2022-06-16

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * being a healthcare professionals (HPs) (physicians, therapists, nurses, social workers, healthcare researcher, pharmacist..) * being an HPs employed at the Health Care Authority of Reggio Emilia; Participants will be included in the qualitative evaluation if they: * are working as a Head of Departments / local Manager at the Local health Authority of Reggio Emilia, and have been contacted by the CEC's President during the dissemination process; * have been a member of the CEC in the last 16 months; * submitted at least 1 ethics consultation request; * participated to at least 1 of the 5 training courses on ethics consultation promoted by the CEC

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Process Evaluation by a quantitative, closed-ended questions surveys and semi-structured interviews with different groups of the Clinical Ethics Committee (CEC)'s stakeholders.

Timeframe: 16 months from the service implementation

Trial details

NCT IDNCT05466292

SponsorAzienda USL Reggio Emilia - IRCCS

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2023-07-05

View on ClinicalTrials.gov More Service Evaluation trials