Evaluating a Clinical Ethics Committee (CEC) Implementation Process

NCT05466292 | Active Not Recruiting

• 1 other identifier: 1085/2021/OSS/IRCCSRE
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ethics Committees, Clinical; Evaluation Studies as Topic

Outcome Measures

Primary Outcomes (1)

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

  The evaluation of the development and implementation process of the CEC will be assessed quantitatively by assessing the activity of the CEC and its diffusions, knowledge and utilization among HPs, while qualitatively, by collecting the opinions and perspectives on it from users and provider healthcare professionals, in terms of perceived barriers/facilitators, expectations and needs towards the service.

  16 months from the service implementation

Secondary Outcomes (5)

• 7 - issues CEC Survey

  16 months from service implementation

• semi-structured one-to-one interview

  16 months from service implementation

• semi-structured one-to-one interview

  16 months from service implementation

• semi-structured interview with HPs who required ethics consultation

  16 months from service implementation

• Normalisation MeAsure Development questionnaire (NoMAD)

  16 months from service implementation

Study Arms (5)

Healthcare Professionals (HPs) employed at the Local Health Authority of Reggio Emilia,

HPs will be included if they are employed at the Health Care Authority of Reggio Emilia. They will receive a closed-ended questions survey.

Other: Survey1

Local Health Authority's Managers/Wards Heads

Managers/Heads who formally supported and promoted the intervention or have been contacted during the dissemination process will be interviewed by semi-structured interview.

Other: semi-structured interview_1

Clinical Ethics Committee (CEC)'s members

CEC's members will be interviewed by semi-structured interview.

Other: semi-structured interview_2

Healthcare Professionals who submitted an ethics consultation request

Healthcare Professionals who submitted an ethics consultation request will be interviewed by semi-structured interview.

Other: semi-structured interview_3

Healthcare Professionals who attended the training provided by the Clinical Ethics Committee

Healthcare Professionals who attended at least one of the five training courses on ethics consultation provided by the Clinical Ethics Committee. They will receive a survey of 20 multiple-choice questions and supplemented by free-text questions.

Other: survey_2

Interventions

Survey1 OTHER

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

Healthcare Professionals (HPs) employed at the Local Health Authority of Reggio Emilia,

semi-structured interview_1 OTHER

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

Local Health Authority's Managers/Wards Heads

semi-structured interview_2 OTHER

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.

Clinical Ethics Committee (CEC)'s members

semi-structured interview_3 OTHER

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

Healthcare Professionals who submitted an ethics consultation request

survey_2 OTHER

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

Healthcare Professionals who attended the training provided by the Clinical Ethics Committee

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from Healthcare professionals employed at the local Health Authority of Reggio Emilia.

You may qualify if:

• 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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Azienda USL-IRCCS di Reggio Emilia

Reggio Emilia, Italia, Italy

Location

Related Publications (1)

• Perin M, Magelssen M, Ghirotto L, De Panfilis L. Evaluating a clinical ethics committee (CEC) implementation process in an oncological research hospital: protocol for a process evaluation study using normalisation process theory (EvaCEC). BMJ Open. 2023 Mar 9;13(3):e067335. doi: 10.1136/bmjopen-2022-067335.

  PMID: 36894200 DERIVED

Study Officials

• Marta Perin, MA

  Azienda USL - IRCCS di Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 20, 2022
• Study Start: July 4, 2022
• Primary Completion: April 30, 2023
• Study Completion: December 30, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)