Evaluating a Clinical Ethics Committee (CEC) Implementation Process (Val_CEC)

Azienda Unità Sanitaria Locale Reggio Emilia

Status: Enrolling

Conditions: Service Evaluation

Treatments: Other: survey_2; Other: Survey1; Other: semi-structured interview_2; Other: semi-structured interview_1; Other: semi-structured interview_3

Study type: Observational

Funder types: Other

Identifiers

NCT05466292

1085/2021/OSS/IRCCSRE

Details and patient eligibility

About

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.

Full description

The investigators will combine quantitative and qualitative methods to collect data on crucial process variables, from sites or participants purposively selected along such elements expected to influence the intervention's functioning.

The study consists of a quantitative and qualitative evaluation.

Quantitative evaluation. It aims to assess the CEC's activities performed within 16 months since its implementation and the spread, use, and knowledge of the service by all the HPs employed at the Local Health Authority of Reggio Emilia. These data will be used to examine the quantity of intervention implemented, and whether and how the intended audience came into contact with the intervention.

Data related to the amount of CEC activities will be collected by the internal database developed by the CEC Secretariat. Moreover, to collect data on the level of knowledge, use, and dissemination of the CEC, a closed-ended questions survey will be disseminated among all the HPs employed at the Oncology Research Hospital. Quantitative data will be analyzed using descriptive techniques.

Qualitative Evaluation. The qualitative evaluation aims to investigate mechanisms of impact and contextual factors among several groups of stakeholders, differently involved in designing, promoting, delivering, and benefitting the CEC. The Normalization Process Theory (NPT) will be applied to determine if, and in what ways, the CEC can be successfully 'normalized' into clinical practice. NPT is a theory aimed at identifying, characterizing, and explaining the empirically identifiable mechanism that motivates and shapes the implementation process of a complex intervention by four conceptual tools (coherence, cognitive participation, collective action, and reflexive monitoring). The NPT will inform the data collection tools of the qualitative part and will be used as a framework for data analysis.

Semi-structured interviews will be performed with different groups of stakeholders. The interviews' topics concern the 4 concepts of the NPT. A specific interview track will be developed for each interviewed group. Moreover, a second online survey will be sent to HPs who have attended at least 1 of the 5 editions of the ethics training promoted by the CEC. The survey will consist of 20 multiple-choice questions, also based on the constructs of the NPT, and will be supplemented by free-text questions aimed at assessing: the acceptability of the CEC within the local context and understanding additional needs and expectations about the service. Qualitative data will be thematically analyzed. After an initial inductive analysis of the qualitative data, the NPT concepts will be applied to the emerging themes to confirm or refine the results.

Ethical Considerations. Eligible subjects may only be included in the study after providing written informed consent. No study procedure can be performed before it has been provided.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

30 participants in 5 patient groups

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

Description:

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

Treatment:

Other: Survey1

Local Health Authority's Managers/Wards Heads

Description:

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

Treatment:

Other: semi-structured interview_1

Clinical Ethics Committee (CEC)'s members

Description:

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

Treatment:

Other: semi-structured interview_2

Healthcare Professionals who submitted an ethics consultation request

Description:

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

Treatment:

Other: semi-structured interview_3

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

Description:

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.

Treatment:

Other: survey_2