Clinical trial NCT05466292: Evaluating a Clinical Ethics Committee (CEC) Implementation Process
Official title: Evaluation of a Clinical Ethics Committee (CEC) Implementation Process in an Oncological Research Hospital. A Process Evaluation Study Using Normalization Process Theory
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Service Evaluation
Keywords: Ethics Committees, Clinical
Evaluation Studies as Topic
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2022-07-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be selected from Healthcare professionals employed at the local Health Authority of Reggio Emilia.

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: 7 - issues CEC Survey
timeFrame: 16 months from service implementation
measure: semi-structured one-to-one interview
timeFrame: 16 months from service implementation
measure: semi-structured one-to-one interview
timeFrame: 16 months from service implementation
measure: semi-structured interview with HPs who required ethics consultation
timeFrame: 16 months from service implementation
measure: Normalisation MeAsure Development questionnaire (NoMAD)
timeFrame: 16 months from service implementation
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Azienda USL-IRCCS di Reggio Emilia
state: Italia
Study officials:
affiliation: Azienda USL - IRCCS di Reggio Emilia
name: Marta Perin, MA
role: PRINCIPAL_INVESTIGATOR
References: