Service EvaluationVal_CECNCT05466292
Evaluating a Clinical Ethics Committee (CEC) Implementation Process
An observational study of Service Evaluation, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Service Evaluation
- What is being tested?
- Survey1, semi-structured interview_1 and semi-structured interview_2
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jun 2022to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be selected from Healthcare professionals employed at the local Health Authority of Reggio Emilia.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Clinical Ethics Committee (CEC) Implementation Process in an Oncological Research Hospital. A Process Evaluation Study Using Normalization Process Theory
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.
Read more
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.
Read the 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.
- Conditions
- Service Evaluation
- Being tested
- Survey1, semi-structured interview_1, semi-structured interview_2, semi-structured interview_3, survey_2
- Keywords
- Ethics Committees, Clinical, Evaluation Studies as Topic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey1Other
Closed-ended survey on the level of knowledge, use, and dissemination of the CEC.
semi-structured interview_1Other
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
semi-structured interview_2Other
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.
semi-structured interview_3Other
semi-structured interview concerns participants' experiences with the ethics consultation service provide by the Clinical Ethics Committee
survey_2Other
survey of 20 multiple-choice questions and supplemented by free-text questions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: semi-structured interview_1 | |
| Clinical Ethics Committee (CEC)'s members | CEC's members will be interviewed by semi-structured interview. Receives: 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. Receives: 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. Receives: Other: survey_2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 months from the service implementation
Secondary outcomes (5)
7 - issues CEC Survey
It is a closed-ended survey aiming to collect information on the level of knowledge, use, and dissemination of the CEC among all the HPs employed at the Local Health Authority of Reggio Emilia.
It is composed by 3 sections: section A asking participant's general information; section B asking participant's previous experience in ethical complex situation; section C asking patient's evaluation of the service in terms of: diffusion, knowledge, access, personal attitude, further suggestions.
Answer are organized into Yes/No or free space.
Measured: 16 months from service implementation
semi-structured one-to-one interview
semi-structured one-to-one interviews to explore the opinions and perspectives on the CEC, in terms of barriers/facilitators, expectations and needs, from the perspectives of Local Health Authority's Managers/Wards Heads who have been involved in the design and delivery of the service.
Measured: 16 months from service implementation
semi-structured one-to-one interview
semi-structured one-to-one interviews with CEC's members' concerns their motivations and expectations to be a member of the CEC, personal attitude toward the service, experience with CEC in terms of facilitators, problems, and critical evaluation of the service delivered.
Measured: 16 months from service implementation
semi-structured interview with HPs who required ethics consultation
semi-structured interview concerns participants' experiences with the ethics consultation service provide by the Clinical Ethics Committee
Measured: 16 months from service implementation
Normalisation MeAsure Development questionnaire (NoMAD)
The NoMAD survey is a set of 20 survey items for assessing implementation processes from the perspective of professionals directly involved in the work of implementing complex interventions in healthcare. This version comprises 20 multiple-choice questions, supplemented by 4 open questions. Answers are organized into a range of 5 options : 1. I do not agree, 2. I partially not agree, 3. I do not agree or disagree, 4. I partially agree, 5. I totally agree. Higher scores mean better outcomes.
Measured: 16 months from service implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start16 Jun 2022
- Primary completion5 Jul 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Service EvaluationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marta Perin, MA, Principal investigator, Azienda USL Reggio Emilia - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466292
- Sponsor's protocol ID
- 1085/2021/OSS/IRCCSRE
- Acronym
- Val_CEC
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2022
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the IPD will be anonimyzed. PErsonal data will be collected in an aggregate way to be shared within research publications.
Publications
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.
PubMed 36894200
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Clinical Ethics Committee (CEC) Implementation Process in an Oncological Research Hospital. A Process Evaluation Study Using Normalization Process Theory
- ClinicalTrials.gov ID
- NCT05466292
- Acronym / sponsor ID
- Val_CEC / 1085/2021/OSS/IRCCSRE
- Conditions
- Service Evaluation
- Keywords
- Ethics Committees, Clinical, Evaluation Studies as Topic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthcare Professionals (HPs) employed at the Local Health Authority of Reggio Emilia, | – | Other: Survey1HPs will be included if they are employed at the Health Care Authority of Reggio Emilia. They will receive a closed-ended questions survey. |
| Local Health Authority's Managers/Wards Heads | – | Other: semi-structured interview_1Managers/Heads who formally supported and promoted the intervention or have been contacted during the dissemination process will be interviewed by semi-structured interview. |
| Clinical Ethics Committee (CEC)'s members | – | Other: semi-structured interview_2CEC's members will be interviewed by semi-structured interview. |
| Healthcare Professionals who submitted an ethics consultation request | – | Other: semi-structured interview_3Healthcare Professionals who submitted an ethics consultation request will be interviewed by semi-structured interview. |
| Healthcare Professionals who attended the training provided by the Clinical Ethics Committee | – | Other: survey_2Healthcare 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from Healthcare professionals employed at the local Health Authority of Reggio Emilia.
Key inclusion criteria (7 listed)
- 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;
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey1Closed-ended survey on the level of knowledge, use, and dissemination of the CEC. | Other | Healthcare Professionals (HPs) employed at the Local Health Authority of Reggio Emilia, |
| semi-structured interview_1the 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 | Local Health Authority's Managers/Wards Heads |
| semi-structured interview_2semi-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 | Clinical Ethics Committee (CEC)'s members |
| semi-structured interview_3semi-structured interview concerns participants' experiences with the ethics consultation service provide by the Clinical Ethics Committee | Other | Healthcare Professionals who submitted an ethics consultation request |
| survey_2survey of 20 multiple-choice questions and supplemented by free-text questions. | Other | Healthcare Professionals who attended the training provided by the Clinical Ethics Committee |
Primary outcome
Process Evaluation by a quantitative, closed-ended questions surveys and semi-structured interviews with different groups of the Clinical Ethics Committee (CEC)'s stakeholders.
Time frame: 16 months from the service implementation
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.
5 secondary outcomes
7 - issues CEC Survey
Time frame: 16 months from service implementation
semi-structured one-to-one interview
Time frame: 16 months from service implementation
semi-structured one-to-one interview
Time frame: 16 months from service implementation
semi-structured interview with HPs who required ethics consultation
Time frame: 16 months from service implementation
Normalisation MeAsure Development questionnaire (NoMAD)
Time frame: 16 months from service implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Derived from this study: PubMed 36894200Perin 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.
- Individual participant dataSharing planned: No. All the IPD will be anonimyzed. PErsonal data will be collected in an aggregate way to be shared within research publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Perin, MA principal investigator
Azienda USL Reggio Emilia - IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Service Evaluation, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 16 months from the service implementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05466292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.