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Validation StudyNCT06814639

The Aims of the Study Are to Translate the Index of Professional Governance (IPG 3.0) Into Italian and Validate It and to Assess the State of Professional Governance in an Italian Hospital (ISMETT)

An observational study of Validation Study, run by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Professional Governance (PG) is a way to actualize better work environments and structural empowerment. PG has a history over many years in the healthcare industry and has been defined as multidimensional organizational characteristics that encompass the structure and processes through which professionals direct… Read more about this study

Who is it for?
Any age
Conditions the study is for
Validation Study
How many people
75 participants
Where
No sites listed yet
Study dates
6 Feb 2025to 31 Oct 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Employees of 5 Italian hospital structures and representative of different professions (the administrative area, the nursing area, the area of the other health professions and the medical area).

Who may be able to join

  • 1 year of professional seniority
  • possess adequate linguistic skills certified by passing an English test (prepared by the linguistic services of the promoting center).

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Giuseppe Enea, Physiotherapy contact

+39 0912192410

genea@ismett.edu

Elena Conoscenti, Nurse contact

+39 0912192410

econoscenti@ismett.edu

About this study

Official title: "Index of Professional Governance" Tool: a Multicentric Validation and Measuring Professional Governance in an Italian Hospital Setting

Professional Governance (PG) is a way to actualize better work environments and structural empowerment. PG has a history over many years in the healthcare industry and has been defined as multidimensional organizational characteristics that encompass the structure and processes through which professionals direct, control and regulate one another's goal-oriented efforts. Multiple studies over the years have shown that PG can lead to empowered personnel and quality of care delivered.

In many organizations, governance is primarily controlled by management. The responsibility for managing professional practice should, however, be shared by staff and leaders, and in order to empower staff, they should be engaged in identifying areas for improvement. In addition, evidence-based practice should be enabled by allocating sufficient time, research and access to evidence sources.

Read more

The participation element refers to who creates and participates in governance activities on different levels. Successful professional governance structures have been linked to a positive professional practice environment. An effective structure with true sharing of decision-making between management and personnel will also contribute to optimal patient outcomes.

To evaluate whether an organization's governance is empowering and professional, it must be measured. Thus, various instruments to measure nurses' participation in professional governance have been presented. The Index of Professional Nursing Governance (IPNG) has been used in more than 250 international healthcare organizations during the last 20 years to evaluate implementation of their management models.

Hess created the IPNG for measuring professional governance along a conceptual continuum from traditional, through shared to self-governance models. Hess has since continued to advance the questionnaire. At the same time, an extended tool was created with all professional figures involved, the so called "Index of Professional Governance" (IPG). Several revisions have been made over time up to the current version of the IPG 3.0 The IPG measures the governance of hospital-based professional, based on a model of governance derived from the literature, in 5 dimensions: personnel, information, resources, participation and practice. Those five dimensions are covered by 50 items. Respondents use a 5-point scale to identify the group that dominates certain areas of governance stated in the items, ranging from 'management/administration only' (1p), through 'equally shared by staff and management/administration' (3p) to 'staff only' (5p). The points for each dimension, and overall governance, are then organized together, analyzed and used to place the organization's governance on the continuum from traditional to self-governance.

Previously translated from its original language, English-American into Arabic, British, Finnish, French, German, Korean, Portuguese, it is structured in five dimensions: staff, information, resources, participation and practice. These 5 dimensions are analyzed in 50 items.

Aims of the study:

  1. To translate the Index of Professional Governance (IPG 3.0) into Italian and validate it;
  2. To assess the state of professional governance in an Italian hospital (ISMETT).
Keywords
IPG tool, professional governance, translation, validation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inter-rater agreement percentage in evaluating the conceptual equivalence of the italian translation of the IPG.

    Measured: Feb-Mar 2025: Recruitment of evaluators and assessment of language proficiency. Apr-Sep 2025: Evaluation of the proposed and collection of evaluators' judgements and final approval of the translated items. Oct 2025: Final data analysis and study closure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2025
  2. Study start6 Feb 2025 (estimated)
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Oct 2025 (estimated)

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06814639
Sponsor's protocol ID
IRRB/37/23
Status last verified
Feb 2025
First submitted
27 Jan 2025
Last updated
7 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Validation Study, run by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies.

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 2 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: opening soon, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giuseppe Enea, Physiotherapy (+39 0912192410, genea@ismett.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inter-rater agreement percentage in evaluating the conceptual equivalence of the italian translation of the IPG. (time frame: Feb-Mar 2025: Recruitment of evaluators and assessment of language proficiency. Apr-Sep 2025: Evaluation of the proposed and collection of evaluators' judgements and final approval of the translated items. Oct 2025: Final data analysis and study closure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Feb 2025.

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