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Not yet recruiting NCT07093047

Effects of Italian Law 219/2017 in Pediatric Intensive Care Units

Observational Refusal of Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire administration.
Who it may be relevant to
Registry conditions: Refusal of Treatment. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A National Survey on the Perceived Effects of Italian Law 219/2017 in Pediatric Intensive Care Units

Overview

This study aims to investigate pediatric intensive care providers' knowledge, perceptions, and experiences with Law 219/2017 by means of a national multicentric non-interventional cross-sectional study.

Detailed description

In Italy in January 2018, Law 219/2017 came into effect after years of discussion regarding the possibility of refusing potentially life-saving health treatments, with its general principles being respect of life, human dignity, and personal self-determination, and introducing the concept of Advance Care Planning, the possibility for the patient to refuse medical treatment stating also that the patient cannot demand health treatments contrary to the law, professional ethics or good clinical-care practices letting the physician protected by the law in not providing interventions that he/she judges contrary to the patient's best health interest.

This study aims to investigate pediatric intensive care providers' knowledge, perceptions, and experiences with Law 219/2017 by means of a national multicentric non-interventional cross-sectional study.

Interventions

  • Other Questionnaire administration
    Participants are required to complete a survey collecting anonymous data

Primary outcome measures

  • Knowledge of the Italian Law 219/2017 [Time frame: Through study completion, an average of three months]
  • Experience about the application of the Italian Law 219/2017 [Time frame: Through study completion, an average of three months]

Eligibility criteria

Inclusion criteria

  • Healthcare personnel employed in a pediatric intensive care units

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 3 centers
  • Ospedale Sant'Orsola Malpighi — Bologna
  • Ospedale Gaslini — Genova
  • Università di Torino — Torino

Identifiers

NCT: NCT07093047 · PES-219-PICU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗