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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06281743
Other study ID # LST-Ped Survey
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2024
Est. completion date December 2026

Study information

Verified date March 2024
Source Göteborg University
Contact Linda Block, PhD, MD
Phone +46709955110
Email linda.block@gu.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to investigate attitudes on decisions to withdraw or withhold life-sustaining treatments in critically ill children in Swedish intensive care units. This is a survey among pediatric critical care physicians.


Description:

Sometimes, the best course of action for a patient is not to receive as much medical care as possible, but rather to prioritize other values. Making a decision to adjust the strategy and goals of care in this manner is referred to as a decision at the breaking point. A breaking point decision often involves decisions about treatment limitations. Treatment limitations in intensive care usually entail decisions to withhold or withdraw one or more life-sustaining treatments. Several events in Swedish society over the past decades may have influenced physicians' attitudes towards making decisions about withdrawing and withholding life-sustaining treatment. In 2009, a pediatric critical care physician was arrested for suspected manslaughter of a child in connection with the termination of intensive care. This initiated a protracted legal process in which the physician was acquitted but suffered significant personal harm due to false accusations. In 2011, the National Board of Health and Welfare issued updated regulations regarding life-sustaining treatments, followed by interpretations in guidelines and strategic documents in subsequent years. In 2020, the opportunity to donate organs was introduced not only after brain death diagnosis but also after circulatory arrest. The coronavirus infectious disease 2019 (COVID-19) pandemic emerged the same year. Sweden faced the threat of having to terminate intensive care not only for the patient's benefit but also due to resource constraints in intensive care. In 2019, a survey was conducted on end-of-life care decisions and practices from the perspective of personnel in pediatric intensive care in large parts of Europe. Sweden was not represented. The investigators are aware that Sweden stands out regarding socio-cultural values (http://www.worldvaluessurvey.org/). Since this has not been studied in Sweden before, and Sweden has a unique position regarding both traditional culture and an individual-centred societal view, it would be exciting to study the attitudes of physicians in Swedish intensive care units. The investigators intend to map the attitudes of intensive care physicians regarding decisions to withhold/ and withdraw life-sustaining treatment in children within Swedish intensive care using an electronic survey. The method will be reported according to the checklist for reporting results of internet e-surveys (CHERRIES) checklist for web surveys. The survey will be explicitly designed for this study, incorporating a combination of new questions and questions previously used in similar surveys in other parts of Europe. The survey will be validated by a small group with expertise in the study subject and experience in survey research. Validity will be further confirmed through the calculation of Cronbach's alpha between the previously used questions and the new ones. Subsequently, a naive small test group will answer the survey and provide comments. Intensive care units with 10 or more instances of pediatric care visits lasting over 48 hours in 2023 will be selected. Data collection will occur by distributing a link to the web survey via email through a network of clinic managers at the selected intensive care units. It will be an open survey without control for duplicate responses and with a convenience sample. The survey introduction will provide information about the purpose of the study and how respondents' answers will be handled according to the General Data Protection Regulation (GDPR). Respondents will then confirm that they have understood the information before completing the survey. The response rate will be calculated as the proportion of completed surveys compared to the number of unique email addresses to which the survey link was sent. No checks for contradictory responses or incomplete surveys will be conducted before the respondent submits the survey. Incomplete surveys and surveys that take disproportionately long to complete will be analyzed. No propensity score matching or other weighting for differences will be performed. Data analysis will involve descriptive statistics, focusing on identifying correlations between respondents' attitudes toward withholding or withdrawing decisions, their clinical experiences, and any influential factors such as theoretical educational needs.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 1 Year to 100 Years
Eligibility Inclusion Criteria: - Critical care physicians working with critically ill children in Swedish intensive care units Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Survey
A web based survey is sent out to pediatric critical care physicians

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Göteborg University

Outcome

Type Measure Description Time frame Safety issue
Primary Attitudes and experiences -questionnaire Attitudes on decisions to withdraw or withhold life sustaining treatments in critically ill children in Swedish intensive care units. A questionnaire. 2024-2026
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