Impact of Information and Participation on Decision Time for Tracheostomy or PEG in ICU Families
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Intensive Care Unit (ICU) Admission, Tracheostomy, Percutaneous Endoscopic Gastrostomy (PEG). Basic parameters: from 18 years · 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Information and Participation Strategies on Decision Time for Tracheostomy or PEG Among Family Members of Intensive Care Patients
Overview
Decisions regarding tracheostomy and percutaneous endoscopic gastrostomy (PEG) in the intensive care unit (ICU) are frequently associated with substantial uncertainty, decisional conflict, and psychosocial burden among patients' relatives. Inadequate or non-tailored information may negatively influence anxiety levels, decision satisfaction, and subsequent adaptation to care responsibilities. Differences in communication patterns and educational background may further affect how families perceive the risks, benefits, and long-term implications of these procedures. This prospective study aims to evaluate the impact of relatives' educational level and different information delivery methods on anxiety, decision satisfaction, and the overall decision-making process related to tracheostomy and PEG in the ICU setting. The findings are expected to contribute to the development of structured, education-level-tailored information strategies to improve shared decision-making and family-centered care in critical care practice.
Detailed description
In the intensive care unit (ICU), decisions regarding tracheostomy and percutaneous endoscopic gastrostomy (PEG) create substantial uncertainty and psychosocial burden for patients' relatives. The literature reports that decisional conflict and regret are common in the tracheostomy decision-making process; one of the principal contributing factors is inadequate information provided to patients and their families. Furthermore, the lack of standardized and effective education regarding tracheostomy care negatively affects families' coping capacity and quality of life.
Differences in communication and perspectives between family members and the healthcare team significantly influence decision satisfaction and the alignment of expectations, underscoring the importance of structured information and counseling strategies. Evidence from tracheostomy care and education studies also indicates that increased knowledge levels are associated with improved caregiving skills and better psychosocial adaptation.
In addition, the literature suggests that tracheostomy decisions are perceived variably by families in terms of both benefits and potential adverse consequences, and that satisfaction levels differ according to individual expectations and the extent of information received. Therefore, it is necessary to systematically investigate the impact of relatives' educational level and different information delivery methods on the decision-making process.
This prospective study aims to evaluate the effects of relatives' educational level and information strategies on anxiety levels, satisfaction, and decision-making processes related to tracheostomy and PEG in the ICU setting.
Primary outcome measures
- Change in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) Score [Time frame: Immediately before information delivery and immediately after completion of the information session (same day).]
Secondary outcome measures (3)
- Mean Total Score of the Family Satisfaction in the Intensive Care Unit Questionnaire (FS-ICU-24) [Time frame: After completion of the decision-making process (within 24-48 hours following the information session).]
- Decision-Making Process Evaluation [Time frame: Within 24-48 hours after the decision regarding tracheostomy and/or PEG.]
- Demographic and Clinical Variables [Time frame: At enrollment (baseline).]
Eligibility criteria
Inclusion criteria
- First-degree relative of an ICU patient with an indication for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG)
- Age ≥ 18 years
- Able to understand and communicate in Turkish
- Provides written informed consent
- Responsible for or involved in the medical decision-making process
Exclusion criteria
- Cognitive impairment or psychiatric condition interfering with questionnaire completion
- Refusal to participate
- Prior participation in this study
- Inability to complete study questionnaires
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07435896 · FSCH-SBÜ-2026/03 TPEG