Impact of Information and Participation on Decision Time for Tracheostomy or PEG in ICU Families
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorElazıg Fethi Sekin Sehir Hastanesi
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Cognitive impairment or psychiatric condition interfering with questionnaire completion
Refusal to participate
Prior participation in this study
Inability to complete study questionnaires
Trial population
First-degree relatives of adult ICU patients with an indication for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG) at Elazığ Fethi Sekin City Hospital. Participants are individuals directly involved in the medical decision-making process and responsible for providing consent for the procedures.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 3 trial groupsGroup A: Group E1
Group B: Group E2
Group C: Group E3
Trial outcomes
Primary outcomes
1
Change in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) Score
Anxiety levels of first-degree relatives will be assessed before and after the standardized information process using the Hospital Anxiety and Depression Scale (HADS), Turkish validated version. The HADS consists of 14 items, with the Anxiety subscale (HADS-A) comprising 7 items. The HADS-Anxiety subscale score ranges from 0 to 21, with higher scores indicating greater anxiety severity (worse outcome). The primary endpoint will be the change in HADS-Anxiety subscale score, calculated as post-information score minus pre-information score.
Time frame
Immediately before information delivery and immediately after completion of the information session (same day).Secondary outcomes
1
Mean Total Score of the Family Satisfaction in the Intensive Care Unit Questionnaire (FS-ICU-24)
Family satisfaction regarding care and decision-making will be evaluated using the Turkish validated version of the Family Satisfaction in the Intensive Care Unit questionnaire (FS-ICU-24). The FS-ICU-24 consists of 24 items assessing satisfaction with care and satisfaction with decision-making. Items are rated on a 5-point Likert scale and transformed to a 0-100 scale according to the standard scoring method, with higher scores indicating greater satisfaction (better outcome). Domain scores will be combined to calculate a single total score (0-100 scale).
Time frame
After completion of the decision-making process (within 24-48 hours following the information session).2
Decision-Making Process Evaluation
Decision clarity, perceived participation in decision-making, and decisional conflict will be assessed using the decision-making domain of the Turkish validated version of the Family Satisfaction in the Intensive Care Unit questionnaire (FS-ICU-24). The FS-ICU-24 consists of 24 items rated on a 5-point Likert scale and transformed to a 0-100 scale according to the standard scoring method, with higher scores indicating greater satisfaction and better perceived decision-making quality. Mean domain scores will be calculated for each group and compared across educational levels and information methods.
Time frame
Within 24-48 hours after the decision regarding tracheostomy and/or PEG.3
Demographic and Clinical Variables
Patient and relative demographic and clinical data will be collected using a standardized data collection form for covariate analysis.
Time frame
At enrollment (baseline).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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