Impact of Information and Participation on Decision Time for Tracheostomy or PEG in ICU Families

NCT07435896 | Not Yet Recruiting

• 1 other identifier: FSCH-SBÜ-2026/03 TPEG
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tracheostomy; Percutaneous Endoscopic Gastrostomy (PEG); Intensive Care Unit (ICU) Admission

Keywords

Percutaneous Endoscopic Gastrostomy; Tracheostomy; Intensive Care Unit

Outcome Measures

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.

  Immediately before information delivery and immediately after completion of the information session (same day).

Secondary Outcomes (3)

• Mean Total Score of the Family Satisfaction in the Intensive Care Unit Questionnaire (FS-ICU-24)

  After completion of the decision-making process (within 24-48 hours following the information session).

• Decision-Making Process Evaluation

  Within 24-48 hours after the decision regarding tracheostomy and/or PEG.

• Demographic and Clinical Variables

  At enrollment (baseline).

Study Arms (3)

Group E1

includes first-degree relatives of ICU patients indicated for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG) who have a self-reported educational level of primary school or below.

Group E2

includes first-degree relatives of ICU patients with an indication for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG) who have a self-reported educational level of secondary school or high school.

Group E3

includes first-degree relatives of ICU patients with an indication for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG) who have a self-reported educational level of university degree or higher.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment or psychiatric condition interfering with questionnaire completion
• Refusal to participate
• Prior participation in this study
• Inability to complete study questionnaires

Sponsors & Collaborators

• Elazıg Fethi Sekin Sehir Hastanesi: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 27, 2026
• Study Start: March 15, 2026
• Primary Completion: May 15, 2026
• Study Completion: June 15, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share