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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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).

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.

Secondary outcomes

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).

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).
Decision-Making Process Evaluation

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

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.
Demographic and Clinical Variables

Time frame: At enrollment (baseline).

Patient and relative demographic and clinical data will be collected using a standardized data collection form for covariate analysis.

Sponsors and collaborators

Lead sponsor

Elazıg Fethi Sekin Sehir Hastanesi

Other

Registry information

Official study title

Impact of Information and Participation Strategies on Decision Time for Tracheostomy or PEG Among Family Members of Intensive Care Patients

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 27, 2026
Registry last updated: Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed