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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tracheostomy; Percutaneous Endoscopic Gastrostomy (PEG); Intensive Care Unit (ICU) Admission

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	After completion of the decision-making process (within 24-48 hours following the information session).
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.	Within 24-48 hours after the decision regarding tracheostomy and/or PEG.
Demographic and Clinical Variables	Patient and relative demographic and clinical data will be collected using a standardized data collection form for covariate analysis.	At enrollment (baseline).

Collaborators and Investigators

• Sponsor: Elazıg Fethi Sekin Sehir Hastanesi

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 21, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 21, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Tracheostomy; Percutaneous Endoscopic Gastrostomy
• Other Study ID Numbers: FSCH-SBÜ-2026/03 TPEG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to the single-center design of the study and the inclusion of sensitive psychosocial and decision-making data from patients' relatives. Although data will be analyzed in anonymized form, sharing individual-level data may pose potential risks to participant confidentiality. Aggregate results will be made publicly available through scientific publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No