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NCT Number: NCT07243041

Code Status Discussions in Muslim ICU Patients: Insights Into Physician-Family Communication

This observational study aims to explore the real-time experiences, perceptions, and challenges faced by intensive care unit (ICU) physicians during goals-of-care discussions-specifically Do Not Attempt Resuscitation (DNAR) and end-of-life decision-making conversations-with families of critically ill patients in a Muslim-majority healthcare setting.

The study seeks to identify factors that influence whether a DNAR decision is reached after physician-family discussions, and how physician experience, family dynamics, religious perspectives, and institutional support affect communication outcomes and care transitions.

Participants will include ICU physicians (residents, fellows, and consultants) who routinely conduct DNAR discussions as part of clinical care. After each discussion, physicians will complete a brief structured questionnaire about their perceptions of the interaction, family emotions, and decision outcomes. These responses will be anonymously linked to limited, de-identified patient-level data (e.g., diagnosis, ICU course, and outcome) extracted retrospectively from the electronic medical record.

No patients or family members will be contacted directly. Data collection will occur prospectively over two years at King Faisal Specialist Hospital & Research Centre-Jeddah.

Findings from this study are expected to provide culturally grounded insights that inform physician training, enhance family-centered communication, and guide policy development for DNAR and end-of-life discussions in Muslim-majority intensive care units.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King Faisal Specialist Hospital & Research Center

Jeddah, Mecca Region, 21499, Saudi Arabia

Location status: Recruiting

Location contact

Imran Khalid, MD

CONTACT

[email protected]

+966126677777 ext. 42539

Imran Khalid, MD

PRINCIPAL_INVESTIGATOR

About this study

Background:

This prospective observational study investigates the real-time experiences, perceptions, and challenges faced by ICU physicians when discussing code status decisions, specifically Do Not Attempt Resuscitation (DNAR), with families of critically ill adult patients in a Muslim-majority healthcare context. It aims to identify clinical, cultural, religious, and institutional factors influencing DNAR discussions, addressing a gap in understanding the interpersonal and theological dynamics that shape decision-making in end-of-life care. Findings will inform culturally sensitive communication practices, policy development, and physician training.

Study Design and Setting:

Prospective, mixed-methods observational study over 24 months (November 2025 - October 2027). Conducted in adult ICUs at King Faisal Specialist Hospital & Research Centre (KFSH&RC), Jeddah. Integrates real-time physician survey data immediately after DNAR discussions with retrospective EMR extraction of patient-level variables. A subsequent qualitative phase with physician interviews will contextualize quantitative findings. No patients or families are directly contacted.

Definitions of DNAR:

Full Resuscitation: Eligible for all life-sustaining interventions (CPR, intubation, mechanical ventilation, vasopressors).

Ward-Level DNAR: Primarily comfort-focused; prohibits CPR/intubation but allows non-invasive supportive care; home ventilator patients may continue care; ICU transfer allowed per order.

ICU-Level DNAR: Allows withholding or withdrawal of life-sustaining interventions within predefined ceilings:

  • Without interventions: Comfort measures only, no invasive procedures.
  • With interventions: Selected invasive therapies (vasopressors, RRT, non-invasive ventilation, cardioversion) allowed, but no ACLS/chest compressions/intubation if not already intubated.

Therapy may be capped at a defined level; full-code patients may convert to ICU-level DNAR during ICU stay.

Study Population:

ICU physicians (residents, fellows, assistant consultants, consultants) conducting DNAR discussions with adult patients' families. Participation is voluntary; physicians who decline or discuss patients <18 years old are excluded.

Outcomes:

Primary: Final code status immediately post-discussion (DNAR [with/without limited interventions] vs. Full Code).

Secondary: Timing and emotional tone of discussions, family conflict/resolution, institutional support, physician experience/confidence, and quality of end-of-life care using ICU-adapted Aggressive Care and Comfort-Oriented (Palliation) Composites in the final 24 hours of life.

Analysis:

Target 320-500 completed DNAR discussion episodes, accounting for clustering by physician.

Primary analysis via mixed-effects logistic regression with up to 11 pre-specified predictors (physician, family, and clinical/timing factors).

Secondary analyses explore associations with ICU course, timing, composite indices, and comparisons with patients without DNAR discussions.

Sensitivity and subgroup analyses include early vs late discussions (≤72h vs >72h) and cancer vs non-cancer diagnoses.

If fewer than 320 completed DNAR discussions are collected within the planned study period, the study duration may be extended to achieve the minimum sample size required for reliable multivariable analysis.

Data Protection and Ethics:

Each questionnaire linked to de-identified EMR data via unique study ID; master linkage file securely stored and encrypted. Physician participation implies consent; retrospective EMR review conducted under a waiver of consent per institutional and international guidelines.

Expected Outcomes:

The study will generate empirical, culturally grounded insights into DNAR discussions in Muslim-majority ICUs, clarifying how physician experience, family dynamics, and religious or institutional context shape communication. Results will guide physician training, policy frameworks, and family-centered, ethically sound end-of-life care practices.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ICU physicians (residents, fellows, assistant consultants, or consultants) involved in direct patient care
  • ICU physicians who conduct code status or Do Not Attempt Resuscitation (DNAR) discussions with patients' families during ICU admission
  • Willingness of ICU physicians to participate voluntarily by completing a post-goals-of-care discussion questionnaire
  • Adult patients (≥18 years) admitted to the ICU during the study period for whom a code status discussion occurred

Exclusion criteria

  • ICU physicians who decline participation
  • Code status discussions involving patients younger than 18 years of age
  • Discussions in which the physician was not directly involved

Treatment and study plan

Primary outcomes

  1. Number of Participants with Do Not Attempt Resuscitation (DNAR) Status After Goals-of-Care Discussion

    Time frame: After each DNAR discussion

    Final resuscitation status immediately following each goals-of-care discussion, categorized as Do Not Attempt Resuscitation (DNAR, including DNAR with or without limited interventions) versus Full Code.

    The outcome will be analyzed as a binary variable representing whether DNAR status was established following the discussion.

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Khalid, MD

CONTACT

[email protected]

+966126677777 ext. 65851

Sponsors and collaborators

Lead sponsor

King Faisal Specialist Hospital & Research Center

Other

Registry information

Official study title

A Prospective Study Exploring Factors Affecting ICU Transitions and Handling of Code Status - Insights Into Physician and Family Communication in a Muslim Patient Population

Acronym: FAITH-ICU

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 21, 2025
Registry last updated
Dec 19, 2025

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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