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

NCT ID: NCT07243041

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-01

Study Completion Date

2027-10-31

Brief Summary

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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.

Detailed Description

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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:

1. Without interventions: Comfort measures only, no invasive procedures.
2. 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.

Conditions

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End of Life Care Muslim Decision Making ,Shared

Keywords

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goals of care do not attempt resuscitation ICU Shared Decision-Making Family Communication Muslim Healthcare Context Cultural Factors palliative care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ICU DNAR Discussion Episodes

Adult ICU patients with DNAR discussions during the study period. Observational study; no interventions. Physicians complete post-discussion questionnaires, and limited retrospective EMR data are collected to examine factors influencing DNAR decision outcomes, including final code status

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role lead

Responsible Party

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Imran Khalid

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Imran Khalid

Role: PRINCIPAL_INVESTIGATOR

King Faisal Specialist Hospital & Research Center

Locations

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King Faisal Specialist Hospital & Research Center

Jeddah, Mecca Region, Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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Imran Khalid, MD

Role: CONTACT

Phone: +966126677777

Email: [email protected]

Facility Contacts

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Imran Khalid, MD

Role: primary

References

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Other Identifiers

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2251305

Identifier Type: -

Identifier Source: org_study_id