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OpenTrials
Completed

NCT Number: NCT07469878

Mobile Shared Decision-Making Program for ICU Caregivers

By developing a smart mobile shared decision-making (SDM) model, this study aims to assist family members of critically ill end-stage patients in making appropriate decisions, enhance their decision quality, and evaluate the model's effectiveness

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Key information

Conditions

Terminally Ill Patients

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ma Chia Hui

New Taipei City, 251, Taiwan

About this study

This study utilized a single-blind experimental design and was conducted in the intensive care unit (ICU) of a medical center in northern Taiwan. The study participants were family members responsible for making end-of-life decisions for patients diagnosed with terminally ill critical conditions. Participants were randomly assigned to either the experimental or control group using block randomization software. A total of 70 participants were enrolled, with 35 assigned to the experimental group and 35 to the control group

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

-Patients diagnosed with terminal cancer or the eight designated non-cancer terminal diseases.

Patients determined to have a terminal and irreversible condition by two attending physicians.

Primary family decision-makers who are aged 20 years or older and provide informed consent to participate in the study.

Able to communicate in Mandarin or Taiwanese and possess basic literacy skills.

Exclusion criteria

  • Cases where all family members reside abroad and have appointed an alternative healthcare proxy.

Those who have already received end-of-life decision-making consultations prior to ICU admission.

Patients who already have a Do Not Resuscitate (DNR) status annotated and have confirmed their end-of-life care preferences.

Treatment and study plan

Experimental: Mobile technology devices

Other

Phase 1 primarily involved scheduling the family meeting and providing decision aids. Family members used smartphones or tablet computers to download a mobile health application or scanned a QR code to access the content. They were instructed to complete reviewing the materials prior to the next phase.

Phase 2 took place within three days, during which the medical team and family members convened a family meeting in the ICU conference room. The team accompanied the family in watching an approximately four-minute video titled 'End-of-Life Options,' explained the details of end-of-life care, and assisted them in selecting appropriate care plans

Placebo Comparator: Placebo

Other

usual care

Primary outcomes

  1. Decisional Conflict

    Time frame: 7days

    To evaluate the changes in decisional conflict among family members."The Decisional Conflict Scale (DCS) was employed to measure participants' uncertainty in making choices. The scale comprises 16 items across five subscales, with a total score exceeding 37.5 indicating significant decisional conflict. The instrument has demonstrated robust internal consistency (Cronbach's alpha = 0.78 - 0.92)."

Sponsors and collaborators

Lead sponsor

CHIA-HUI MA

Other

Collaborators

  • Mackay Memorial Hospital

Registry information

Official study title

Effectiveness of a Mobile Technology Share Decision-Making Program for Critically Ill Patients' Caregiver in Intensive Care Unit.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2026
Registry last updated
Mar 13, 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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