Mobile Shared Decision-Making Program for ICU Caregivers

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

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

Study Overview

• Status: Completed
• Conditions: Terminally Ill Patients
• Intervention / Treatment: Other: Experimental: Mobile technology devices; Other: Placebo Comparator: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 251
    • Ma Chia Hui

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile technology devices; mHealth tools 7days	Other: Experimental: Mobile technology devices; 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; Usual Care	Other: Placebo Comparator: Placebo; usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional Conflict	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)."	7days

Collaborators and Investigators

• Sponsor: CHIA-HUI MA
• Collaborators: Mackay Memorial Hospital
• Investigators: Study Chair: MA C HUI, Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2021
• Primary Completion (Actual): November 9, 2022
• Study Completion (Actual): November 9, 2022

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Mobile technology devices; Terminally ill patients in critical care
• Other Study ID Numbers: 21MMHIS127e

Drug and device information, study documents

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