Mobile Shared Decision-Making Program for ICU Caregivers

CHIA-HUI MA70 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Terminally Ill Patients

Interventions

Experimental: Mobile technology devicesOTHER

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: PlaceboOTHER

usual care

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ma Chia Hui

New Taipei City, Taiwan

Outcomes

Primary Outcomes

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)."

Time frame: 7days

Data from ClinicalTrials.gov

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