An interventional study of Animated tracheostomy patient decision aid and Paper-based tracheostomy patient decision aid in Tracheostomy Patients, Decision Making ,Shared and Prolonged Mechanical Ventilation, sponsored by National Taiwan University Hospital. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Health services research
Patients who need a breathing machine (ventilator) for a long time are often considered for a tracheostomy, a surgical opening in the front of the neck through which a breathing tube is placed. Because most of these patients cannot speak for themselves, family members are usually asked to make this decision on their behalf, often with limited information, high uncertainty, and common misconceptions about what life after tracheostomy will be like. Patient decision aids are tools that explain the options, their benefits and downsides, and help people think about what matters most to them.
The investigators have developed a short animated video decision aid about tracheostomy for families in Taiwan, with Mandarin narration and subtitles and a Taiwanese local-language version. This study will test whether the animated video helps family members more than a printed booklet that contains exactly the same information.
Adult family decision-makers of ventilated patients in the Respiratory Care Center of National Taiwan University Hospital Hsin-Chu Branch whose care team is considering a tracheostomy will be invited to take part. After answering baseline questions, participants will be randomly assigned, to either watch the animated video (about 8 to 10 minutes on a tablet) or read the printed booklet (about 8 to 10 minutes). A trained nurse will then go over the key points with them in the same way for both groups, and participants will complete a questionnaire right away. Everything takes place in a single visit, and usual care and family meetings with the care team continue as normal.
The main question is whether family members who watch the animated video will know more about tracheostomy immediately afterward than those who read the booklet. The study will also compare how prepared family members feel to make the decision, what they value most when weighing the two options, and how anxious they feel. The investigators hypothesize that the animated decision aid will lead to higher tracheostomy knowledge scores and greater preparation for decision making than the paper booklet.
Background
Tracheostomy is a key treatment option for patients who cannot be weaned from mechanical ventilation in the short term. In Taiwan, patients ventilated for more than 21 days cou transferred to sub-acute respiratory care centers (RCCs) for weaning, and about 39% of prolonged mechanical ventilation (PMV) patients in RCCs undergo tracheostomy. Because most of these patients have impaired consciousness or cannot speak, family members act as surrogate decision-makers and commonly experience uncertainty, decisional conflict, and misconceptions (for example, that a patient will never speak, eat, or leave bed after tracheostomy). Patient decision aids (PDAs) improve knowledge and reduce decisional conflict compared with usual care, and animated videos, which present information through both visual and auditory channels, have been shown to improve patient knowledge compared with standard education. However, existing tracheostomy decision aids are mainly paper-based, web-based, or narrative tools; none uses animation adapted to the Taiwanese context, and no trial has directly compared media formats of a tracheostomy decision aid with identical content.
Objectives
Hypothesis: compared with the paper-based PDA, the animated PDA will produce higher post-intervention tracheostomy knowledge scores (adjusted for baseline knowledge) and higher Preparation for Decision Making (PrepDM) scores.
Hypothesis: compared with the paper-based PDA, the animated PDA will produce higher post-intervention tracheostomy knowledge scores (adjusted for baseline knowledge) and higher Preparation for Decision Making (PrepDM) scores.
The paper-based PDA is a B5, color-printed, illustrated booklet that keeps the content structure of the paper decision aid currently used in the RCC, with a redesigned layout. The animated PDA is a two-dimensional animation of 8 to 10 minutes, adapted from the same content and designed and produced by the investigators. It has Mandarin voice-over narration with synchronized Traditional Chinese subtitles, and a Taiwanese local-language version. Narration is produced with licensed AI voice-synthesis software using only the reviewed script, and every line is checked by the research team for medical terminology, pronunciation, meaning, and consistency with the subtitles.
National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Family decision-makers watch a two-dimensional animated tracheostomy decision-aid video (8 to 10 minutes) on a tablet computer, with Mandarin narration and synchronized Traditional Chinese subtitles; a Taiwanese local-language version is also available. A trained RCC nurse provides the video at the start of the shared decision-making process or before the family meeting, then conducts a brief scripted check of understanding. Content is identical to the paper-based decision aid.
Behavioral: Animated tracheostomy patient decision aid
Family decision-makers read a B5 color-printed, illustrated tracheostomy decision-aid booklet for 8 to 10 minutes. The booklet is a redesigned version of the paper decision aid currently used in the RCC. A trained RCC nurse provides it at the start of the shared decision-making process or before the family meeting, then conducts the same brief scripted check of understanding. Content is identical to the animated decision aid.
Behavioral: Paper-based tracheostomy patient decision aid
A two-dimensional animated video (8 to 10 minutes) designed and produced by the investigators from the same content as the paper decision aid, following IPDAS quality criteria and the Ottawa Decision Support Framework. It covers seven domains: prolonged ventilator dependence; what tracheostomy is and how it is performed; indications; advantages and disadvantages of tracheostomy versus continued oral endotracheal intubation; daily life after tracheostomy (eating, speaking, activity, care); common misconceptions; and the possibility of ventilator weaning. Mandarin narration with Traditional Chinese subtitles; a Taiwanese local-language version is available. Shown once on a tablet by a trained nurse, followed by a scripted check of understanding.
A B5 color-printed booklet with text and illustrations covering the same seven domains with content identical to the animated decision aid, developed according to IPDAS quality criteria and the Ottawa Decision Support Framework. It keeps the content structure of the paper decision aid currently used in the RCC, with a redesigned layout. Participants read it for 8 to 10 minutes, followed by the same scripted nurse check of understanding.
Tracheostomy Knowledge Score
Measured with an investigator-developed 10-item true/false tracheostomy knowledge test. Items 1-4 address common misconceptions (reverse-keyed) and items 5-10 address correct facts. Each correct answer scores 1 point; total score range 0-10, with higher scores indicating greater knowledge. The between-group difference in the post-intervention score will be estimated by ANCOVA adjusted for the baseline score.
Time frame: Baseline (before randomization) and immediately after the decision-aid session (Day 1, same study visit)
Preparation for Decision Making (PrepDM) Scale Score
10-item PrepDM scale (Chinese version) assessing how useful the decision aid was in preparing the respondent to communicate with clinicians and make the decision. Each item is rated from 1 (not at all) to 5 (a great deal). The mean item score (1-5) is converted to a 0-100 scale as (mean - 1) x 25; higher scores indicate greater perceived preparation for decision making.
Time frame: Immediately after the decision-aid session
Values Clarification Scale Score
Investigator-developed 7-item scale. Each item presents a pair of contrasting considerations about tracheostomy versus continued endotracheal intubation (eating and speaking, going home, body integrity and stoma, tube fixation, infection risk, mouth closure, and type of pain), rated from 1 (leaning toward maintaining intubation) to 10 (leaning toward tracheostomy). Total score range 7-70; higher scores indicate values leaning toward tracheostomy. There is no better or worse direction. Total scores will be compared between groups, and item-level distributions will be reported descriptively.
Time frame: Immediately after the decision-aid session
Change in Self-Rated Anxiety (Retrospective Pre-Post Rating)
Two investigator-developed items completed after the decision-aid session ask participants to rate their anxiety about the patient's current medical situation before and after the intervention, each from 1 (not at all) to 5 (a great deal). Change score = after minus before (range -4 to +4); negative values indicate reduced anxiety. This is a non-validated, supplementary descriptive measure.
Time frame: Immediately after the decision-aid session
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared. Data are stored in the institutional REDCap system with access restricted to the principal investigator and co-principal investigator, retained for at least three years after study completion, and then securely destroyed in accordance with institutional policy and Taiwan's Personal Data Protection Act. Aggregate results will be published in peer-reviewed journals.
Start is estimated for Mar 2027; primary completion for Dec 2029, 33 months later.
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