Animated Versus Paper-Based Patient Decision Aids for Tracheostomy: Effects on Family Caregivers' Knowledge and Preparation for Decision Making-A Randomized Controlled Trial

November 3, 2026 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

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

  1. To develop an animated tracheostomy shared decision-making aid adapted to the Taiwanese context, with a Mandarin version and a Taiwanese local-language version.
  2. To compare an animated PDA with a paper-based PDA containing identical content on tracheostomy knowledge (primary outcome), preparation for decision making, values clarification, and self-rated anxiety among family decision-makers of mechanically ventilated patients.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
178

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 years or older.
  • The primary decision-maker, family member, or legally authorized representative of a mechanically ventilated patient in the Respiratory Care Center (RCC).
  • The patient has been assessed by the medical team as a candidate for tracheostomy.
  • Basic ability to read Chinese or to understand spoken Chinese.
  • After a verbal explanation of the study purpose, procedures, anticipated risks, and participant rights by the investigators, understands the study and signs the written informed consent form.

Exclusion Criteria:

  • Has previously had a family member undergo tracheostomy.
  • Is a healthcare professional.
  • Has cognitive impairment that prevents independent completion of the questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Animated Decision Aid

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

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.
Active Comparator: Paper-Based 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 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tracheostomy Knowledge Score
Time Frame: Baseline (before randomization) and immediately after the decision-aid session (Day 1, same study visit)

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.
Baseline (before randomization) and immediately after the decision-aid session (Day 1, same study visit)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preparation for Decision Making (PrepDM) Scale Score
Time Frame: Immediately after the decision-aid session

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.
Immediately after the decision-aid session
Values Clarification Scale Score
Time Frame: Immediately after the decision-aid session

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.
Immediately after the decision-aid session
Change in Self-Rated Anxiety (Retrospective Pre-Post Rating)
Time Frame: Immediately after the decision-aid session

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.
Immediately after the decision-aid session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Taiwan University Hospital Hsin-Chu Branch

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202608127RINE
  • 116-S0079 (Other Grant/Funding Number: National Taiwan University Hospital Hsin-Chu Branch)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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