Animated Versus Paper-Based Patient Decision Aids for Tracheostomy: Effects on Family Caregivers' Knowledge and Preparation for Decision Making-A Randomized Controlled Trial
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
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
- To develop an animated tracheostomy shared decision-making aid adapted to the Taiwanese context, with a Mandarin version and a Taiwanese local-language version.
- 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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: CHENG-JUNG LI, BS
- Phone Number: 886-978-957027
- Email: G04924@hch.gov.tw
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
|---|---|
|
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. |
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. |
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
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
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
Collaborators
Publications and helpful links
General Publications
- Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007 Dec;60(12):1234-8. doi: 10.1016/j.jclinepi.2007.02.006. Epub 2007 Jun 6.
- Bennett C, Graham ID, Kristjansson E, Kearing SA, Clay KF, O'Connor AM. Validation of a preparation for decision making scale. Patient Educ Couns. 2010 Jan;78(1):130-3. doi: 10.1016/j.pec.2009.05.012. Epub 2009 Jun 26.
- Stacey D, Lewis KB, Smith M, Carley M, Volk R, Douglas EE, Pacheco-Brousseau L, Finderup J, Gunderson J, Barry MJ, Bennett CL, Bravo P, Steffensen K, Gogovor A, Graham ID, Kelly SE, Legare F, Sondergaard H, Thomson R, Trenaman L, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2024 Jan 29;1(1):CD001431. doi: 10.1002/14651858.CD001431.pub6.
- Huang CH, Chen IH. The Clinical Application of the Tracheostomy Decision-Making Program in Respiratory Care Center Prolonged Mechanical Ventilation Patients in Taiwan. Int J Gen Med. 2020 Dec 10;13:1487-1494. doi: 10.2147/IJGM.S285795. eCollection 2020.
- Feeley TH, Keller M, Kayler L. Using Animated Videos to Increase Patient Knowledge: A Meta-Analytic Review. Health Educ Behav. 2023 Apr;50(2):240-249. doi: 10.1177/10901981221116791. Epub 2022 Aug 11.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID 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)?
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
Studies a U.S. FDA-regulated device product
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