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

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.

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.

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.

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.

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.

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.