The Effects of a Respiratory Assistive Device Health Education Manual on Readmission Rates and Self-Care Efficacy: A Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFu Jen Catholic University Hospital

About this trial

This study evaluates whether adding an easy-to-read, illustrated education booklet to routine discharge planning helps patients and their family caregivers safely use home respiratory equipment.

Patients who need breathing devices after leaving the hospital often face challenges managing equipment and recognizing warning symptoms, which can lead to complications or hospital readmissions. Participants in this study are randomly assigned (by chance) to one of two groups: one group receives standard hospital discharge instructions, while the other group receives the standard instructions along with a specialized, step-by-step respiratory care booklet. Researchers will assess how prepared patients feel to return home the day before discharge, and will follow up by phone one week later to check on device use, daily care confidence, and any unexpected doctor or emergency room visits.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hospitalized patients enrolled in the discharge planning service of Fu Jen Catholic University Hospital who are evaluated as requiring referral to respiratory assistive devices, long-term care services, or home respiratory care facilities/resources.

Evaluated and confirmed by the hospital healthcare team as in need of discharge planning services specifically related to respiratory assistive devices.

Aged 18 years or older.

Able to comprehend the study purpose and provide written informed consent (if the patient is unable to communicate or express consent, a primary caregiver may provide consent and complete responses on their behalf).

Disqualifiers

Patients receiving palliative or hospice care with an anticipated life expectancy of less than 1 month.

Patients with altered consciousness or dementia who do not have an eligible primary caregiver available to receive education and participate on their behalf.

Severe visual impairment or inability to comprehend Chinese text and pictorial materials.

Refusal to sign the written informed consent form despite meeting the inclusion criteria.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Structured Discharge Educational Manual for Respiratory Assistive Devices

    Behavioral

    In addition to routine discharge planning, participants receive a structured, pictorial educational manual developed by the Division of Thoracic Medicine at Fu Jen Catholic University Hospital. The manual comprises four structured modules: 1. Patient triage for home mechanical ventilation, discharge planning workflow, respiratory assistive devices introduction, and operational precautions; 2. Verification of eligibility and application procedures for medical assistive device subsidies provided by the New Taipei City Department of Health; 3. Relevant information and documentation preparation for home respiratory care institutions for ventilator-dependent cases; and 4. Long-term Care 2.0 application procedures and service introduction for eligible participants.

  • Routine Discharge Planning Service

    Other intervention

    Participants receive conventional hospital discharge planning care delivered by a discharge planning respiratory therapist. This includes verbal education, individual patient care need assessment, and standard operational guidance on prescribed respiratory assistive devices.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Readiness for Hospital Discharge Scale (RHDS) Score

Assessed using the Chinese version of the Readiness for Hospital Discharge Scale (RHDS). The scale consists of 23 items across four dimensions: personal status, knowledge, coping ability, and expected support. Item 1 is a dichotomous question ("Yes/No") regarding readiness for discharge, while the remaining 22 items are rated on an 11-point numeric scale ranging from 0 to 10 (with Items 3 and 6 reverse-scored). Higher total scores indicate a higher level of readiness for hospital discharge.

Time frame
1 day prior to hospital discharge

Secondary outcomes

1

Home Readiness Score for Respiratory Assistive Devices

Measured using the Home Readiness Questionnaire for Respiratory Assistive Devices developed by the research team. It assesses 11 items covering three domains: equipment and service satisfaction, device knowledge and operation, and alarm management/emergency handling. Items are scored on a 5-point Likert scale (1 = very dissatisfied/unable to perform to 5 = very satisfied/independent). The final score is calculated as a percentage: 70-100% indicates excellent readiness, 40-69% indicates adequate readiness, and 0-39% indicates high risk requiring re-education.

Time frame
1 week after hospital discharge
2

Assistive Technology Satisfaction Score (T-QUEST 2.0)

Evaluated using the Taiwanese version of the Quebec User Evaluation of Satisfaction with Assistive Technology (T-QUEST 2.0). The scale includes 8 items assessing satisfaction with the assistive device itself and 5 items evaluating satisfaction with related services, providing a comprehensive assessment of patient satisfaction with home respiratory assistive technology.

Time frame
1 week after hospital discharge
3

Utilization Rate of Respiratory Assistive Devices

The proportion (percentage) of participants who consistently use the prescribed home respiratory assistive devices (e.g., oxygen therapy, nebulizers, suction units, or non-invasive ventilators) as instructed, assessed via telephone follow-up.

Time frame
1 week after hospital discharge
4

Hospital Readmission Rate

The percentage of participants who experience an unplanned all-cause hospital readmission following index discharge.

Time frame
At 7 days and 30 days post-discharge

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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