Using "Decision Aids" to Help the Infant Family to Decide Whether the Baby Will Receive the Self-paid Oral Rotavirus Vaccine: A Randomized Controlled Trial.
| Registry | NCT03804489 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, health services research |
| Enrollment | 180 (Estimated) |
| Sponsor | Taipei Medical University Shuang Ho Hospital (Other) |
| Conditions | Rotavirus Vaccines |
| Interventions | Decision aids (Other) |
| Dates | start 2019-01-25 (estimated), primary completion 2019-10-25 (estimated), completion 2019-12-25 (estimated), first posted 2019-01-15, last updated 2019-01-15 |
| Locations | 1 site in Taiwan |
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Using decision aids (DA) is one way to provide information to infant family and to involve them in making decisions about their baby's vaccination. We developed a DA administered after consultation for baby's family deciding on whether the baby will receive the self-paid oral rotavirus vaccine
Background:
Acute gastroenteritis is one of the most common infectious diseases and still a major cause of pediatric morbidity and mortality worldwide. Rotavirus was still the major cause of acute gastroenteritis in infants and young children worldwide, including in Taiwan. The World Health Organization has recommended rotavirus vaccine, which became available in 2006, for all countries. However, not all of children in Taiwan received rotavirus vaccination. Using decision aids (DA) is one way to provide information to infant family and to involve them in making decisions about their baby's vaccination. We developed a DA administered after consultation for baby's family deciding on whether the baby will receive the self-paid oral rotavirus vaccine Patients and Methods Decision aids are interventions designed to help infant family make choices among options by providing information relevant to oral rotavirus vaccine. Infant coming to receiving regular routine vaccination at 1 month old are randomly assigned to receive a DA or the standard oral conversation (control condition) after the initial consultation. Infant family complete interview-based questionnaires 1 month later when they came back to hospital receiving 2-month-old regular routine vaccination and decide to receive self-paid oral rotavirus vaccine or not at that time. Primary outcome measures: decisional conflict and decision-making difficulties at 2-month-old.
Results and Conclusion The DA group are predicted to lower decisional conflict scores when compared with the control group. Our study hopes to support the efficacy of DA in helping the infant family to decide whether the baby will receive the self-paid oral rotavirus vaccine.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Decision aids group | Experimental | Other: Decision aids | Shared decision making using decision aids, |
| Control group | No intervention | Standard oral explanation with booklet. |
Sex: All, ages: 20 Years to 80 Years, accepts healthy volunteers
Inclusion Criteria: The one-month-old baby's family whose age is between 20 and 80 years old. Exclusion Criteria: 1. . The doctor determines that the baby's family is not suitable; if baby's family cannot understand Chinese languages what we said. 2. . The participants' baby who have fever or contraindication for oral rotavirus.
| Facility | City | Country | Status |
|---|---|---|---|
| Sheng-Chieh Lin | New Taipei City, No.291, Zhongzheng Road, Zhonghe District, New Taipei City | Taiwan |