Using Decision Aids to Help the Infant Family to Decide the Use of Oral Rotavirus Vaccine

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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.

Conditions
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Rotavirus Vaccines

Intervention / Treatment
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* Other: Decision aids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The one-month-old baby's family whose age is between 20 and 80 years old. Exclusion Criteria: . The doctor determines that the baby's family is not suitable; if baby's family cannot understand Chinese languages what we said. . The participants' baby who have fever or contraindication for oral rotavirus.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Decision aids
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision aids group<br>Shared decision making using decision aids, | Other: Decision aids<br>* Decision aids in helping the infant family to decide whether the infant will or will not receive the oral rotavirus vaccine.<br>|
| No Intervention: Control group<br>Standard oral explanation with booklet. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict | Total score of decisional conflict scale | An average of 1 month after intervention | 
| Decision-making difficulties | Total score of decision-making scale | An average of 1 month after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision Aids; Shared decision making; Rotavirus Vaccines