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

T

Taipei Medical University

Status

Unknown

Conditions

Rotavirus Vaccines

Treatments

Other: Decision aids

Study type

Interventional

Funder types

Other

Identifiers

NCT03804489
108HHC-03

Details and patient eligibility

About

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

Full description

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.

Enrollment

180 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

180 participants in 2 patient groups

Decision aids group
Experimental group
Description:
Shared decision making using decision aids,
Treatment:
Other: Decision aids
Control group
No Intervention group
Description:
Standard oral explanation with booklet.

Trial contacts and locations

1

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Central trial contact

Sheng-Chieh Lin, MD

Data sourced from clinicaltrials.gov

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