Clinical trial NCT03804489: Using "Decision Aids" to Help the Infant Family to Decide the Use of Oral Rotavirus Vaccine
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotavirus Vaccines
Keywords: Decision Aids; Shared decision making; Rotavirus Vaccines
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Decision aids
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Decisional conflict
timeFrame: An average of 1 month after intervention
measure: Decision-making difficulties
timeFrame: An average of 1 month after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Sheng-Chieh Lin
state: No.291, Zhongzheng Road, Zhonghe District, New Taipei City
Study officials:
affiliation: Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University
name: Sheng-Chieh Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin SC, Tam KW, Yen JY, Lu MC, Chen EY, Kuo YT, Lin WC, Chen SH, Loh EW, Chen SY. The impact of shared decision making with patient decision aids on the rotavirus vaccination rate in children: A randomized controlled trial. Prev Med. 2020 Dec;141:106244. doi: 10.1016/j.ypmed.2020.106244. Epub 2020 Sep 4.