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

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.

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

Study Overview

• Status: Unknown
• Conditions: Rotavirus Vaccines
• Intervention / Treatment: Other: Decision aids

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • No.291, Zhongzheng Road, Zhonghe District, New Taipei City
    • New Taipei City, No.291, Zhongzheng Road, Zhonghe District, New Taipei City, Taiwan, 23561
      • Sheng-Chieh Lin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Investigators: Principal Investigator: Sheng-Chieh Lin, MD, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 25, 2019
• Primary Completion (Anticipated): October 25, 2019
• Study Completion (Anticipated): December 25, 2019

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Decision Aids; Shared decision making; Rotavirus Vaccines
• Other Study ID Numbers: 108HHC-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No