Using "SDM With PDAs" to Help Infant Family to Decide the Third Primary Dosing Pneumococcal Conjugate Vaccine

Sponsor
Taipei Medical University Shuang Ho Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05578144
Collaborator
(none)
180
2
11

Study Details

Study Description

Brief Summary

Pneumococcal infection is one the common infectious disease in the world. Pneumococcal conjugate vaccine may decrease the incidence of pneumococcal infection. In Taiwan, infants usually received 2 primary dosing pneumococcal conjugate vaccines . The third primary dose of pneumococcal conjugate vaccine is still not included in public health insurance. Some infants in Taiwan did not receive the third primary dose of pneumococcal vaccine. Share decision making (SDM) with patient decision aids (PDA) provide information to infant family and to help them in making decisions about their baby's vaccination. We develop a PDA administered for baby's family to decide whether the baby will receive the third primary dosing pneumococcal conjugate vaccine.

Condition or Disease Intervention/Treatment Phase
  • Other: Patients Decision Aids (PDA)
N/A

Detailed Description

Pneumococcal infection is one of the most major infectious disease that cause morbidity and mortality due to pneumonia, meningitis, acute otitis media, acute rhinosinusitis and septicemia. Although pneumococcal infection may affect people in all ages, children below 5-year-old and adults over 65-year-old are high risk group. Pneumococcal conjugate vaccine has decreased the incidence of pneumococcal infection in the world. Infants usually received 2 primary dosing pneumococcal conjugate vaccines on schedule in Taiwan. The third primary dose of pneumococcal conjugate vaccine is still not included in public health insurance. Many infants' family did not know the information of the third primary dosing pneumococcal conjugate vaccine; and not all of the infants in Taiwan received the third primary dose of pneumococcal vaccine. Share decision making (SDM) with patient decision aids (PDA) is one way to provide information to infants' family and to help them in making decisions about their baby's vaccination. We develop a PDA administered for baby's family to decide whether the baby will receive the third primary dosing pneumococcal conjugate vaccine.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Using "Share Decision Making With Patient Decision Aids" to Help the Infant Family to Decide Whether the Baby Will Receive the Third Primary Dosing Pneumococcal Conjugate Vaccine
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patient decision aids group

shared decision making with using patient decision aids. (SDM group)

Other: Patients Decision Aids (PDA)
Patient Decision Aids (PDA) administer to case group

No Intervention: Control group

oral explanation. (Non-SDM group)

Outcome Measures

Primary Outcome Measures

  1. Decisional conflict [An average of 3month after intervention]

    Total scores of decisional conflict scale

  2. Decision-making difficulties [An average of 3month after intervention]

    Total scores of decision-making scale

Secondary Outcome Measures

  1. Percentage of the infant's families let baby receiving third primary PCV [An average of 3month after intervention]

    vaccination rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

The 4-month-old baby's family aged between 20 and 80 years old.

Exclusion Criteria:

The baby's family is not suitable; baby's family cannot understand languages what we said; the participants' baby who have fever or contraindication for self-paid third primary PCV.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Taipei Medical University Shuang Ho Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier:
NCT05578144
Other Study ID Numbers:
  • 111HHC-05
First Posted:
Oct 13, 2022
Last Update Posted:
Oct 13, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Taipei Medical University Shuang Ho Hospital

Study Results

No Results Posted as of Oct 13, 2022