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

Not Applicable

Not yet recruiting

• Conditions: Infants' Family Decide Baby's Vaccine
• Interventions: Other: Patients Decision Aids (PDA)

• Registration Number: NCT05578144
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

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.

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 Timeline

• Status Verified: 2022-10
• Study Start: 2022-10
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-10
• Last Update Submitted: 2022-10-10
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13
• Primary Completion: 2023-07
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient decision aids group	Patients Decision Aids (PDA)	shared decision making with using patient decision aids. (SDM group)

Primary Outcome Measures

Name	Time	Method
Decisional conflict	An average of ３month after intervention	Total scores of decisional conflict scale
Decision-making difficulties	An average of ３month after intervention	Total scores of decision-making scale

Secondary Outcome Measures

Name	Time	Method
Percentage of the infant's families let baby receiving third primary PCV	An average of ３month after intervention	vaccination rate