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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Infants' Family Decide Baby's Vaccine

Intervention / Treatment
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* Other: Patients Decision Aids (PDA)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient decision aids group<br>shared decision making with using patient decision aids. (SDM group) | Other: Patients Decision Aids (PDA)<br>* Patient Decision Aids (PDA) administer to case group<br>|
| No Intervention: Control group<br>oral explanation. (Non-SDM group) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict | Total scores of decisional conflict scale | An average of ３month after intervention | 
| Decision-making difficulties | Total scores of decision-making scale | An average of ３month after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of the infant's families let baby receiving third primary PCV | vaccination rate | An average of ３month after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SDM; PDAs; Pneumococcal vaccine