Use of a Novel Parent-Report Measure to Improve Childhood Vaccine Uptake: The Screening for Hesitancy to Optimize Talk (SHOT) Study
Phase: NA
Conditions: Preventive Health Services
Sponsor: Seattle Children's Hospital

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 1 of 24
 
LOCAL IMPLEMENTATION PLAN (LIP) 
 
**NOTE: This protocol refers to a study titled “Screening Parents about 
Recommended Care for Kids (SPARCK) Study”, which is the study name we used 
to refer to the Screening for Hesitancy to Optimize Talk (SHOT) trial when 
conducting the trial. The SPARCK Study and SHOT Trial are therefore 
synonymous, and this protocol is therefore the study protocol for the SHOT trial. 
  
PART I 
 
*Fill in header information.  
 
 
 
Instructions: 
• 
This form is required for new study submissions; it should be submitted with the 
Institutional Review Board (IRB) – Institute of Translational Health Sciences (ITHS) 
Application and any relevant Supplements. 
• 
Answering the questions posed in this form, provide a summary of your Local 
Implementation Plan (LIP).  The purpose of this document is to provide a summary of 
how your study will be implemented at Seattle Children’s.  
• 
The LIP is considered a “living” document that should be updated and submitted to the 
IRB with each modification or renewal that involves change to the LIP. 
 
Note:  There are two (2) Parts to this form 
• 
Part I must always be completed. 
• 
Part II must be completed if there is no protocol provided.  If a protocol is attached, then 
Part II may be skipped. 
• 
Please note that protocol templates have been developed for optional use.  These are 
available on the IRB Web site. 
 
1. Summary of the Research (1 to 1 ½ pages or less) 
 
1.1. Concise Description 
Using lay language, please provide a concise summary outlining the purpose of the research, 
the rationale for this study and the general study design (how the aims of the study will be 
Key:  
(Text highlighted throughout form are hyperlinks to these types of information) 
 
Investigator Help (includes background information and/or sample answers)  
Federal Regulations  
Seattle Children’s Policy  
 
Type in text as appropriate (for text boxes, etc.)  

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 2 of 24
 
accomplished).  The description should be detailed enough to allow someone who is not an 
expert in the field to understand the context of the research question(s) being asked.  
 
Parental refusal or delay of childhood vaccines due to vaccine concerns is an important 
contributor to under-immunization1,2 and a growing public health problem.3-5 Non-medical 
exemption rates from required school entry vaccines are rising6,7 and vaccine refusal increases 
the risk of developing and transmitting vaccine-preventable diseases (VPD).8-12 Consequently, it 
remains a national priority to sustain and improve childhood vaccine coverage.14 
 
Important candidates for targeted interventions to improve acceptance of vaccines are vaccine 
hesitant parents (VHPs),15 a large, heterogeneous group of parents who refuse or delay ≥1 
vaccines.16,17 Compared to parents who completely reject vaccines, VHPs may be more 
amenable to behavior change because they hold less negative vaccine attitudes and beliefs16-20 
and they consider their child’s pediatric provider to be influential in their decision-making about 
vaccines and their child’s health.1,16-18,21 Parents initially hesitant to accept a vaccine have 
changed their mind after their child’s provider addressed their concerns, provided them with 
additional information, or gave them reassurance.17,21,22 
 
Several barriers, however, exist to optimizing provider-parent vaccine discussions. Both parents 
and providers cite insufficient time to discuss parental vaccine concerns during health 
supervision visits.23-28 Parents also have difficulty openly discussing their vaccine concerns29,30 
and providers struggle to accurately identify VHPs and their specific vaccine concerns.31 As a 
result, parental vaccine concerns are often neglected16 and opportunities to improve vaccine 
uptake are missed. 
 
The primary goal of this project is to evaluate the effectiveness of an innovative 
intervention designed to address barriers to parental acceptance of vaccines—the 
Screening Parents about Recommended Care for Kids (SPARCK) intervention—in 
improving provider-parent vaccine discussions and increasing vaccine acceptance. The 
SPARCK intervention involves administering a validated parent-report measure, the Parent 
Attitudes about Childhood Vaccines (PACV) survey32-34 (Appendix A), to parents and 
communicating their score and item-specific responses to their child’s provider before their 
child’s 2 and 6 month health supervision visits (Appendix C). The PACV contains 15 questions 
regarding Health Belief Model concepts that influence parent vaccination behavior and has been 
shown to predict under-immunization. We hypothesize that using the PACV to solicit parental 
vaccine concerns and hesitancy status prior to health supervision visits in which vaccines are 
administered will improve providers’ ability to adequately address parental vaccine concerns 
and increase parental vaccine acceptance.  
 
The specific aims of this project are as follows: 
Aim 1: Evaluate the impact of the SPARCK intervention on a child’s immunization status. 
We will use a matched-pair, cluster randomized controlled trial design in which we assign up to 
30 primary care clinics in the Seattle area and within the Group Health healthcare delivery 
system in Western Washington to a control arm or the SPARCK arm and enroll 160 vaccine-
hesitant parents whose newborns receive health supervision at study clinics. 
Aim 2: Assess how parents’ ratings of their vaccine discussions with their child’s 
provider change as a function of the SPARCK intervention. This will be accomplished by 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 3 of 24
 
assessing parent visit satisfaction with a questionnaire after their child’s 6 month health 
supervision visit. 
Aim 3: Compare pre- and post-study perceptions of barriers to quality vaccine 
discussions with parents between providers in the SPARCK and control arm. This will be 
accomplished by having providers complete a survey assessing their perceptions of specific 
barriers to quality preventive care discussions with parents before the study begins and then 
again after the study ends. 
 
Investigator Help  
 
 
2. Local Study Population  
 
Investigator Help 
 
2.1 
Approximate Number and Ages of Study Population 
 
Participant Group: 
Parents/Children 
 
Age at Enrollment* 
 
Non-Children’s Sites 
Screen 
Enroll 
Entire Study 
Healthy Participants/Controls 
  
Parents 
Approximately 
2400 
Approximately 
160 
18+ years 
Other: Children [indirectly] of 
enrolled parents 
Approximately 
2400  
Approximately 
160 
Newborn-8 months  
*If participants will be greater than age 21 (not including parents participating with their 
children), institutional sign-off will be required.   
 
Participant Group: 
Providers 
 
Age at Enrollment* 
 
Non-Children’s Sites 
Screen 
Enroll 
Entire Study 
Group Health Primary Care 
Pediatric Providers 
 Approximately 
289 
Approximately 
200 
18+ years 
Seattle area Pediatric Primary 
Care Clinic Providers 
Approximately 
100 
Approximately 
85 
18+ years 
 
 
Seattle Children’s Policy  
 
3. Recruitment:  Screening and Approach of Local Study Population 
 
Screening and Approach 
 
Investigator Help 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 4 of 24
 
Seattle Children’s Policy 
 
3.1. Indicate how local team will advertise for/identify potential participants for approach 
(e.g., medical records, other studies, etc.).  Please check all that apply & provide 
with application:  
 Web site 
 
 
 Other studies 
 
 
 
 Flyer(s) 
 
 Advertisement(s)   
 In person through clinic  
 Medical records/Clinic schedules (Parents/Children) 
 Existing databases (Parents/Children)  
 
 Other (please explain): We will 
send clinic leaders at Group Health primary care clinics in a 5 county region in western 
Washington and other Seattle area pediatric primary care clinics an email that explains the 
study and invites their clinic to participate (Appendix H). Among those clinics whose leaders 
agree to participate, all pediatric and family practice providers (MD, DO, ARNP, PA-C) at 
those clinics will be eligible to participate in the study survey.  
 
3.2. Once identified as possible participants, describe how individuals will be 
approached about the research (check all that apply): 
 
 In person (e.g., during clinic visit/hospital stay) (Parents/Children attending Seattle area 
primary care clinics and Group Health clinics) 
 By letter 
 By telephone – investigator initiated (e.g., investigator makes first contact) 
(Parents/Children attending Group Health clinics only) 
 By telephone – participant initiated (e.g., potential participant makes first contact) 
 Other (please explain):  Providers at participating clinics will receive an email from the 
research team that explains the study (Appendix I). 
 
3.3. Describe who will approach potential participants about the research.  
Parents/Children: A Group Health RA will approach parents at Group Health clinics. A 
Seattle Children’s RA will approach parents at non-Group Health clinics. 
Providers: After clinics are enrolled, Drs. Opel, Henrikson, and Dunn will send an email to 
all providers at that clinic inviting them to participate in the study survey(Appendix I). 
 
3.4. Describe where (e.g., sites, clinics, units, etc.) potential participants will be 
approached about the research.   
Parents/Children: Group Health parents will be approached over the telephone or in the 
waiting room of their child’s doctor’s office. Non-Group Health parents will only be 
approached in the waiting room of their child’s doctor’s office. 
Providers: Providers will receive an email (Appendix I) that explains the study. 
 
3.5. If you are recruiting/approaching potential participants from more than one 
site/location, do your recruitment/approach strategies differ at each site/location? 
 Yes  Describe your recruitment practices at each site/location.        
 No  
 N/A 
 
3.6. Describe when (the timing of) potential participants will be approached about the 
research.   

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 5 of 24
 
Parents: Parents will be recruited at or prior to their child’s 2 month check-up. 
Providers: Providers at eligible clinics will be emailed to ask for their participation in the 
study survey only after clinic leadership has agreed to participate in the study.  
 
3.7. Are recruitment/approach materials attached to the application (e.g., flyers, 
advertisements, approach letters, telephone script, etc.)?  
 Yes  Please list.  
1. Parent Eligibility Survey (Appendix F) 
2. Clinic leadership recruitment email (Appendix H) 
3. Provider study introduction email (Appendix I) 
4. Provider study introduction reminder email (Appendix O) 
5. Provider study fact sheet (Appendix J) 
6. RA in-person recruitment script (Appendix N) 
7. RA telephone recruitment script (Appendix P) 
 No  Please explain why.       
 
Investigator Help 
Seattle Children’s Policy 
 
3.8. How will the approach protect the privacy of research participants and their 
families? 
 
 Use of a private room to discuss potential participation.   
 Use of an intermediary known to potential participant if s/he does not know researcher 
(usually required). 
 
 Other (please explain):  
Parents: Parents will be approached in clinic waiting rooms (or over the phone prior to a 
clinic visit if they are a Group Health parent). If they are approached in the waiting room 
they will be offered the opportunity to learn more about the study in a private room or 
private area of the waiting room. Participants will be given a unique study ID that contains 
their study information. For those newborn/parent dyads who choose not to participate or 
are ineligible, their names will be the only identifiable information retained until the end of 
study recruitment to avoid approaching them in the future. This is necessary given the 
longitudinal nature of the study. Names will not be shared outside the research team. 
 
Providers: Providers will be sent an email that they may view privately which includes a 
description of the study. Providers who take the survey (the link to which will be included in 
the email; see AppendicesI and Q), will be given a unique study ID that contains their 
study information so will not be directly identifiable.  
 
3.9. What steps will be taken to avoid coercion or undue influence in the 
approach/recruitment process? Please check all that apply:   
 Sufficient time will be allowed to consider participation.  Please describe amount of 
time allowed and rationale.  
 
Parents: It is estimated that the recruitment and consent process will take about 10 
minutes to complete. We hope to complete the approach/recruitment process over the 
phone prior to a clinic visit (for Group Health parents) or while the parent is in the 
waiting room prior to being called back to the exam room. For Group Health parents 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 6 of 24
 
who we screen by phone, we will attempt to contact them up to 3 times total over the 
phone and leave 1 voicemail. The RA will emphasize that participation is voluntary and 
that they may stop the study at any time.  
Providers: Providers will be allowed several days to weeks to consider participation.  
Regarding the survey component of the study, providers will not be  
re-contacted for 3-5 days if no response is received. We will recontact survey non-
responders by email up to 3 times(see Appendices O and R-provider reminder email).. 
 
Investigator Help  
 
 No individual in a position of authority/influence (e.g., treating physician) will approach 
potential participants for participation in the study.  
 Individual(s) in a position of authority/influence (e.g., treating physician) will approach 
potential participants but there will be steps taken to avoid coercion/undue influence.  
Please describe those steps and rationale.        
 
 Emphasis on concept that deciding not to participate will not impact patient’s care. 
 Other (please explain).          
 
4.. 
Study Incentives   
 
Investigator Help 
Seattle Children’s Policy  
 
4.1 
Will research participants receive an incentive to take part in the research activity 
(e.g., gifts, payments, services without charge)?  
 Yes  Answer the following questions 4.2 – 4.5. 
 No  Skip to section 4.5.  
 
4.2 
Describe the incentive and the reason for this incentive.        
 
Parents will receive a $10 gift card after enrollment and a $15 gift card after they 
complete the 6 month post-visit satisfaction survey to thank them for participating. 
 
Investigator Help  
  
4.3 
Describe who will receive the incentive payment (child, parent, etc.).  
See 4.2 
 
4.4 
Describe the amount, method (check or gift cards), and timing (schedule) of the 
incentive payments.  See 4.2 
 
Investigator Help  
 
4.5 
Are there any plans to provide incentives to persons who help in recruiting 
participants for the study?  
 Yes  Please Explain.       
 No       
 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 7 of 24
 
Investigator Help 
Seattle Children’s Policy  
 
5. Study Conduct 
 
Data Collection 
 
5.1  Indicate the manner in which data will be recorded (check all that apply): 
 Forms  Attach all data collection forms.   
 
 Audio/Video/Photograph data  The recordings should be described in the consent 
form, or in a separate addendum consent. 
 Participant diary  Attach a sample form. 
 Surveys, questionnaires, interview scripts  Attach at the time of initial review.  
 
The following recruitment and data collection materials are attached:  
1. Parent SPARK intervention survey (Appendix A) 
2. Parent placebo survey (Appendix B) 
3. Parent post-study survey (Appendix E) 
4. Parent Eligibility Survey (Appendix F) 
5. Parent demographic survey (Appendix G) 
6. Clinic leadership recruitment email (Appendix H) 
7. Provider study introduction email (Appendix I) 
8. Provider study fact sheet (Appendix J) 
9. Provider baseline survey (Appendix K) 
10. Provider follow-up survey (Appendix L) 
11. Parent in-person recruitment Script (Appendix N)  
12. Provider study introduction reminder email (Appendix O) 
13. RA telephone recruitment script (Appendix P) 
14. Provider post-study follow-up email (Appendix Q) 
15. Provider post-study follow-up reminder email (Appendix R) 
16. Vaccine data collection form for Allegro Pediatrics sites (Appendix S) 
 
 
 Other  Describe and attach:        
 
5.2 
Please provide a complete list of all questionnaires/assessments below 
that will be used for the study. As noted above, copies only need to be provided at initial 
review, except if the questionnaires are modified after study approval, in which case 
updated versions should be submitted with the modification request.    
 
Name of 
Questionnaire/Instrument 
How will the 
questionnaire/instrument 
be administered? 
(Examples: study personnel, 
self-administered, computer, 
etc.) 
Who answers 
the 
questionnaire? 
(Examples: 
parent, child) 
If modified 
after initial 
approval, 
note current 
revision 
date: 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 8 of 24
 
Name of 
Questionnaire/Instrument 
How will the 
questionnaire/instrument 
be administered? 
(Examples: study personnel, 
self-administered, computer, 
etc.) 
Who answers 
the 
questionnaire? 
(Examples: 
parent, child) 
If modified 
after initial 
approval, 
note current 
revision 
date: 
Parent SPARCK 
intervention survey  
(Appendix A) 
Self-administered on iPad® 
Parent 
      
Parent SPARCK Placebo 
Survey (Appendix B) 
Self-administered on iPad® 
Parent 
      
Parent post-visit 
satisfaction survey 
(Appendix E) 
Self-administered on paper 
Parent 
 
Parent Eligibility Survey 
(Appendix F) 
Study personnel verbally 
Parent 
 
Parent demographic 
survey (Appendix G) 
Self-administered on paper 
Parent 
 
Provider Baseline Survey 
(Appendix K) 
Self-administered 
electronically 
Provider 
      
Provider Follow-Up Survey 
(Appendix L) 
Self-administered 
electronically 
Provider 
      
Vaccine data collection 
form for Allegro Pediatrics 
sites 
Study personnel  
Study 
personnel 
 
 
Duration of Study 
 
5.3 Explain how long the study visits will last for individual research participants, 
and how long they will participate in the overall study.  
 
Parent/child participation for each study visit will be confined to the day of the child’s 2 and 
6 month health supervision visits.  
Providers will participate for the duration of the study (approximately 15  
months).  
 
Investigator Help  
 
 
6. Research and Test Results 
 
6.1. Plan re Sharing Overall Research Results with Participants:  In relation to the 
sharing of “overall, collective” research results, explain what information 
participants will receive at what point in the research, and who will convey the 
information to participants.  In the alternative, please explain why such overall 
study results will not be shared.   
 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 9 of 24
 
Return of overall study results:  Parents and providers will be told that they can receive 
copies of publications resulting from the study by contacting the PI. 
 
Investigator Help 
 
6.2. Plan re Sharing Individual Research Results with Participants:  In relation to the 
sharing of “individual” research results, explain what information (e.g., referral to 
appropriate practitioners) the participants or care practitioners will receive at what 
point in the research, and who will convey the information.  In the alternative, please 
explain why such individual research results will not be shared. 
 
Return of individual results:  There are no plans to disclose individual results to the 
participants. This study is designed to guide future practice and improve vaccine 
discussions between future patients and their providers. 
 
Investigator Help 
 
6.3.   Are results of the research likely to have diagnostic, predictive, or reproductive 
implications (positive or negative) for the participants?  
 Yes  Answer questions 6.3.1 - 6.3.2. 
 No  Skip to question 6.4.    
 
 
6.3.1 Please explain.       
 
6.3.2 Include information about the plan to place results in participant medical 
records.  If you are including results from the research in the medical 
records, then be sure that the consent forms explain this to the participant. 
      
 
6.4.   Interim/Inconclusive Results:  If applicable, explain how interim or inconclusive 
results will be handled with respect to the research participants and care 
practitioners.  If not applicable, please indicate “N/A”.  N/A 
 
Investigator Help  
 
Laboratories  
 
6.5. If you plan to provide test/research results to participants or care practitioners but 
plan to use an outside lab for this purpose, please explain why (rare exception): N/A 
 
Investigator Help 
 
6.6. Does the proposed research involve a laboratory, which will report patient or 
participant results for the diagnosis, prevention or treatment of any disease or 
impairment, or the assessment of patient or participant results? 
 
 Yes  
 No  Skip to section 7: Protocol. 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 10 of 24
 
 
6.7. Is the laboratory certified? 
 
 Yes  Skip to section 7: Protocol. 
 No  Answer question 6.8. 
 
6.8. If the laboratory is not certified, will data from the laboratory be shared with 
physicians, counselors, the participant or participant family?       
 Yes  Please explain.          
 
Investigator Help 
 No  
 
7. Protocol 
 
7.1.   Does your study have an existing protocol that the local investigative team must 
implement (e.g., industry sponsored, etc.)? 
 Yes  Please attach protocol and answer question 7.1.1. After answering 7.1.1, you 
are finished w/the LIP.  
 No  Please complete Part II of the LIP OR you may submit a protocol based on one 
of the following templates provided for your convenience.  
 Basic Protocol Template 
 Biomedical / Interventional Protocol Template (including Pharmacokinetics and 
Pharmacodynamics Studies)  
 Behavioral / Interventional Protocol Template 
 Observational Protocol Template  
 
7.1.1. Are there any planned differences between the study protocol and the 
plan for implementation at Seattle Children’s?   
 Yes  Please describe. (For example – At Seattle Children’s, we will only 
enroll into the first two arms of the study because…)       
 No  Study will be conducted as described in the attached protocol.   

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 11 of 24
 
 
LOCAL IMPLEMENTATION PLAN 
 
PART II 
 
 
Note:  You may choose to attach a protocol instead of filling out this Part II. 
 
Investigator Help 
 
8. Background / Rationale for the Study 
 
8.1. Describe the background and rationale for the study.  
 
National estimates for the percentage of 19 – 35 month old children who are up-to-date on 
recommended vaccines remain below the Healthy People 2020 goal.13 An important contributor 
to under-immunization is parental refusal or delay of childhood vaccines due to significant 
vaccine concerns.2,35 Since vaccine refusal heightens the risk of developing and 
transmitting vaccine-preventable disease,8-12 efforts to sustain and improve childhood 
vaccine coverage remain a national priority.14 However, there are few well-designed and 
rigorously evaluated interventions to reduce parental vaccine hesitancy or refusal.36 
 
Important candidates for targeted interventions to improve acceptance of vaccines are vaccine 
hesitant parents (VHPs),15 a large, heterogeneous group of parents who refuse or delay ≥1 
vaccines.16,17 Compared to parents who completely reject vaccines, VHPs may be more 
amenable to behavior change because they hold less negative vaccine attitudes and beliefs16-20 
and they consider their child’s pediatric provider to be influential in their decision-making about 
vaccines and their child’s health.1,16-18,21 Parents initially hesitant to accept a vaccine have 
changed their mind after their child’s provider addressed their concerns, provided them with 
additional information, or gave them reassurance.17,21,22 
 
Additionally, pediatric providers are an important influence on parental vaccine decision-
making.1,2,16-18,21,23,24,29,37-42 In particular, their vaccine discussions with parents can increase 
vaccine acceptance.17,21,22 However, several parent- and provider-level barriers to improving the 
vaccine discussion exist. Parents have trouble openly discussing their vaccine concerns with 
providers,29,30 providers struggle to accurately identify parental vaccine concerns,31 and both cite 
insufficient time during health supervision visits to adequately discuss vaccines.23,25-28,42  
 
We have developed and validated a novel parent-report measure—the Parent Attitudes 
about Childhood Vaccines (PACV) survey—to identify vaccine-hesitant parents (VHPs) 
and their specific vaccine concerns. The PACV contains 15 questions regarding parents’ 
vaccine attitudes, beliefs, and behavior, reads at a 6 – 7th grade level, takes <5 minutes to 
complete,32,33 and predicts under-immunization.34 Use of validated parent-report measures in 
pediatric primary care contexts have been found to be an efficient way to triage visits that may 
require more time for assessment.43 They also enhance provider-parent communication by 
facilitating discussion of parental concerns,44 increase early identification of problems and 
access to beneficial interventions,45,46 and improve outcomes.47 This study will be the first to 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 12 of 24
 
demonstrate the effect of integrating a screening tool for vaccine hesitancy into the clinical 
setting on parental acceptance of childhood vaccines. 
 
Investigator Help 
 
9. Study Objectives 
 
Describe the objectives (aims) of the study.  
The primary goal of this project is to evaluate the effectiveness of an innovative intervention 
designed to address barriers to parental acceptance of vaccines—the Screening Parents about 
Recommended Care for Kids (SPARCK) intervention—in improving provider-parent vaccine 
discussions and increasing vaccine acceptance. The SPARCK intervention involves 
administering our validated parent-report measure, the Parent Attitudes about Childhood 
Vaccines (PACV) survey (Appendix A), to parents and communicating their score and item-
specific responses to their child’s provider before their child’s 2 and 6 month health supervision 
visits. 
 
Investigator Help  
 
9.1. Primary objective (or aim): To evaluate the effectiveness of the SPARCK intervention in 
increasing vaccine acceptance. 
9.2. Secondary objectives (or aims): (1) To assess how parent-rated experience of the 
vaccine discussion changes as a function of the SPARCK intervention and (2) to 
characterize the effect of the SPARCK intervention on provider perceptions of barriers to 
quality vaccine discussions. 
9.3. Outcome measures and rationale for selection: The primary outcome measure will be 
child’s immunization status at 8 months of age. Our secondary outcomes will be (1) parent 
ratings of their visit experience and vaccine discussion with their child’s provider after the 6 
month health supervision and (2) pre- and post-study provider perceptions of barriers to 
quality vaccine discussions with parents. These outcomes will allow us to measure the 
effectiveness of the SPARCK intervention. 
 
10. Study Medication / Study Intervention 
 
10.1. Describe the study medication or study intervention (if applicable). Parent 
participants randomized to the intervention arm will receive the intervention survey (within 
which the PACV is embedded) before their child’s 2 and 6 month health supervision visits 
(Appendix A). These results will be communicated to their child’s provider in paper form 
(Appendix C) before the provider enters the exam room for each of these visits. 
 
10.2. Describe the study agent (include dosing and rationale for dosing) or study 
intervention (include who will provide the intervention/therapy, when and where, as 
applicable). Parents will complete the intervention survey (Appendix A) on a study iPad® 
in their child’s clinic prior to their child’s 2 and 6 month health supervision visits. 
 
10.3. Describe treatment compliance and adherence assessment. N/A 
 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 13 of 24
 
Investigator Help 
 
11. Investigational Plan 
   
11.1. Describe the general schema of the study design.       
 
 
This study is a cluster randomized controlled trial. 
We will pair up to 30 Seattle area primary care 
clinics and Group Health primary care clinics 
based upon the number of vaccine doses ordered 
and enroll and randomize clinics to control and 
SPARCK arms. We will screen parents for 
vaccine hesitancy using the Parent Attitudes 
about Childhood Vaccines Short Form survey 
(PACV-SF) (Appendix F). Parents in the 
SPARCK arm of the study will take the 
intervention survey (which has the PACV 
embedded in it) to their child’s 2 and 6 month 
visits (Appendix A) whereas parents in the control 
arm of the study will take a placebo survey about 
childhood health topics (Appendix B). The results 
of these surveys will be communicated to the 
child’s provider (Appendices C and D). After the 
child’s 6 month visit, parents in both arms will 
complete a satisfaction survey about their visit 
experience (Appendix E). When the child is 8 
months of age, we will use an automated clinic 
immunization database to determine their 
immunization status. For participants who were 
lost to follow up (i.e. those who did not have a 6 
month appointment, or those who did not have a 
2 and 6 month appointment), we will also use 
Washington State Immunization information 
System records to determine participant 
immunization status.  
 
 
 
 
 
 
 
 
 
 
 
Figure 1. Study Design 
Recruit and randomize clinics (N=approx 26) 
 Seattle area and GH 
Clinics (N=30) 
Control Arm (N=13) 
Pair clinics on # vaccine doses ordered 
SPARCK Arm 
(N=13)
Determine parent eligibility, including vaccine 
hesitancy status using embedded PACV-SF 
Study RA administers 
placebo survey to 
study parents upon 
check-in at 2 and 6 
month visits  
 
 
Study RA administers 
intervention survey to 
study parents upon 
check-in at 2 and 6 
month visits 
Provider receives 
placebo survey 
results prior to 2 and 
6 month visits  
 
 
Provider receives 
intervention survey 
results prior to 2 and 
6 month visits  
 
 
Immunization Status at 8 months of age 
Enroll eligible VHPs 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 14 of 24
 
 
Investigator Help  
 
Trial Phases 
 
11.2. Describe the trial phases (if applicable). N/A 
 
Control Group 
 
11.3. Describe the control group (if applicable). Parents in the control arm will receive a 
placebo survey that asks questions about their attitudes about childhood health topics 
(Appendix B). These results will be conveyed to their child’s provider (Appendix D). 
 
Randomization Method and Blinding 
 
11.4. Describe the randomization method and blinding (if applicable).  
Among interested Seattle area primary care practices and 21 Group Health primary care 
clinics in 5 western Washington counties (King, Snohomish, Pierce, Thurston, and Kitsap), 
we will pair clinics based upon the number of vaccines doses ordered in the prior year and 
subsequently enroll and randomize up to 30 to the control and SPARCK intervention arms. 
We will conceal study arm allocation and describe the study generally as one that seeks to 
determine the impact of soliciting parent attitudes regarding preventive care topics before 
health supervision visits on improved health outcomes.  
 
Investigator Help 
 
Plan for Non-Responders 
 
11.5. Describe the plan for non-responders (if applicable). N/A 
 
11.6. Define who will be considered a “non-responder”.  N/A 
 
11.7. Describe the alternative therapy non-responders will be transitioned to, the 
rationale for that therapy, and when they will be transitioned to the alternative. N/A 
 
11.8. Explain how non-responders will be followed and for what variables. N/A 
 
11.9. Discuss risks of transition and measures taken to minimize risks. N/A 
 
Early Withdrawal of Participants 
 
11.10. Describe potential reasons for withdrawal, plan for tracking withdrawals, how 
participants’ safety will be assessed in response to withdrawal, plan for follow up 
of withdrawn participants.  
Parents and providers may withdraw at any time. A wish to no longer spend time filling 
out surveys may be the reason that parents and providers withdraw. If parents or 
providers withdraw before the study ends, we will consider this as missing data. We will 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 15 of 24
 
not follow up with withdrawn participants. Our sample size and power calculations 
account for this expected attrition. 
 
12. Study Population 
 
12.1. Describe inclusion criteria.       
Parents: Parents must be English speaking, ≥18 years old, have a newborn singleton 
infant ≤2 months, born at ≥35 weeks gestation who is receiving pediatric care at an 
enrolled Seattle area clinic or Group Health clinic, and be vaccine hesitant (defined as ≥2 
positive responses on questions 1, 3, 6 and 8 on the eligibility screening survey 
(Appendices F and P); these questions constitute the PACV-SF).  
 
Newborns: Newborns 0 – 2 months old whose parents enroll in the study will be included.  
 
Providers: All Seattle area primary care practices and Group Health primary care clinics 
within a 5 county region in western Washington (Snohomish, King, Pierce, Thurston, and 
Kitsap Counties) will be eligible to participate. Once clinic leadership has agreed to 
participate, all pediatric and family practice providers (MD, DO, ARNP, PA-C) at those 
clinics will be eligible to participate. 
 
12.2. Describe exclusion criteria.  
Parents/Children: Parents who are not 18 years or older, require language interpretation for 
medical care, have an infant born <35 weeks gestation, are not vaccine hesitant or will not 
be taking their child to a participating clinic for health supervision visits will be excluded. 
 
Providers: Clinics and providers outside the Seattle area or 5 county region in western 
Washington (Snohomish, King, Pierce, Thurston, and Kitsap) will be excluded. 
 
 
13. Study Procedures 
 
This section should list the procedures, observations, measures, etc. at each study visit, 
including history, examination, study drug administration or other interventions 
(can be provided in table form as a Table of Evaluations often used in protocols). 
 
13.1. Describe study visits. Parents will be approached and screened for this study by a 
research assistant (RA) over the telephone (Group Health parents only) or at their child’s 
clinic upon check-in for their child’s health supervision visit that occurs at or before 2 
months of age. For Group Health parents who are screened over the telephone, an RA will 
meet the parent at their child’s 2 month health supervision visit to complete the consent and 
enrollment process. This enrollment encounter will include having the parents who are 
eligible and agree to participate complete the demographic survey (Appendix G). If 
enrollment occurs at a health supervision visit prior to 2 months of age, an RA will meet the 
parent back at their child’s clinic at the time of their child’s 2 month health supervision visits 
to have them complete an electronic version of the study survey using an iPad® (i.e. the 
intervention survey at SPARCK clinics (Appendix A) and the placebo survey at control 
clinics (Appendix B)). If enrollment occurs at the 2 month health supervision visit, the RA 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 16 of 24
 
will simply proceed to administer the intervention or placebo survey right after enrollment. 
The RA will generate and print an automated summary sheet of the parent’s screening 
results, and hand the printed summary sheet to the child’s provider before the visit begins 
(Appendices C and D). They will also alert the provider that their patient is a SPARCK study 
participant by writing, “SPARCK STUDY” in the scheduling notes section of the child’s 
electronic health record. This process will be repeated before the child’s 6 month health 
supervision visit. After their child’s 6 month health supervision visit, parents will complete a 
survey about their satisfaction with their child’s provider at the clinic (Appendix E). 
 
14. Study Evaluations 
 
This section should list the details of all of the measurements, procedures, laboratory tests, etc. 
that are included in the Table of Evaluations including where they will be performed.  Example:  
Hematology testing includes Complete Blood Count with differential performed in the Seattle 
Children’s lab.  In particular, non-standard tests should be described including specific sample 
collection information. 
 
Information in this section can also be summarized in a table, or appended to the Table of 
Evaluations. 
 
14.1. Describe study evaluations. Study evaluations are:  
1. SPARCK Intervention Survey (Appendix A) 
2. SPARCK placebo survey (Appendix B) 
3. Parent post-visit satisfaction survey (Appendix E) 
4. PACV-Short form screening survey (Appendix F) 
5. Parent demographic survey (Appendix G) 
6. Provider baseline survey (Appendix K) 
7. Provider follow-up survey (Appendix L) 
8. Child’s vaccination status by age 8 months  
 
15. Risks and Benefits 
 
Potential Risks 
 
15.1. Describe the potential risks associated with this research.    
 
Parent/Child: Parents being recruited for the study may experience anxiety or discomfort 
because they do not meet inclusion criteria. Enrolled parents may experience anxiety or 
discomfort from having to complete questionnaires. In addition, participation in the project 
might be associated with some risks such as confusion about or disruption in the parent-
provider relationship. In particular, parents may be concerned that their answers to the pre-
visit screening questions might hurt their relationship with their child’s doctor. Alternatively, 
they may feel inconvenienced by having to discuss their responses with their child’s doctor. 
In total, however, the risks to parents and their children who participate in this study are 
minimal and are not greater in and of themselves than those ordinarily encountered in daily 
life or during the performance of routine physical or psychological examinations or tests. 
 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 17 of 24
 
Providers: The main risk for providers in the study is the possibility of information on the 
immunization status of their child patients and/or parent-ratings of their vaccine discussions 
will be revealed to their colleagues, patients, or the public at large. Another risk is disruption 
in the parent-provider relationship. In particular, disclosure to providers of a parent’s overall 
vaccine hesitancy or specific vaccine concerns may highlight disagreements between 
provider and parent and lead to a difficult conversation during the visit. In total, however, 
the risks to providers who participate in this study are minimal and are not greater in and of 
themselves than those ordinarily encountered in daily life or during the performance of 
routine physical or psychological examinations or tests. 
 
Investigator Help 
 
Protection Against Risks 
 
15.2. Describe how the study design will prevent or minimize any potential risks or 
discomfort.  Pease explain what steps you will take to minimize risks of harm and 
protect participants’ rights and welfare.  If the study procedures or intervention may 
pose possible harms to study team, family members or others, please also discuss 
methods of reducing risks here.     
Parent/Child: Data kept for research evaluation purposes on parents and children will be 
de-identified with linking information kept in separate files. Only Group Health and Seattle 
Children’s study staff will have access to the linked file with identifying information for the 
purposes of conducting research. No individual parent or child data will be publicly 
reported and no individual will be identified in any published findings, with all study results 
analyzed and presented only at the aggregate level. 
 
Drs. Opel and Henrikson will provide oversight for the collection, management and 
protection of study data. Data collected from Group Health parents will be securely stored 
at GHRI. Data collected from non-Group Health parents will be securely stored at SCRI. 
To ensure confidentiality and protection of the data, we will use the following strategies: 1) 
we will create a unique study ID for each participant in the study; 2) de-identified data will 
be placed on a secure, password-protected file transfer protocol server; and 3) all linkages 
between the unique study ID and the individual-level data will be destroyed 5 years after 
the completion of the study. We will adhere to all HIPAA requirements as required by the 
law. For Group Health parents, identifiable data will be stored in the GHRI Data 
Warehouse where access is limited to GHRI study staff, and data are backed up 
automatically at least nightly. For non-Group Health parents, data will be stored at SCRI 
where access is limited to SCRI study staff and data are backed up automatically at least 
nightly. We will maintain each dataset separately and index the records using unique 
encrypted identifiers to facilitate linkages between files while maintaining confidentiality of 
personal health information. Only de-identified data from Group Health will be sent to 
SCRI investigators for analysis. 
 
Providers: No individual provider data will be publicly reported and no individual will be 
identified in any published findings, with all study results analyzed and presented only at 
the aggregate level. All survey data will be confidential. These data files will only contain a 
unique study ID for each survey and no direct identifiers. The electronic survey data files 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 18 of 24
 
will be stored at Seattle Children’s Research Institute where access is limited to study 
staff.  
 
Potential Benefits  
 
15.3. Describe potential benefits associated with this research.    
Parent/Child: Parents will receive a $10 gift card upon enrollment and a $15 gift card after 
completing the 4 and 6 month surveys to thank them for their time. Parents might also 
benefit from improved provider-parent communication by having their attitudes regarding 
preventive care topics explicitly solicited and conveyed to their child’s provider. In the face 
of these potential benefits, the risks to study subjects, which themselves are minimal, seem 
reasonable. 
 
Providers: There is no direct benefit for providers who participate in the study. Participating 
providers, however, may benefit from pre-visit knowledge of parental preventive care 
concerns if it increases parental satisfaction by reducing parental unmet concerns. In the 
face of these potential benefits, the risks to study subjects, which themselves are minimal, 
seem reasonable. 
 
 
16. Statistical Considerations 
 
This section should provide sufficient detail to permit assurance that the sample size is justified 
and the statistical methods sufficient and appropriate for the research question(s).  
 
Analysis Plan and Statistical Methods  
 
16.1. Outline the data analysis plans relating to each specific aim/objective or research 
hypothesis mentioned in section 11 above.  It should be clear how the analysis results 
will allow each aim/objective to be answered.  The analysis plans for the primary aim should 
be detailed.  Analysis plans for secondary aims may be brief, but must be included.  Give 
the names of specific statistical methods and state which variables will be used with them.  
 
Aim1: To evaluate the effectiveness of the SPARCK intervention in increasing 
vaccine acceptance. We will conduct an intention-to-treat analysis for Aim 1. Parents will 
be the unit of analysis. We will examine baseline characteristics among control and 
SPARCK parents using Pearson’s χ2 tests (or Fisher’s exact tests) for categorical variables 
and t-tests for continuous variables to assess for any unbalanced confounders between 
control and SPARCK arms. To compare our primary outcome of percent days under-
immunized between control and SPARCK arms, we will apply linear mixed effects 
regression modeling to the percent days under-immunized with clinic-specific random-
effects to account for within-clinic correlation. If unbalanced confounders are detected 
between arms, they will be adjusted for in the mixed effects models.  
 
Aim 2: To assess how parent-rated experience of the vaccine discussion changes as 
a function of the SPARCK intervention. For Aim 2, we will use Pearson’s χ2 test to 
compare parent (binary) ratings of their vaccine discussion between control and SPARCK 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 19 of 24
 
arms. We will apply mixed effects logistic regression model to this outcome to account for 
within-clinic correlation and any unbalanced parent confounding factors. When summarizing 
parent experience as a continuous variable, we will apply Box-Cox transformation if it is 
highly skewed and linear mixed effect models to examine the differences in parent 
experience between control and SPARCK arms.  
 
Aim 3: To characterize the effect of the SPARCK intervention on provider 
perceptions of barriers to quality vaccine discussions. For Aim 3, providers will be the 
unit of analysis. We will compare the pre- and post-study proportions of control and 
SPARCK providers reporting that time, understanding of specific parental vaccine 
concerns, and knowledge of overall parental vaccine attitudes were significant barriers 
(defined as 4 or 5 on a 1 – 5 scale) to quality vaccine discussions. We will use t-tests for an 
unadjusted analysis of the pre-post differences between control and SPARCK arms and 
multivariate linear regression for adjusted analyses that control for potential confounding 
variables such as provider demographic and practice characteristics. 
 
16.2. Provide a justification for the sample size and power calculations.  
Based on preliminary data, children of parents with a positive PACV-SF had a mean 
percentage of days under-immunized of 27.1% (standard deviation [SD] 33.3) from birth to 
8 months of age for 4 vaccines combined (hepatitis B, DTaP, Hib, and IPV). To be able to 
detect with adequate power (90%) a decrease in under-immunization of 30 days per 
vaccine—a decrease that has the potential to be clinical meaningful since it equals the 1 
month recommended interval a parent has before their child is considered late for a 
vaccination dose48—we need to enroll 160 parent/newborn pairs total, with 80 per arm and 
10 at each of the 16 study clinics (assuming an α of 0.05 and an intraclass correlation 
coefficient for within-clinic correlation of 0.02).49  
 
In our original calculation, we assumed 80% of GH parents would be reached, a 
conservative estimate of a 20% prevalence of GH parents who will have a positive PACV-
SF, 10% of VHPs who fail to meet other study eligibility requirements, 25% of VHPs who do 
not agree to participate (unpublished data),22 a 10% attrition rate over the course of the 
study, and 70% who remain continuous GH members,34 resulting in the need to approach 
2400 parents to reach our sample size goal. From 2010 – 2012, there was an average of 
2679 GH births per year in the 5 Washington State counties from which we will recruit 
parents. Reaching our sample size goal should therefore be feasible given our designated 
15 month recruitment period. However, we now know that the vaccine hesitancy rate at GH 
is about 5%. Therefore, we need to screen approximately 3500 parents to reach the desired 
sample size goals of 160. 
 
For Aim 2, we will have 80% power with a sample size of 160 parents to detect a 17% 
increase in the proportion of parents who rate their visit highly, assuming a baseline 
proportion of 72%.50 For Aim 3, we will have 80% power to detect a 14% pre-post difference 
in the proportion of providers who perceive time as a barrier to quality vaccine discussions 
between control (1% pre-post difference) and SPARCK arms (15% pre-post difference), 
assuming a baseline proportion of 62%28 and 56 providers in each arm.  
 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 20 of 24
 
16.3. Describe how missing data will be handled. Missing data will be excluded from 
analysis. 
 
16.4. Describe plans for interim analysis and early stopping rules (if applicable). N/A 
 
16.5. Describe under what circumstances will un-blinding occur and the procedures to do 
so (if applicable). N/A 
  
17. Safety and Adverse Event Management 
 
Note:  You may refer to the Data Safety Monitoring section in the application for your answers 
in this section if this is an initial LIP.  If any of these plans is modified at some point in time after 
initial study approval, then the modifications should be described in this section as part of a 
subsequent LIP.    
 
Safety and Adverse Event Monitoring 
 
17.1. Describe methods used to ensure participant safety monitoring.  Include specific 
management plans for expected or unexpected adverse events as applicable.  
  See Data Safety Monitoring section of application. 
 
17.2. If there are specific criteria for study drug/intervention, modification or 
discontinuation for adverse reactions, they should be described here.  N/A 
 
Monitoring Plan 
 
17.3. Describe Monitoring Plan.   
See Data Safety Monitoring section of application. 
 
Adverse Event Reporting 
 
17.4. Describe how adverse events will be defined, graded, and reported.  If there are any 
potential adverse events that will not be considered related to the study, these 
should be described here.   
See Data Safety Monitoring section of application. 
 
Investigator Help  
 
Data Collection Procedures for Adverse Events 
 
17.5. Indicate who will be collecting and reviewing adverse events and with what 
frequency.  
See Data Safety Monitoring section of application. 
 
 
Review of Study Conduct and Safety Data 
 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
Page 21 of 24
 
17.6. Describe who (individual or group) will periodically review the study conduct and 
data to assess safety for current or future participants.  Include what data will be 
reviewed and the frequency of the review.   
Drs. Opel (PI), Henrikson (co-investigator) and Taylor (co-investigator) will monitor the 
progress of the trial through quarterly assessments of data quality and timeliness, 
participant recruitment, accrual and retention, participant risk versus benefit, and other 
factors that could affect study outcomes. We will make quarterly determinations regarding 
continuation or conclusion of the trial based on these assessments. 
 
Investigator Help  
 
18. Data/Specimen Sharing 
 
18.1. Discuss if data or samples will be shared with other investigators outside of the 
research team.  Provide details as to when the data/samples will be shared (eg 
during trial, banked for future indefinite use), who will have access to the 
data/samples, how access will be controlled and whether data/samples will be 
coded or de-identified.   Data will not be shared outside the research team. 
 
19. References  
 
19.1. Provide references.  List the various references cited in support of research plan.       
 
1. 
Smith PJ, Kennedy AM, Wooten K, Gust DA, Pickering LK. Association between health care 
providers' influence on parents who have concerns about vaccine safety and vaccination coverage. 
Pediatrics 2006;118:e1287-92. 
2. 
Gust DA, Strine TW, Maurice E, et al. Underimmunization among children: effects of vaccine 
safety concerns on immunization status. Pediatrics 2004;114:e16-22. 
3. 
Gowda C, Dempsey AF. The rise (and fall?) of parental vaccine hesitancy. Hum Vaccin 
Immunother 2013;9:1755-62. 
4. 
Centers for Disease C, Prevention. National, state, and local area vaccination coverage among 
children aged 19-35 months--United States, 2011. MMWR Morb Mortal Wkly Rep 2012;61:689-96. 
5. 
Centers for Disease C, Prevention. Measles - United States, January 1-August 24, 2013. MMWR 
Morb Mortal Wkly Rep 2013;62:741-3. 
6. 
Omer SB, Richards JL, Ward M, Bednarczyk RA. Vaccination policies and rates of exemption 
from immunization, 2005-2011. N Engl J Med 2012;367:1170-1. 
7. 
Richards JL, Wagenaar BH, Van Otterloo J, et al. Nonmedical exemptions to immunization 
requirements in California: a 16-year longitudinal analysis of trends and associated community factors. 
Vaccine 2013;31:3009-13. 
8. 
Feikin DR, Lezotte DC, Hamman RF, Salmon DA, Chen RT, Hoffman RE. Individual and 
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9. 
Glanz JM, McClure DL, Magid DJ, Daley MF, France EK, Hambidge SJ. Parental refusal of 
varicella vaccination and the associated risk of varicella infection in children. Arch Pediatr Adolesc Med 
2010;164:66-70. 
10. 
Glanz JM, McClure DL, Magid DJ, et al. Parental refusal of pertussis vaccination is associated 
with an increased risk of pertussis infection in children. Pediatrics 2009;123:1446-51. 
11. 
Glanz JM, McClure DL, O'Leary ST, et al. Parental decline of pneumococcal vaccination and risk 
of pneumococcal related disease in children. Vaccine 2011;29:994-9. 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
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Page 22 of 24
 
12. 
Salmon DA, Haber M, Gangarosa EJ, Phillips L, Smith NJ, Chen RT. Health consequences of 
religious and philosophical exemptions from immunization laws: individual and societal risk of measles. 
JAMA 1999;282:47-53. 
13. 
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objectives/topic/immunization-and-infectious-diseases/objectives.) 
14. 
Hammer LD, Curry ES, Harlor AD, et al. Increasing immunization coverage. Pediatrics 
2010;125:1295-304. 
15. 
Leask J. Target the fence-sitters. Nature 2011;473:443-5. 
16. 
Benin AL, Wisler-Scher DJ, Colson E, Shapiro ED, Holmboe ES. Qualitative analysis of mothers' 
decision-making about vaccines for infants: the importance of trust. Pediatrics 2006;117:1532-41. 
17. 
Gust DA, Darling N, Kennedy A, Schwartz B. Parents with doubts about vaccines: which vaccines 
and reasons why. Pediatrics 2008;122:718-25. 
18. 
Gust D, Brown C, Sheedy K, Hibbs B, Weaver D, Nowak G. Immunization attitudes and beliefs 
among parents: beyond a dichotomous perspective. Am J Health Behav 2005;29:81-92. 
19. 
Gust DA, Kennedy A, Weber D, Evans G, Kong Y, Salmon D. Parents questioning immunization: 
evaluation of an intervention. Am J Health Behav 2009;33:287-98. 
20. 
Kennedy AM, Brown CJ, Gust DA. Vaccine beliefs of parents who oppose compulsory 
vaccination. Public Health Rep 2005;120:252-8. 
21. 
Fredrickson DD, Davis TC, Arnould CL, et al. Childhood immunization refusal: provider and 
parent perceptions. Fam Med 2004;36:431-9. 
22. 
Opel DJ, Heritage J, Taylor JA, et al. The architecture of provider-parent vaccine discussions at 
health supervision visits. Pediatrics 2013;132:1037-46. 
23. 
McCauley MM, Kennedy A, Basket M, Sheedy K. Exploring the choice to refuse or delay 
vaccines: a national survey of parents of 6- through 23-month-olds. Acad Pediatr 2012;12:375-83. 
24. 
Leask J, Chapman S, Hawe P, Burgess M. What maintains parental support for vaccination when 
challenged by anti-vaccination messages? A qualitative study. Vaccine 2006;24:7238-45. 
25. 
Brown KF, Kroll JS, Hudson MJ, et al. Factors underlying parental decisions about combination 
childhood vaccinations including MMR: a systematic review. Vaccine 2010;28:4235-48. 
26. 
Davis TC, Fredrickson DD, Arnold CL, et al. Childhood vaccine risk/benefit communication in 
private practice office settings: a national survey. Pediatrics 2001;107:E17. 
27. 
Walther S. A parent's decision on immunization: making the right choice. Pediatrics 2011;127 
Suppl 1:S5-8. 
28. 
Kempe A, Daley MF, McCauley MM, et al. Prevalence of parental concerns about childhood 
vaccines: the experience of primary care physicians. Am J Prev Med 2011;40:548-55. 
29. 
Kennedy A, Lavail K, Nowak G, Basket M, Landry S. Confidence about vaccines in the United 
States: understanding parents' perceptions. Health Aff (Millwood) 2011;30:1151-9. 
30. 
Evans M, Stoddart H, Condon L, Freeman E, Grizzell M, Mullen R. Parents' perspectives on the 
MMR immunisation: a focus group study. Br J Gen Pract 2001;51:904-10. 
31. 
Healy CM, Montesinos DP, Middleman AB. Parent and provider perspectives on immunization: 
are providers overestimating parental concerns? Vaccine 2014;32:579-84. 
32. 
Opel DJ, Mangione-Smith R, Taylor JA, et al. Development of a survey to identify vaccine-
hesitant parents: the parent attitudes about childhood vaccines survey. Hum Vaccin 2011;7:419-25. 
33. 
Opel DJ, Taylor JA, Mangione-Smith R, et al. Validity and reliability of a survey to identify 
vaccine-hesitant parents. Vaccine 2011;29:6598-605. 
34. 
Opel DJ, Taylor JA, Zhou C, Catz S, Myaing M, Mangione-Smith R. The relationship between 
parent attitudes about childhood vaccines survey scores and future child immunization status: a validation 
study. JAMA Pediatr 2013;167:1065-71. 
35. 
Smith PJ, Humiston SG, Parnell T, Vannice KS, Salmon DA. The association between intentional 
delay of vaccine administration and timely childhood vaccination coverage. Public Health Rep 
2010;125:534-41. 
36. 
Sadaf A, Richards JL, Glanz J, Salmon DA, Omer SB. A systematic review of interventions for 
reducing parental vaccine refusal and vaccine hesitancy. Vaccine 2013;31:4293-304. 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
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Page 23 of 24
 
37. 
Freed GL, Clark SJ, Butchart AT, Singer DC, Davis MM. Sources and perceived credibility of 
vaccine-safety information for parents. Pediatrics 2011;127 Suppl 1:S107-12. 
38. 
Gellin BG, Maibach EW, Marcuse EK. Do parents understand immunizations? A national 
telephone survey. Pediatrics 2000;106:1097-102. 
39. 
Gust DA, Woodruff R, Kennedy A, Brown C, Sheedy K, Hibbs B. Parental perceptions 
surrounding risks and benefits of immunization. Semin Pediatr Infect Dis 2003;14:207-12. 
40. 
Kennedy A, Basket M, Sheedy K. Vaccine attitudes, concerns, and information sources reported 
by parents of young children: results from the 2009 HealthStyles survey. Pediatrics 2011;127 Suppl 
1:S92-9. 
41. 
Taylor JA, Newman RD. Parental attitudes toward varicella vaccination. The Puget Sound 
Pediatric Research Network. Arch Pediatr Adolesc Med 2000;154:302-6. 
42. 
Senier L. "It's your most precious thing": worst-case thinking, trust, and parental decision making 
about vaccinations. Sociological Inquiry 2008;78:207-29. 
43. 
Glascoe FP, Dworkin PH. The role of parents in the detection of developmental and behavioral 
problems. Pediatrics 1995;95:829-36. 
44. 
Hayutin LG, Reed-Knight B, Blount RL, Lewis J, McCormick ML. Increasing parent-pediatrician 
communication about children's psychosocial problems. J Pediatr Psychol 2009;34:1155-64. 
45. 
Jellinek MS, Murphy JM, Little M, Pagano ME, Comer DM, Kelleher KJ. Use of the Pediatric 
Symptom Checklist to screen for psychosocial problems in pediatric primary care: a national feasibility 
study. Arch Pediatr Adolesc Med 1999;153:254-60. 
46. 
Murphy JM, Ichinose C, Hicks RC, et al. Utility of the Pediatric Symptom Checklist as a 
psychosocial screen to meet the federal Early and Periodic Screening, Diagnosis, and Treatment 
(EPSDT) standards: a pilot study. J Pediatr 1996;129:864-9. 
47. 
Nelson HD, Nygren P, Walker M, Panoscha R. Screening for speech and language delay in 
preschool children: systematic evidence review for the US Preventive Services Task Force. Pediatrics 
2006;117:e298-319. 
48. 
Committee on Infectious Diseases AAoP. Recommended childhood and adolescent immunization 
schedule--United States, 2014. Pediatrics 2014;133:357-63. 
49. 
Henrikson NB, Opel DJ, Grothaus L, et al. Physician Communication Training and Parental 
Vaccine Hesitancy: A Randomized Trial. Pediatrics 2015;136:70-9. 
50. 
Opel DJ, Mangione-Smith R, Robinson JD, et al. The Influence of Provider Communication 
Behaviors on Parental Vaccine Acceptance and Visit Experience. Am J Public Health 2015:e1-e7. 
 
19.2. Research Team’s Previous Experience in Conducting This Type of Study.  Describe 
the previous experience of the Principal Investigator and/or study team in conducting this 
type of study.  This can include unpublished and in-progress endeavors as well as 
published reports.  Participation in studies which used a similar research design, but in a 
different setting/patient population may also be considered relevant. If the investigators 
have not participated in any preliminary studies leading up to the current one, please reply 
“None” to this question.  
 
Dr. Opel has extensive experience using survey methods and qualitative analyses similar 
to that proposed in this project. This projects builds upon earlier Seattle Children’s 
Research Institute-funded work that he conducted as PI to develop the Parent Attitudes 
about Childhood Vaccines (PACV) survey and evaluate its construct validity, predictive 
validity, and test-retest reliability. These foundational projects yielded 3 peer-reviewed 
publications and helped foster a strong collaborative relationship with investigators at 
Group Health Research Institute/Group Health Cooperative. To develop his overall 
research program, he successfully competed for NIH support through the K23 mechanism 
and has efficiently and effectively administered his K23-associated projects: he has 

 
IRB # (if known): 15782 
Study Title: Screening Parents about Recommended 
Care for Kids (SPARCK) Study 
Principal Investigator: Doug Opel, MD, MPH 
Version Date: 5/1/2018 
 
 
Local Implementation Plan (short) 10.07.15 
 
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provided leadership and oversight to research staff, fostered research collaborations, and 
to date has published two manuscripts. This, in combination with his clinical and research 
training in general pediatrics and health services research, has provided him with the 
research environment, expertise and insight needed to successfully conduct and complete 
the proposed work. In summary, he is an early stage investigator with a productive 
research record and the relevant background and research skills needed to successfully 
lead and conduct the proposed research.