Communication to Improve Shared Decision-Making in Attention-Deficit/Hyperactivity Disorder
Phase: NA
Conditions: Attention-Deficit/Hyperactivity Disorder
Sponsor: Children's Hospital of Philadelphia

 
 
 
 
 
Communication to Improve Shared-Decision Making in Attention-Deficit/Hyperactivity 
Disorder (ADHD) 
NCT02716324 
4/17/18 

 
 
 
 
 
 
 
 
ii 
  
Title: 
Communication to Improve Shared-Decision Making in 
Attention-Deficit/Hyperactivity Disorder (ADHD) 
Short Title 
ADHD Link Study 
Regulatory Sponsor: 
Patient-Centered Outcomes Research Institute (PCORI) 
eIRB Number 
 
Protocol Date: 
April 17, 2018 
Amendment 1 Date: 6/30/2016 
Amendment 3 Date: 8/15/2016 
Amendment 5 Date: Withdrawn  
Amendment 7 Date: 5/12/2017 
Amendment 9 Date: 6/27/2017 
Amendment 11 Date: Withdrawn 
Amendment 13 Date: 12/6/2017 
Amendment 15 Date: 2/9/2018 
Amendment 2 Date: 7/142016  
Amendment 4 Date: 2/14/2017 
Amendment 6 Date: 5/8/2017 
Amendment 8 Date: 6/12/2017 
Amendment 10 Date: 11/16/2017 
Amendment 12 Date: 11/27/2017 
Amendment 14 Date: 1/17/2018 
 
 
 
Site Principal Investigator 
James Guevara, MD, MPH 
The Children’s Hospital of Philadelphia 
2716 South St, 11-172 
Philadelphia, PA, 19146 
Phone (215) 590-1130  
email: guevara@email.chop.edu 
 

 
 
 
 
 
 
 
 
iii 
TABLE OF CONTENTS 
Table of Contents....................................................................................................................... iii 
Abbreviations and Definitions of Terms ..................................................................................v 
Abstract ....................................................................................................................................... vi 
Protocol Synopsis ..................................................................................................................... viii 
Table 1: Schedule of Study Procedures ................................................................................ xii 
1 
BACKGROUND INFORMATION AND RATIONALE ............................................................................. 1 
1.1 
INTRODUCTION ................................................................................................................................. 1 
1.2 
NAME AND DESCRIPTION OF INVESTIGATIONAL PRODUCT OR INTERVENTION ...................................... 1 
1.3 
RELEVANT LITERATURE AND DATA ................................................................................................... 1 
1.4 
COMPLIANCE STATEMENT ................................................................................................................. 3 
2 
STUDY OBJECTIVES ...................................................................................................................................... 3 
2.1 
PRIMARY OBJECTIVE (OR AIM) .......................................................................................................... 3 
2.2 
SECONDARY OBJECTIVES (OR AIM) .................................................................................................... 3 
3 
INVESTIGATIONAL PLAN............................................................................................................................ 4 
3.1 
GENERAL SCHEMA OF STUDY DESIGN................................................................................................ 4 
3.1.1 
Screening Phase ........................................................................................................................ 4 
3.2 
ALLOCATION TO TREATMENT GROUPS AND BLINDING ....................................................................... 5 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES................................................................... 5 
3.3.1 
Duration of Study Participation ................................................................................................. 5 
3.3.2 
Total Number of Study Sites/Total Number of Subjects Projected................................................ 5 
3.4 
STUDY POPULATION .......................................................................................................................... 5 
3.4.1 
Inclusion Criteria ...................................................................................................................... 6 
3.4.2 
Exclusion Criteria ..................................................................................................................... 6 
4 
STUDY PROCEDURES .................................................................................................................................... 6 
4.1 
SCREENING VISIT .............................................................................................................................. 6 
4.2 
STUDY TREATMENT PHASE................................................................................................................ 7 
4.3 
SUBJECT COMPLETION/WITHDRAWAL ............................................................................................... 8 
4.4 
SCREENING AND MONITORING ........................................................................................................... 9 
4.4.1 
Medical Record Review ............................................................................................................. 9 
4.4.2 
Other Evaluations, Measures ..................................................................................................... 9 
4.5 
EFFICACY EVALUATIONS ................................................................................................................. 10 
4.5.1 
Diagnostic Tests, Scales, Measures, etc.................................................................................... 10 
4.6 
SAFETY EVALUATION...................................................................................................................... 11 
5 
STATISTICAL CONSIDERATIONS ........................................................................................................... 11 
5.1 
PRIMARY ENDPOINT ........................................................................................................................ 11 
5.2 
SECONDARY ENDPOINTS ................................................................................................................. 11 
5.3 
STATISTICAL METHODS ................................................................................................................... 11 
5.3.1 
Baseline Data .......................................................................................................................... 11 
5.3.2 
Efficacy Analysis ..................................................................................................................... 11 
5.4 
SAFETY ANALYSIS .......................................................................................................................... 12 
5.5 
SAMPLE SIZE AND POWER ............................................................................................................... 12 
6 
SAFETY MANAGEMENT ............................................................................................................................. 14 
6.1 
CLINICAL ADVERSE EVENTS ............................................................................................................ 14 
6.2 
ADVERSE EVENT REPORTING .......................................................................................................... 14 
7 
STUDY ADMINISTRATION ......................................................................................................................... 15 

  
 
 
 
 
 
 
 
iv 
7.1 
TREATMENT ASSIGNMENT METHODS ............................................................................................... 15 
7.1.1 
Randomization ........................................................................................................................ 15 
7.2 
DATA COLLECTION AND MANAGEMENT .......................................................................................... 15 
7.3 
CONFIDENTIALITY ........................................................................................................................... 16 
7.4 
REGULATORY AND ETHICAL CONSIDERATIONS ................................................................................ 17 
7.4.1 
Data and Safety Monitoring Plan ............................................................................................. 17 
7.4.2 
Risk Assessment ....................................................................................................................... 17 
7.4.3 
Potential Benefits of Trial Participation ................................................................................... 18 
7.4.4 
Risk-Benefit Assessment ........................................................................................................... 18 
7.5 
RECRUITMENT STRATEGY ............................................................................................................... 18 
7.5.1 
Consent ................................................................................................................................... 19 
7.5.2 
HIPAA Authorization ............................................................................................................... 19 
7.6 
PAYMENT TO SUBJECTS/FAMILIES ................................................................................................... 19 
7.6.1 
Payments to parent for time and inconvenience (i.e. compensation) .......................................... 20 
7.6.2 
Payments to child for time, effort and inconvenience (i.e. compensation) .................................. 20 
7.6.3 
Gifts ........................................................................................................................................ 20 
8 
PUBLICATION ................................................................................................................................................ 20 
9 
REFERENCES .................................................................................................................................................. 22 
 

  
 
 
 
 
 
 
 
v 
ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
 
 
 
 
 
 
ADHD 
AHRQ 
CHOP 
CM 
EHR 
GAS 
 
Attention-Deficit/Hyperactivity Disorder 
Agency for Healthcare Research and Quality 
Children’s Hospital of Philadelphia 
Care Manager 
Electronic Health Records 
Goal Attainment Scaling 
HP 
PCP 
 
Healthy Pathway Scales 
Primary Care Provider 
PCORI 
 
Patient-Centered Outcomes Research Institute 
PeRC 
PFCC 
PGI 
PRO 
PROMIS 
 
REDCap 
SACA 
SDM 
 
 
 
Pediatric Research Consortium Network 
Patient and Family-Centered ADHD Care 
Preference and Goal Instrument 
Patient-Reported Outcomes 
Patient Reported Outcomes Measurement 
Information System 
Research Electronic Data Capture  
Services Assessment for Children and 
Adolescents  
Share-Decision Making 
VPRS 
VTRS 
 
Vanderbilt Parent Rating Scales 
Vanderbilt Teacher Rating Scales 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
 
 
 
 
 
 
vi 
ABSTRACT 
Context:  
Health care for children with ADHD is fragmented between patients and families, teachers, 
and clinicians. This fragmentation can result in poorly coordinated services, and suboptimal 
outcomes for children with this common mental health disorder. Little attention has been 
devoted to developing and testing communication strategies as a means to improve ADHD 
care. 
Objectives:  
1. Determine the comparative effectiveness of an electronic patient portal (usual care, 
see Appendix 1), with the electronic patient portal combined with a care manager 
(CM, Appendix 2) to facilitate family-centered communication and treatment for 
children with ADHD.  
2. Assess treatment initiation, adherence and family engagement as mediators of 
intervention treatment effects. 
3. Geocode and conduct spatial analysis to explore individual, family and community 
factors that moderate intervention treatment effects.  
Study Design:  
This study is a prospective, randomized comparative effectiveness trial. 
Setting/Participants: 
This study will enroll 300 parent-child dyads in which the child has ADHD and is 5 through 
12 years old from up to 15 outpatient pediatric primary care clinics in The Children’s 
Hospital of Philadelphia (CHOP)’s Care Network. Eligible children must have an ADHD 
diagnosis and receive care at a participating clinic within the past 12 months. Children will 
be excluded if they and/or their parents/caregivers are non-English speaking, have a 
diagnosis of autistic spectrum disorder, conduct disorder, psychosis, bipolar disorder, or 
suicide attempt in the past 12 months. Participants will be randomized to either the patient 
portal only, or the patient portal combined with a Care Manger (CM) and will complete 3 
follow-up visits over 9-12 months. 
Study Interventions and Measures:  
Families enrolled in the intervention will receive The ADHD portal and a CM. Participants 
will complete a screening to determine their treatment preferences and goals, and will be 
contacted weekly to every 3 months by the CM, who will provide education on common 
ADHD problems, assess treatment use, and identify new concerns. The CM will also 
communicate with their pediatric clinicians, mental health providers, and teachers to clarify 
family treatment preferences and goals, communicate information, coordinate care, and 
address emerging treatment issues.  
Families enrolled in the usual care arm will receive care as usual from their PCP and access 
the ADHD portal to complete rating scales, view teacher rating scales, and download 

 
 
 
 
 
 
 
 
 
 
vii 
educational handouts. 
Primary study outcome measures are: Vanderbilt Parent and Teacher Rating Scales to 
measure ADHD Symptoms, ADHD Preference and Goal Instrument, Goal Attainment 
Scale, and Patient Reported Outcomes Measurement Information System short forms and 
Healthy Pathway Scales to measure patient-reported outcomes. Secondary outcome 
assessments will include measure patient and family engagement and treatment initiation 
and adherence. These measures will be completed at baseline, 3-5 months, 6-8 months, and 
9-12 months following enrollment.

 
 
 
 
 
 
 
 
 
 
viii 
PROTOCOL SYNOPSIS 
Study Title 
Communication to Improve Shared-Decision Making in Attention-
Deficit/Hyperactivity Disorder (ADHD) 
Funder 
Patient-Centered Outcomes Research Institute (PCORI) 
Clinical Phase 
Phase III 
Study Rationale 
Fragmentation in health care and poor communication across 
systems adversely impact engagement and adherence to treatment 
by children with ADHD and their families. Fragmentation of 
services for ADHD impairs communication and collaboration 
between families and primary care providers, mental health 
providers, and educators, and leads to suboptimal outcomes for 
children.  
Fragmentation in the systems of care has been cited by a 
presidential commission as a major obstacle to effective care. To 
obtain treatment from diverse providers, families of affected 
children must negotiate the physical, mental health, and educational 
systems, but fragmentation in the system limits their ability to 
complete this task. Prior studies have documented that little 
communication and coordination exist among providers across 
different systems despite calls for better system integration.  
Fragmentation in communication between providers has the 
potential to impair shared decision-making. To promote shared 
decision-making, we have developed an electronic health record 
(EHR)-linked portal to collect information from parents, teachers 
and clinicians on children’s ADHD symptoms and treatment-related 
preferences and goals. We have also developed an ADHD care 
manager intervention manual. 
Study Objective(s) 
Primary  
• Determine the comparative effectiveness of an electronic 
patient portal designed to communicate family-centered 
preferences and goals for treatment of ADHD with providers 
and educators (tier 1) with the electronic patient portal 
combined with a Care Manger (CM)(tier 2) to facilitate 
communication for children with ADHD.  
Secondary 
• Assess treatment initiation and adherence and family 
engagement as mediators of intervention treatment effects. 
• Explore individual, family, and community factors that 
moderate intervention treatment effects 
• Investigate test-retest reliability of PFCC survey 

  
 
 
 
 
 
 
 
ix 
• Investigate intervention group parent satisfaction with the 
care manager 
• Evaluate intervention group outcome experience with care 
management and study feedback  
Test Article(s) 
(If Applicable) 
Patient portal with CM:  
• The CM will meet with families at the beginning of the study to 
confirm their treatment preferences and goals. 
• The CM will follow up with families weekly to every 3 months. 
• The CM will also communicate with the clinicians, mental 
health providers, and teachers.  
Study Design 
 
• Prospective, randomized comparative effectiveness trial. 
• Participants will be randomized 1:1 to the ADHD portal (tier 1) 
or the ADHD portal plus CM (tier 2). 
• Randomization will be stratified by practice, child gender, and 
age groups (5 though 8 years old and 9 through 12 years old). 
• Treatment assignment will be done at the time of enrollment 
following informed consent, and patient-reported outcomes 
collected at baseline, 3-5, 6-8, and 9-12 months. 
Subject Population 
key criteria for 
Inclusion and Exclusion: 
Inclusion Criteria 
1. Ages 5 through 12 years old. 
2. Receiving ADHD treatment from participating practices. 
3. ADHD or ADD diagnosis code recorded in the past year. 
4. Parental/guardian permission and if appropriate, child 
assent. 
Exclusion Criteria 
Subjects with a diagnosis of any of the following in the past 
12 months, as measured by self report: autistic spectrum 
disorder, conduct disorder, psychosis, bipolar disorder, 
suicide risk, or non-English speaking 
Number Of Subjects  
 
Total number of Subjects: 300 parent-child dyads 
Total Number at CHOP: 300 parent-child dyads 
Total Number of Sites: up to15 CHOP practices 
Study Duration 
Each subject’s participation will last 9-12 months. 
The entire study is expected to last 36 months 
Study Phases 
Screening 
Study Treatment 
 
Screening: Families will be mailed recruitment letters signed by 
their PCP or practice, including a stamped self-addressed postcard 
to permit families to opt out. Families who do not opt out will be 
called to screen for eligibility and schedule a consent visit. 

  
 
 
 
 
 
 
 
x 
Intervention:  
• The CM will meet with families at the beginning of the 
study to confirm their treatment preferences and goals, and 
will contact families weekly to every 3 months to assess 
treatment use, identify new concerns, and assist families 
with problem-solving.  
• The CM will also communicate with pediatric clinicians, 
mental health providers, and teachers to clarify family 
treatment preferences and goals and address emerging 
treatment issues.  
• Efficacy 
Evaluations 
• ADHD Symptoms: Vanderbilt Parent and Teacher Rating 
Scales (VPRS and VTRS, Appendices 9 and 10) 
• Goal Attainment: ADHD Preference and Goal Instrument 
and Goal Attainment Scaling (Appendices 15 and 5) 
• Patient-reported Outcome (PRO) Measures: Patient 
Reported Outcomes Measurement Information System 
(PROMIS) short forms and Healthy Pathway (HP) Scales 
(Appendix 17) 
• Treatment initiation and adherence: Monthly EHR data 
review and the Services Assessment for Children and 
Adolescents (SACA) (Appendix 14) 
• Family engagement: PFCC Questionnaire (Appendix 18) 
• Satisfaction Survey: Investigate intervention group parent 
satisfaction with the care manager 
 
Safety Evaluations 
• Subject safety will be monitored by adverse events, and 
follow-up surveys (Appendices 3 and 6).  
• The research team will query participants at least every 6 
months to determine if personal health information has been 
disclosed.  
Statistical And Analytic 
Plan 
• Study data will be collected and managed using the secure 
web-based REDCap database at CHOP. 138  
• Repeated measures longitudinal analysis that models 
baseline, 3-5 month, 6-8 month, and 9-12 month 
measurements as outcomes.  
• For the primary outcomes of ADHD symptoms and goal 
attainment, and secondary PRO measures, both linear mixed 
effects and marginal (GEE) models will be implemented.  
DATA AND SAFETY 
MONITORING PLAN 
• The Principal Investigator is responsible for data quality 
management and ongoing assessment of safety.  

  
 
 
 
 
 
 
 
xi 
• Study data will be collected and managed using the secure 
web-based REDCap database at CHOP 
• Data will be encrypted and transferred from its origin to the 
database housed in CHOP’s secure data center.  
• All data management and analysis will proceed on secure 
data and software servers that have daily back-up.  
• All participants will be provided with a unique study 
identifier, which will permit linking of study measures in the 
REDCap database.  

 
xii  
 
 
 
 
 
 
 
TABLE 1: SCHEDULE OF STUDY PROCEDURES  
Study Phase 
Screening 
Intervention 
Visit Number 
Phone 
Call 
1 
2 
3 
4 
5 
Study Days 
 
Baseline 
3-5 Months 
6-8 Months 
9-12 Months 
9.5-12 Months 
Review Inclusion/Exclusion 
Criteria 
X`1 
 
 
 
 
 
Informed Consent/Assent 
 
X 
 
 
 
X 
Randomization 
 
X 
 
 
 
 
Demographics/Medical History 
 
X 
 
 
 
 
ADHD Symptoms 
 
X 
X 
X 
X 
 
Goal Attainment 
 
 
X 
X 
X 
 
Patient 
Reported 
Outcome 
Measures 
 
X 
X 
X 
X 
 
Treatment initiation and 
adherence 
 
X 
X 
X 
X 
 
PFCC Questionnaire  
 
 
 
 
X 
X 
Satisfaction Survey 
 
 
 
 
X 
 
Qualitative Interview 
 
 
 
 
 
X 

 
page xiii 
  
 
 
 
FIGURE 1: STUDY DIAGRAM 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TELEPHONE 
SCREENING 
NOT 
ELIGIBLE 
VISIT 1 
Consent, 
Randomization, 
Baseline 
3-5 MONTHS 
Data Collection 
6-8 MONTHS 
Data Collection 
9-12 MONTHS 
Data Collection 
6-8 MONTHS 
Data Collection 
3-5 MONTHS 
Data Collection 
9-12 MONTHS  
Data Collection 
(Tier 1): The ADHD 
Portal 
(Tier 2): The ADHD 
Portal with CM 
9.5-12 MONTHS 
Additional PFCC 
 
*10-21 days after 9 Month 
PFCC completion 
9.5-12 MONTHS 
Additional PFCC 
 
*10-21 days after 9 Month 
PFCC completion 
9+ MONTHS 
Satisfaction 
Survey 
9+ MONTHS 
Qualitative 
Interview 

 
  
 
 
 
1 
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 
Introduction 
Electronic patient portals are online healthcare applications that allow patients to interact 
and communicate with their healthcare providers and manage their health. These portals are 
increasingly common in healthcare and have the potential to overcome fragmentation, 
promote SDM, and improve patient outcomes (Yamin, Emani, Williams, et al., 2011; North 
et. al., 2011). Clinicians and families are interested in having families manage their own 
health information within electronic systems, (Wynia, Torres & Lemieux, 2011; Markle 
Foundation, 2011a; Markle Foundation, 2011b) and electronic communication is common 
(Mariano, 2000; Rosen & Kwoh, 2007). One pediatric study in ADHD found that 
community pediatricians using a portal were significantly more likely to collect information 
from parents and teachers.83 In family medicine, use of a portal focused on preventive care 
resulted in increased patient activation and greater patient-centered care, and users were 
more likely to receive needed preventive care (Nagykaldi, Aspy, Chou & Mold, 2012).  
Although the research linking portal use to patient engagement and adherence is promising, 
portals traditionally have been designed for simple tasks such as appointment scheduling 
and results review, not facilitating SDM and coordinating care around families’ clearly 
defined preferences and goals, a broadly applicable innovation in this proposal. To address 
this gap, we have developed an electronic health record (EHR)-linked portal with separate 
funding in order to collect information from parents and teachers on children’s ADHD 
symptoms, symptoms suggestive of common comorbidities, as well as parents’ treatment-
related preferences and goals (Bell, Grundmeier & Localio, et al., 2010). 
1.2 
Name and Description of Investigational Product or Intervention 
This intervention includes the EHR-linked portal created for ADHD patients, in addition to 
care mangers as a means to improve SDM and care of ADHD patients. Using data captured 
through the portal, the CM will meet with families at the beginning of the study to confirm 
their treatment preferences and goals, provide additional education on ADHD treatment, and 
distribute handouts on common concerns among ADHD patients and families. The CM will 
contact families weekly to every 3 months by phone, email, or in-person as needed to assess 
treatment use, identify new concerns, and assist families with problem-solving. Using the 
portal or other means, the CM will also communicate with pediatric clinicians, mental health 
providers, and teachers to clarify family treatment preferences and goals and address 
emerging treatment issues. A fidelity checklist developed in the pilot study will be utilized 
to assess self-reported task completion of each intervention component by the CM (0- not 
completed, 1- partially completed, 2- fully completed). In addition, the CM will summarize 
clinically relevant encounters in the ADHD portal, facilitating communication.  
1.3 
Relevant Literature and Data 
ADHD, characterized by inattention, impulsivity, and hyperactivity (Guevara & Stein, 
2001a; Guevara & Stein, 2001b; Elia, Ambrosini & Rapoport, 1999; American Psychiatric 
Association, 2008) is the most common chronic neurobehavioral disorder in children 
(Kelleher, McInerny, Gardner, Childs & Wasserman, 2000; Green, Wong, Atkins, Taylor & 

 
  
 
 
 
2 
Feinleib, 1999). According to the National Survey of Children’s Health conducted by the 
Centers for Disease Control, 5.4 million children ages 4 to 17 years old in the United States 
have been diagnosed with the condition (MMWR Morb Mortal Wkly Rep, 2010). 
Evidence-based treatments improve outcomes for children with ADHD. The effectiveness of 
treatment for ADHD is supported by a large number of clinical trials and consists of 
psychotropic medications like methylphenidate, behavior therapy, and school-based 
modifications either alone or in combination (American Academy of Pediatrics, 2011; 
Pelham, Wheeler & Chronis, 1998; MTA Cooperative Group, 1999; Hoffman & DuPaul, 
2000, American Academy of Child and Adolescent Psychiatry,1997; Charach, Dashti, 
Carson, et al., 2011; Subcommittee on Attention-Deficit/Hyperactivity Disorder, 2011). 
 
Unfortunately, engagement in and adherence to ADHD treatment is poor, limiting the 
effectiveness of evidence-based strategies. Despite the availability of proven treatments, 
many children with ADHD do not receive evidence-based care over the long-term (Zima, 
Hurlburt, Knapp, et al., 2005). Research has found poor adherence and inconsistent use of 
effective treatments in community studies, with only a third of children receiving treatment 
over a year (Froehlich, Lamphear, Epstein, et al., 2007; Agency for Healthcare Research and 
Quality, 2011). In fact, up to 44% may receive no evidence-based treatment. Of those who 
are treated, a majority of children (80%) receive medication, and less than half receive 
behavioral interventions (Zima, Bussing & Tang, 2010). National guidelines prioritize 
shared decision making (SDM) as a strategy to engage families in treatment and improve 
adherence and outcomes. SDM is particularly helpful for conditions like ADHD that have 
multiple evidence-based options and in which variation exists in how families weigh their 
risks and benefits (Barry, 2002).  
 
Our prior research found that families who were more easily able to contact their child’s 
doctor outside of office visits were more likely to report high levels of SDM (Fiks, Localio, 
Alessandrini, Asch & Guevara, 2010), suggesting that interventions that facilitate 
communication and information sharing outside the context of office visits may improve 
SDM and engagement in care. However, the bulk of research and conceptual work on SDM 
has focused on a single point-in-time decision in a single patient-provider interaction 
(Brinkman et. al., 2011; O'Connor, Bennett, Stacey, et al., 2009). This proposal broadens the 
definition of SDM by focusing on a chronic childhood condition (ADHD) with longitudinal 
decision-making between patients/parents and multiple providers. 
For this study The Vanderbilt Parent and Teacher Rating Scales (VPRS and VTRS) will be 
used to measure ADHD symptoms, and are standard validated measures of ADHD symptom 
severity that are commonly employed in clinical care and ADHD research studies. The 
VPRS will be measured at baseline and 3-5 months, 6-8 months, and 9-12 months, while the 
VTRS will be obtained by medical record review. The Services Assessment for Children 
and Adolescents (SACA) will be used to measure treatment initiation and adherence, and is 
a valid and reliable parent-report measure of the types of mental health services used over 
the previous 9-12 months, service settings, reasons for service use, and quality of services. 
Goal Attainment Scaling (GAS) will be used to measure goal attainment, and is a validated 
method to rating the degree to which parents feel their goals have been met. Families will 
identify individual goals using the ADHD PGI and rate their progress towards completing 

 
  
 
 
 
3 
the goals individually. Patient-reported outcomes will be measured by the Patient Reported 
Outcomes Measurement Information System (PROMIS) short forms and by the Healthy 
Pathway (HP) Scales. Both of these tools are validated, reliable and accurate measures of 
patient reported outcomes and aspects of health and well-being. Treatment initiation and 
adherence will be measured by monthly HER reviews, and by the completion of the Services 
Assessment for Children and Adolescents (SACA). The SACA is a valid and reliable parent-
reported service use and quality of services.  
1.4 
Compliance Statement 
This study will be conducted in full accordance all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws and 
regulations including 45 CFR 46. All episodes of noncompliance will be documented. 
The investigators will perform the study in accordance with this protocol, will obtain 
consent and assent, and will report unanticipated problems involving risks to subjects or 
others in accordance with The Children’s Hospital of Philadelphia IRB Policies and 
Procedures and all federal requirements. Collection, recording, and reporting of data will be 
accurate and will ensure the privacy, health, and welfare of research subjects during and 
after the study.  
2 
STUDY OBJECTIVES 
The purpose of the study is to determine the comparative effectiveness of an electronic 
patient portal designed to communicate family-centered preferences and goals for treatment 
of ADHD with providers and educators (Tier 1) with the electronic patient portal combined 
with a CM to facilitate communication (Tier 2) for children with ADHD. This study also 
aims to assess treatment initiation and adherence and family engagement as mediators of 
intervention treatment effects. Additionally, this study aims to investigate test-retest 
reliability of the PFCC measure. Parents in the intervention arm who have otherwise 
completed the study will be asked to fill out a satisfaction survey about their use of the care 
manager. Finally, this study aims to explore individual, family, and community factors that 
moderate intervention treatment effects. 
2.1 
Primary Objective (or Aim) 
The primary objective of this study is to determine the comparative effectiveness of an 
electronic patient portal designed to communicate family-centered preferences and goals for 
treatment of ADHD with providers and educators (Tier 1) with the electronic patient portal 
combined with a CM to facilitate communication (Tier 2) for children with ADHD. This aim 
will test whether children in the portal plus CM arm (Tier 2) have greater goal attainment at 
9-12 months and fewer symptoms than children in the portal only arm (Tier 1) at 3-5, 6-8, 
and 9-12 months.  
 
2.2 
Secondary Objectives (or Aim) 
The secondary objectives are to: 

 
  
 
 
 
4 
•  Assess treatment initiation and adherence and family engagement as mediators of 
intervention treatment effects  
• Explore individual, family, and community factors that moderate intervention treatment 
effects. 
• Investigate test-retest reliability of PFCC survey 
• Investigate intervention group parent satisfaction with the care manager 
• Evaluate intervention group outcome experience with care management and study 
feedback 
 
3 
INVESTIGATIONAL PLAN 
3.1 
General Schema of Study Design 
We will conduct a prospective, randomized comparative effectiveness trial. Children will be 
randomized 1:1 to the ADHD portal (Tier 1) or the ADHD portal plus CM (Tier 2). We 
chose a prospective randomized design, because it is most effective at guarding against bias 
and will ensure that the patients in both arms are similar in observed and unobserved 
characteristics. We plan to control statistically for any differences in treatment preferences 
between arms in the analysis.  
3.1.1 Screening Phase 
15 practices will be recruited to participate using letters of invitation and in-person 
presentations. Patient treatment assignment will be done at the time of enrollment following 
informed consent and patients will be followed with measures related to ADHD symptom 
severity, goal attainment, and patient-reported outcomes collected at baseline, 3-5 months, 
6-8 months, and 9-12 months. Eligible children will be identified at each practice using Epic 
data and clinicians at each practice will review the list and nominate children that they 
manage for ADHD. Depending on the number of practices participating, twenty or more 
children will be randomly selected from each practice using a random numbers generator to 
achieve a sample of 300 eligible parent-child dyads. Half the families will be mailed 
recruitment letters signed by their PCP or practice in the first wave of the study and the other 
half in the second wave of the study. Included in the mailing will be a stamped self-
addressed postcard to permit families to opt out. Families who do not opt out will be called 
to screen for eligibility and schedule a consent visit. We will randomly select additional 
children from the same strata for any families that opt out and if recruitment targets are not 
met.  
Families who do not opt out will be called to be read the list of eligibility criteria and will 
not be asked any study questions. Families who are interested in participating will have a 
baseline visit scheduled where written informed consent will be completed. 
Families who consent to participate will complete additional study visits at 3-5 months, 6-8 
months, and 9-12 months to complete study measures using all available means including 
letters, telephone calls, text messages, and emails to ensure data are collected thoroughly 

 
  
 
 
 
5 
and systematically from all participants. Contact information on each participant will be 
updated at every opportunity during telephone calls and by reviewing clinic EHR records. 
Participation incentives will include compensation to complete study measures, quarterly 
newsletters, and child birthday card mailings, all of which have been used in our prior work 
with urban populations to maintain >80% participant follow-up (Power et al., 2010).  
Study Treatment Phase (start of the study intervention) 
Tier 1 will consist of an electronic patient portal designed specifically for ADHD (Appendix 
1). Tier 2 will consist of the electronic patient portal combined with an ADHD CM 
(Appendix 2). Tier 2 also will permit us to test whether the addition of a CM can improve 
outcomes for specific patient subgroups including patients from urban communities, of 
minority, or lower socioeconomic status who might be less engaged with the portal.  
3.2 
Allocation to Treatment Groups and Blinding 
We will conduct a prospective, randomized comparative effectiveness trial. Children will be 
randomized 1:1 to the ADHD portal (tier 1) or the ADHD portal plus Care Manager (tier 2). 
We chose a prospective randomized design, because it is most effective at guarding against 
bias and will ensure that the patients in both arms are similar in observed and unobserved 
characteristics. Planned centrally by our biostatistician, randomization will be stratified by 
practice, gender, and age groups (5-7 years old and 8-12 years old) to ensure balance. We 
plan to control statistically for any differences in treatment preferences between arms in the 
analysis. Allocation concealment (blinding of the treatment assignment) will be 
implemented using sealed, opaque envelopes, along with stratification, and randomly 
permuted blocks of unequal sizes (to prevent providers and patients from manipulating the 
randomization to favor any treatment). Treatment assignment will be done at the time of 
enrollment following informed consent and patients will be followed with measures related 
to ADHD symptom severity, goal attainment, and patient-reported outcomes collected at 
baseline, 3-5 months, 6-8 months, and 9-12 months. Blinding in this study is not relevant. 
3.3 
Study Duration, Enrollment and Number of Sites 
3.3.1 Duration of Study Participation 
Families who consent to participate will be enrolled in the study for 9-12 months and 
contacted for follow-up at 3-5 months, 6-8 months, and 9-12 months to complete study 
measures.  
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
We will recruit up to 15 practices to participate in the study. At each practice, we will recruit 
20 or more participants to achieve a total sample size of 300 parent-child dyads. 
3.4 
Study Population 
Patients 5 through 12 years old with ADHD will be recruited from up to 15 pediatric 
primary care practices within the Pediatric Research Consortium (PeRC), an Agency for 
Healthcare Research and Quality (AHRQ) supported practice-based research network at The 
Children's Hospital of Philadelphia (CHOP). 

 
  
 
 
 
6 
3.4.1 Inclusion Criteria 
1) Aged 5 through12 years old 
2) Receiving ADHD treatment from participating practices 
3) ADHD or ADD diagnosis code, ICD-10-CM F90.9 or F90.0, listed in the problem list or 
recorded at an ambulatory visit in the past year.  
4) Parental/guardian permission (informed consent) and if appropriate, child assent. 
3.4.2 Exclusion Criteria 
1) Children will be excluded if, as measured by self report, in the past 12 months they 
and/or their parents/caregivers are non-English speaking or have any of the following 
diagnoses: 
a) Autism spectrum disorder, ICD-10-CM F84.0 
b) Conduct disorder, ICD-10-CM F91.1 
c) Psychosis, ICD-10-CM F29 
d) Bipolar disorder, ICD-10-CM F31.9 
e) Suicide attempt, ICD-10-CM T14.91, or suicide ideation, ICD-10-CM R45.851 
2) Parents/guardians or subjects who are non-English speaking or who, in the opinion of 
the Investigator, may be non-compliant with study schedules or procedures. 
4 
STUDY PROCEDURES 
The study research materials will consist of parent- and child-reported instruments and will 
be separate from information entered into the ADHD portal. Parents will complete measures 
of treatment preferences and goals (ADHD PGI), ADHD symptoms (VPRS), and PRO at 
baseline. They will complete a measure of engagement at 0 and 9-12 months. They will also 
complete VPRS, and goal attainment (GAS) at 3-5 months, 6-8 months, and 9-12 months. 
Parents will complete a measure of treatment initiation and adherence (SACA) at 9-12 
months. Parents and children, as appropriate, will complete the PRO measures (school 
performance, student engagement, peer relationships, family belonging, and teacher 
connectedness) at 9-12 months. Parents will complete PFCC measure at 9-12 months and up 
to 40 participants will complete second PFCC measure. Parents and children will complete 
the study measures using a subject-specific embedded email link to a REDCap survey on a 
secure server. Tier 1 will consist of an electronic patient portal designed specifically for 
ADHD (Appendix 1). Tier 2 will consist of the electronic patient portal combined with an 
ADHD CM (Appendix 2). Tier 2 also will permit us to test whether the addition of a CM 
can improve outcomes for specific patient subgroups including patients from urban 
communities, of minority, or lower socioeconomic status that might be less engaged with the 
portal (Specific Aim #3). Tier 2 will also be asked to complete a satisfaction survey about 
using the care manager (Appendix 19). In addition, 40 Tier 2 participants will be asked to do 
an interview about their experience with care management and for study feedback 
(Appendix 20). 
4.1 
Screening Visit 
Eligible children will be identified at each practice using Epic data and clinicians at each 
practice will review the list and nominate families of children for whom they manage for 

 
  
 
 
 
7 
ADHD. 300 families will be randomly selected from the list of nominated families. The 
randomly selected families will be mailed recruitment letters signed by their PCP or the 
practice (Appendix 7) informing them about the study. Included in the mailing will be a 
stamped self-addressed postcard for families to return should they elect to opt out of the 
study (Appendix 11). Families who do not opt out will be called to screen for eligibility and 
schedule a consent visit. Additional children will be randomly selected from the same strata 
for any families that opt out and if recruitment targets are not met. 
 
4.2 
Study Treatment Phase 
The study research materials will consist of parent- and child-reported instruments and will 
be separate from information entered into the ADHD portal. Patients and their families will 
be randomized 1:1 to 1) ADHD electronic patient portal (Tier 1) or 2) ADHD electronic 
patient portal paired with a CM (Tier 2).  
(Tier 1) The ADHD portal. The ADHD system was developed with extensive user input and 
usability testing. As part of the development of this grant, we have already engaged parent, 
teacher, and clinician stakeholder members in establishing a preliminary set of system 
requirements. These requirements include that the portal (1) capture and share patient and 
family treatment preferences and goals, (2) monitor ADHD symptoms, treatment receipt and 
side effects as well as goal attainment, and (3) facilitate communication. The system will 
prompt completion of periodic check-in surveys (bi-weekly to 3 months). Within the portal, 
preferences and goals for ADHD treatment will be measured using the ADHD PGI (Fiks et 
al., 2012). Parents will be encouraged to consult with their children when completing the 
tool.  
(Tier 2) Patient portal with CM to facilitate SDM and promote adherence (Appendix 2): The 
use of a patient portal combined with a CM addresses the potential limitations of reliance on 
technology alone to communicate information (Michel et al., 2015; Jackson, Cheater, & 
Reid, 2008). The CM provides an individual responsible for communicating information and 
facilitating coordination of care. Using data captured in the portal, the CM will meet with 
families at the beginning of the study to confirm their treatment preferences and goals, 
provide additional education on ADHD treatment, and distribute handouts on common 
concerns among ADHD patients and families. The CM will contact families weekly to every 
3 months by phone or in-person as needed to assess treatment use, identify new concerns, 
and assist families with problem-solving. Using the portal or other means, the CM will also 
communicate with pediatric clinicians, mental health providers, and teachers to clarify 
family treatment preferences and goals and address emerging treatment issues. A fidelity 
checklist developed in the pilot study will be utilized to assess self-reported task completion 
of treatment components by the CM (0- not completed, 1- partially completed, 2- fully 
completed). In addition, the CM will summarize clinically relevant encounters in the ADHD 
portal, facilitating communication.  

 
  
 
 
 
8 
4.3 
Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care. They may 
also be discontinued from the study at the discretion of the Investigator for lack of adherence 
to study treatment or visit schedules, AEs, or due to development of exclusion criteria. It 
will be documented whether or not each subject completes the clinical, and data collected 
while the subject was enrolled in the study will be kept on file. Collected data will be kept 
until data collection and data analysis have been finalized, after which all personal 
identifiers will be removed. 
 

 
  
 
 
 
9 
4.4 
Screening and Monitoring  
4.4.1 Medical Record Review 
Include a listing of the variables that will be abstracted from the medical chart (paper or 
electronic). 
• Name 
• Date of Birth 
• MRN (medical record number) number 
• Outpatient clinical visits 
• Medications 
• Problem list 
• VPRS scores 
• VTRS scores 
 
4.4.2 Other Evaluations, Measures 
To measure ADHD symptoms, we will use the NICHQ Vanderbilt Assessment Follow Up—
PARENT Informant (Appendix 9) Scale, a follow-up form of the Vanderbilt Parent Rating 
Scale (VPRS) a standard validated measure of ADHD symptom severity that is commonly 
employed in clinical care and ADHD research studies, at baseline and 3-5 months, 6-8 
months, and 9-12 months (Wolraich et al., 1998; Wolraich, et al., 2003). The VPRS is a 
public domain tool that consists of parent forms (separate from teachers, the Vanderbilt 
Teacher Rating Scale, or VTRS) and includes 18 items corresponding to the DSM-5 ADHD 
symptom criteria, 8 items that screen for opposition-defiant disorder, 7 items that screen for 
conduct disorder, and 12 items that screen for anxiety and depression. The Vanderbilt 
Follow Up items from the VPRS are scaled on a 4-point Likert rating (“never” to “very 
often”), but the scales used in this study will be restricted to the 18 ADHD symptom items 
and the 8 Performance Items, excluding further questions regarding Medication. In 
validation studies, the internal consistency of the VPRS and VTRS were excellent 
(alpha=0.90-0.94), and concurrent validity was high (r=0.79) in relation to diagnostic 
interviews. The Vanderbilt scale will permit us to compare effects between treatment arms 
and with the results of other studies. These scores have been identified as important by 
clinician stakeholders and will be provided to practices to assist with ADHD management.  
To determine goal attainment, patient and family treatment goals will be identified through 
use of the ADHD PGI. Goal Attainment Scaling (GAS), will then be used to allow parents 
to rate the degree to which each of their goals, identified using the ADHD PGI, is met 
(Grissom, Erchul, & Sheridan, 2003; Jitendra et al., 2007; Sheridan, Eagle, Cowan, & 
Mickelson, 2001). The GAS response categories are ordered from -2 (“situation got 
significantly worse”) to +2 (“goal completely met”). Parents will complete the GAS 
(Appendix 5) at 3-5 months, 6-8 months, and 9-12 months.  
The PFCC questionnaire will be administered at month 9-12 to assess family engagement as 
mediators of intervention treatment effects. Up to 40 participants will receive this 
questionnaire 10-21 days after completing their 9-12 month study measures to examine test-
retest reliability. The study team developed this questionnaire. Questionnaire items are based 

 
  
 
 
 
10 
on the semi-structured interviews of caregivers. The participants interviewed identified 
critical dimensions of caregiver engagement in the treatment of ADHD. Participants also 
completed a card sort procedure to rate the importance of engagement questionnaire items 
for one or more outcome domain. An alternative group of parents who completed the card 
sort procedure also participated in cognitive interviews. Cognitive interviews were used to 
evaluate the appropriateness and understandability of caregiver engagement questionnaire 
items for parents of children with ADHD. A cognitive debriefing technique identified 
problematic phrasing and elicited alternative words and phrases that parents use to describe 
the item concepts. Prior to completing the questionnaire parents will be able to identify 
whom they consider part of their ADHD study team. Then parents will rate to the degree in 
which they are engaged in their child’s ADHD treatment planning and implementation 
The satisfaction survey will be administered after month 9-12 to families in the intervention 
arm to evaluate their satisfaction with having a care manager. This will consist of 8 
questions scaled on a 5-point Likert scale (“Strongly Disagree” to “Strongly Agree”). This 
survey will also include two open-ended questions, “What did you like about the care 
manager program?” and “How would you suggest improving the care manager program?”. 
The qualitative interview will be conducted after the 9 month care management is complete 
with the intervention arm to assess their experience with care management and for study 
feedback. This will consist of 9 open-ended questions (Appendix 20 Qualitative Interview) 
4.5 
Efficacy Evaluations 
4.5.1 Diagnostic Tests, Scales, Measures, etc. 
Methods and timing the measures that will be used to assess efficacy 
Study Measures and Timing 
Measure 
Source 
Time to 
Complete 
(minutes) 
Timing 
(months) 
ADHD PGI (primary) 
Parent 
5 
0 
VPRS (primary) 
Parent 
5 
0, 3-5, 6-8, 9-12 
VTRS (primary) 
Epic 
records 
n/a (usual care) 
n/a (usual care) 
GAS (primary) 
Parent 
1-2 
3-5, 6-8, 9-12 
Engagement (M) 
Parent 
3-5 
3 
Medications (M) 
her 
0 
1-9-12 
SACA (M) 
Parent 
10 
9-12 
PROs (secondary) 
 
 
 
School performance 
Child, 
Parent 
3-5 
0,9-12 
Student engagement 
Child, 
Parent 
3-5 
0,9-12 
Peer relationships 
Child, 
Parent 
3-5 
0,9-12 
Family belonging 
Child, 
Parent 
3-5 
0,9-12 
Teacher connectedness 
Child, 
Parent 
3-5 
0,9-12 
PFCC Questionnaire 
Parent 
10 
9-12, 9.5-12 
Satisfaction Survey 
Parent 
10 
9+ 

 
  
 
 
 
11 
Qualitative Interview 
Parent 
30 
9+ 
School performance, student engagement, and teacher connectedness are 
Healthy Pathways scales; peer relationships and family belonging are PROMIS 
scales. (M) denotes a mediator. 
 
 
4.6 
Safety Evaluation 
Subject safety will be monitored by adverse events, and follow-up surveys. The research 
team will query participants at every follow up visit to determine if personal health 
information has been disclosed.  
5 
STATISTICAL CONSIDERATIONS 
5.1 
Primary Endpoint 
The primary endpoints will be the change in ADHD Symptoms (as measured by the VPRS 
and VTRS) and the change in Goal Attainment (as determined by the treatment goals of the 
patients and their families) between baseline and the 3-5, 6-8, and 9-12-month points. 
5.2 
Secondary Endpoints 
Secondary endpoints will include the following: 
• The change in PROs, which parents of children with ADHD and teachers have identified 
as most important: school performance, student engagement, peer relationships, family 
belonging, and teacher connectedness. 
• To evaluate consistency of PFCC measure that was developed for purposes of this study. 
• Parent satisfaction in the intervention group with the services rendered by their care 
manager. 
• Parent outcome experience and feedback in the intervention group with care 
management.  
5.3 
Statistical Methods 
5.3.1 Baseline Data  
Based on intake data across the CHOP Care Network, the study team expects a racial and 
ethnic breakdown to be representative of patient population seen over the past two years: 
59% white, 31% black or African American, and 5% Hispanic. The actual demographic 
distribution of enrolled participants may differ slightly. The study team also expects that the 
gender distribution will reflect the gender distribution of children with ADHD in the CHOP 
Care Network: 72% male, 28% female. 
 
5.3.2 Efficacy Analysis 
Primary analyses will be based on an intention to treat approach and will include all subjects 
as randomized. We will follow usual guidelines for reporting results (CONSORT) 

 
  
 
 
 
12 
(CONSORT Group, 2010), and will report all outcomes in both absolute (how much change) 
and relative terms (percentage change). In sensitivity analyses to examine the impact of 
preference and treatment intensity, we will look at the effects of the intervention stratified by 
baseline preferences and intervention dosage (frequency of interaction with the portal/CM).  
The primary endpoints will be the change in ADHD Symptoms (as measured by the VPRS 
and VTRS) and the change in Goal Attainment (as determined by the treatment goals of the 
patients and their families) between baseline and the 3-5, 6-8, and 9-12-month points. 
• Secondary endpoints will include the change in PROs, which parents of children with 
ADHD and teachers have identified as most important: school performance, student 
engagement, peer relationships, family belonging, and teacher connectedness. In 
addition, PFCC measure will be examined for internal consistency with test-retest 
reliability. The satisfaction survey will measure how satisfied parents in the intervention 
arm were with the services provided by their care manager. The qualitative interview 
will evaluate outcome experience and feedback in the intervention group with care 
management.  
 
5.4 
Safety Analysis 
AE incidence will be summarized along with the corresponding exact binomial 95% two-
sided confidence intervals. 
5.5 
Sample Size and Power 
Aim 1: The investigative team assumed that there will be 240 evaluable children parent-
child dyads (from 300 enrolled), and that these will be divided 1:1 across the two groups. 
From these assumptions, power analyses we conducted based on simulations, in which two 
groups of 120 children were generated, followed over 3 time periods (totaling 9-12 months), 
where the measurements were correlated from baseline to 6-8 months (corr=0.8) and from 
baseline to 9-12 months (r=0.6). The investigative team assumed that the true differences 
between treatment groups was a score of 5.0 units over time. Once a dataset was simulated, 
a marginal model for longitudinal data was applied (GEE with a first order auto-regressive 
working correlation structure and robust variance estimates). For comparing the effect of 
the intervention, power of 0.87 was found to detect a difference of 2.5 points along the 
Vanderbilt score (assuming a standard deviation of 6 points, and a difference of 2 points 
assuming a standard deviation of 5). These good levels of power are achievable with the 
longitudinal design.  
Aim 2: For the outcomes of initiation and adherence, binary outcomes were assumed and 
performed analyses using the PASS 13 software (Hintze, 2011). For the purposes of this 
study, the ADHD PGI will be used to determine the level of initiation and adherence. 
Initiation is defined as starting a treatment plan for which one has moderate to greater 
preference. Adherence is defined as the continuation of treatment through month 9-12. 
Assuming that the tier 1 group of 120 children experiences a 50% rate of initiation and 
adherence, power would be about 0.89 to detect an increase in that rate among the tier 2 
group to 70% and would be greater than 0.98 to detect an increase to 75%.  

 
  
 
 
 
13 
Aim 3: Again, the investigative team resorted to simulation to determine the power to detect 
an interaction of group and intervention. For this analysis, it was assumed that 50% of the 
children will come from inner city practices and the other 50% for non-urban locations. The 
investigative team also assumed further that the electronic intervention would work less well 
than the in-person intervention among inner-city children, but that it would work equally 
well among the suburban children. (1) Power is greater than 0.90 if the suburban tier 2, 
suburban tier 1, and urban tier 2 practices improve by 7 points on the symptoms scale 
(assuming a standard deviation of 6), and urban tier 1 practices improved by only 2.5 points, 
a clinically meaningful difference. 

 
  
 
 
 
14 
6 
SAFETY MANAGEMENT  
6.1 
Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  
6.2 
Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen 
during the course of this study (including SAEs) they will be reported to the IRB in 
accordance with CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. 
AEs that are not serious but that are notable and could involve risks to subjects will be 
summarized in narrative or other format and submitted to the IRB at the time of continuing 
review.  

 
  
 
 
 
15 
7 
STUDY ADMINISTRATION 
7.1 
Treatment Assignment Methods 
7.1.1 Randomization 
Planned centrally by the investigative team’s biostatistician, randomization will be stratified 
by practice, gender, and age groups (5-7 years old and 8-12 years old) to ensure balance. 
Any differences in treatment preferences between arms in the analysis will be statistically 
controlled.  
Allocation concealment (blinding of the treatment assignment) will be implemented using 
sealed, opaque envelopes, along with stratification, and randomly permuted blocks of 
unequal sizes (to prevent providers and patients from manipulating the randomization to 
favor any treatment). Treatment assignment will be done at the time of enrollment following 
informed consent 
7.2 
Data Collection and Management 
1. Confidentiality. 
To ensure confidentiality of information, data will be stripped of potential identifiers and all 
written and computerized files will be indexed by a unique identification number. Only 
research staff will have access to this information, and the PI will keep a separate master list 
stored as a password protected document on a password-protected computer. All databases 
for these study procedures will be maintained on CHOP’s secure research server, and all 
analyses will be performed on de-identified data only. All collected study measures will be 
entered directly into a REDCap database. Qualitative data will be entered into an NVivo 
database. The unique identifiers will be used to track enrolled families over the course of the 
study. Audio recordings will be transcribed by ADA Transcription 
(http://www.adatranscription.com/). Audio recordings will be de-identified and sent via their 
secure server, and subsequent transcripts will be saved on a secure server accessed only by 
members of the study team. Confidentiality will also be maintained by use of subject code 
numbers in all presentations and publications. Each member of the research team, including 
investigators, research assistants, and stakeholder-investigators will receive appropriate 
training in human subjects research and patient confidentiality. 
 
2. Security  
Study data will be collected and managed using the secure web-based REDCap 
database at CHOP, an active participant of the REDCap consortium (Fitzmaurice, 
Laird, & Ware, 2011). Participants will enter outcome data using a web-based 
interface that supports encrypted data transfer from its origin to the database housed 
in a secure data center in Norristown, PA. REDCap supports a simple interface for 
validated data entry, audit trails for tracking data manipulation, export procedures for 
seamless data downloads to statistical packages, and procedures for importing data 
from external sources. All data management and analysis will proceed on secure data 
and software servers that have daily back-up, This approach will facilitate data 
acquisition, prevent data theft and loss, and achieve maximum protection from 

 
  
 
 
 
16 
unnecessary access. All participants will be provided with a unique study identifier, 
which will permit linking of study measures in the REDCap database. Qualitative 
study data will be de-identified, transcribed by ADA Transcription, and managed 
using the secure software NVivo. This software is designed to evaluate data such as 
interviews, open-ended survey responses, review patient feedback, and articles.  
3. Anonymization  
To ensure confidentiality of information, data will be stripped of potential identifiers 
and all written and computerized files will be indexed by a unique identification 
number. Only research staff will have access to this information, and the PI will keep 
a separate master list stored as a password protected document on a password-
protected computer. All databases for these study procedures will be maintained on 
CHOP’s secure research server, and all analyses will be performed on de-identified 
data only. A complete, cleaned, and de-identified dataset will be made available to 
PCORI and other investigators after all analyses have been conducted and within 
nine months of the end of the final year of funding. To obtain this data set, other 
investigators may contact the study PI who will provide a data sharing agreement. 
The data sharing agreement will permit the data set to be shared once an IRB 
protocol has been approved at the investigators’ home institution and the 
investigators have signed a pledge to not attempt to identify individual study 
subjects. The data set will be made available on a CD-ROM or a secure FTP site. 
7.3 
Confidentiality 
No identifiable data will be used for future study without first obtaining IRB approval. The 
investigative team will obtain a data use agreement between the provider (the PI) of the data 
and any recipient researchers (including others at CHOP) before sharing a limited dataset 
(PHI limited to dates and zip codes).  
To ensure confidentiality of information, data will be stripped of potential identifiers and all 
written and computerized files will be indexed by a unique identification number. Only 
research staff will have access to this information, and the PI will keep a separate master list 
stored as a password protected document on a password-protected computer. All databases 
for these study procedures will be maintained on CHOP’s secure research server, and all 
analyses will be performed on de-identified data only. All collected study measures will be 
entered directly into a REDCap database. Qualitative data will be managed on NVivo. The 
unique identifiers will be used to track enrolled families over the course of the study. 
Confidentiality will also be maintained by use of subject code numbers in all presentations 
and publications. Each member of the research team, including investigators, research 
assistants, and stakeholder-investigators will receive appropriate training in human subjects 
research and patient confidentiality. The identifiable information from this study will be 
destroyed 6 months after the results have been published. 
 

 
  
 
 
 
17 
7.4 
Regulatory and Ethical Considerations 
7.4.1 Data and Safety Monitoring Plan 
The investigative team will evaluate for disclosures of PHI at each follow up visit from 
participating families and will provide reports of preliminary data to the stakeholder groups 
on a quarterly basis and to the CHOP IRB on a yearly basis throughout the duration of the 
study. Since this study is minimal risk, there are no plans for a data safety and monitoring 
board. In the unlikely event of an adverse outcome associated with this study protocol, it 
will be documented and discussed with the research group, the home physician practice 
office staff with parental permission, and reported to the CHOP IRB and the PCORI board, 
if appropriate. Any serious adverse events will be reported to the CHOP IRB within 72 
hours and the PCORI board. Families will be promptly informed of any disclosures of PHI.  
 
7.4.2 Risk Assessment 
The research involves the collection of information from parents, children and teachers. The 
risk of participation is considered minimal. There is a potential risk of breach of 
confidentiality of information and study result about individuals. This risk is made minimal 
by measures taken by the study team to ensure confidentiality; risks are greatly reduced by 
using secure files, storing data on secure computers, using unique study identifiers, and de-
identification of data prior to analysis. A second risk is that participants become 
uncomfortable in completing study measures. If this occurs, the protocol will allow 
participants to stop at any time. Should any specific concerns arise throughout the project 
period, the CHOP IRB will be promptly informed. Since the purpose of the intervention is to 
help families clarify their treatment preferences and goals and promote communication 
between families and clinicians, we expect that serious adverse consequences will be 
extremely rare and unlikely.  
 
A further risk is that parents may use the portal (intended for non-urgent communication) for 
urgent behavioral health issues. This risk will be mitigated through direct instruction to 
parents at the time of consent and portal enrollment, warnings within the portal that it should 
not be used if immediate attention is needed, and clear guidance in any message transmitted 
through the portal that it is only meant for routine communication. This approach has proven 
effective in our prior trial of the MyAsthma portal. 
 
This project will also involve the mapping of geocoded data, which presents a risk of loss of 
confidentiality if maps are presented. To address this potential problem, and in instances 
where the number of subjects is less than 5, the CML will work closely with the PI to 
determine whether geographical masks should be used to protect student confidentiality 
from identification through deductive or other disclosure that could result from displaying 
small numbers of students and their school or home locations on a map. Among the 
techniques that may be applied if the case warrants are microaggregation—replacing the 
coordinates for a data point by an average of some number of data points similar to them—
or blurring—placing data points on an irregular lattice by an ordered list of x and y 
coordinates and replacing each successive group of 10 with its average. These approaches 
will be implemented when needed in order to protect the privacy of research subjects. 
 

 
  
 
 
 
18 
7.4.3 Potential Benefits of Trial Participation 
Patients and parents may benefit directly from inclusion in this study if their 
preferences and goals are adequately communicated and treatment reflecting those 
preferences and goals is implemented and adhered to. However, this cannot be guaranteed. 
The results of this study may assist health care providers in caring for patients in terms of 
fostering joint decision-making. This model may be replicated in different care settings and 
other diseases and thus generate generalizable knowledge. Further, the information obtained 
will be disseminated as widely as possible, including through submission for publication in 
peer-reviewed journals and presented at scientific and lay conferences.  
The investigative team’s prior research found that families who were more easily 
able to contact their child’s doctor outside of office visits were more likely to report high 
levels of SDM, suggesting that interventions that facilitate communication and information 
sharing outside the context of office visits may improve SDM and engagement in care (Fiks 
et al., 2010). However, the bulk of research and conceptual work on SDM has focused on a 
single point-in-time decision in a single patient-provider interaction (Brinkman et al., 2011; 
O’Connor et al, 2009). This study broadens the definition of SDM by focusing on a chronic 
childhood condition (ADHD) with longitudinal decision-making between patients/parents 
and multiple providers. By recognizing patients and parents as experts, prioritizing their 
treatment preferences and goals, and necessitating information sharing over time across the 
health and school systems that impact all children, SDM in ADHD is an ideal prototype to 
define strategies to foster patient-centered care, engagement, adherence, and improved 
outcomes in varied pediatric chronic conditions (e.g. asthma, depression). As such, the 
lessons learned regarding interventions to foster SDM in ADHD in this protocol are likely to 
yield generalizable knowledge for fostering patient-centered pediatric care.  
7.4.4 Risk-Benefit Assessment 
Patients and parents may benefit directly from inclusion in this study if their preferences and 
goals are adequately communicated and treatment reflecting those preferences and goals is 
implemented and adhered to. However, this cannot be guaranteed. The results of this study 
may assist health care providers in caring for patients in terms of fostering joint decision-
making. This model may be replicated in different care settings and other diseases and thus 
generate generalizable knowledge. Further, the information obtained will be disseminated as 
widely as possible, including through submission for publication in peer-reviewed journals 
and presented at scientific and lay conferences. Given the minimal risk nature of the study 
and the potential for benefit, the risk:benefit ratio is considered favorable. 
 
7.5 
Recruitment Strategy 
To obtain an unbiased sample, a stratified random sample of 300 eligible parent-child dyads 
will be drawn from participating practices taking into consideration the race/ethnicity/gender 
of the patients they serve to achieve a representative sample of children from the greater 
Philadelphia area. Physicians will distribute recruitment flyers to eligible families who are 
interested in learning more about the study to direct them to contact the research team for 
more information. Families will also be mailed recruitment letters signed by their primary 
care provider (PCP) or practice. Included in the mailing will be a stamped self-addressed 
postcard to permit families to opt out. Families who do not opt out will be called to screen 

 
  
 
 
 
19 
for eligibility and schedule a consent visit. We will randomly select additional children from 
the same strata for any families that opt out and if recruitment targets are not met. Families 
who consent to participate will be contacted at baseline, 3-5 months, 6-8 months, and 9-12 
months to complete study measures using all available means including letters, telephone 
calls, text messages, and emails to ensure data are collected thoroughly and systematically 
from all participants. Contact information on each participant will be updated every 3 
months using interpersonal exchanges and clinic EHR records. Participation incentives will 
include compensation to complete study measures, quarterly newsletters, and child birthday 
card mailings, all of which have been used in our prior work with urban populations to 
maintain >80% participant follow-up (Power et al., 2010).  
Informed Consent/Assent and HIPAA Authorization 
7.5.1 Consent 
Eligible children and their parents will be identified using electronic health record data and 
sent recruitment letters from their participating practices. Those families that do not return 
opt out postcards will be called by the study team to explain the study, screen for eligibility, 
and arrange for a consent visit. At the consent visit, parents will be asked to provide 
informed consent to participate in the study and to sign a HIPAA and FERPA waiver to 
enable the research team to reach out to individuals involved in their child’s ADHD care 
(Appendix 4). Up to 40 participants previously enrolled in the study will be asked to 
complete a verbal consent in order to fill out second PFCC measure. Up to 40 participants 
previously enrolled will be asked to complete a verbal consent before proceeding with the 
qualitative interview (Appendix 20 Qualitative Interview)  
Waiver of Assent  
Target population is age 5 through 12. Assent is requested to be waived for participants 
under the age of 7. Assent will be obtained from children aged 7-12 because they will be 
completing child PRO measures (Appendix 4). 
 
7.5.2 HIPAA Authorization 
At the consent visit, parents will be asked to provide informed consent to 
participate in the study and to sign a HIPAA and FERPA waiver to enable the 
research team to reach out to individuals involved in their child’s ADHD care 
(Appendix 4).  
 
7.6 
Payment to Subjects/Families 
Participation incentives will include compensation to complete study measures, 
quarterly newsletters, and child birthday card mailings, all of which have been used in 
our prior work with urban populations to maintain >80% participant follow-up (Power 
et al., 2010). 
Participation incentives will include compensation of $100 on a ClinCard to complete 
parent reported study measures, $20 in gift cards to complete child reported study 

 
  
 
 
 
20 
measures, quarterly newsletters, and child birthday card mailings. Parents will receive 
the compensation listed above ($40 for first visit and travel, $10 for second visit, $20 
for third visit, and $30 for fourth visit) for the completion of study visits per 
participant dyads. If subjects do not complete a study survey to completion they will 
not be compensated for their time. Therefore, only participants who complete all study 
visits will receive the full $100. After completing study measures compensation to 
parents will be processed immediately. Children who complete the Child PROs survey 
will receive a $5 gift card upon completing each study visit, earning up to $20 in gift 
cards throughout the study.  
 
Participants who complete additional PFCC questionnaire will be paid $10. 
 
Participants from the intervention arm who complete the satisfaction survey will be 
paid $5. 
 
Participants from the intervention arm who complete the qualitative interview will be 
paid $40. 
 
All payments will be completed through a refillable ClinCard. 
 
7.6.1 Payments to parent for time and inconvenience (i.e. compensation) 
Parents will receive the compensation listed above ($40 for first visit and travel, $10 
for second visit, $20 for third visit, and $30 for fourth visit) for the completion of 
study visits per participant dyads. Parents who complete second PFCC questionnaire 
will be paid $10. Parents who complete the intervention group satisfaction survey will 
be paid $5. Parents from the intervention group who complete the qualitative interview 
will be paid $40. 
 
7.6.2 Payments to child for time, effort and inconvenience (i.e. compensation) 
Children ages 8-12 will receive compensation for completing the Child PROs survey. 
Children of participant dyads will be compensated up to $20, $5 per survey.   
7.6.3 Gifts 
Families will be sent birthday cards on the child’s birthday. 
8 
PUBLICATION 
Caregiver and stakeholder partners will be involved in all dissemination activities. They will 
co-author manuscripts and participate in presentations at scientific and lay conferences. 
These conferences may include the Pediatric Academic Societies annual meetings where 
new pediatric science is presented and local meetings of the Parents Informed Network and 
the Philadelphia Department of Behavioral Health. Caregiver and stakeholder partners will 
participate with the research team in planning dissemination strategies. These will include a 
mixture of papers, reports, and presentations both locally and nationally. Caregiver and 

 
  
 
 
 
21 
stakeholder partners will be involved in disseminating their study results through their local 
employers (e.g. CHOP practices, local school districts) and through their affiliated societies. 
The following groups have been identified as key stakeholders for this project: 1) Pediatric 
patients with ADHD and their caregivers; 2) Clinical providers, including primary care 
physicians, social workers, case managers, psychiatrists, and therapists who manage ADHD; 
and 3) Educators, including teachers, guidance counselors. Our dissemination strategy 
prioritizes dissemination to these groups of stakeholders and to the broader public and 
scientific community in order to facilitate implementation of the findings among these 
groups in real-world settings (PC-4). This strategy will be facilitated by the inclusion of 
caregiver and stakeholder partners representing these groups on our research team and 
separate stakeholder groups (caregivers, teachers, clinicians) composed of 5 individuals each 
who will meet on a quarterly basis during the contract award period. Our stakeholder 
partners include Lisa Snitzer, MSS, LSW and Denise Stewart, BS (caregiver partners), 
Siobhan Leavy, EdD (teacher stakeholder), and Steven Berkowitz, MD and Nathan Blum, 
MD (clinician stakeholders). 
 
The research team plans to work closely with key stakeholders to disseminate and 
implement the findings of the research study into accessible and usable formats in research, 
clinical and community-based settings, including schools and pediatric practices. Aspects of 
the proposed research plan that facilitate dissemination include the implementation of an 
electronic ADHD portal that can be adapted for other EHRs, a Care Manager intervention 
that is manualized and thus transportable to other health care settings, and the use of patient-
centered outcome measures written in an easy-to-read, user-friendly, low-literacy format 
that can be adopted by health care institutions to assess ADHD treatment.  
 
The study team plans to work with the following local and national partners to disseminate 
findings from this study. These partners were identified by members of our research team 
including our caregiver and stakeholder partners. 
• PolicyLab: Center to Bridge Research, Practice and Policy: Drs. Fiks and Guevara are 
both PolicyLab faculty. PolicyLab has a strong track record of engaging policymakers 
on issues related to child health and utilizes evidence-to-action briefs, social media, and 
in-person meetings and congressional testimony to translate findings to policymakers. 
The center has a staff composed of attorneys, strategy specialists, public relations staff, 
and public health and policy staff that provide expertise in dissemination. We will work 
with PolicyLab staff to strategize dissemination to policymakers and child health 
advocates. 
• Department of Behavioral Health (DBH)/Office of Medical Assistance Programs 
(OMAP): DBH manages the Medicaid managed behavioral care program in 
Philadelphia, covering 75% of children in Philadelphia. Dr. Berkowitz is actively 
engaged with this department and will present study findings to coordinate dissemination 
locally throughout the city. OMAP administers the Medicaid program in the 
commonwealth of Pennsylvania. Dr. Guevara will reach out to state administrators at 
OMAP to disseminate study results. 
• American Academy of Child and Adolescent Psychiatry and the American 
Psychological Association: Drs. Power and Berkowitz are members of these 
organizations and will plan to present results at national meetings of these groups to 

 
  
 
 
 
22 
engage these specialists in conversations regarding study findings and efforts to broadly 
implement approaches proven effect in the proposed trial. 
• Pennsylvania (PA) Medical Home Program, also known as “Educating Practices in 
Community Integrated Care (EPIC-IC)”, is a collaboration between the PA Department 
of Health and the PA Chapter of the AAP designed to enhance the quality of life for 
children and youth with special health care needs through effective community-based 
care coordination and improved primary health care. Dr. Blum will work with the PA 
Medical Home Program to disseminate findings to primary care practices in the state. 
• American Academy of Pediatrics: The AAP is the largest pediatric professional 
organization in the U.S. Drs. Blum, Guevara, and Fiks are AAP Fellows and will work 
with the AAP to disseminate study findings to a national audience of practicing 
pediatricians including presenting findings at the AAP National Convention and 
Exhibition and disseminating results through its newsletter and section programs. In 
addition, Dr. Fiks is a member of the AAP’s Child Health Informatics Center is a 
primary vehicle for communication between practicing pediatricians and the EHR 
vendor community and will work through CHIC to disseminate study findings and 
provide EHR vendors with specifications to implement the portal. 
• Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD) is the 
largest family-driven education and advocacy group for affected families. Drs. Fiks and 
Power have previously collaborated with CHADD and plan to reach out to CHADD 
leadership to disseminate findings to a national audience of families with ADHD. 
• Parents Informed Network (PIN): Lisa Snitzer is Director of PIN in Southeastern 
Pennsylvania. She will assist in disseminating study results to parents and families in 
this area that are members of PIN through newsletters and their website. 
• CHOP Parent Advisory Group: Ms. Stewart is a member of the Parent Advisory Group 
and will work to disseminate study findings to other parents in the CHOP clinical 
practice network. 
• Local school districts and the Pennsylvania State Education Association (PSEA): Dr. 
Leavy is a teacher in the Chichester School District in suburban Philadelphia and a 
member of PSEA. She will work to disseminate findings locally and state-wide to 
teachers, to create professional development activities for teachers (Act 48 credit) based 
on project findings, present at Home and School Association Meetings, and would draft 
a publication for the Council for Exceptional Children publication. 
 
9 
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