Abstract
Background:
Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups. The shared medical appointment (SMA) model has been effective in multiple healthcare populations, but the feasibility and effectiveness of SMA in AYA patients with T1D is unclear.
Methods:
This research leverages the team’s multidisciplinary expertise to develop an engaging intervention toolkit and test the implementation of the Team Clinic care model for the treatment of T1D among middle school adolescents in a large urban children’s hospital serving an economically, racially and ethnically diverse population. In Phase 1, the team will manualize the Team Clinic care model into an engaging, age-appropriate educational and intervention toolkit. In Phase 2, the team will conduct a randomized clinical trial to test the feasibility and usability of the toolkit from the provider perspective (team member satisfaction; clinical efficiency; compliance with American Diabetes Association, American Association of Diabetes Educators, and California Children’s Services standards; and payor-level cost data) and the preliminary efficacy of the intervention toolkit on patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression).
Discussion:
AYA patients with T1D often receive care in clinics and institutions with limited resources and time. This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards.
Keywords: Diabetes, Multidisciplinary care model, Adolescents
1. Introduction
Data from the Type 1 Diabetes (T1D) Exchange indicate that adolescent and young adults (AYA) with T1D experience more difficulty with glycemic control than patients in all other age groups [1]. Even more concerning, new data from the 2016–2018 T1D Exchange cohort found hemoglobin A1c (HbA1c) levels in youth have worsened over the past six years with the peak average HbA1c now reaching 9.3% [2]. Despite advances in T1D care management, and research on issues and obstacles encountered by adolescents and young adults [3–6], many professionals still feel ill-equipped to address age-specific challenges and concerns related to T1D management.
The shared medical appointment (SMA) model is a promising approach to improve T1D clinical outcomes and reduce healthcare costs. SMAs are provider-patient visits in which groups of patients are seen by one or more health care providers in a concurrent session [7]. SMAs have been effective in multiple healthcare populations [8–11], but the feasibility and effectiveness of SMAs in ethnically, racially and economically diverse adolescents with T1D is unclear [12,13]. Over the last seven years, our multidisciplinary team has developed and studied an innovative model of SMA (hereafter referred to as Team Clinic) to address patient developmental, psychosocial, and familial challenges; while also tackling the medical infrastructure and multidisciplinary care challenges encountered by adolescents with T1D. The implementation of Team Clinic at the Barbara Davis Center for Diabetes (BDC) in Colorado resulted in increased satisfaction for patients, families, and providers, while simultaneously allowing a busy clinic to meet the American Diabetes Association (ADA) and American Association of Diabetes Educators (AADE) recommendation that patients meet with their diabetes care team providers at least annually [13–16].
This research leverages our team’s expertise to develop and test the Team Clinic toolkit for treatment of T1D among middle school adolescents in a large urban children’s hospital serving an economically, ethnically and racially diverse population (Children Hospital of Los Angeles). The development of cost-effective and scalable models of care is important to allow clinics to address the unique needs of an increasingly diverse populations, while meeting national and state diabetes care guidelines.
2. Methods
In Phase 1, the team will manualize the Team Clinic multidisciplinary care model into an engaging, age-appropriate educational and intervention toolkit. In Phase 2, the team will conduct a randomized clinical trial to test the feasibility and usability of the toolkit from the provider perspective (team satisfaction; clinical efficiency; compliance with ADA, AADE, and California Children’s Services standards; and payor-level cost data) and the preliminary efficacy of the intervention toolkit on patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression).
2.1. Phase 1: Development of the team clinic toolkit
The development of the intervention toolkit will involve four steps (Table 1). The resulting deliverable will include a comprehensive curriculum to standardize the implementation of Team Clinic (Table 2). Our creative partner, Booster Shot Media (BSM) specialized in the creation of patient education materials using engaging visuals and narratives. BSM uses an iterative creative process that incorporates input from stakeholders to ensure that the material is customized for the target audience.
Table 1.
Steps involved in the development of the Team Clinic toolkit.
| Objectives | Activities | |
|---|---|---|
| Step 1 6 months | Completion of toolkit -Version 1 |
|
| Step 2 1–2 months | Collaboration and iterative processing of toolkit with the BDC team experienced with Team Clinic |
|
| Step 3 1–2 months | Collaboration and iterative processing of toolkit with CHLA stakeholders (administration, providers, staff, patients, and families) |
|
| Step 4 5–6 months | Completion of toolkit -Version 2 |
|
Table 2.
Sections of the team clinic toolkit.
| Introduction | Overview of design, purpose, and value gains for clinics and patients. |
| Implementation guide | Guide for clinic staff detailing how to plan and run Team Clinic. |
| Facilitator guides | Session-by-session guides for running each group visit. |
| Patient education materials | Printable handouts, templates, and other materials that are used during each session. |
| Clinic administrator resources | Resources for documentation, billing, communication, and other logistics. |
| Appendices | Supplemental content that may be helpful to group facilitators. |
2.2. Phase 2: Randomized clinical trial
2.2.1. Overview of study design
This will be a Randomized Clinical Trial, utilizing a 4 × 4 factorial design, with patients (and their families) block-randomized into Treatment (Team Clinic) versus Control (Standard of Care), sub-grouped by patients using continuous insulin pumps versus insulin injections. Multiple satisfaction, fidelity, and clinical outcome measures (described in section 2.2.7. Measurements below) will be assessed, and then tested between study arms.
The Children Hospital of Los Angeles (CHLA) staff implementing Team Clinic will be trained following the completion of the toolkit. Training will involve a variety of pedagogical activities including didactic training, role-play and supervised practice. The team will include a psychologist, social workers (2–3), diabetes nurse educators (2–3), dietitians (2), nurse practitioners (3), and physicians (2–3). Following the initial training, staff will complete questionnaires documenting their satisfaction, experiences, and recommendations. They will complete similar questionnaires after finishing each Team Clinic. Providers and clinic staff will have four debriefing meetings after all cohorts finish each Team Clinic session and at the end of the intervention, patients will participate in a Discrete Choice Experiment. All additional feedback will provide input on the toolkit implementation and future dissemination.
Families interested in participating in the study will be required to provide both verbal assent (patients < 18 years of age) and parental/caregiver written consent prior to enrollment. Once enrolled, participants will be randomized in a block design, stratified by diabetes regimen (insulin pump versus injections) to either Team Clinic or Standard Care (Control).
Participants randomized to Team Clinic will attend quarterly Team Clinic visits over 12-month period. Control participants will attend quarterly medical appointments, as recommended by the ADA. All participants and their caregivers will complete measurements at enrollment/baseline and at each quarterly visit. Each patient and parent/caregiver will receive a $20.00 gift card for completion of the baseline assessment, a $10.00 gift card for completion of each assessment completed in visits 1–3, and a $20.00 gift card for assessment completed in the fourth visit.
2.2.2. Participant recruitment and eligibility criteria
CHLA currently follows 451 patients with T1D ages 10–13. Our research team has experience recruiting patients into pharmaceutical and behavioral randomized clinical trials, as well as a variety of observational studies. Based on our experience, we anticipate that 50% of approached patients will agree to participate, with 20% attrition over the course of the study. Power calculations (described in the 2.2.8. Analytic plan and power analysis section below) indicate that data from at least 64 participants in total will be required. Using this conservative estimate, we will recruit 80 participants for an effective sample of 64 patients.
Participants will be eligible if they have had T1D for at least 6 months prior to enrollment in the study and are not currently participating in another interventional study. Adolescents will be ineligible to participate in the study if they (or their family): (1) display severe behavioral or developmental disabilities, (2) have severe comorbid medical (e.g. cystic fibrosis, uncontrolled thyroid disease) or mental health conditions (e.g., Schizophrenia) that require additional expertise or intensive management, or (3) if they are unable to communicate comfortably in English.
2.2.3. Team clinic model
The Team Clinic patient flow follows the implementation structure originally tested in Colorado [13–16] (Fig. 1). Team Clinic in-corporatesdevelopmentally tailored peer-support and novel learning tools into a SMA model. The four quarterly modules (Table 3) cover knowledge and skills recommended by the ADA and the AADE. A family component is also included in the Team Clinic model as family support is instrumental to effective adolescent diabetes care [17]. Parents/caregivers participate in an adult-only group, while their children attend a separate group.
Fig. 1.

Team Clinic patient flow.
Table 3.
Team clinic sessions.
| Session 1: Energy Training | Activity: Patients complete a physical activity (e.g., obstacle course) and perform blood sugar checks at beginning, midpoint, and end of activity. |
| Discussion: Patients discuss the relationship between glucose and physical activities, as well as the challenges and safety issues related to activity. | |
| ADA Guidelines: Physical Activity and Exercise, Glycemic Control, Nutrition Therapy | |
| AADE 7 Self-Care Behaviors: Being Active, Monitoring, Taking Medication, Healthy Eating | |
| Session 2: Proficiency Training | Activity: Patients rotate through three skills stations: Carbohydrate Awareness Game, Sick Day Strategy Game, and Insulin Injection Practice. |
| Patients will then problem-solve daily diabetes obstacles. | |
| Discussion: Patients discuss challenges and strategies related to carbohydrate counting, sick day management, and insulin injections. | |
| ADA Guidelines: Glycemic Control, Nutrition Therapy, Psychological Issues, Transition | |
| AADE 7 Self-Care Behaviors: Monitoring, Taking Medication, Healthy Eating, Problem Solving, Reducing Risks | |
| Session 3: Resilience Training | Activity: Patients play “Burnout Tug-Of-War” and “Resilient Reaction Bingo” as prompts for discussion. |
| Discussion: Patients discuss definitions of burnout and resilience. They share experiences of burnout and identify actions they can take to avoid burnout and increase resilience. | |
| ADA Guidelines: Psychological Issues | |
| AADE 7 Self-Care Behaviors: Problem Solving, Healthy Coping, Reducing Risks | |
| Session 4: Balance Training | Activity: Patients play a group game with balloons (each representing a different responsibility they have identified) as prompt for discussion about balance and asking for help. |
| Discussion: Patients discuss their responsibilities in daily life, including diabetes-related responsibilities. Patients identify people and activities that can help them when they feel overwhelmed. | |
| ADA Guidelines: Psychological Issues, Transition | |
| AADE 7 Self-Care Behaviors: Problem Solving, Healthy Coping Reducing Risks |
All adolescent groups start with an ice-breaker activity, followed by a hands-on activity and then a group discussion of empirically supported strategies that maximize self-care and diabetes management, while simultaneously reinforcing youths’ self-efficacy, self-advocacy and resiliency [18]. Team Clinic utilizes a patient-centered approach, and fosters the expression of individual concerns and patients’ personal “diabetes story”, while garnering peer support [19]. The facilitator directs the discussion using motivational interviewing techniques, including open-ended questions, affirmations, reflective listening, and summarizing [19]. At the completion of the activity and group discussion, adolescents formulate a personal goal for their next Team Clinic visit. Goal setting involves: the review of a personal accomplishment and identification of a problem area; the formulation of solutions and evaluation of options; and designing a specific plan to achieve the selected goal. After the groups, adolescents and caregivers reunite to discuss with the provider how the family will support the adolescent in meeting his/her goal.
The family groups start with introductions, followed by a discussion of the topic covered in the children group, while addressing challenges associated with emerging adolescence, and the influence of diabetes on key developmental milestones. During the session, caregivers are asked to: (1) identify a moment when they felt proud of their child; (2) articulate a positive statement they will communicate to their child after clinic; and (3) formulate a question to ask their child after clinic. The group harnesses peer and staff support, while providing action-oriented parenting strategies for addressing specific challenges with diabetes management [20].
2.2.4. Standard of care
Patients randomized to the Control group will receive Standard of Care. The ADA recommends all patients with T1D to complete visits with their diabetes care provider on a quarterly basis. The ADA also recommends routine psychosocial screening and regular diabetes education for youth with T1D. In the State of California, California Children’s Services (CCS) provides an additional recommendation for annual assessments from all members of the diabetes team (specifically a registered nurse or nurse practitioner, registered dietitian, and social worker, in addition to physician) for publicly insured patients with chronic diseases, such as T1D. Patients in the Control group of the RCT are anticipated to complete quarterly appointments with their diabetes provider and annual visits with their diabetes care team members, as recommended by both the ADA and CCS.
2.2.5. Intervention fidelity
Intervention fidelity encompasses integrity (interventions are implemented according to established procedures) and differentiation (interventions are distinct from one another). Group facilitators and providers will be required to complete a checklist after each clinic session to ensure that the intervention was implemented as intended (e.g., completion of the ice breaker activity, addressing key learning points/topics, establishing a goal, reviewing positive aspects of their current diabetes management, etc.). All provider visits and groups will be audio recorded. A minimum of 25% of the recordings will be evaluated, and feedback will be provided. Training refreshers will be provided prior to each new Team Clinic session.
2.2.6. Measurements
Individual components of the assessment battery (Tables 4 and 5) will either be conducted at both enrollment and after completion of the last visit, or at every visit.
Table 4.
Summary of outcomes.
| Provider and payor level outcomes | ||||
|---|---|---|---|---|
| Construct | Instrument/Data | Source | Frequency | Description |
| Feasibility | Electronic Medical Record (EMR) review | EMR | End of study | Total number of Team Clinics completed |
| Acceptability | Satisfaction survey | Survey | Every visit | Provider and staff quantitative and qualitative satisfaction data collection |
| Focus group | Focus group | End of study | Qualitative focus group data | |
| Efficiency | Patient numbers | EMR and study team | Every visit | Number of patients seen by each professional in a given time period |
| Appointment duration | Study team | Every visit | Appointment duration for each patient and staff member | |
| Patient interaction and management | EMR and study team | Monthly | Intensity of care required for each patient based on interactions and contacts | |
| Space needed | Study team | Every visit | Number of rooms and space needed for patient visits | |
| Compliance w/standards | ADA, AADE, and CCS Standards | EMR and study team | Every visit | Tracking of visits with all team members to meet ADA and CCS Standards [21–23] |
| Cost | Health care utilization survey | Survey | Every visit | Self-report of health care utilization data over the past 3 months |
| Patient and family level outcomes | ||||
| Construct | Instrument/Data | Source | Frequency | Description |
| Feasibility | EMR review | EMR | Baseline; End of study | Total number of visits completed prior to the intervention and during the intervention |
| Acceptability | Satisfaction survey | Survey | Every visit | Patient and family quantitative and qualitative satisfaction data collection, including number of families who attend appointment |
| Focus group | Focus group | End of study | Qualitative patient and family focus group data | |
| Cost | Time and expense survey | Survey | Every visit | Self-report of travel expense, time missed work or school |
Table 5.
Summary of RTC outcomes.
| Personal factors | |||
|---|---|---|---|
| Construct | Instrument/Data | Frequency | Description |
| Socio-demographic data | Questionnaire | Baseline; End of study | Education, income, race, ethnicity, insurance status, family components, home environment, additional demographics |
| Diabetes and medical history | Questionnaire | Baseline | Diabetes and general health history, treatment regimen |
| Diabetes health related factors | |||
| Construct | Instrument/Data | Frequency | Description |
| Glycemic Control | HbAlc point-of-care assay | Every visit | Meets National Glycohemoglobin Standardization Program certification criteria |
| Adherence | Diabetes device downloads | Every visit | Blood glucose checks per day from glucometer downloads; insulin boluses per day from insulin pump downloads; average sensor glucose level, and percentage of glucose values low, in target, or high for patients on continuous glucose monitors |
| Diabetes-specific events | EMR review and self-report | Every visit | Diabetic ketoacidosis and severe hypoglycemia reports both by EMR and patient-reported survey data |
| Psychosocial outcomes | |||
| Construct | Instrument/Data | Frequency | Description |
| Diabetes Family Conflict | Diabetes Family Conflict Scale, DFCS [24,25] | Baseline; End of study | 19 items; completed by both youth and family; youth report α = 0.85; family report α = 0.81. |
| Diabetes Distress | Problem Areas in Diabetes-Teen PAID-T [26] | Baseline; End of study | 26 items; completed by both youth and family; PAID-T α = 0.96; PAID-T family α = 0.96. |
2.2.7. Analytic plan and power analysis
We will utilize data collected during Phase 2 to test differences in clinical, behavioral, and psychosocial variables between the two groups of patients, seen over a 15-month period – those who attend Team Clinic and those who receive Standard of Care. We will tally appointment attendance and adherence to treatment regimen (the two discontinuous outcomes) and compare the relative performance of both treatment groups using Cochran’s Q test, assuming a Chi-Squared distribution. Most other variables (e.g. HbA1c, time, questionnaire scores) are continuous in nature and will be analyzed using paired Student’s t-tests for the preliminary analyses and linear mixed models (LMM) adjusted for small samples for the final analyses. LMM allow us to examine changes over the entire intervention period, across both treatment groups, while accounting for other clinical and demographic variables that may explain some variability in these measures, similar to Repeated Measures Analysis of
Covariance (RMANCOVA). However, unlike RMANCOVA, LMM will also allow us to examine data from patients with one or more missing data points, versus adopting the less desirable alternative of simply removing patients with missing data (i.e., listwise deletion). We will conduct all analyses using Stata/SE 14.2 (StataCorp, LLC, College Station, TX).
Assuming 20% attrition in a sample of 80 recruited patients, we will examine data from N = 64 patients measured over five time points (enrollment/baseline and 4 visits) using a 2 × 2 factorial design (Treatment x Regimen; 4 groups; n = 16 per group after attrition). Although final analyses will be conducted using LMM, estimating power and sample size requirements for these models is complex, requiring simulations based on parameters obtained from existing datasets. For parsimony, we have calculated sample size requirements using the RMANOCOVA framework, and will describe effect sizes in terms of Cohen’s d, a measure of mean differences between groups divided by pooled standard deviation [27]. To account for potential random crossover during the study, where patients in one Regimen group start another method of medication administration, we have made additional calculations based on three levels of the variable Regimen (insulin pump only, injection only, mixed use of pump and injection).
Assuming an overall Type I error rate of 5% and Type II error rate of 20% (i.e., 80% Power), we will be able to detect treatment effects as small as d = 0.43 between any two groups without crossover (e.g., Insulin Pump Users in Usual Care versus Injection Users in Team Clinic) and d = 0.49 while accounting for crossover. Further, we will be able to measure changes within each group as small as d = 0.53 without crossover, and d = 0.61 with crossover, as well as an interactive effect as small as d = 0.52. During previous pilot studies at BDC, a treatment effect of d = 0.5 between groups was observed, which is larger than the expected treatment effect in the current study (d = 0.43). Thus, we are confident that the study is sufficiently powered.
In addition, because we are concerned about the effects of conducting multiple tests on the same dataset, we will adjust the significance values of all analyses of continuous measures using the Holm-Bonferroni method [28]. The overall Type I α error rate of 0.05 is partitioned based on the total number of tests run, and the smallest p-value among those obtained from analyses of continuous measures is compared to the partitioned α value. If it is smaller, this value is subtracted, and the remaining α is partitioned among remaining tests. This process repeats until a test is no longer significant based on the restricted criteria. The correction will be applied to all overall p-values for final LMM of total scores for each measure (i.e., evaluations of subscales, or individual p-values within each model will not be corrected). All other observed p-values, including demographic comparisons, will be evaluated relative to α = 0.05.
2.2.8. Cost effectiveness analysis
For this study, we will examine both the short-term (within study) net costs and health benefits associated with participating in Team Clinic (versus usual care), considered from a payer perspective, as well as the longer-term costs and benefits, from a societal perspective. A particular focus will be the frequency of urgent and life-threatening events (e.g., diabetic ketoacidosis, severe hypoglycemia (requiring clinician intervention), Emergency Department visits, and hospitalizations), as well as other forms of outpatient healthcare utilization. While results will be reported as incremental cost effectiveness ratios (ICERs), we will also report stratified costs relative to: the patient (time and costs associated with travel, missed work and school, and acute care episodes), the institution (differences in space and staff requirements), and overall costs to the medical system. This will provide critical information to healthcare systems and payers considering implementing TEAM Clinic.
3. Discussion
Despite advances in T1D care management, and research on obstacles encountered by adolescents and young adults [3–6], many professionals feel ill-equipped to address age-specific challenges and concerns related to T1D management [29]. Adhering to national and state guidelines is often challenging and even more so for clinics of modest means and those in remote areas. It is also burdensome for patients and families to attend multiple appointments with all members of the diabetes team, while a lack of staff, resources, and time further limits implementation from the clinic (and family) perspective. Promising, cost-effective models of care are needed to address the needs of diverse youths with diabetes, while meeting national and state guidelines.
The Team Clinic model is a theoretically and clinically innovative approach to address challenges faced by clinics around the United-States in a way that is engaging for patients, families and care providers. To our knowledge, Team Clinic is the first SMA model specifically tailored to address T1D challenges during the critical period of adolescence. Early adolescence is associated with important life transitions, including increased patient autonomy and independence over diabetes self-management. Adolescents and young adults also experience more difficulty with glycemic control than patients in all other age groups [2]. This is concerning for both families and professionals who often feel ill-equipped to address age-specific challenges and concerns related to T1D management. By involving both adolescents and their families, Team Clinic addresses developmental, psychosocial, and familial challenges and barriers that are often left unaddressed in alternative models of care.
There are a number of potential challenges and considerations related to SMA implementation. The original delivery of Team Clinic resulted in increased satisfaction for patients, families, and providers, while also allowing a busy clinic to meet the ADA’s Standards of Care [13–16]. This work made it possible to fine-tune procedures and address challenges and delivery considerations. For instance, we were concerned that scheduling more than 6–8 patients would not allow sufficient time with providers and other team members. On the other hand, including too few patients, would result in very small groups if patients miss a visit. Ultimately, we felt that scheduling 6–8 patients per visit would result in the optimal group size. With these considerations in mind, groups are not predetermined or fixed. Patients receive a schedule of when Team Clinics are delivered, and patients schedule their visits based on their availabilities. Patients and families have organically chosen to continue within the same groups, which fostered cohesion in the groups, but this is not required for the model.
We also recognize the importance of educating and supporting team members who may not be naturally oriented to work within the parameters of the Team Clinic model. The toolkit has been designed to include all material needed to implement Team Clinic from the perspective of professionals who are new to group facilitation. This material includes references on how to handle a variety of groups dynamics, as well as available resources on motivational interviewing and group facilitation skills. Historically, professionals involved in Team Clinic have completed informal debriefings immediately following clinics. Post-clinic debriefing allows professionals to discuss what worked, what didn’t, and whether adjustments need to be made. We have also conducted more formal monthly meetings to review plans for upcoming clinics, while allowing opportunities to review facilitator skills and growth.
Finally, we understand that appropriate space for SMA may be seen as a barrier for implementation. The team has used alternative sites (e.g. outside, open spaces on campus) when space was a challenge and/or when clinics were conducive to different locations. Creativity with space and adjustments of clinic delivery is definitely welcomed, and often required, with SMA.
The dissemination and implementation of Team Clinic into different care settings, with varying resources and infrastructures, will necessitate careful tailoring that is both sensitive to organizational needs, and respectful of intervention fidelity and integrity. Ultimately, successful dissemination will require the input of local providers and families, since they remain best suited to identify the available staffing and physical resources that can be harnessed most effectively to promote uptake and feasibility of the Team Clinic model.
3.1. Conclusion
The proposed study aims to adapt the Team Clinic model to a large urban children’s hospital primarily serving a low-income, publicly insured, minority population. This project will allow for gathering additional data and valuable information on how to best adapt the model, while preserving the original intent and effectiveness of Team Clinic. The current study will further generate the tools required for systematic and standardized dissemination of the Team Clinic model. Replication of Team Clinic at CHLA, prior to wider dissemination, provides an incredible opportunity to test an innovative, scalable, effective, sustainable, and potentially cost-effective model in a low income, publicly insured, minority population at the greatest risk for health inequities.
Acknowledgements
The authors wish to thank the providers, staff, and administration from the Barbara Davis Center for their support and participation in Team Clinic. Additional thanks to the patients and families who participated in the intervention and assisted with development of Team Clinic content.
Funding statement
This work is supported by a grant from Leona M. and Harry B. Helmsley Charitable Trust. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Leona M. and Harry B. Helmsley Charitable Trust.
Footnotes
Trial registration
The study is registered with ClinicalTrials.gov (Protocol Record: NCT04190368).
Ethics approval and consent to participate
The study protocol has been reviewed and approved by the Children’s Hospital of Los Angeles (CHLA-19-00340) and by the Cedars-Sinai Medical Center Institutional Review Board (Proposal # Pro00056865). Parental consent will be required before youth can participate in the research.
Availability of data and material
The datasets from this study will be available from the investigators on written request.
Declaration of Competing Interest
The authors declare that they have no conflict of interest or competing interests pertinent to this study. The authors have no financial relationships relevant to this article to disclose.
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