Increasing Follow-up for Adolescents With Depressive Symptoms.

BACKGROUND: Prompt follow-up for positive depression screen results is important in providing high-quality care for adolescents. We sought to improve follow-up within 30 days for adolescents (≥12 years) with Patient Health Questionnaire-9 scores ≥10, or those with a positive question 9, from 25% to 40%. METHODS: We conducted a quality improvement project at 6 primary care locations serving ∼33,300 patients (70% Black, 7.3% Hispanic, 80% Medicaid-enrolled). Our team identified key drivers and iteratively tested interventions, including contacting patients after antidepressant medication initiation, scheduling patients for follow-up during index visits, collaborating with integrated psychologists to expedite therapy for higher-risk patients, and reaching out to patients without scheduled follow-ups. RESULTS: Pre-intervention, 13.3% (589 of 4427) of adolescent encounters met the criteria for follow-up within 30 days, and 25.8% had a documented follow-up within 30 days. During the intervention period, 12.3% (764 of 6224) of adolescent encounters met the criteria for follow-up within 30 days, and the mean follow-up rate increased to 43.1%. By monitoring process measures, we scheduled follow-up visits for 18.9% of patients during the index encounter. Outreach to the remainder led to 32.6% of these patients completing follow-up. Our balancing measure of monitoring integrated psychology visit volumes remained stable. CONCLUSIONS: The application of quality improvement methods in primary care practices increased the frequency of follow-up care for high-risk adolescents after a positive depression screen.

Improving Screening for Social Determinants of Health in an Outpatient Complex Care Clinic.

BACKGROUND: Families of children with medical complexity (CMC) may face challenges related to Social Determinants of Health (SDoH). Although standardized SDoH screening has been implemented in numerous medical settings, there has been limited study of screening among CMC. Our global aim is to improve access to institutional and community resources for families of CMC with identified needs. Here, we aimed to establish SDoH screening for families in our outpatient Complex Care Center and attain a screening rate of 80%. METHODS: A multidisciplinary team in our clinic used quality improvement methods to implement and study an expanded SDoH screen, which included 3 questions specific to the needs of CMC (ie, emergency planning, social support, and medical equipment concerns). Interventions, informed and refined by 5 key drivers, were tested over a 12-month period. A statistical process control chart tracked key outcome and process measures over time. RESULTS: SDoH screening sustained a mean of 80% after implementation during the study period. Incorporating registration staff in screen distribution was our most impactful intervention. At least 1 SDoH concern was identified on 56% of screens; concerns specific to CMC and mental health were most frequently reported. A total of 309 responses to positive screens were reported in total. CONCLUSIONS: Successful implementation of an expanded, tailored SDoH screen revealed a multitude of social needs specific to families of CMC that otherwise may not have been recognized. Our team continues to develop and distribute resources to address identified needs.

The Impact of Statewide Enumerated Antibullying Laws and Local School Interventions on School Spaces, Physical Harm, and Suicide Attempts for LGBTQ Youth.

Purpose: Our goal was to evaluate the impact of enumerated antibullying laws and local interventions on school affirmation, risk of physical threat or harm, and suicide attempts for lesbian, gay, bisexual, transgender, and questioning (LGBTQ) youth. Methods: This study used cross-sectional data from three national sources that provided outcomes and potential predictors: (1) The Trevor Project National Survey 2022: based on the LGBTQ youth report, (2) Movement Advancement Project: presence of LGBTQ enumerated antibullying state laws, and (3) School Health Profiles 2020: statewide prevalence of school-level strategies to improve student wellness reported by school personnel. Bivariate and multivariable logistic regression models calculated the relative risks (RRs) for each outcome. Results: LGBTQ youth (n = 27,697) were surveyed. Youth were less likely to identify their school as nonaffirming in states with enumerated laws (RR: 0.97, confidence interval [CI]: 0.94-0.99) and in states with higher percentages of gay/straight alliances (GSAs) (RR: 0.97, 95% CI: 0.96-0.97). Youth were less likely to report a history of physical threat or harm in states with more GSAs (RR: 0.96, 95% CI: 0.95-0.97). Enumerated state laws were associated with a lower risk of suicide attempts among LGBTQ youth (RR: 0.82, 95% CI: 0.77-0.87). Universal strategies/policies not specific to LGBTQ youth did not reduce risk of physical threat/harm or suicide attempts. Conclusions: Statewide enumerated antibullying protections and the presence of a GSA were associated with a decreased risk of poor outcomes among LGBTQ youth. Longitudinal studies are needed to assess the impact of recent legislative changes.

Measure of Caregiver Attention-Deficit/Hyperactivity Disorder Knowledge Is Responsive to Decision Aid on Treatment for Attention-Deficit/Hyperactivity Disorder.

OBJECTIVE: Adapt and test a measure of knowledge for caregivers of children with attention-deficit/hyperactivity disorder (ADHD) and evaluate the impact of the information component of a decision aid (DA) on participant knowledge. METHODS: A set of seven knowledge items were created based on prior knowledge measures and clinical guidelines. As part of a larger cross-sectional survey study of caregivers of children diagnosed with ADHD, caregivers were randomized to one of two arms: 1) a DA arm, where participants reviewed the information component of the Cincinnati Children's Hospital's DA, and 2) a control arm, where participants were not shown a DA. All participants completed the seven knowledge items. Knowledge items were assessed for difficulty, quality of distractors, acceptability, and redundancy. Total knowledge scores (0-100) for the DA and control arm were compared. RESULTS: Caregivers were assigned to the DA arm (n = 243) or the control arm (n = 260). All 7 knowledge items were retained as no items were too difficult or too easy, all response options were used, there were little missing data, and no items were redundant. The overall knowledge score was normally distributed, and almost covered the full range of scores (5-100). Those who received the DA component had higher knowledge scores (M=68, SD=23) than those who did not receive the DA component (M=60, SD=19, P < .01, d=0.4). CONCLUSIONS: The Caregiver ADHD Knowledge (CAKe) measure was acceptable and demonstrated construct validity as those who were assigned to review the DA component demonstrated greater knowledge than those who were not assigned to review the DA component.

Effect of Automated and Personalized Outreach Messages on Well-Child Visit Catch Up: A Randomized Clinical Trial.

OBJECTIVE: To determine the effectiveness of text/telephone outreach messages and personal contact attempts on well-child care (WCC) scheduling and completion and measles, mumps, and rubella (MMR) vaccine receipt. METHODS: We conducted an intent-to-treat, 2 × 2 factorial randomized clinical trial with 3 replications at 3 academic pediatric primary care practices from September 27, 2020 to August 6, 2021. We randomized participants to 1 of 4 groups: 1 automated message (group 1), 2 automated messages (group 2), 1 automated message plus personal contact attempts (group 3), or 2 automated messages plus personal contact attempts (group 4). Outcomes included: 1) scheduled WCC within 2 weeks (secondary outcome), 2) completed WCC within 8 weeks (secondary outcome), 3) receipt of first MMR by 15 months of age or second MMR within 3 months of first message for 4-year-olds (primary outcome). RESULTS: We randomized 1312 patients (mean [SD] age = 38.8 [19.3] months, 53.5% male, 72.8% non-Hispanic Black, 86.9% Medicaid-enrolled). Scheduling rates were significantly higher in groups with personal contact attempts compared to those without (1 = 15.2%, 2 = 12.5%, 3 = 29.3%, and 4 = 31.5%). WCC completion rates also differed across groups: 1 = 27.4%, 2 = 22.3%, 3 = 32.0%, and 4 = 29.4%, with groups 3 and 4 having significantly higher rates than group 2. Similarly, groups 3 (30.2%) and 4 (31.8%) had significantly higher rates of receiving the MMR vaccine compared to group 2 (23.5%) but not group 1 (28.0%). CONCLUSIONS: Outreach messages that were followed by personal contact attempts increased the rates of scheduling and completing WCCs and receiving the MMR vaccine, providing a useful tool to re-engage at-risk populations.

Decisional Support Needed when Facing Tough Decisions: Survey of Parents with Children having Differences of Sex Development.

Introduction: Parents of infants and young children newly diagnosed with differences of sex development (DSD) commonly face medical and psychosocial management decisions at a time when they are first learning about the condition and cannot consult their child for input. The aim of this study was to identify areas of greatest need for parental decisional support. Methods: 34 parents of children receiving care for DSD at one of three US children's hospitals participated in a survey to learn what clinical and psychosocial decisions needed to be made on behalf of their child. Parents were then asked to identify and focus on a "tough" decision and respond to questions assessing factors affecting decision-making, decision-making preferences, decisional conflict, and decision regret. Descriptive analyses were conducted. Results: Decisions about surgery and aspects of sharing information about their child's condition with others were the two most frequently reported decisions overall, experienced by 97% and 88% of parents, as well as most frequently nominated as tough decisions. Many parents reported mild to moderate levels of decisional conflict (59%) and decision regret (74%). Almost all parents (94%) reported experiencing at least one factor as interfering with decision-making (e.g., "worried too much about choosing the 'wrong' option"). Parents universally reported a desire to be involved in decision-making - preferably making the final decision primarily on their own (79%), or together with their child's healthcare providers (21%). The majority of parents judged healthcare providers (82%) and patient/family organizations (58%) as trustworthy sources of information. Discussion: Parents of children with DSD encounter medical, surgical, and psychosocial management decisions. Despite difficulties including emotional distress and informational concerns (including gaps and overload), parents express strong desires to play key roles in decision-making on behalf of their children. Healthcare providers can help identify family-specific needs through observation and inquiry in the clinical context. Together with families, providers should focus on specific clinical management decisions and support parental involvement in making decisions on behalf of young children with DSD.

"I'd like more options!": Interviews to explore young people and family decision-making needs for pain management in juvenile idiopathic arthritis.

BACKGROUND: Juvenile idiopathic arthritis (JIA) is a common pediatric rheumatic condition and is associated with symptoms such as joint pain that can negatively impact health-related quality of life. To effectively manage pain in JIA, young people, their families, and health care providers (HCPs) should be supported to discuss pain management options and make a shared decision. However, pain is often under-recognized, and pain management discussions are not optimal. No studies have explored decision-making needs for pain management in JIA using a shared decision making (SDM) model. We sought to explore families' decision-making needs with respect to pain management among young people with JIA, parents/caregivers, and HCPs. METHODS: We conducted semi-structured virtual or face-to-face individual interviews with young people with JIA 8-18 years of age, parents/caregivers and HCPs using a qualitative descriptive study design. We recruited participants online across Canada and the United States, from a hospital and from a quality improvement network. We used interview guides based on the Ottawa Decision Support Framework to assess decision-making needs. We audiotaped, transcribed verbatim and analyzed interviews using thematic analysis. RESULTS: A total of 12 young people (n = 6 children and n = 6 adolescents), 13 parents/caregivers and 11 HCPs participated in interviews. Pediatric HCPs were comprised of rheumatologists (n = 4), physical therapists (n = 3), rheumatology nurses (n = 2) and occupational therapists (n = 2). The following themes were identified: (1) need to assess pain in an accurate manner; (2) need to address pain in pediatric rheumatology consultations; (3) need for information on pain management options, especially nonpharmacological approaches; (4) importance of effectiveness, safety and ease of use of treatments; (5) need to discuss young people/families' values and preferences for pain management options; and the (6) need for decision support. Themes were similar for young people, parents/caregivers and HCPs, although their respective importance varied. CONCLUSIONS: Findings suggest a need for evidence-based information and communication about pain management options, which would be addressed by decision support interventions and HCP training in pain and SDM. Work is underway to develop such interventions and implement them into practice to improve pain management in JIA and in turn lead to better health outcomes.

Adolescent Decision-Making Involvement in the Receipt of Genomic Testing Results.

OBJECTIVE: To examine hypothesized predictors of adolescent and parent involvement in the decision about which genomic results to receive. STUDY DESIGN: We conducted a longitudinal cohort study during phase 3 of the electronic Medical Records and Genomics (eMERGE) Network. Dyads reported on how they preferred to make choices (adolescent only, parent only, or jointly). Dyads used a decision tool to choose independently the categories of genetic testing results they wanted. We summarized independent choices, identifying initially discordant dyads. After a facilitated discussion, dyads made a joint decision. Dyads then completed the Decision-Making Involvement Scale (DMIS). We conducted bivariate correlations between DMIS subscale scores and the following hypothesized predictors: adolescent age, preference for adolescent to make their own decision, and discordance on initial independent choices. RESULTS: The sample included 163 adolescents, aged 13-17 years and parents (86.5% mothers). Dyads lacked agreement on how they wanted to make the final decision (weighted kappa statistic 0.04; 95% CI -0.08 to 0.16). These preferences, as well as the adolescent's age and adolescent-parent discordance on initial choices for specific categories of genetic testing results to receive, were associated with subsequent decision-making involvement behaviors as measured by DMIS subscales. Dyads with discordant initial preferences had significantly greater scores on the DMIS Joint/Options subscale than those with concordant initial preferences (adolescent report M [SD] 2.46 [0.60] vs 2.10 [0.68], P < .001). CONCLUSIONS: Through facilitated discussion, adolescents and parents can work together and reach agreement about receipt of genomic screening results.

Comparative Effectiveness of Anti-TNF in Combination With Low-Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn's Disease: A Pragmatic Randomized Trial.

BACKGROUND & AIMS: Tumor necrosis factor inhibitors, including infliximab and adalimumab, are a mainstay of pediatric Crohn's disease therapy; however, nonresponse and loss of response are common. As combination therapy with methotrexate may improve response, we performed a multicenter, randomized, double-blind, placebo-controlled pragmatic trial to compare tumor necrosis factor inhibitors with oral methotrexate to tumor necrosis factor inhibitor monotherapy. METHODS: Patients with pediatric Crohn's disease initiating infliximab or adalimumab were randomized in 1:1 allocation to methotrexate or placebo and followed for 12-36 months. The primary outcome was a composite indicator of treatment failure. Secondary outcomes included anti-drug antibodies and patient-reported outcomes of pain interference and fatigue. Adverse events (AEs) and serious AEs (SAEs) were collected. RESULTS: Of 297 participants (mean age, 13.9 years, 35% were female), 156 were assigned to methotrexate (110 infliximab initiators and 46 adalimumab initiators) and 141 to placebo (102 infliximab initiators and 39 adalimumab initiators). In the overall population, time to treatment failure did not differ by study arm (hazard ratio, 0.69; 95% CI, 0.45-1.05). Among infliximab initiators, there were no differences between combination and monotherapy (hazard ratio, 0.93; 95% CI, 0.55-1.56). Among adalimumab initiators, combination therapy was associated with longer time to treatment failure (hazard ratio, 0.40; 95% CI, 0.19-0.81). A trend toward lower anti-drug antibody development in the combination therapy arm was not significant (infliximab: odds ratio, 0.72; 95% CI, 0.49-1.07; adalimumab: odds ratio, 0.71; 95% CI, 0.24-2.07). No differences in patient-reported outcomes were observed. Combination therapy resulted in more AEs but fewer SAEs. CONCLUSIONS: Among adalimumab but not infliximab initiators, patients with pediatric Crohn's disease treated with methotrexate combination therapy experienced a 2-fold reduction in treatment failure with a tolerable safety profile. CLINICALTRIALS: gov, Number: NCT02772965.

Effect of Outreach Messages on Adolescent Well-Child Visits and Coronavirus Disease 2019 Vaccine Rates: A Randomized, Controlled Trial.

OBJECTIVE: To determine effectiveness of text/telephone outreach messages, with and without coronavirus disease 2019 (COVID-19) vaccine information. STUDY DESIGN: We conducted an intent-to-treat, multiarm, randomized clinical trial with adolescents aged 12-17 years. Eligible patients did not have an adolescent well-care visit in the past year or scheduled in the next 45 days or an active electronic health record portal account. We randomized participants to the standard message, COVID-19 vaccine message, or no message (control) group and delivered 2 text messages or telephone calls (per family preference) to the message groups. The primary outcome was adolescent well-care visit completion within 8 weeks, and secondary outcomes were adolescent well-care visit scheduled within 2 weeks and receiving COVID-19 vaccine within 8 weeks. RESULTS: We randomized 1235 adolescents (mean age, 14 ± 1.5 years; 51.6% male; 76.7% Black; 4.1% Hispanic/Latinx; 88.3% publicly insured). The standard message group had higher odds of scheduling an adolescent well-care visit compared with the control group (OR, 2.07; 95% CI, 1.21-3.52) and COVID-19 vaccine message group (OR, 1.66; 95% CI, 1.00-2.74). The odds of completing an adolescent well-care visit did not differ significantly (standard message group vs control group; OR, 1.35; 95% CI, 0.88-2.06; COVID-19 vaccine message group vs control group, OR, 1.33; 95% CI, 0.87-2.03). In per-protocol analyses, adolescents in the standard message group were twice as likely as the control group to receive the COVID-19 vaccine (OR, 2.48; 95% CI, 1.05-5.86). CONCLUSIONS: Outreach messages were minimally effective. Efforts are needed to address widening disparities. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT04904744.

Examining the Unified Theory of Behavior Change Constructs Among Adolescents Taking Attention-Deficit/Hyperactivity Disorder Medicine: A Longitudinal Study.

OBJECTIVE: To quantitatively validate the preintention factors, behavioral intentions, and implementation factors and examine the relationships theorized by the Unified Theory of Behavior Change (UTBC) model among adolescents with attention-deficit/hyperactivity disorder (ADHD). METHODS: We conducted longitudinal analyses of data from 40 adolescents with ADHD, aged 11 to 15 years old, and their parents, including self-report of UTBC constructs using standardized measures. We collected pharmacy dispensing records for adolescents for the 4 months that followed. We used bivariate correlations to examine relationships between medication continuity, behavioral intentions, preintention factors, and the implementation factors. We conducted paired sample t-tests to compare adolescent and parent responses on UTBC items. RESULTS: Adolescents (mean [standard deviation {SD}] age = 13.3 [1.2] years, 75% male, 77.5% non-Hispanic Black, 90% publicly insured) reported a mean total ADHD symptom score = 29.8/54 (SD = 10.94) and mean total impairment score = 18.7/52 (SD = 10.90) and had a mean percentage of days covered with medicine over 4 months = 0.21 (range = 0-0.97). Adolescent intention to take ADHD medicine every school day was significantly related to adolescents' subsequent medication continuity (r = 0.37, P < .05). Adolescent self-concept/image and confidence taking ADHD medicine were the most important factors related to the intention to take ADHD medicine every school day. Adolescents reported less belief and intention to take ADHD medicine and more barriers to taking ADHD medicine compared to their parents. CONCLUSION: The UTBC model shed light on factors related to subsequent medication use, providing a plausible mechanism for additional research to intervene to promote future medication continuity.

Effect of Electronic Outreach Using Patient Portal Messages on Well Child Care Visit Completion: A Randomized Clinical Trial.

Importance: Outreach messages to patients overdue for well child care (WCC) can be delivered different ways (ie, telephone calls and text messages). Use of electronic health record patient portals is increasingly common but their effectiveness is uncertain. Objective: To determine the effectiveness of patient portal outreach messages, with and without the date of the last WCC, on the scheduling and completion of WCC visits and completion of vaccinations. Design, Setting, and Participants: An intention-to-treat, multigroup, randomized clinical trial was conducted at 3 academic primary care practices from July 30 to October 4, 2021. The population included predominantly non-Hispanic Black, low-income children (age, 6-17 years) whose parent had an active portal account. Interventions: Participants were randomized to the standard message, tailored message, or no message (control) group. Two messages were delivered to those in the message groups. Main Outcomes and Measures: Outcomes included WCC visit scheduled within 2 weeks of the first intervention message, WCC visit completed within 8 weeks (primary outcome), and receipt of COVID-19 vaccine within 8 weeks. Results: Nine hundred forty-five patients participated (mean [SD] age, 9.9 [3.3] years, 493 [52.2%] girls, 590 [62.4%] non-Hispanic Black, 807 [85.4%] publicly insured). Scheduling rates were 18.4% in the standard message group (adjusted risk ratio [aRR], 1.97; 95% CI, 1.32-2.84) and 14.9% in the tailored message group (aRR, 1.57; 95% CI, 1.02-2.34) compared with the control group (9.5%). Well child care visit completion rates were 24.1% in the standard message group (aRR, 1.92; 95% CI, 1.38-2.60) and 19.4% in the tailored message group (aRR, 1.52; 95% CI, 1.06-2.13) compared with the control group (12.7%). Among eligible children, rates of receiving the COVID-19 vaccine were 16.7% in the standard message group compared with 4.8% in the tailored message (aRR, 3.41; 95% CI, 1.14-9.58) and 3.7% in the control groups (aRR, 4.84; 95% CI, 1.44-15.12). Conclusions and Relevance: In this randomized clinical trial, outreach messages delivered via electronic health record patient portals increased the rates of scheduling and completing WCC visits and receiving the COVID-19 vaccine, providing a useful tool to help restore WCC in populations whose care was delayed during the pandemic. Trial Registration: ClinicalTrials.gov Identifier: NCT04994691.

Predictors of Stimulant Medication Continuity in Children with Attention-Deficit/Hyperactivity Disorder.

OBJECTIVE: The objective of this study was to examine the simultaneous impact of patient-related and parent-related factors, medication-related factors, and health care system-related factors on attention-deficit/hyperactivity disorder (ADHD) medication continuity. METHOD: Stimulant-naïve children (N = 144, M age = 8 yrs, 71% male) with ADHD completed a methylphenidate (MPH) trial and were followed for 1 year after trial completion and return to community care. Multivariable analysis investigated predictors of (1) having at least 1 filled ADHD prescription after return to community care versus none and (2) having more days covered with medicine after return to community care. Predictors included race; age; sex; income; baseline ADHD symptom severity; MPH trial experience; child and parent mental health conditions; and parent beliefs about ADHD, ADHD medications, and therapeutic alliance. RESULTS: One hundred twenty-one children (84%) had at least 1 filled ADHD medication prescription (mean = 178 d covered by medication) in the year after return to community care. Multivariable models found that a weaker perceived clinician-family working alliance predicted not filling any ADHD prescriptions. Among those who filled ≥1 prescription, factors linked to fewer days of ADHD medication coverage included child sociodemographic factors (non-White race, older age, being female, and lower income), lower parent beliefs that the child's ADHD affects their lives, and higher parent beliefs that medication is harmful, while child oppositional defiant disorder and parental ADHD predicted having more days of medication coverage. CONCLUSION: Child demographic factors, parent beliefs, and medication-related factors are associated with continuation of ADHD medication. These findings may facilitate the development of effective strategies to improve ADHD medication continuity for children from diverse groups.

An Immersive Virtual Reality Curriculum for Pediatric Hematology Clinicians on Shared Decision-making for Hydroxyurea in Sickle Cell Anemia.

Although hydroxyurea (HU) is an effective treatment for sickle cell anemia, uptake remains low. Shared decision-making (SDM) is a recommended strategy for HU initiation to elicit family preferences; however, clinicians lack SDM training. We implemented an immersive virtual reality (VR) curriculum at 8 pediatric institutions to train clinicians on SDM that included counseling virtual patients. Clinicians' self-reported confidence significantly improved following the VR simulations on all communication skills assessed, including asking open-ended questions, eliciting specific concerns, and confirming understanding (Ps≤0.01 for all). VR may be an effective method for educating clinicians to engage in SDM for HU.

Resolving Pediatric Preventive Care Gaps Through Hospital Inreach.

OBJECTIVES: Panel management processes have been used to help improve population-level care and outreach to patients outside the health care system. Opportunities to resolve gaps in preventive care are often missed when patients present outside of primary care settings but still within the larger health care system. We hypothesized that we could design a process of "inreach" capable of resolving care gaps traditionally addressed solely in primary care settings. Our aim was to identify and resolve gaps in vaccinations and screening for lead exposure for children within our primary care registry aged 2 to 66 months who were admitted to the hospital. We sought to increase care gaps closed from 12% to 50%. METHODS: We formed a multidisciplinary team composed of primary care and hospital medicine physicians, nursing leadership, and quality improvement experts within the Division of General and Community Pediatrics. The team identified a smart aim, mapped the process, predicted failure modes, and developed a key driver diagram. We identified, tested, and implemented multiple interventions related to role assignment, identification of admitted patients with care gaps, and communication with the inpatient teams. RESULTS: After increasing the reliability of our process to identify and contact the hospital medicine team caring for patients who needed action to 88%, we observed an increase in the preventive care gaps closed from 12% to 41%. CONCLUSIONS: A process to help improve preventive care for children can be successfully implemented by using quality improvement methodologies outside of the traditional domains of primary care.

Decision making about anti-TNF therapy: A pilot trial of a shared decision-making intervention.

OBJECTIVE: We conducted a pre-post pilot trial to determine the feasibility and acceptability of a multi-component intervention (pre-clinic letter, shared decision making cards and follow-up phone call) designed to facilitate SDM in pediatric inflammatory bowel disease (IBD). METHODS: We recruited physicians (n = 11) caring for IBD patients and families (n = 36) expected to discuss anti-tumor necrosis treatment. We measured feasibility and acceptability of the intervention, observed SDM, perceived SDM, decision conflict, and regret. Medical records were used to assess clinical outcomes, time to decision and adherence. We compared all outcomes between the usual care and intervention study arms. RESULTS: Two out of three intervention components were feasible. Visit length increased significantly in the intervention arm. Parents and patients rated the intervention as acceptable, as did most physicians. The intervention was associated with a higher-level of observed SDM. There was no difference perceived SDM, decision conflict, regret or quality of life outcomes between arms. Physician global assessment improved over time in the intervention arm. CONCLUSIONS: This pilot trial provides important guidance for developing a larger scale trial of a modified intervention. PRACTICE IMPLICATIONS: Overall, our intervention shows promise in supporting SDM and engaging both parents and patients in pediatric IBD decisions.

Engaging Caregivers and Providers of Children With Sickle Cell Anemia in Shared Decision Making for Hydroxyurea: Protocol for a Multicenter Randomized Controlled Trial.

BACKGROUND: Sickle cell anemia (SCA) is a genetic blood disorder that puts children at a risk of serious medical complications, early morbidity and mortality, and high health care utilization. Until recently, hydroxyurea was the only disease-modifying treatment for this life-threatening disease and has remained the only option for children younger than 5 years. Evidence-based guidelines recommend using a shared decision-making (SDM) approach for offering hydroxyurea to children with SCA (HbSS or HbS/ß0 thalassemia) aged as early as 9 months. However, the uptake remains suboptimal, likely because caregivers lack information about hydroxyurea and have concerns about its safety and potential long-term side effects. Moreover, clinicians do not routinely receive training or tools, especially those that provide medical evidence and consider caregivers' preferences and values, to facilitate a shared discussion with caregivers. OBJECTIVE: The aim of this study is to understand how best to help parents of young children with sickle cell disease and their clinicians have a shared discussion about hydroxyurea (one that considers medical evidence and parent values and preferences). METHODS: We designed our study to compare the effectiveness of two methods for disseminating hydroxyurea guidelines to facilitate SDM: a clinician pocket guide (ie, usual care) and a clinician hydroxyurea SDM toolkit (H-SDM toolkit). Our primary outcomes are caregiver reports of decisional uncertainty and knowledge of hydroxyurea. The study also assesses the number of children (aged 0-5 years) who were offered and prescribed hydroxyurea and the resultant health outcomes. RESULTS: The Ethics Committee of the Cincinnati Children's Hospital Medical Center approved this study in November 2017. As of February 2021, we have enrolled 120 caregiver participants. CONCLUSIONS: The long-term objective of this study is to improve the quality of care for children with SCA. Using multicomponent dissemination methods developed in partnership with key stakeholders and designed to address barriers to high-quality care, caregivers of patients with SCA can make informed and shared decisions about their health. TRIAL REGISTRATION: ClinicalTrials.gov NCT03442114; https://clinicaltrials.gov/ct2/show/NCT03442114. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27650.

Integrating shared decision making into trial consent: A nested, cluster-randomized trial.

OBJECTIVE: Using a nested, cluster-randomized trial, we tested the hypothesis that a shared decision-making intervention, as part of consent, would improve study-related knowledge. METHODS: We developed a shared decision-makingintervention then randomized sites in a clinical trial to intervention or control (standard consent). We collected participants' knowledge (primary outcome) and decisional support data. Other data came from a clinical registry and research coordinator surveys. We compared outcomes between study arms using generalized estimating equation models, accounting for clustering. We used qualitative description to understand variation in intervention use. RESULTS: 265 individuals, from 34 sites, enrolled in the parent trial during our study period. Of those, 241 participants completed our survey. There was no knowledge difference between arms (mean difference = 0.56 (95 %CI: -3.8, 4.9)). Both groups had a considerable number of participants with misunderstandings. We also found no difference for decisional support (mean difference = 1.5 (95 %CI: -1.8, 4.8)) or enrollment rate between arms. Clinician use of the intervention varied between sites. CONCLUSIONS: We found no differences in outcomes but demonstrated the feasibility and acceptability of incorporating a shared decision-making intervention into consent. PRACTICE IMPLICATIONS: Future work should consider adapting our intervention to other trials and more robust measurement strategies.

Pre-Existing Comorbid Emotional Symptoms Moderate Short-Term Methylphenidate Adverse Effects in a Randomized Trial of Children with Attention-Deficit/Hyperactivity Disorder.

Objective: We sought to ascertain whether baseline anxiety/depression and oppositional defiant disorder (ODD) symptoms impacted the experience of short-term methylphenidate (MPH) adverse effects (AEs) in 7- to 11-year-old children with attention-deficit/hyperactivity disorder (ADHD) (n = 171) undergoing a double-blind MPH crossover trial. Method: The Vanderbilt ADHD Diagnostic Parent Rating Scale measured baseline child anxiety/depression and ODD symptomology. The parent-completed Pittsburgh Side Effect Rating Scale assessed the AEs of anxiety, sadness, and irritability at baseline, on placebo, and on three MPH dosages. For each AE, we evaluated comorbidity main effects, dose main effects, and comorbidity × dose interactions. Results: Baseline anxiety/depression × dose and ODD × dose interactions were significant for the AEs of anxiety, sadness, and irritability. Compared with premedication baseline, these AEs attenuated on MPH for children with initially higher comorbidity symptoms, whereas those with initially lower comorbidity symptoms tended toward no change or increasing AE levels. Conclusion: Premedication anxiety/depressive and ODD symptoms may be important predictors of short-term MPH emotional AEs.

Comparison of Performance on ADHD Quality of Care Indicators: Practitioner Self-Report Versus Chart Review.

Objective: This study compared practitioner self-report of ADHD quality of care measures with actual performance, as documented by chart review. Method: In total, 188 practitioners from 50 pediatric practices completed questionnaires in which they self-reported estimates of ADHD quality of care indicators. A total of 1,599 charts were reviewed. Results: The percentage of patients for whom practitioners self-reported that they used evidence-based care was higher in every performance category when compared with chart review, including higher use of parent and teacher rating scales during assessment and treatment compared with chart review. Self-reported use of Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) criteria during assessment was also higher than by chart review. The actual number of days until the first contact after starting medication was nearly three times longer than self-report estimates. Conclusion: Practitioners overreport performance on quality of care indicators. These differences were large and consistent across ADHD diagnostic and treatment monitoring practices. Practitioner self-report of ADHD guideline adherence should not be considered a valid measure of performance.