Provider and Practice Factors Associated With On-Time HPV Vaccination in Primary Care.

BACKGROUND: In 2018, only one third of girls and boys completed the 2-dose series of the human papillomavirus vaccine by their 13th birthday, the target for on-time vaccination. The study objective was to identify key patient, provider and practice-level factors associated with on-time vaccination in the primary care setting. METHODS: We examined data from 20 primary care pediatric practices (89 providers) in St. Louis including: the percentage of eligible patients with on-time vaccination assessed from medical records; providers' knowledge, attitudes and behaviors regarding on-time vaccination assessed with a survey; and practice-level strategies used to optimize vaccine delivery assessed with a 19-item vaccine delivery system score (VDSS). Factors that increased on-time vaccination were identified using logistic regression, controlling for clustering within providers. RESULTS: Completion of on-time vaccination occurred in 1347/3125 (43.10%) of patients (95% confidence interval [CI], 41.36%-44.86%) and varied among practices (7.39%-64.24%) and among providers (2.63%-82.50%). Independent predictors for higher completion of on-time vaccination included more frequent use by providers of the announcement style for vaccine recommendation (odds ratio [OR] 1.18, 95% CI, 1.04, 1.35), higher provider self-efficacy to deliver the vaccine according to guideline recommendations if parents were hesitant (OR 1.21, 95% CI, 1.05, 1.40), and higher VDSS (OR 1.20, 95% CI, 1.10, 1.31). CONCLUSIONS: Provider and practice-level factors were identified that may represent modifiable targets for improvement in on-time vaccine uptake. Future research is needed to test interventions built on these findings.

Chatbot-Delivered Cognitive Behavioral Therapy in Adolescents With Depression and Anxiety During the COVID-19 Pandemic: Feasibility and Acceptability Study.

BACKGROUND: Symptoms of depression and anxiety, suicidal ideation, and self-harm have escalated among adolescents to crisis levels during the COVID-19 pandemic. As a result, primary care providers (PCPs) are often called on to provide first-line care for these youth. Digital health interventions can extend mental health specialty care, but few are evidence based. We evaluated the feasibility of delivering an evidence-based mobile health (mHealth) app with an embedded conversational agent to deliver cognitive behavioral therapy (CBT) to symptomatic adolescents presenting in primary care settings during the pandemic. OBJECTIVE: In this 12-week pilot study, we evaluated the feasibility of delivering the app-based intervention to adolescents aged 13 to 17 years with moderate depressive symptoms who were treated in a practice-based research network (PBRN) of academically affiliated primary care clinics. We also obtained preliminary estimates of app acceptability, effectiveness, and usability. METHODS: This small, pilot randomized controlled trial (RCT) evaluated depressive symptom severity in adolescents randomized to the app or to a wait list control condition. The primary end point was depression severity at 4-weeks, measured by the 9-item Patient Health Questionnaire (PHQ-9). Data on acceptability, feasibility, and usability were collected from adolescents and their parent or legal guardian. Qualitative interviews were conducted with 13 PCPs from 11 PBRN clinics to identify facilitators and barriers to incorporating mental health apps in treatment planning for adolescents with depression and anxiety. RESULTS: The pilot randomized 18 participants to the app (n=10, 56%) or to a wait list control condition (n=8, 44%); 17 participants were included in the analysis, and 1 became ineligible upon chart review due to lack of eligibility based on documented diagnosis. The overall sample was predominantly female (15/17, 88%), White (15/17, 88%), and privately insured (15/17, 88%). Mean PHQ-9 scores at 4 weeks decreased by 3.3 points in the active treatment group (representing a shift in mean depression score from moderate to mild symptom severity categories) and 2 points in the wait list control group (no shift in symptom severity category). Teen- and parent-reported usability, feasibility, and acceptability of the app was high. PCPs reported preference for introducing mHealth interventions like the one in this study early in the course of care for individuals presenting with mild or moderate symptoms. CONCLUSIONS: In this small study, we demonstrated the feasibility, acceptability, usability, and safety of using a CBT-based chatbot for adolescents presenting with moderate depressive symptoms in a network of PBRN-based primary care clinics. This pilot study could not establish effectiveness, but our results suggest that further study in a larger pediatric population is warranted. Future study inclusive of rural, socioeconomically disadvantaged, and underrepresented communities is needed to establish generalizability of effectiveness and identify implementation-related adaptations needed to promote broader uptake in pediatric primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04603053; https://clinicaltrials.gov/ct2/show/NCT04603053.

Primary care experiences of providing mental healthcare for children in the USA during the COVID-19 pandemic: a qualitative study.

BACKGROUND: The increased demand for mental healthcare associated with the COVID-19 pandemic adds to the already high unmet mental health needs among paediatric patients, resulting in a declared 'mental health emergency'. The study objective was to describe paediatric primary care providers (PCPs') experience of meeting their patients' needs for mental healthcare during the pandemic and to identify opportunities to optimise care. METHODS: 19 paediatricians and 2 nurse practitioners completed a 30 min video interview in May 2021. Interviews were recorded and transcribed, and transcripts were analysed using consensual qualitative research methods. RESULTS: Participants reported marked increases in patient mental health needs during the COVID-19 pandemic. These included new diagnoses of anxiety and depression and increased treatment needs for patients with a prior mental health diagnosis. They identified that the mental health needs of their patients were greater, more severe and more challenging to manage with the resources currently available. While they were frustrated with the lack of communication and support from their mental health colleagues, and felt isolated and overwhelmed, they approached the increased demand for mental healthcare with a growth mindset. This outlook included providing care, seeking help to improve their skills and engaging with local resources such as the Child Psychiatry Access Project (CPAP). CONCLUSIONS: Our findings suggest that urgent action is needed to better support paediatric PCPs to provide mental healthcare in our community. Providers identified an ongoing need for timely access to and effective communication with mental health providers to guide care in the medical home. This need could be addressed immediately by providing training for new and experienced clinicians, expanding the scope of CPAP programmes to include patient assessment and supporting implementation of integrated behavioural health programmes into the medical home.

Improving Follow-Up for Adolescents With Depression in Primary Care.

BACKGROUND: Few adolescents with depression receive treatment in accordance with national guidelines. This quality improvement project took place in 11 primary care practices with the primary aim of increasing the percentage of teens with depression who received follow-up care within 6 weeks of diagnosis and within 3 months, once stable. METHODS: The primary strategy was external practice facilitation for 12 months. The change process used goal setting and plan-do-study-act cycles to identify and implement change ideas. A preanalysis and postanalysis was completed to evaluate process change, provider confidence, and patient improvement. RESULTS: Randomly selected samples of 199 and 217 charts of teens newly diagnosed with depression were reviewed before and after the intervention, respectively. Chart data for these measurements was provided by 10 and 9 practices, respectively. The percentage of patients with follow-up care within 6 weeks after diagnosis increased from 40% to 81% (P < .001), the percentage with a follow-up visit within 3 months once stable increased from 30% to 60% (P < .001), and the percentage in remission at 6 months increased from 7% to 21% (P < .001). Providers reported increased confidence to diagnose and manage depression, assess severity, provide pharmacotherapy, and educate families. CONCLUSIONS: Practices improved follow-up care for teens with depression. In addition, providers experienced an improvement in their confidence to diagnose and manage depression. Working with a facilitator, each practice implemented standardized systems to provide effective care in the medical home, increase providers' confidence to address this common problem, and improve patient outcomes.

A Novel Innovation and Entrepreneurship (I&E) Training Program for Biomedical Research Trainees.

PROBLEM: Contemporary science emphasizes efficient translation of scientific discoveries into tangible, innovative products and services to improve human health. Therefore, researchers need skills in innovation and entrepreneurship (I&E) to select which problems to address and bring to market the most promising solutions. Training in this skillset is not currently available to most biomedical research trainees. APPROACH: The Entrepreneurship for Biomedicine (E4B) training program was created to develop biomedical researchers' I&E skills. The program comprises 2 semester-length courses: E4B1 teaches core skills; E4B2 focuses on advanced skills for those interested in pursuing funding for a new venture. In addition to traditional entrepreneurship training, E4B teaches ethics and personal skills such as resilience, communication, and team-building. Each course is delivered online and requires about 4 hours weekly. Program elements include short videos for didactic content; a team-based capstone project; mentorship from experienced entrepreneurs; and a live, virtual pitch presentation. The program is housed at Washington University School of Medicine in St. Louis and is open to pre- and postdoctoral biomedical research trainees and faculty nationwide. OUTCOMES: In 2020, 77 trainees completed E4B1 and 13 went on to complete E4B2. Trainees in both courses were satisfied with learning content and mentorship and would recommend the program to a friend. Pre- and postanalyses demonstrated that trainees' confidence in their knowledge about and ability to perform I&E tasks taught throughout the program increased. Since completion, 4 graduates have received external funding for an innovation and 3 have started a company. NEXT STEPS: E4B is well accepted, and this preliminary evaluation suggests the program is effective. It could serve to support medical school curricula, business competitions, and technology transfer efforts, which are opportunities for future exploration. A more robust evaluation is planned and recruitment will be expanded to increase participation from women and underrepresented populations.

An informed approach to the development of primary care pediatric firearm safety messages.

BACKGROUND: Firearm ownership is prevalent in the US and many children spend time in areas where firearms are not stored safely. The AAP recommends firearm safety counseling at pediatric well-visits. METHODS: We developed and tested six contextual messages to promote safe firearm storage based on: absence of harm, collective appeal to understanding child behavior, pediatrician's authority, evidence-based, fear appeal, and general safety considerations. One hundred four parents who keep firearms at home were recruited from Amazon Mechanical Turk Prime and viewed video messages and reported behavioral intentions and emotional reactions following each message. RESULTS: All six contextual messages were perceived as important and believable and increased parents' intentions to follow safety advice provided, but also elicited negative emotions. The authority message elicited more negative emotions and resulted in lower intentions to follow safe storage advice. CONCLUSIONS: Including firearm messages with other child safety advice merits further evaluation. Authority messages should be avoided.

Development of a Health Information Technology Tool for Behavior Change to Address Obesity and Prevent Chronic Disease Among Adolescents: Designing for Dissemination and Sustainment Using the ORBIT Model.

Health information technology (HIT) has not been broadly adopted for use in outpatient healthcare settings to effectively address obesity in youth, especially among disadvantaged populations that face greater barriers to good health. A well-designed HIT tool can deliver behavior change recommendations and provide community resources to address this gap, and the Obesity-Related Behavioral Intervention Trials (ORBIT) model can guide its development and refinement. This article reports the application of the ORBIT model to (1) describe the characteristics and design of a novel HIT tool (the PREVENT tool) using behavioral theory, (2) illustrate the use of stakeholder-centered "designing for dissemination and sustainability" principles, and (3) discuss the practical implications and directions for future research. Two types of stakeholder engagement (customer discovery and user testing) were conducted with end users (outpatient healthcare teams). Customer discovery interviews (n = 20) informed PREVENT tool components and intervention targets by identifying (1) what healthcare teams (e.g., physicians, dietitians) identified as their most important "jobs to be done" in helping adolescents who are overweight/obese adopt healthy behaviors, (2) their most critical "pains" and "gains" related to overweight/obesity treatment, and (3) how they define success compared to competing alternatives. Interviews revealed the need for a tool to help healthcare teams efficiently deliver tailored, evidence-based behavior change recommendations, motivate patients, and follow-up with patients within the constraints of clinic schedules and workflows. The PREVENT tool was developed to meet these needs. It facilitates prevention discussions, delivers tailored, evidence-based recommendations for physical activity and food intake, includes an interactive map of community resources to support behavior change, and automates patient follow-up. Based on Self-Determination Theory, the PREVENT tool engages the patient to encourage competence and autonomy to motivate behavior change. The use of this intentional, user-centered design process should increase the likelihood of the intended outcomes (e.g., behavior change, weight stabilization/loss) and ultimately increase uptake, implementation success, and long-term results. After initial tool development, user-testing interviews (n = 13) were conducted using a think-aloud protocol that provided insight into users' (i.e., healthcare teams) cognitive processes, attitudes, and challenges when using the tool. Overall, the PREVENT tool was perceived to be useful, well-organized, and visually appealing.

Collaborating to Advocate in Primary Care for Children During COVID-19.

The St Louis Regional Pediatric Learning Collaborative of pediatric primary care providers and infectious diseases specialists formed in March 2020 to address the needs of children and families during the coronavirus disease 2019 (COVID-19) pandemic. More than 400 pediatric primary care providers participated, using a listserv to discuss care and organize webinars to provide updates on local and national data and plan next steps. To inform local decision-making about care and testing for severe acute respiratory syndrome coronavirus 2, 95 providers from 26 practices partnered with the local practice-based research network to rapidly collect and share data about children with COVID-19-like symptoms. Of 2162 children tested for severe acute respiratory syndrome coronavirus 2, 9% had positive test results. Test result positivity was 33% if a patient was exposed to a confirmed case of COVID-19 and 4% if they had COVID-19-like symptoms and no exposure. School or day care attendance was associated with lower rates of positive test results. Although not originally planned, these findings drove local advocacy efforts by the Collaborative for increased access to testing and contact tracing and safe in-person school. Members communicated directly and collectively with local politicians, provided advice and resources for school boards and superintendent groups, and appeared on various media platforms. In these efforts, they shared local data, highlighting the lower rate of positive test results for children in school to support the idea that schools could be safely open. Outreach from trusted pediatricians sharing prospective, timely, local data sustained in-person school for some districts and aided in future in-person openings for other school districts.

The Third Rail of Pediatric Communication: Discussing Firearm Risk and Safety in Well-Child Exams.

This research endeavors to understand how pediatricians and parents discuss - or do not discuss - firearm risks for children during well-child visits. Through individual semi-structured interviews with 16 pediatric providers and 20 parents, the research explores discursive barriers to open conversation, perspectives on anticipatory guidance, and new ideas for culturally competent messaging. The research focuses particularly on how parents' and providers' perspectives on firearm risk communication are tied to cultural norms and expectations. One salient theme that emerged is that the American Academy of Pediatrics recommendation that pediatricians ask parents about ownership status is deemed undesirable by pediatricians and parents because of the delicate intercultural setting. Born out of pediatric and parent experiences, and mindful of culturally salient barriers, this study offers alternative strategies for discussing firearm risk in well-child exams.

A Pragmatic Trial of Symptom-Based Inhaled Corticosteroid Use in African-American Children with Mild Asthma.

BACKGROUND: Symptom-based adjustment (SBA) of inhaled corticosteroids may be an alternative patient-centered approach in which day-to-day inhaled corticosteroid use is adjusted by symptoms and short-acting ß-agonist need. OBJECTIVE: To evaluate the effectiveness of SBA in the primary care setting. METHODS: We conducted a randomized, open-label, pragmatic equivalence trial in African-American children (6-17 years old) with mild asthma managed by 12 primary care providers (PCPs). A total of 206 participants were randomized to SBA (as-needed beclomethasone 80 µg with rescue short-acting ß-agonist) or provider-based guideline-directed adjustment (PBA): maintenance beclomethasone 80 µg/d (6-11 years old), 160 µg/d (12-17 years old), with subsequent guideline-based dose adjustment by PCPs. PCPs implemented both treatment assignments, with outcomes measured by blinded staff. All participants received symptom recognition and albuterol use education from peer educators. Primary outcome was change in asthma control (measured by Asthma Control Test [ACT]/childhood ACT [cACT]) over 12 months. RESULTS: Participants had adequately controlled asthma (mean ACT or cACT score = 21.6 ± 2.8) at baseline. After 1 year, there was no significant between-group difference in change in ACT scores (SBA - PBA): ACT: -0.88 (95% CI, -2.19 to 0.42), cACT: -0.73 (-2.09 to 0.62), or combined ACT and cACT (P = .10), and was within the predefined statistical clinical equivalence. The proportion with an exacerbation and measures of lung function were similar between groups. Compared with PBA, SBA led to less beclomethasone use (SBA: 526 µg/mo [95% CI, 412-639 µg] vs PBA: 1961 µg/mo [95% CI, 1681-2241]; P < .0001). More parents in the SBA arm felt they were managing their child's asthma. CONCLUSIONS: SBA in African-American children with mild asthma was similar to PBA in asthma control and events when implemented by PCPs with lower inhaled corticosteroid exposure.

Validating curricular competencies in innovation and entrepreneurship for biomedical research trainees: A modified Delphi approach.

INTRODUCTION: Biomedical researchers need skills in innovation and entrepreneurship (I&E) to efficiently translate scientific discoveries into products and services to be used to improve health. METHODS: In 2016, the European Union identified and published 15 entrepreneurial competencies (EntreComp) for the general population. To validate the appropriateness of these competencies for I&E training for biomedical researchers and to identify program content, we conducted six modified Delphi panels of 45 experts (6-9 per panel). Participating experts had diverse experience, representing such fields as entrepreneurship, academic research, venture capital, and industry. RESULTS: The experts agreed that all 15 EntreComp competencies were important for biomedical research trainees and no additional competencies were identified. In a two-round Delphi process, the experts identified 120 topics to be included in a training curriculum. They rated the importance of each topic using a 5-point scale from not at all important (1) to extremely important (5) for two student groups: entrepreneurs (those interested in starting their own ventures) and intrapreneurs (those wanting to be innovative and strategic within academia or industry). Consensus (mean importance score >4) was reached that 85 (71%) topics were of high importance for the curriculum. Four topics were identified by multiple panels for both student groups: resiliency, goal setting, team management, and communication skills. CONCLUSIONS: I&E training for biomedical trainees should address all 15 EntreComp competencies, including "soft skills," and be flexible to accommodate the needs of trainees on different career trajectories.

Designing for Accelerated Translation (DART) of Emerging Innovations in Health.

Accelerating innovation translation is a priority for improving healthcare and health. Although dissemination and implementation (D&I) research has made significant advances over the past decade, it has attended primarily to the implementation of long-standing, well-established practices and policies. We present a conceptual architecture for speeding translation of promising innovations as candidates for iterative testing in practice. Our framework to Design for Accelerated Translation (DART) aims to clarify whether, when, and how to act on evolving evidence to improve healthcare. We view translation of evidence to practice as a dynamic process and argue that much evidence can be acted upon even when uncertainty is moderately high, recognizing that this evidence is evolving and subject to frequent reevaluation. The DART framework proposes that additional factors-demand, risk, and cost, in addition to the evolving evidence base-should influence the pace of translation over time. Attention to these underemphasized factors may lead to more dynamic decision-making about whether or not to adopt an emerging innovation or de-implement a suboptimal intervention. Finally, the DART framework outlines key actions that will speed movement from evidence to practice, including forming meaningful stakeholder partnerships, designing innovations for D&I, and engaging in a learning health system.

Low Back Pain--Related Disability in Parkinson Disease: Impact on Functional Mobility, Physical Activity, and Quality of Life.

BACKGROUND: People with Parkinson disease (PD) frequently experience low back pain (LBP), yet the impact of LBP on functional mobility, physical activity, and quality of life (QOL) has not been described in PD. OBJECTIVE: The objectives of this study were to describe body positions and functional activities associated with LBP and to determine the relationships between LBP-related disability and PD motor sign severity, physical activity level, and QOL. DESIGN: The study was a cross-sectional study. METHODS: Thirty participants with idiopathic PD (mean age = 64.6 years [SD = 10.3]; 15 women) completed the Revised Oswestry Disability Questionnaire (RODQ), a measure of LBP-related disability. PD motor symptom severity was measured using the Movement Disorder Society-Unified Parkinson Disease Rating Scale Part III (MDS-UPRDS III). The Physical Activity Scale for the Elderly (PASE) was used to measure self-reported physical activity. The Parkinson Disease Questionnaire-39 (PDQ-39) was used to measure QOL. Descriptive statistics were used to characterize LBP intensity and LBP-related disability. Spearman correlations were used to determine relationships between the RODQ and the MDS-UPDRS III, PASE, and PDQ-39. RESULTS: LBP was reported to be of at least moderate intensity by 63.3% of participants. LBP most frequently impaired standing, sleeping, lifting, and walking. The RODQ was significantly related to the MDS-UPDRS III (r = 0.38), PASE (r = -0.37), PDQ-39 summary index (r = 0.55), PDQ-39 mobility subdomain (r = 0.54), and PDQ-39 bodily pain subdomain (r = 0.44). LIMITATIONS: Limitations included a small sample of people with mild to moderate PD severity, the fact that RODQ is a less frequently used measure of LBP-related disability, and the lack of a non-PD control group. CONCLUSIONS: LBP affected walking, sleeping, standing, and lifting in this small sample of people with mild to moderate PD. Greater LBP-related disability was associated with greater motor sign severity, lower physical activity level, and lower QOL in people with PD.

Opioids in Adolescents' Homes: Prevalence, Caregiver Attitudes, and Risk Reduction Opportunities.

OBJECTIVE: The most common source of misused opioids is pain relievers prescribed for family and friends. This study was conducted to assess knowledge, attitudes, and behaviors of adolescents' caregivers regarding prescribed opioids in the home. METHODS: The self-administered survey was completed by caregivers in the waiting rooms of 12 pediatric practices in the Midwest. Eligibility required living in a home where youth age ≥10 years were frequently present. Out of 793 eligible caregivers, 700 (88.3%) completed the survey, 76.8% of whom were the parent. RESULTS: Among the 700 caregiver respondents, 34.6% reported opioids in the home (13.6% active prescriptions, 12.7% leftover medications, 8.3% both). Of those with an active prescription, 66.0% intended to keep any leftover medications for future needs (for the patient, 60.1%; for someone else, 5.9%). Of those with leftover medications, 60.5% retained them for the same reason (for the patient, 51.0%; for someone else, 9.5%). Others kept medications unintentionally, either because they never got around to disposing of them (30.6%), they did not know how to dispose of them properly (15.7%), or it never occurred to them to dispose of the medications (7.5%). Many caregivers were unaware that adolescents commonly misuse opioids (30.0%) and use them to attempt suicide (52.3%), and that opioid use can lead to heroin addiction (38.6%). According to the surveys, 7.1% would give leftover opioid medications to an adolescent to manage pain and 5.9% might do so. CONCLUSIONS: Opioids are prevalent in homes in our community, and many parents are unaware of the risks they pose. Study findings can inform strategies to educate parents about opioid risk and encourage and facilitate timely, safe disposal of unused medications.

Implementation of Strategies to Improve Human Papillomavirus Vaccine Coverage: A Provider Survey.

INTRODUCTION: Human papillomavirus (HPV) vaccine coverage in the U.S. is persistently suboptimal, despite research describing barriers to vaccination and strategies to increase vaccination coverage. The objective was to assess providers' approach to the HPV vaccine and their implementation of strategies to increase HPV vaccination coverage. The hypothesis was that adoption of improvement measures to address underuse of the HPV vaccine has not occurred. METHODS: Community pediatric providers from two Midwestern practice-based research networks completed self-administered electronic surveys. Data were collected over 6 months in 2015 and organized and analyzed in 2016. RESULTS: There were 100 providers that participated. Despite agreement with national recommendations, some providers delayed their recommendation until the adolescent was older and many reported missed vaccination opportunities. Many providers experienced parental concerns including safety of the HPV vaccine, belief their child was not at risk of HPV infection, and their child's resistance to receiving multiple shots. Providers identified the following as barriers to adherence to Advisory Committee on Immunization Practices guidelines: bad publicity of the HPV vaccine, information about the HPV vaccine on the web, and a lack of a follow-up system for those who delayed HPV vaccine initiation. Approximately half of the participants had implemented strategies to address these barriers beyond offering immunization-only appointments. CONCLUSIONS: Participants were aware of barriers to HPV vaccine use, but many had not adopted a systematic approach to increase vaccine coverage. A better understanding of the challenges facing providers to adopting improvement measures and a strategy to address barriers to implementation are needed to improve HPV coverage.

Barriers and facilitators to HPV vaccination in primary care practices: a mixed methods study using the Consolidated Framework for Implementation Research.

BACKGROUND: In the United States, the effective, safe huma papilloma virus (HPV) vaccine is underused and opportunities to prevent cancer continue to be missed. National guidelines recommend completing the 2-3 dose HPV vaccine series by age 13, well before exposure to the sexually transmitted virus. Accurate characterization of the facilitators and barriers to full implementation of HPV vaccine recommendations in the primary care setting could inform effective implementation strategies. METHODS: We used the Consolidated Framework for Implementation Research (CFIR) to systematically investigate and characterize factors that influence HPV vaccine use in 10 primary care practices (16 providers) using a concurrent mixed methods design. The CFIR was used to guide collection and analysis of qualitative data collected through in-person semi-structured interviews with the primary care providers. We analyzed HPV vaccine use with data abstracted from medical charts. Constructs that most strongly influenced vaccine use were identified by integrating the qualitative and quantitative data. RESULTS: Of the 72 CFIR constructs assessed, seven strongly distinguished and seven weakly distinguished between providers with higher versus lower HPV vaccine coverage. The majority of strongly distinguishing constructs were facilitators and were related to characteristics of the providers (knowledge and beliefs; self-efficacy; readiness for change), their perception of the intervention (relative advantage of vaccinating younger vs. older adolescents), and their process to deliver the vaccine (executing). Additional weakly distinguishing constructs that were facilitators were from outer setting (peer pressure; financial incentives), inner setting (networks and communications and readiness for implementation) and process (planning; engaging, and reflecting and evaluating). Two strongly distinguishing constructs were barriers to use, one from the intervention (adaptability of the age of initiation) and the other from outer setting (patient needs and resources). CONCLUSIONS: Using CFIR to systematically examine the use of this vaccine in independent primary care practices enabled us to identify facilitators and barriers at the provider, interpersonal and practice level that need to be addressed in future efforts to increase vaccine use in such settings. Our findings suggest that implementation strategies that target the provider and help them to address multi-level barriers to HPV vaccine use merit further investigation.

Caregiver and pediatric provider perspectives on symptom-based inhaled corticosteroid therapy in asthma.

OBJECTIVES: Guidelines recommend that healthcare providers adjust the dose of inhaled corticosteroids (ICS) in asthma patients based on the degree of symptom severity and control. Symptom-based, intermittent ICS therapy (use of ICS together with short acting bronchodilators- symptom-based adjustment: SBA) has been demonstrated to be comparable to guideline-based management by providers in controlled clinical trials. We sought input from African American caregivers and pediatricians on the acceptability and barriers for this alternative management strategy. METHODS: Focus group interviews of caregivers and individual interviews with community providers of African-American children ages 6-17 years with mild-moderate persistent asthma were conducted by trained facilitators to assess perceptions of how asthma affects children and their caregivers, and of SBA as a management strategy. Interview data were transcribed and analyzed using inductive thematic based coding. RESULTS: Twenty-six parents participated in six focus groups. Fourteen pediatricians were interviewed. Caregivers reported facing financial burden and difficulty with tracking medications. Caregivers and pediatricians were favorable about SBA, citing its potential for decreased use of medications and cost and similarity to actual care provided. Some caregivers voiced concern that SBA would not be as effective as daily ICS. Caregivers suggested that education on symptom recognition and close communication between physician and patient would facilitate the implementation of SBA. CONCLUSIONS: SBA was generally viewed favorably by caregivers and providers of African American children. However, concerns regarding effectiveness of SBA were voiced by both caregivers and providers. Patient education and provider-patient communication is important in implementing this alternative asthma management strategy.

Theory-based development of an implementation intervention to increase HPV vaccination in pediatric primary care practices.

BACKGROUND: The national guideline for use of the vaccine targeting oncogenic strains of the human papillomavirus (HPV) is an evidence-based practice that is poorly implemented in primary care. Recommendations include completion of the vaccine series before the 13th birthday for girls and boys, giving the first dose at the 11- to 12-year-old check-up visit, concurrent with other recommended vaccines. Interventions to increase implementation of this guideline have had little impact, and opportunities to prevent cancer continue to be missed. METHODS: We used a theory-informed approach to develop a pragmatic intervention for use in primary care settings to increase implementation of the HPV vaccine guideline recommendation. Using a concurrent mixed methods design in 10 primary care practices, we applied the Consolidated Framework for Implementation Research (CFIR) to systematically investigate and characterize factors strongly influencing vaccine use. We then used the Behavior Change Wheel (BCW) and the Theoretical Domains Framework (TDF) to analyze provider behavior and identify behaviors to target for change and behavioral change strategies to include in the intervention. RESULTS: We identified facilitators and barriers to guideline use across the five CFIR domains: most distinguishing factors related to provider characteristics, their perception of the intervention, and their process to deliver the vaccine. Targeted behaviors were for the provider to recommend the HPV vaccine the same way and at the same time as the other adolescent vaccines, to answer parents' questions with confidence, and to implement a vaccine delivery system. To this end, the intervention targeted improving provider's capability (knowledge, communication skills) and motivation (action planning, belief about consequences, social influences) regarding implementing guideline recommendations, and increasing their opportunity to do so (vaccine delivery system). Behavior change strategies included providing information and communication skill training with graded tasks and modeling, feedback of coverage rates, goal setting, and social support. These strategies were combined in an implementation intervention to be delivered using practice facilitation, educational outreach visits, and cyclical small tests of change. CONCLUSIONS: Using CFIR, the BCW and the TDF facilitated the development of a pragmatic, multi-component implementation intervention to increase use of the HPV vaccine in the primary care setting.

Physical therapy and deep brain stimulation in Parkinson's Disease: protocol for a pilot randomized controlled trial.

BACKGROUND: Subthalamic nucleus deep brain stimulation (STN-DBS) reduces tremor, muscle stiffness, and bradykinesia in people with Parkinson's Disease (PD). Walking speed, known to be reduced in PD, typically improves after surgery; however, other important aspects of gait may not improve. Furthermore, balance may worsen and falls may increase after STN-DBS. Thus, interventions to improve balance and gait could reduce morbidity and improve quality of life following STN-DBS. Physical therapy (PT) effectively improves balance and gait in people with PD, but studies on the effects of PT have not been extended to those treated with STN-DBS. As such, the efficacy, safety, and feasibility of PT in this population remain to be determined. The purpose of this pilot study is to address these unmet needs. We hypothesize that PT designed to target balance and gait impairment will be effective, safe, and feasible in this population. METHODS/DESIGN: Participants with PD treated with STN-DBS will be randomly assigned to either a PT or control group. Participants assigned to PT will complete an 8-week, twice-weekly PT program consisting of exercises designed to improve balance and gait. Control group participants will receive the current standard of care following STN-DBS, which does not include prescription of PT. The primary aim is to assess preliminary efficacy of PT on balance (Balance Evaluation Systems Test). A secondary aim is to assess efficacy of PT on gait (GAITRite instrumented walkway). Participants will be assessed OFF medication/OFF stimulation and ON medication/ON stimulation at baseline and at 8 and 12 weeks after baseline. Adverse events will be measured over the duration of the study, and adherence to PT will be measured to determine feasibility. DISCUSSION: To our knowledge, this will be the first study to explore the preliminary efficacy, safety, and feasibility of PT for individuals with PD with STN-DBS. If the study suggests potential efficacy, then this would justify larger trials to test effectiveness and safety of PT for those with PD with STN-DBS. TRIAL REGISTRATION: NCT03181282 (clinicaltrials.gov). Registered on 7 June 2017.