A randomized prospective trial of an ostomy telehealth intervention for cancer survivors.

BACKGROUND: Cancer survivors with ostomies face complex challenges. This study compared the Ostomy Self-Management Telehealth program (OSMT) versus attention control usual care (UC). METHODS: Three academic centers randomized participants. OSMT group sessions were led by ostomy nurses and peer ostomates (three for ostomates-only, one for support persons, and one review session for both). Surveys at baseline, OSMT completion, and 6 months were primary outcome patient activation (PAM), self-efficacy (SE), City of Hope quality of life-Ostomy (COH-O), and Hospital Anxiety and Depression Scale (HADS). Surveys were scored per guidelines for those completing at least two surveys. Linear mixed effects models were used to select potential covariates for the final model and to test the impact of OSMT within each timeframe. RESULTS: A total of 90 OSMT and 101 UC fulfilled analysis criteria. Arms were well-matched but types of tumors were unevenly distributed (p = .023). The OSMT arm had a nonsignificant improvement in PAM (confidence interval [CI], -3.65 to 5.3]; 4.0 vs. 2.9) at 6 months. There were no significant differences in other surveys. There was a significant OSMT benefit for urinary tumors (four SE domains). Higher OSMT session attendance was associated with post-session improvements in five SE domains (p < .05), two COH-O domains (p < .05), and HADS anxiety (p = .01). At 6 months, there remained improvements in one SE domain (p < .05), one COH-O domain (p < .05), and HADS anxiety (p < .01). CONCLUSIONS: No clear benefit was seen for the OSMT intervention, although there may be an advantage based on type of tumor. Benefit with greater session attendance was also encouraging. PLAIN LANGUAGE SUMMARY: Cancer patients with ostomies have many challenges. We tested a telehealth curriculum compared to usual care. There are indications of benefit for the program for those that attend more sessions and those with urostomies.

Increasing antiretroviral therapy adherence and retention in care among adults living with HIV in Philadelphia: a study protocol for a stepped-wedge cluster-randomised type 2 hybrid effectiveness-implementation trial of managed problem-solving plus (MAPS+) delivered by community health workers.

INTRODUCTION: To end the HIV epidemic in Philadelphia, implementation of evidence-based practices (EBP) to increase viral suppression and retention in HIV care is critical. Managed problem solving (MAPS), an EBP for antiretroviral therapy adherence, follows a problem-solving approach to empower people living with HIV (PWH) to manage their health. To overcome barriers to care experienced by PWH in Philadelphia, the EBP was adapted to include a focus on care retention and delivery by community health workers (CHWs). The adapted intervention is MAPS+. To maximise the clinical impact and reach of the intervention, evaluation of the effectiveness and implementation of MAPS+ is necessary. METHODS AND ANALYSIS: This manuscript describes the protocol for a stepped-wedge cluster-randomised type 2 hybrid effectiveness-implementation trial in 10 clinics in Philadelphia. This research incorporates innovative approaches to accomplish three objectives: (1) to evaluate the effectiveness of the CHW-led MAPS+ intervention to improve viral suppression and retention in care 1 year after the individual implementation period (N=390 participants), (2) to examine the effect of the menu of implementation strategies on reach and implementation cost and (3) to examine processes, mechanisms, and sustainment of the implementation strategies for MAPS+ (N=56 participants). Due to various factors (eg, COVID-19), protocol modifications have occurred. ETHICS AND DISSEMINATION: The institutional review board (IRB) at the city of Philadelphia serves as the primary IRB; initial approval was granted on 21 December 2020. The University of Pennsylvania and Northwestern University executed reliance agreements. A safety monitoring committee comprised experts in implementation science, biostatistics and infectious diseases oversee this study. This research will offer insights into achieving the goals to end the HIV epidemic in Philadelphia as well as implementation efforts of MAPS+ and other behavioural interventions aimed at increasing medication adherence and retention in care. Dissemination will include deliverables (eg, peer-reviewed manuscripts and lay publications) to reach multiple constituents. TRIAL REGISTRATION NUMBER: NCT04560621.

Eliminating Monitor Overuse (EMO) type III effectiveness-deimplementation cluster-randomized trial: Statistical analysis plan.

Background: Deimplementing overused health interventions is essential to maximizing quality and value while minimizing harm, waste, and inefficiencies. Three national guidelines discourage continuous pulse oximetry (SpO2) monitoring in children who are not receiving supplemental oxygen, but the guideline-discordant practice remains prevalent, making it a prime target for deimplementation. This paper details the statistical analysis plan for the Eliminating Monitor Overuse (EMO) SpO2 trial, which compares the effect of two competing deimplementation strategies (unlearning only vs. unlearning plus substitution) on the sustainment of deimplementation of SpO2 monitoring in children with bronchiolitis who are in room air. Methods: The EMO Trial is a hybrid type 3 effectiveness-deimplementation trial with a longitudinal cluster-randomized design, conducted in Pediatric Research in Inpatient Settings Network hospitals. The primary outcome is deimplementation sustainment, analyzed as a longitudinal difference-in-differences comparison between study arms. This analysis will use generalized hierarchical mixed-effects models for longitudinal clustering outcomes. Secondary outcomes include the length of hospital stay and oxygen supplementation duration, modeled using linear mixed-effects regressions. Using the well-established counterfactual approach, we will also perform a mediation analysis of hospital-level mechanistic measures on the association between the deimplementation strategy and the sustainment outcome. Discussion: We anticipate that the EMO Trial will advance the science of deimplementation by providing new insights into the processes, mechanisms, and likelihood of sustained practice change using rigorously designed deimplementation strategies. This pre-specified statistical analysis plan will mitigate reporting bias and support data-driven approaches. Trial registration: ClinicalTrials.gov NCT05132322. Registered on 24 November 2021.

Programmatic Costs of Project ImPACT for Children with Autism: A Time-Driven Activity Based Costing Study.

Programmatic cost assessment of clinical interventions can inform future dissemination and implementation efforts. We conducted a randomized trial of Project ImPACT (Improving Parents As Communication Teachers) in which community early intervention (EI) providers coached caregivers in techniques to improve young children's social communication skills. We estimated implementation and intervention costs while demonstrating an application of Time-Driven Activity-Based Costing (TDABC). We defined Project ImPACT implementation and intervention as processes that can be broken down successively into a set of procedures. We created process maps for both implementation and intervention delivery. We determined resource use and costs, per unit procedure in the first year of the program, from a payer perspective. We estimated total implementation cost per clinician and per site, intervention cost per child, and provided estimates of total hours spent and associated costs for implementation strategies, intervention activities and their detailed procedures. Total implementation cost was $43,509 per clinic and $14,503 per clinician. Clinician time (60%) and coach time (12%) were the most expensive personnel resources. Implementation coordination and monitoring (47%), ongoing consultation (26%) and clinician training (19%) comprised most of the implementation cost, followed by fidelity assessment (7%), and stakeholder engagement (1%). Per-child intervention costs were $2619 and $9650, respectively, at a dose of one hour per week and four hours per week Project ImPACT. Clinician and clinic leader time accounted for 98% of per child intervention costs. Highest cost intervention activity was ImPACT delivery to parents (89%) followed by assessment for child's ImPACT eligibility (10%). The findings can be used to inform funding and policy decision-making to enhance early intervention options for young children with autism. Uncompensated time costs of clinicians are large which raises practical and ethical concerns and should be considered in planning of implementation initiatives. In program budgeting, decisionmakers should anticipate resource needs for coordination and monitoring activities. TDABC may encourage researchers to assess costs more systematically, relying on process mapping and gathering prospective data on resource use and costs concurrently with their collection of other trial data.

The Effect of Psychiatric Comorbidity on Healthcare Utilization for Youth With Newly Diagnosed Systemic Lupus Erythematosus.

OBJECTIVE: To examine the effect of psychiatric diagnoses on healthcare use in youth with systemic lupus erythematosus (SLE) during their first year of SLE care. METHODS: We conducted a retrospective cohort study using claims from 2000 to 2013 from Clinformatics Data Mart (OptumInsight). Youth aged 10 years to 24 years with an incident diagnosis of SLE (≥ 3 International Classification of Diseases, 9th revision, codes for SLE 710.0, > 30 days apart) were categorized as having: (1) a preceding psychiatric diagnosis in the year before SLE diagnosis, (2) an incident psychiatric diagnosis in the year after SLE diagnosis, or (3) no psychiatric diagnosis. We compared ambulatory, emergency, and inpatient visits in the year after SLE diagnosis, stratified by nonpsychiatric and psychiatric visits. We examined the effect of childhood-onset vs adult-onset SLE by testing for an interaction between age and psychiatric exposure on outcome. RESULTS: We identified 650 youth with an incident diagnosis of SLE, of which 122 (19%) had a preceding psychiatric diagnosis and 105 (16%) had an incident psychiatric diagnosis. Compared with those without a psychiatric diagnosis, youth with SLE and a preceding or incident psychiatric diagnosis had more healthcare use across both ambulatory and emergency settings for both nonpsychiatric and psychiatric-related care. These associations were minimally affected by age at time of SLE diagnosis. CONCLUSION: Psychiatric comorbidity is common among youth with newly diagnosed SLE and is associated with greater healthcare use. Interventions to address preceding and incident psychiatric comorbidity may decrease healthcare burden for youth with SLE.

Adapting to the burdens of care: a telehealth program for cancer survivors with ostomies.

PURPOSE: An ostomy introduces to cancer survivors new demands for self-care and healthcare resource use. A curriculum that teaches ostomates self-management skills may affect survivors' use of resources. METHODS: A prospective randomized trial comparing usual care (UC) with an Ostomy Self-Management Training (OSMT) program delivered by telehealth was conducted in patients with ostomies due to cancer. The intervention occurred over 5 weeks with survey administration at baseline, program completion, and 6 months after completion. Quantitative data were analyzed using a mixed-effects logistic model to predict mean values of resource and service use. Responses to the open-ended question were coded and analyzed with directed content analysis. RESULTS: One hundred and sixty-seven subjects (89 in the OSMT arm and 78 in the UC arm) completed the questionnaire at all time points. The changes in likelihoods of emptying one's ostomy bag > 8 times/week and of incurring any out-of-pocket costs on accessories were 14% greater for the intervention group (p = .029 and p = .063, respectively). Qualitative analysis reveals among the OSMT arm an increase in the proportion of ostomy-specific comments and a decrease in the same metric among the UC arm. Common themes included learning to work with equipment, dealing with gas build-up and finding well-fitting clothing. CONCLUSIONS: There are some indications that participants in this structured telehealth program are more active in ostomy self-care. The reported ostomy self-care activities, healthcare consumables, and healthcare services reported by both groups illustrate the complexity of survivorship care following ostomy surgery. National Clinical Trial Identifier: NCT02974634.

Sustainable deimplementation of continuous pulse oximetry monitoring in children hospitalized with bronchiolitis: study protocol for the Eliminating Monitor Overuse (EMO) type III effectiveness-deimplementation cluster-randomized trial.

BACKGROUND: Methods of sustaining the deimplementation of overused medical practices (i.e., practices not supported by evidence) are understudied. In pediatric hospital medicine, continuous pulse oximetry monitoring of children with the common viral respiratory illness bronchiolitis is recommended only under specific circumstances. Three national guidelines discourage its use for children who are not receiving supplemental oxygen, but guideline-discordant practice (i.e., overuse) remains prevalent. A 6-hospital pilot of educational outreach with audit and feedback resulted in immediate reductions in overuse; however, the best strategies to optimize sustainment of deimplementation success are unknown. METHODS: The Eliminating Monitor Overuse (EMO) trial will compare two deimplementation strategies in a hybrid type III effectiveness-deimplementation trial. This longitudinal cluster-randomized design will be conducted in Pediatric Research in Inpatient Settings (PRIS) Network hospitals and will include baseline measurement, active deimplementation, and sustainment phases. After a baseline measurement period, 16-19 hospitals will be randomized to a deimplementation strategy that targets unlearning (educational outreach with audit and feedback), and the other 16-19 will be randomized to a strategy that targets unlearning and substitution (adding an EHR-integrated clinical pathway decision support tool). The primary outcome is the sustainment of deimplementation in bronchiolitis patients who are not receiving any supplemental oxygen, analyzed as a longitudinal difference-in-differences comparison of overuse rates across study arms. Secondary outcomes include equity of deimplementation and the fidelity to, and cost of, each deimplementation strategy. To understand how the deimplementation strategies work, we will test hypothesized mechanisms of routinization (clinicians developing new routines supporting practice change) and institutionalization (embedding of practice change into existing organizational systems). DISCUSSION: The EMO trial will advance the science of deimplementation by providing new insights into the processes, mechanisms, costs, and likelihood of sustained practice change using rigorously designed deimplementation strategies. The trial will also advance care for a high-incidence, costly pediatric lung disease. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05132322 . Registered on November 10, 2021.

Clinic navigation and home visits to improve asthma care in low income adults with poorly controlled asthma: Before and during the pandemic.

Asthma-related deaths, hospitalizations, and emergency visits are more numerous among low-income patients, yet management guidelines do not address this high-risk group's special needs. We recently demonstrated feasibility, acceptability, and preliminary evidence of effectiveness of two interventions to improve access to care, patient-provider communication, and asthma outcomes: 1) Clinic Intervention (CI): study staff facilitated patient preparations for office visits, attended visits, and afterwards confirmed patient understanding of physician recommendations, and 2) Home Visit (HV) by community health workers for care coordination and informing clinicians of home barriers to managing asthma. The current project, denominated "HAP3," combines these interventions for greater effectiveness, delivery of guideline-based asthma care, and asthma control for low-income patients recruited from 6 primary care and 3 asthma specialty practices. We assess whether patients of clinicians receiving guideline-relevant, real-time feedback on patient health and home status have better asthma outcomes. In a pragmatic factorial longitudinal trial, HAP3 enrolls 400 adults with uncontrolled asthma living in low-income urban neighborhoods. 100 participants will be randomized to each of four interventions: (1) CI, (2) CI with HVs, (3) CI and real-time feedback to asthma clinician of guideline-relevant elements of patients' current care, or (4) both (2) and (3). The outcomes are asthma control, quality of life, ED visits, hospitalizations, prednisone bursts, and intervention costs. The COVID-19 pandemic struck 6.5 months into recruitment. We describe study development, design, methodology, planned analysis, baseline findings and adaptions to achieve the original aims of improving patient-clinician communication and asthma outcomes despite the markedly changed pandemic environment.

Stakeholder engagement and participation in the design, delivery, and dissemination of the ostomy self-management telehealth (OSMT) program.

PURPOSE: Stakeholder engagement is increasingly integrated into clinical research processes. We conducted a mixed methods analysis to describe stakeholders' (peer ostomates, ostomy nurses, telehealth engineers) perceptions of their engagement and participation in a multisite, randomized trial of a telehealth-delivered curriculum for cancer survivors with ostomies. METHODS: Stakeholder notes were analyzed using narrative analysis. We constructed a 15-item survey that assessed the following areas: adherence to stakeholder engagement principles, engagement/influence throughout the study process, impact on perceived well-being, and satisfaction. Stakeholders were invited to complete the survey anonymously. Quantitative survey data were tabulated through summary statistics. RESULTS: Across intervention sessions, an average of 7.7 ± 1.4 stakeholders attended and 2.6 ± 1.4 submitted a note per session. The survey response rate was 73% (11/15). Stakeholders reported high agreement that the study adhered to engagement principles (91% reciprocal relationships, 100% co-learning, partnership, and transparency/honesty/trust). They felt highly engaged (18% moderate, 73% great deal) and that they had influence on study initiation (27% moderate, 55% great deal), intervention delivery (9% moderate, 82% great deal), fidelity assessment (18% moderate, 73% great deal), analysis and interpretation (55% moderate, 27% great deal), and dissemination (45% moderate, 45% great deal). They reported high overall satisfaction with roles (91% great deal), believed the program was helpful for participants (91%), and that serving on study team benefited their own well-being (100%). CONCLUSIONS: Our strategy of stakeholder inclusion led to high engagement, input, satisfaction, and belief in success of program, which could be mirrored in other trials.

The Association of the Medicaid 1915(c) Home and Community-Based Services Waivers with Emergency Department Utilization among Youth with Autism Spectrum Disorder.

Using the 2008-2013 Medicaid Analytic eXtract files, this retrospective cohort study was to evaluate the effect of Medicaid home and community-based services (HCBS) waiver programs on emergency department (ED) utilizations among youth with autism spectrum disorder (ASD). Our study showed that the annual ED utilization rates were 13.5% and 18.8% for individuals on autism specific and intellectual and developmental disabilities (IDD) waivers respectively, vs. 28.5% for those without a waiver. Multivariable logistic regression showed that, compared to no waiver, autism specific waivers (adjusted odds ratio: 0.62; 95% Confidence Interval: [0.58-0.66]) and IDD waivers (0.65; [0.64-0.66]) were strongly associated with reduced ED. These findings suggest that HCBS waivers are effective in reducing the incidence of ED visits among youth with ASD.

Strategic Implementation Planning for Integrated Behavioral Health Services in Pediatric Primary Care.

BACKGROUND: Delivering physical and behavioral health services in a single setting is associated with improved quality of care and reduced health care costs. Few health systems implementing integrated care develop conceptual models and targeted measurement strategies a priori with an eye toward adoption, implementation, sustainment, and evaluation. This is a broad challenge in the field, which can make it difficult to disentangle why implementation is or is not successful. METHOD: This paper discusses strategic implementation and evaluation planning for a pediatric integrated care program in a large health system. Our team developed a logic model, which defines resources and community characteristics, program components, evaluation activities, short-term activities, and intermediate and anticipated long-term patient-, clinician-, and practice-related outcomes. The model was designed based on research and stakeholder input to support strategic implementation and evaluation of the program. For each aspect of the logic model, a measurement battery was selected. Initial implementation data and intermediate outcomes from a pilot in five practices in a 30-practice pediatric primary care network are presented to illustrate how the logic model and evaluation plan have been used to guide the iterative process of program development. RESULTS: A total of 4,619 office visits were completed during the two years of the pilot. Primary care clinicians were highly satisfied with the integrated primary care program and provided feedback on ways to further improve the program. Members of the primary care team and behavioral health providers rated the program as being relatively well integrated into the practices after the second year of the pilot. CONCLUSIONS: This logic model and evaluation plan provide a template for future projects integrating behavioral health services in non-specialty mental health settings, including pediatric primary care, and can be used broadly to provide structure to implementation and evaluation activities and promote replication of effective initiatives.

Programmatic Costs of the Telehealth Ostomy Self-Management Training: An Application of Time-Driven Activity-Based Costing.

OBJECTIVES: Programmatic cost assessment of novel clinical interventions can inform their widespread dissemination and implementation. This study aimed to determine the programmatic costs of a telehealth Ostomy Self-Management Training (OSMT) intervention for cancer survivors using Time-Driven Activity-Based Costing (TDABC) methodology. METHODS: We demonstrated a step-by-step application of TDABC based on a process map with core OSMT intervention activities and associated procedures and determined resource use and costs, per unit procedure. We also assessed per-patient costs from a payer perspective and provided estimates of total hours and costs by personnel, activity, and procedure. RESULTS: The per-patient cost of the OSMT was $1758. Personnel time accounted for 91% of the total cost. Site supervisor and information technology technician time were the most expensive personnel resources. Telehealth technical and communication equipment accounted for 8% of the total cost. Intervention coordination and monitoring efforts represented most of the total time cost (62%), followed by the intervention delivery (35%). The procedures with the highest cost were communication via phone or virtual meetings (24%), email exchanges (18%), and telehealth session delivery (18%). CONCLUSIONS: Future efforts to replicate, disseminate, and implement the OSMT intervention should anticipate funding for nonclinical components of the intervention, including coordination and monitoring, and consider how these activities can be performed most efficiently. For institutions without established telemedicine programs, selection of videoconferencing platforms and adequate staffing for participant technical support should be considered. Our step-by-step application of TDABC serves as a case study demonstrating how interventionists can gather data on resource use and costs of intervention activities concurrently with their collection of trial data.

An Ostomy Self-management Telehealth Intervention for Cancer Survivors: Technology-Related Findings From a Randomized Controlled Trial.

BACKGROUND: An Ostomy Self-management Telehealth (OSMT) intervention by nurse educators and peer ostomates can equip new ostomates with critical knowledge regarding ostomy care. A telehealth technology assessment aim was to measure telehealth engineer support requirements for telehealth technology-related (TTR) incidents encountered during OSMT intervention sessions held via a secure cloud-based videoconferencing service, Zoom for Healthcare. OBJECTIVE: This paper examines technology-related challenges, issues, and opportunities encountered in the use of telehealth in a randomized controlled trial intervention for cancer survivors living with a permanent ostomy. METHODS: The Arizona Telemedicine Program provided telehealth engineering support for 105 OSMT sessions, scheduled for 90 to 120 minutes each, over a 2-year period. The OSMT groups included up to 15 participants, comprising 4-6 ostomates, 4-6 peer ostomates, 2 nurse educators, and 1 telehealth engineer. OSMT-session TTR incidents were recorded contemporaneously in detailed notes by the research staff. TTR incidents were categorized and tallied. RESULTS: A total of 97.1% (102/105) OSMT sessions were completed as scheduled. In total, 3 OSMT sessions were not held owing to non-technology-related reasons. Of the 93 ostomates who participated in OSMT sessions, 80 (86%) completed their OSMT curriculum. TTR incidents occurred in 36.3% (37/102) of the completed sessions with varying disruptive impacts. No sessions were canceled or rescheduled because of TTR incidents. Disruptions from TTR incidents were minimized by following the TTR incident prevention and incident response plans. CONCLUSIONS: Telehealth videoconferencing technology can enable ostomates to participate in ostomy self-management education by incorporating dedicated telehealth engineering support. Potentially, OSMT greatly expands the availability of ostomy self-management education for new ostomates. TRIAL REGISTRATION: ClinicalTrials.gov NCT02974634; https://clinicaltrials.gov/ct2/show/NCT02974634.

Collaborative care in the treatment of opioid use disorder and mental health conditions in primary care: A clinical study protocol.

BACKGROUND: People with opioid use disorder (OUD) often have a co-occurring psychiatric disorder, which elevates the risk of morbidity and mortality. Promising evidence supports the use of collaborative care for treating people with OUD in primary care. Whether collaborative care interventions that treat both OUD and psychiatric disorders will result in better outcomes is presently unknown. METHODS: The Whole Health Study is a 3-arm randomized controlled trial designed to test collaborative care treatment for OUD and the psychiatric disorders that commonly accompany OUD. Approximately 1200 primary care patients aged ≥18 years with OUD and depression, anxiety, or PTSD will be randomized to one of three conditions: (1) Augmented Usual Care, which consists of a primary care physician (PCP) waivered to prescribe buprenorphine and an addiction psychiatrist to consult on medication-assisted treatment; (2) Collaborative Care, which consists of a waivered PCP, a mental health care manager trained in psychosocial treatments for OUD and psychiatric disorders, and an addiction psychiatrist who provides consultation for OUD and mental health; or (3) Collaborative Care Plus, which consists of all the elements of the Collaborative Care arm plus a Certified Recovery Specialist to help with treatment engagement and retention. Primary outcomes are six-month rates of opioid use and six-month rates of remission of co-occurring psychiatric disorders. DISCUSSION: The Whole Health Study will investigate whether collaborative care models that address OUD and co-occurring depression, anxiety, or PTSD will result in better patient outcomes. The results will inform clinical care delivery during the current opioid crisis. CLINICAL TRIALS REGISTRATION: www.clinicaltrials.gov registration: NCT04245423.

Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) to Improve Collaboration in School Mental Health: Protocol for a Mixed Methods Hybrid Effectiveness-Implementation Study.

BACKGROUND: Public schools in the United States are the main providers of mental health services to children but are often ill equipped to provide quality mental health care, especially in low-income urban communities. Schools often rely on partnerships with community organizations to provide mental health services to students. However, collaboration and communication challenges often hinder implementation of evidence-based mental health strategies. Interventions informed by team science, such as Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS), have the potential to improve treatment implementation and collaboration within schools. OBJECTIVE: The objective of this study is to improve communication and collaboration strategies among mental health and school staff by adapting an evidence-based team science intervention for school settings. We present a protocol for a hybrid effectiveness-implementation study to adapt TeamSTEPPS using stakeholder feedback, develop a tailored implementation plan, and pilot the adapted content in eight schools. METHODS: Study participants will be recruited from public and charter schools and agencies overseeing school mental health services in the local metro area. We will characterize current services by conducting a needs assessment including stakeholder interviews, observations, and review of administrative data. Thereafter, we will establish an advisory board to understand challenges and develop possible solutions to guide additional TeamSTEPPS adaptations along with a complementary implementation plan. In aim 3, we will implement the adapted TeamSTEPPS plus tailored implementation strategies in eight schools using a pre-post design. The primary outcome measures include the feasibility and acceptability of the adapted TeamSTEPPS. In addition, self-report measures of interprofessional collaboration and teamwork will be collected from 80 participating mental health and school personnel. School observations will be conducted prior to and at three time points following the intervention along with stakeholder interviews. The analysis plan includes qualitative, quantitative, and mixed methods analysis of feasibility and acceptability, school observations, stakeholder interviews, and administrative data of behavioral health and school outcomes for students receiving mental health services. RESULTS: Recruitment for the study has begun. Goals for aim 1 are expected to be completed in Spring 2021. CONCLUSIONS: This study utilizes team science to improve interprofessional collaboration among school and mental health staff and contributes broadly to the team science literature by developing and specifying implementation strategies to promote sustainability. Results from this study will provide knowledge about whether interventions to improve school culture and climate can ready both mental health and school systems for implementation of evidence-based mental health practices. TRIAL REGISTRATION: ClinicalTrials.gov NCT04440228; https://clinicaltrials.gov/ct2/show/NCT04440228. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26567.

Partnerships in Research to Implement and Disseminate Sustainable and Scalable Evidence-Based Practices (PRIDE) in Mozambique.

BACKGROUND: Mental health conditions impose a major burden worldwide, especially in low- and middle-income countries (LMICs), where health specialists are scarce. A challenge to closing LMICs' mental health treatment gap is determining the most cost-effective task-shifting pathway for delivering mental health services using evidence-based interventions (EBIs). This article discusses the protocol for the first study implementing comprehensive mental health services in LMICs. METHODS: In partnership with the Mozambican Ministry of Health, this cluster-randomized, hybrid implementation effectiveness type-2 trial will evaluate implementation, patient, and service outcomes of three task-shifting delivery pathways in 20 Mozambican districts (population 4.7 million). In pathway 1 (usual care), community health workers (CHWs) and primary care providers (PCPs) refer patients to district-level mental health clinics. In pathway 2 (screen, refer, and treat), CHWs screen and refer patients to PCPs for behavioral and pharmacological EBIs in community clinics. In pathway 3 (community mental health stepped care), CHWs screen patients and deliver behavioral EBIs in the community and refer medication management cases to PCPs in clinics. Mixed-methods process evaluation will be used to examine factors affecting pathway implementation, adoption, and sustainability. Clinical activities will occur without research team support. Ministry of Health personnel will coordinate training and supervision. RESULTS: The most cost-effective pathway will be scaled up in all districts for 12 months. NEXT STEPS: This novel study integrating comprehensive mental health services into primary care will inform a toolkit to help the Mozambican Ministry of Health scale up the most cost-effective pathway for mental health services and can be a template for other LMICs.

Impact of Psychiatric Diagnosis and Treatment on Medication Adherence in Youth With Systemic Lupus Erythematosus.

OBJECTIVE: Youth with systemic lupus erythematosus (SLE) experience high rates of psychiatric comorbidities, which may affect medication adherence. We undertook this study to examine the association between psychiatric disorders and hydroxychloroquine adherence and to determine whether psychiatric treatment modifies this association. METHODS: We identified incident hydroxychloroquine users among youth with SLE (ages 10-24 years) using de-identified US commercial insurance claims in Optum Clinformatics Data Mart (2000-2016). Adherence was estimated using medication possession ratios (MPRs) over a 365-day time period. Multivariable linear regression models were used to estimate the effect of having any psychiatric disorder on MPRs, as well as the independent effects of depression, anxiety, adjustment, and other psychiatric disorders. We tested for interactions between psychiatric diagnoses and treatment with psychotropic medications or psychotherapy. RESULTS: Among 873 subjects, 20% had a psychiatric diagnosis, most commonly depression. Only adjustment disorders were independently associated with decreased MPRs (ß -0.12, P = 0.05). We observed significant crossover interactions, in which psychiatric disorders had opposite effects on adherence depending on the receipt of psychiatric treatment. Among youth with any psychiatric diagnosis, psychotropic medication use was associated with a 0.15 increase in the MPR compared with no psychotropic medication use (P = 0.02 for interaction). Among youth with depression or anxiety, psychotherapy was also associated with a higher MPR compared with no psychotherapy (P = 0.05 and P < 0.01 for interaction, respectively). CONCLUSION: The impact of psychiatric disorders on medication adherence differed by whether youth had received psychiatric treatment. Improving recognition and treatment of psychiatric conditions may increase medication adherence in youth with SLE.

Healthy behaviors are associated with positive outcomes for cancer survivors with ostomies: a cross-sectional study.

BACKGROUND: Cancer survivors (CS) with ostomies may face challenges in sustaining physical activity (PA) levels and maintaining healthy diets. This analysis describes lifestyle behaviors and their relationships with health-related quality of life (HRQOL) in CS with ostomies. METHODS: This is a cross-sectional, secondary analysis of a multisite randomized self-management education trial for CS with ostomies. The baseline self-reported measures were queried on aerobic PA and diet using the City of Hope Quality of Life Ostomy measure, and the Self-Efficacy to Perform Self-Management Behaviors questionnaire (SE). PA was compared against the American Cancer Society PA guidelines for CS. Relationships between PA and HRQOL were evaluated using multiple linear regression, stratified by BMI. RESULTS: Among 200 responders, fewer than 20% met or exceeded the PA guideline for cancer survivors; overall, confidence in the ability to perform gentle or aerobic PA was moderate (6/10 on the SE). Overall HRQOL (p = 0.038), psychological well-being (p = 0.017), and physical strength (p = 0.025) were associated with increased PA. Almost half (48.7%) of CS reported a special diet. CS with urostomies were less likely to report diet adjustments after their ostomy surgeries (OR: 0.16, 95% CI [0.08-0.38]) than CS with fecal ostomies. CONCLUSIONS: Better HRQOL is associated with PA guideline achievement among CS with ostomies. Additionally, diet adjustments were reported more frequently in CS with fecal ostomies. Our findings bear clinical relevance for designing ostomy self-management and lifestyle recommendations for CS with ostomies. IMPLICATIONS FOR CANCER SURVIVORS: The evaluation of lifestyle behaviors may be an especially important focus for CS with ostomies.

Validation of the Developmental Check-In Tool for Low-Literacy Autism Screening.

BACKGROUND: Persistent disparities exist in early identification of autism spectrum disorder (ASD) among children from low-income families who are racial and/or ethnic minorities and where English is not the primary language. Parental literacy and level of maternal education may contribute to disparities. The Developmental Check-In (DCI) is a visually based ASD screening tool created to reduce literacy demands and to be easily administered and scored across settings. In a previous study, the DCI showed acceptable discriminative ability between ASD versus non-ASD in a young, underserved sample at high-risk for ASD. In this study, we tested the DCI among an unselected, general sample of young underserved children. METHODS: Six hundred twenty-four children ages 24 to 60 months were recruited through Head Start and Early Head Start. Parents completed the DCI, Modified Checklist for Autism in Toddlers, Revised with Follow-Up, and Social Communication Questionnaire. Children scoring positive on any measure received evaluation for ASD. Those screening negative on both Modified Checklist for Autism in Toddlers, Revised with Follow-Up and Social Communication Questionnaire were considered non-ASD. RESULTS: Parents were primarily Hispanic, reported high school education or less, and had public or no insurance. The DCI demonstrated good discriminative power (area under the curve = 0.80), performing well across all age groups, genders, levels of maternal education, primary language, and included ethnic and racial groups. Item-level analyses indicated that 24 of 26 DCI items discriminated ASD from non-ASD. CONCLUSIONS: The DCI is a promising ASD screening tool for young, underserved children and may be of particular value in screening for ASD for those with low literacy levels or with limited English proficiency.

Immunomodulatory Medication Use in Newly Diagnosed Youth With Systemic Lupus Erythematosus.

OBJECTIVE: To examine glucocorticoid-sparing immunomodulatory medication use in youth with systemic lupus erythematosus (SLE) during their first year of care. METHODS: We conducted a retrospective cohort study using administrative claims for 2000 to 2013 from Clinformatics DataMart for youth ages 10-24 years with an incident diagnosis of SLE (≥3 International Classification of Diseases, Ninth Revision codes for SLE [710.0], each >30 days apart). We determined the proportion of subjects filling a prescription for immunomodulatory medications within 12 months of the first SLE code (index date). We used multivariable regression to examine associations between demographic/disease factors and time to prescription fill in the first year, and also between prescription fill at any time after the index date. RESULTS: We identified 532 youth with an incident SLE diagnosis, of which 413 (78%) had a glucocorticoid-sparing immunomodulatory prescription fill in the first year. Prescriptions for hydroxychloroquine and immunosuppressants were filled in the first year by 366 youth (69%) and by 182 (34%), respectively. Those with adult-onset (versus childhood-onset) disease were less likely to fill an immunomodulatory medication by 12 months. No other statistically significant associations were found, although there was increasing likelihood of immunomodulatory medication fills with each subsequent calendar year. CONCLUSION: Among youth with newly diagnosed SLE, hydroxychloroquine use is prevalent although not universal, and prescription immunosuppressant use is notably low during the first year of care. Further research is needed to identify factors contributing to suboptimal immunomodulatory medication use during the first year of care.