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A study protocol testing the implementation, efficacy, and cost effectiveness of the ezParent program in pediatric primary care.

ABSTRACT: Up to 20% of children demonstrate behavior problems that interfere with relationship development and academic achievement. Parent participation in behavioral parent training programs has been shown to decrease child problem behaviors and promote positive parent-child relationships. However, attendance and parent involvement in face-to-face parent training remain low. Testing the implementation, efficacy, and cost of alternative delivery models is needed to (a) increase the reach and sustainability of parent training interventions and (b) address the barriers to parent participation and implementation of such programs, specifically in primary health care settings. The purpose of this paper is to describe the study protocol evaluating the implementation, efficacy, and cost-effectiveness of delivering the tablet-based ezParent program in pediatric primary care sites.The implementation of the ezParent in four pediatric primary care sites will be evaluated using a descriptive design and cost-effectiveness analysis. The efficacy of the ezParent will be tested using a randomized controlled trial design with 312 parents of 2 to 5year old children from pediatric primary care settings. Data on parenting and child behavior outcomes will be obtained from all participants at baseline, and 3, 6, and 12months post baseline.Integrating and evaluating the implementation of the ezParent in pediatric primary care is an innovative opportunity to promote positive parenting with potential for universal access to the preschool population and for low cost by building on existing infrastructure in pediatric primary care.

SUBMITTER: Breitenstein SM

PROVIDER: S-EPMC5053093 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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A study protocol testing the implementation, efficacy, and cost effectiveness of the ezParent program in pediatric primary care.

Breitenstein Susan M SM Schoeny Michael M Risser Heather H Johnson Tricia T

Contemporary clinical trials 20160831

<h4>Introduction</h4>Up to 20% of children demonstrate behavior problems that interfere with relationship development and academic achievement. Parent participation in behavioral parent training programs has been shown to decrease child problem behaviors and promote positive parent-child relationships. However, attendance and parent involvement in face-to-face parent training remain low. Testing the implementation, efficacy, and cost of alternative delivery models is needed to (a) increase the r ...[more]

PMID: 27592122

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Project description:INTRODUCTION:HIV remains underdiagnosed. Guidelines recommend routine HIV testing in primary care, but evidence on implementing testing is lacking. In a previous study, the Rapid HIV Assessment 2 (RHIVA2) cluster randomised controlled trial, we showed that providing training and rapid point-of-care HIV testing at general practice registration (RHIVA2 intervention) in Hackney led to cost-effective, increased and earlier diagnosis of HIV. However, interventions effective in a trial context may be less so when implemented in routine practice. We describe the protocol for an MRC phase IV implementation programme, evaluating the impact of rolling out the RHIVA2 intervention in a post-trial setting. We will use a longitudinal study to examine if the post-trial implementation in Hackney practices is effective and cost-effective, and a cross-sectional study to compare Hackney with two adjacent boroughs providing usual primary care (Newham) and an enhanced service promoting HIV testing in primary care (Tower Hamlets). METHODS AND ANALYSIS:Service evaluation using interrupted time series and cost-effectiveness analyses. We will include all general practices in three contiguous high HIV prevalence East London boroughs. All adults aged 16 and above registered with the practices will be included. The interventions to be examined are: a post-trial RHIVA2 implementation programme (including practice-based education and training, external quality assurance, incentive payments for rapid HIV testing and incorporation of rapid HIV testing in the sexual health Local Enhanced Service) in Hackney; the general practice sexual health Network Improved Service in Tower Hamlets and usual care in Newham. Coprimary outcomes are rates of HIV testing and new HIV diagnoses. ETHICS AND DISSEMINATION:The chair of the Camden and Islington NHS Research Ethics Committee, London, has endorsed this programme as an evaluation of routine care. Study results will be published in peer-reviewed journals and reported to commissioners.

Project description:ImportanceParental smoking adversely affects parents' and children's health. There are effective interventions delivered in pediatric settings to help parents quit smoking. The cost-effectiveness of this type of intervention is not known.ObjectiveTo evaluate the cost-effectiveness of a parental smoking cessation intervention, the Clinical Effort Against Secondhand Smoke Exposure (CEASE) program, delivered in pediatric primary care, compared with usual care from a health care organization's perspective.Design, setting, and participantsThis economic evaluation used data on intervention costs and parental smoking cessation collected prospectively as part of the CEASE randomized clinical trial. Data were collected at pediatric offices in 5 US states from April 2015 to October 2017. Participants included parents of children attending 10 pediatric primary care practices (5 control, 5 intervention). Data analysis was performed from October 2019 to August 2020.ExposuresThe trial compared CEASE (practice training and support to address family tobacco use) vs usual care.Main outcomes and measuresThe overall cost and incremental cost per quit of the CEASE intervention were calculated using microcosting methods. CEASE effectiveness was estimated using 2 trial outcomes measures assessed in repeated cross-sections: (1) change in smoking prevalence assessed by parental report for intervention vs usual care practices at 2 weeks after program initiation (baseline) and at 2-year follow-up and (2) changes in the proportion of smokers who achieved cotinine-confirmed smoking cessation in the previous 2 years at baseline vs follow-up. Monte Carlo analyses were used to provide 95% CIs.ResultsThe study included a total of 3054 participants (1523 at baseline and 1531 at follow-up); 2163 (70.8%) were aged 25 to 44 years old, and 2481 (81.2%) were women. Over 2 years, the total cost of implementing and sustaining CEASE across 5 intervention practices was $115 778. The incremental cost per quit for CEASE compared with usual care was $1132 (95% CI, $653-$3603), according to the change in parent-reported smoking prevalence, and $762 (95% CI, $418-$2883), according to cotinine-confirmed cessation. CEASE was cost-effective at a willingness-to-pay threshold of $2000 per quit in 88.0% of simulations based on the parent-reported smoking prevalence and 94.6% of simulations based on cotinine-confirmed smoking cessation measures.Conclusions and relevanceThese findings suggest that the CEASE intervention was associated with an incremental cost per quit that compared favorably with those of other clinical smoking cessation interventions. CEASE is inexpensive to initiate and maintain in the clinical pediatric setting, suggesting that it has the potential for a high impact on population health.

Project description:BackgroundDissemination of evidence-based practices that can reduce morbidity and mortality is important to combat the growing opioid overdose crisis in the USA. Research and expert consensus support reducing high-dose opioid therapy, avoiding risky opioid-benzodiazepine combination therapy, and promoting multi-modal, collaborative models of pain care. Collaborative care interventions that support primary care providers have been effective in medication tapering. We developed a patient-centered Primary Care-Integrated Pain Support (PIPS) collaborative care clinical program based on effective components of previous collaborative care interventions. Implementation facilitation, a multi-faceted and dynamic strategy involving the provision of interactive problem-solving and support during implementation of a new program, is used to support key organizational staff throughout PIPS implementation. The primary aim of this study is to evaluate the effectiveness of the implementation facilitation strategy for implementing and sustaining PIPS in the Veterans Health Administration (VHA). The secondary aim is to examine the effect of the program on key patient-level clinical outcomes-transitioning to safer regimens and enhancing access to complementary and integrative health treatments. The tertiary aim is to determine the categorical costs and ultimate budget impact of PIPS implementation.MethodsThis multi-site study employs an interrupted time series, hybrid type III design to evaluate the effectiveness of implementation facilitation for a collaborative care clinical program-PIPS-in primary care clinics in three geographically diverse VHA health care systems (sites). Participants include pharmacists and allied staff involved in the delivery of clinical pain management services as well as patients. Eligible patients are prescribed either an outpatient opioid prescription greater than or equal to 90 mg morphine equivalent daily dose or a combination opioid-benzodiazepine regimen. They must also have an upcoming appointment in primary care. The Consolidated Framework for Implementation Research will guide the mixed methods work across the formative evaluation phases and informs the selection of activities included in implementation facilitation. The RE-AIM framework will be used to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance of PIPS.DiscussionThis implementation study will provide important insight into the effectiveness of implementation facilitation to enhance uptake of a collaborative care program in primary care, which targets unsafe opioid prescribing practices.

Project description:BackgroundSepsis is a clinical syndrome characterized by organ dysfunction due to presumed or proven infection. Severe cases can have case fatality ratio 25% or higher in low-middle income countries, but early diagnosis and timely treatment have a proven benefit. The Smart Triage program in Jinja Regional Referral Hospital in Uganda will provide expedited sepsis treatment in children through a data-driven electronic patient triage system. To complement the ongoing Smart Triage interventional trial, we propose methods for a concurrent cost-effectiveness analysis of the Smart Triage platform.MethodsWe will use a decision-analytic model taking a societal perspective, combining government and out-of-pocket costs, as patients bear a sizeable portion of healthcare costs in Uganda due to the lack of universal health coverage. Previously published secondary data will be used to link healthcare utilization with costs and intermediate outcomes with mortality. We will model uncertainty via probabilistic sensitivity analysis and present findings at various willingness-to-pay thresholds using a cost-effectiveness acceptability curve.DiscussionOur proposed analysis represents a first step in evaluating the cost-effectiveness of an innovative digital triage platform designed to improve clinical outcomes in pediatric sepsis through expediting care in low-resource settings. Our use of a decision analytic model to link secondary costing data, incorporate post-discharge healthcare utilization, and model clinical endpoints is also novel in the pediatric sepsis triage literature for low-middle income countries. Our analysis, together with subsequent analyses modelling budget impact and scale up, will inform future modifications to the Smart Triage platform, as well as motivate scale-up to the district and national levels.Trial registrationTrial registration of parent clinical trial: NCT04304235, https://clinicaltrials.gov/ct2/show/NCT04304235. Registered 11 March 2020.

Project description:ImportanceYouth anxiety and depression are common and undertreated. Pediatric transdiagnostic interventions for anxiety and/or depression may be associated with improved access to treatment among youths.ObjectiveTo evaluate the cost-effectiveness of a pediatric transdiagnostic brief behavioral therapy (BBT) program for anxiety and/or depression compared with assisted referral to community outpatient mental health care (ARC).Design, setting, and participantsIn this economic evaluation, an incremental cost-effectiveness analysis was performed from the societal perspective using data from a randomized clinical trial of youths with full or probable diagnoses of anxiety or depression who were recruited from pediatric clinics in San Diego, California, and Pittsburgh, Pennsylvania. The trial was conducted from October 6, 2010, through December 5, 2014, and this analysis was performed from January 1, 2019, through October 20, 2020.InterventionsIn the randomized clinical trial, youths were randomized to BBT (n = 95) or ARC (n = 90). The BBT program consisted of 8 to 12 weekly 45-minute sessions of behavioral therapy delivered in pediatric clinics by master's-level therapists. Families randomized to ARC received personalized referrals to mental health care and telephone calls to support access to care.Main outcomes and measuresAnxiety-free days, depression-free days, quality-adjusted life-years (QALYs), and costs based on incremental cost-effectiveness ratios from intake through 32-week follow-up. A cost-effectiveness acceptability curve for QALYs was used to assess the probability that BBT was cost-effective compared with ARC over a range of amounts that a decision-maker might be willing to pay for an additional outcome.ResultsEnrolled patients included 185 youths (mean [SD] age, 11.3 [2.6] years; 107 [57.8%] female; 144 [77.8%] White; and 38 [20.7%] Hispanic). Youths who received BBT experienced significantly more anxiety-free days (difference, 28.63 days; 95% CI, 5.86-50.71 days; P = .01) and QALYs (difference, 0.026; 95% CI, 0.009-0.046; P = .007) compared with youths who received ARC. Youths who received BBT experienced more depression-free days than did youths who received ARC (difference, 10.52 days; 95% CI, -4.50 to 25.76 days; P = .18), but the difference was not statistically significant. The mean incremental cost-effectiveness ratio was -$41 414 per QALY (95% CI, -$220 601 to $11 468). The cost-effectiveness acceptability curve analysis indicated that, at a recommended willingness-to-pay threshold of $50 000 per QALY, the probability that BBT would be cost-effective compared with ARC at 32 weeks was 95.6%.Conclusions and relevanceIn this economic evaluation, BBT in primary care was significantly associated with better outcomes and a greater probability of cost-effectiveness at 32 weeks compared with ARC. The findings suggest that transdiagnostic BBT may be associated with improved youth anxiety and functioning at a reasonable cost.

Project description:INTRODUCTION:To address the know-do gap in the integration of mental health care into primary care in resource-limited settings, a multi-faceted implementation program initially designed to integrate HIV/AIDS care into primary care was adapted for severe mental disorders and epilepsy in Burera District, Rwanda. The Mentoring and Enhanced Supervision at Health Centers (MESH MH) program supported primary care-delivered mental health service delivery scale-up from 6 to 19 government-run health centers over two years. This quasi-experimental study assessed implementation reach, fidelity, and clinical outcomes at health centers supported by MESH MH during the scale up period. METHODS:MESH MH consisted of four strategies to ensure the delivery of the priority care packages at health centers: training; supervision and mentorship; audit and feedback; and systems-based quality improvement (QI). Implementation reach (service use) across the 19 health centers supported by MESH MH during the two year scale-up period was described using routine service data. Implementation fidelity was measured at four select health centers by comparing total clinical supervisory visits and checklists to target goals, and by tracking clinical observation checklist item completion rates over a nine month period. A prospective before and after evaluation measured clinical outcomes in consecutive adults presenting to four select health centers over a nine month period. Primary outcome assessments at baseline, 2 and 6 months included symptoms and functioning, measured by the General Health Questionnaire (GHQ-12) and the World Health Organization Disability Assessment Scale (WHO-DAS Brief), respectively. Secondary outcome assessments included engagement in income generating work and caregiver burden using a quantitative scale adapted to context. RESULTS:A total of 2239 mental health service users completed 15,744 visits during the scale up period. MESH MH facilitated 70% and 76% of supervisory visit and clinical checklist utilization target goals, respectively. Checklist item completion rates significantly improved overall, and for three of five checklist item subgroups examined. 121 of 146 consecutive service users completed outcome measurements six months after entry into care. Scores improved significantly over six months on both the GHQ-12, with median score improving from 26 to 10 (mean within-person change 12.5 [95% CI: 10.9-14.0] p< 0.0001), and the WHO-DAS Brief, with median score improving from 26.5 to 7 (mean within-person change 16.9 [95% CI: 14.9-18.8] p< 0.0001). Over the same period, the percentage of surveyed service users reporting an inability to work decreased significantly (51% to 6% (p < 0.001)), and the proportion of households reporting that a caregiver had left income-generating work decreased significantly (41% to 4% (p < 0.001)). CONCLUSION:MESH MH was associated with high service use, improvements in mental health care delivery by primary care nurses, and significant improvements in clinical symptoms and functional disability of service users receiving care at health centers supported by the program. Multifaceted implementation programs such as MESH MH can reduce the evidence to practice gap for mental health care delivery by nonspecialists in resource-limited settings. The primary limitation of this study is the lack of a control condition, consistent with the implementation science approach of the study. STUDY REGISTRATION:ISRCTN #37231.

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A study protocol testing the implementation, efficacy, and cost effectiveness of the ezParent program in pediatric primary care.

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A study protocol testing the implementation, efficacy, and cost effectiveness of the ezParent program in pediatric primary care.

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