Hybrid Effectiveness-implementation Trial Research Articles

Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): A cluster-randomized type 3 hybrid effectiveness-implementation trial

BackgroundOpioid-related overdoses and harms have been declared a public health emergency in the United States, highlighting an urgent need to implement evidence-based treatments. Contingency management (CM) is one of the most effective behavioral interventions when delivered in combination with medication for opioid use disorder, but its implementation in opioid treatment programs is woefully limited. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics) was funded by the National Institute on Drug Abuse to identify effective strategies for helping opioid treatment programs improve CM implementation as an adjunct to medication. Specific aims will test the impact of two different strategies on implementation outcomes (primary aim) and patient outcomes (secondary aims), as well as test putative mediators of implementation effectiveness (exploratory aim).MethodsA 3-cohort, cluster-randomized, type 3 hybrid design is used with the opioid treatment programs as the unit of randomization. Thirty programs are randomized to one of two conditions. The control condition is the Addiction Technology Transfer Center (ATTC) Network implementation strategy, which consists of three core approaches: didactic training, performance feedback, and on-going consultation. The experimental condition is an enhanced ATTC strategy, with the same core ATTC elements plus two additional theory-driven elements. The two additional elements are Pay-for-Performance, which aims to increase implementing staff’s extrinsic motivations, and Implementation & Sustainment Facilitation, which targets staff’s intrinsic motivations. Data will be collected using a novel, CM Tracker tool to document CM session delivery, session audio recordings, provider surveys, and patient surveys. Implementation outcomes include CM Exposure (number of CM sessions delivered per patient), CM Skill (ratings of CM fidelity), and CM Sustainment (number of patients receiving CM after removal of support). Patient outcomes include self-reported opioid abstinence and opioid-related problems (both assessed at 3- and 6-months post-baseline).DiscussionThere is urgent public health need to improve the implementation of CM as an adjunct to medication for opioid use disorder. Consistent with its hybrid type 3 design, Project MIMIC is advancing implementation science by comparing impacts of these two multifaceted strategies on both implementation and patient outcomes, and by examining the extent to which the impacts of those strategies can be explained by putative mediators.Trial registration: This clinical trial has been registered with clinicaltrials.gov (NCT03931174).Registered April 30, 2019. https://clinicaltrials.gov/ct2/show/NCT03931174?term=project+mimic&draw=2&rank=1

Centralized colorectal cancer screening outreach and patient navigation for vulnerable populations in North Carolina: study protocol for the SCORE randomized controlled trial

BackgroundAlthough colorectal cancer (CRC) screening is effective in reducing CRC mortality, screening rates in vulnerable populations served by community health centers (CHCs) remain below national targets. CHCs in North Carolina are challenged to reach CRC screening targets as they tend to be under-resourced, have limited capacity to implement and sustain population health interventions, and typically operate independently from one another and from regional colonoscopy providers. The Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE) project is designed to address barriers to CRC screening in partnership with CHCs by implementing a multilevel intervention that includes centralized support infrastructure for mailed fecal immunochemical test (FIT) outreach and patient navigation to follow-up colonoscopy. This paper describes protocols for the SCORE implementation trial.MethodsWe will conduct a type 2 hybrid effectiveness-implementation trial that will assess effectiveness at increasing CRC screening and follow-up rates while also assessing implementation outcomes. The planned trial sample will include 4000 CHC patients who are at average CRC risk and due for screening. Participants will be randomized 1:1 to receive either usual care or a multilevel intervention that includes mailed FIT outreach and patient navigation support to follow-up colonoscopy for those with abnormal FIT. The primary effectiveness outcome is completion of any CRC screening test at six months after randomization. We will also conduct a multilevel assessment of implementation outcomes and determinants.DiscussionThis hybrid effectiveness-implementation trial will evaluate the effectiveness and implementation of an intervention that provides centralized infrastructure for mailed FIT screening and patient navigation for CHCs that operate independently of other healthcare facilities. Findings from this research will enhance understanding of the effectiveness of a centralized approach and factors that determine successful implementation in vulnerable patient populations.Trial registrationThe trial was registered on May 28, 2020, at ClinicalTrials.gov (identifier NCT04406714).

9.4 CHALLENGES AND CONSIDERATIONS FOR SCREENING FOR PARENT ADHD IN PEDIATRIC PRIMARY CARE

ADHD is common in both parents and children, yet African American families are less likely to be diagnosed or treated, or to participate in clinical trials. Parent ADHD can significantly impact child development and treatment response. Most children receive primary care annually, presenting an opportunity to screen for ADHD in children and parents. Although pediatric providers are familiar with screening and managing ADHD in children, there is little guidance on how to effectively approach parents about their own ADHD. The current qualitative study describes challenges encountered and lessons learned when implementing a parent ADHD screening protocol in primary care serving a large population of African American youth and families. The study occurred within the context of a hybrid effectiveness-implementation trial treating parents and children with ADHD with parental stimulant medication and behavioral parent training. To guide study implementation, a stakeholder advisory group was formed including pediatricians, behavioral health providers, clinic staff, and parents with ADHD or with a child with ADHD. Meetings were held before and during the study to seek feedback from stakeholders regarding factors that may influence recruitment and implementation of the treatment trial. Two meetings were held with 9 stakeholders during June and November 2020. Meetings were recorded, transcribed, coded, and analyzed for themes. Stakeholder members were predominantly female (89%) and White (44%). Thematic analyses identified 6 themes: 1) centering Black people’s experiences with mental health care; 2) the value of integrating parent mental health with child mental health care; 3) sensitivity required when talking about parent mental health; 4) attention to medication hesitation; 5) effective vs ineffective strategies to identify parent mental health; and 6) structural barriers for screening parent ADHD in pediatric primary care. Findings provide suggestions (eg, describing symptoms vs using clinical labels, having conversations initiated by trusted providers) for pediatricians on how to engage parents effectively and sensitively in discussions about their own ADHD in the context of working with underserved multiplex families in primary care.

Lessons Learned and Future Actions: Implementing a Stroke Specific Self-Management Program Research Study

<h3>Research Objectives</h3> To highlight a research study investigating a stroke specific self-management program. We report the implementation process, lessons learned, and strategies developed in response to the barriers encountered. <h3>Design</h3> Hybrid effectiveness implementation trial. <h3>Setting</h3> Community. <h3>Participants</h3> Inclusion criteria: (1) acute stroke, (2) ≥ one chronic condition, (3) independent consent, (4) community dwelling at the start of the intervention, > 3 months post stroke, and (5) > 18 years old. <h3>Interventions</h3> Evidence-based self-management program, pre-adapted for stroke survivors. Six, 2-hour weekly group sessions on topics such as symptom management. <h3>Main Outcome Measures</h3> Information on lessons learned (barriers to implementation) and strategies to address the barrier, reported using the Consolidated Framework for Implementation Research (CFIR) guidelines. <h3>Results</h3> 352 charts screened; 59 people met the inclusion criteria, 25 consented (42% of eligible sample) and five were interested in continuing at the 3-month call. We addressed barriers to implementation continuously. For example, before the group sessions began, the COVID-19 pandemic necessitated changes to the intervention delivery. We adapted the protocol to an online format, via a virtual platform. After making this change, we determined that almost all participants did not have computers or iPads, nor internet. Therefore, our strategy to remove this barrier was to deliver the intervention over the phone and we distributed the study materials via the mail. We classified this information in CFIR under Domain I, Intervention Characteristics and Construct D- Adaptability. <h3>Conclusions</h3> The CFIR was essential to reporting of barriers and strategies. Essentially, we decided to stop implementation due to poor participation and recruit additional participants. Future work will evaluate the strategies developed as well as report the clinical outcomes with the new cohort. <h3>Author(s) Disclosures</h3> No conflicts of interest.

Study protocol for a type III hybrid effectiveness-implementation trial of strategies to implement firearm safety promotion as a universal suicide prevention strategy in pediatric primary care

BackgroundInsights from behavioral economics, or how individuals’ decisions and behaviors are shaped by finite cognitive resources (e.g., time, attention) and mental heuristics, have been underutilized in efforts to increase the use of evidence-based practices in implementation science. Using the example of firearm safety promotion in pediatric primary care, which addresses an evidence-to-practice gap in universal suicide prevention, we aim to determine: is a less costly and more scalable behavioral economic-informed implementation strategy (i.e., “Nudge”) powerful enough to change clinician behavior or is a more intensive and expensive facilitation strategy needed to overcome implementation barriers?MethodsThe Adolescent and child Suicide Prevention in Routine clinical Encounters (ASPIRE) hybrid type III effectiveness-implementation trial uses a longitudinal cluster randomized design. We will test the comparative effectiveness of two implementation strategies to support clinicians’ use of an evidence-based firearm safety practice, S.A.F.E. Firearm, in 32 pediatric practices across two health systems. All pediatric practices in the two health systems will receive S.A.F.E. Firearm materials, including training and cable locks. Half of the practices (k = 16) will be randomized to receive Nudge; the other half (k = 16) will be randomized to receive Nudge plus 1 year of facilitation to target additional practice and clinician implementation barriers (Nudge+). The primary implementation outcome is parent-reported clinician fidelity to the S.A.F.E Firearm program. Secondary implementation outcomes include reach and cost. To understand how the implementation strategies work, the primary mechanism to be tested is practice adaptive reserve, a self-report practice-level measure that includes relationship infrastructure, facilitative leadership, sense-making, teamwork, work environment, and culture of learning.DiscussionThe ASPIRE trial will integrate implementation science and behavioral economic approaches to advance our understanding of methods for implementing evidence-based firearm safety promotion practices in pediatric primary care. The study answers a question at the heart of many practice change efforts: which strategies are sufficient to support change, and why? Results of the trial will offer valuable insights into how best to implement evidence-based practices that address sensitive health matters in pediatric primary care.Trial registrationClinicalTrials.gov, NCT04844021. Registered 14 April 2021.

Optimising symptom management in children with cancer using a novel mobile phone application: protocol for a controlled hybrid effectiveness implementation trial (RESPONSE)

BackgroundIntense and aggressive treatment regimens for most children’s cancer have achieved vast improvements in survival but are also responsible for both a high number and burden of symptoms. The use of Patient Reported Outcome Measures (PROMs) demonstrates a range of benefits for improved symptom management in adults with cancer. There are, however, multiple barriers to integrating PROMs into routine care in children and adolescents with cancer. This study aims to evaluate: (1) the effectiveness of electronic PROMs to generate stratified alerts, symptom management recommendations and graphical summaries (the RESPONSE system) to improve health outcomes and (2) the implementation of the RESPONSE system by assessing feasibility, acceptability, satisfaction, and sustainability.MethodsA pragmatic hybrid II effectiveness-implementation controlled trial, using mixed methods, will be undertaken, advancing both knowledge of the effectiveness of the intervention and implementation factors. One-hundred and sixty children with cancer receiving active treatment will be recruited 1:1 to a non-randomised study involving two groups with an equal number of participants in each group. The intervention group (n = 80) will be prospectively recruited to receive the RESPONSE system intervention over eight weeks, versus the historical matched control group (n = 80) who will complete the ePROMs without access to the RESPONSE system. The primary outcome of the effectiveness trial is change between groups in total symptom burden. Secondary outcomes include child health-related quality-of-life and implementation outcomes. Trial data will be analysed using linear mixed-effects models. Formative implementation evaluation is informed by CFIR and ERIC frameworks and implementation outcomes will be mapped to the RE-AIM framework and include interviews, field notes, as well as administrative data to evaluate feasibility, acceptability, satisfaction and sustainability.Trial registration numberACTRN12621001084875. Retrospectively Registered 16 August 2021.

A Type III Hybrid Effectiveness-Implementation Pilot Trial Testing Dissemination and Implementation Strategies for a Pediatric Weight Management Intervention: The Nebraska Childhood Obesity Research Demonstration Project.

Background: Several family-based efficacious pediatric weight management interventions (PWMIs) have been developed to reduce child weight status. These programs are typically based in larger cities delivered by an interdisciplinary team in a hospital or medical center. The degree to which these efficacious PWMIs have been translated to, and are feasible in, rural or micropolitan areas is unclear. This study protocol describes a pilot Type III hybrid effectiveness-implementation (T3HEI) trial testing a multilevel strategy that focuses on the adoption, implementation, and sustainability of a PWMI online training program and resource package designed for implementation in micropolitan and rural areas. Methods: The trial design employed the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to evaluate outcomes and the Promoting Action on Research Implementation in Health Services framework to specify potential mechanisms of adoption, implementation, and sustainability. The study will test the feasibility of a fund and contract dissemination strategy in the adoption of a PWMI in four to eight rural communities, compare a learning collaborative implementation strategy including embedded training and sustainability action planning with communities who receive the PWMI online program and resources alone, and determine whether the PWMI reach, effectiveness, and maintenance are of magnitude similar to previous effectiveness trials. The dissemination and implementation process focused on an integrated research-practice partnership process model that includes a systems-based approach with multiple sectors and vertical decision-making representation. Conclusions: Our pilot T3HEI study has the potential to inform how best to move and sustain evidence-based PWMIs into practice. The findings will inform larger scale dissemination, implementation, and sustainability efforts in medically underserved areas across the country. Trial registration: This protocol is registered with clinicaltrials.gov (NCT04719442).

Protocol for the Rhode Island CORD 3.0 Study: Adapting, Testing, and Packaging the JOIN for ME Family-Based Childhood Obesity Program in Low-Income Communities.

Background: Overweight and obesity in children is a public health crisis in the United States. Although evidence-based interventions have been developed, such programs are difficult to access. Dissemination of evidence-based pediatric weight management interventions (PWMIs) to families from diverse low-income communities is the primary objective of the CDC Childhood Obesity Research Demonstration (CORD) projects. Methods: The goal of the Rhode Island CORD 3.0 project is to adapt the evidence-based PWMI, JOIN for ME, for delivery among diverse families from low-income backgrounds and to test it in a hybrid effectiveness-implementation trial design in which the aims are to examine implementation and patient-centered outcomes. Children between the ages of 6 and 12 years with BMI ≥85th percentile and a caregiver will be recruited through two settings, a federally qualified health center, which serves as a patient-centered medical home, or low-income housing. Dyads will receive a remotely delivered group-based intervention that is 10 months in duration and includes 16 weekly sessions, followed by 4 biweekly and 4 monthly meetings. Assessments of child and caregiver weight status and child health-related quality of life will be conducted at baseline, and at 4 and 10 months after the start of intervention. Implementation outcomes assessing intervention acceptability, adoption, feasibility, fidelity, and penetration/reach will be collected to inform subsequent dissemination. Conclusions: If the adapted version of the JOIN for ME intervention can be successfully implemented and is shown to be effective, this project will provide a model for a scalable PWMI for families from low-income backgrounds. ClinicalTrials.gov no. NCT04647760.

Handoffs and transitions in critical care\u2014understanding scalability: study protocol for a multicenter stepped wedge type 2 hybrid effectiveness-implementation trial

BackgroundThe implementation of evidence-based practices in critical care faces specific challenges, including intense time pressure and patient acuity. These challenges result in evidence-to-practice gaps that diminish the impact of proven-effective interventions for patients requiring intensive care unit support. Research is needed to understand and address implementation determinants in critical care settings.MethodsThe Handoffs and Transitions in Critical Care—Understanding Scalability (HATRICC-US) study is a Type 2 hybrid effectiveness-implementation trial of standardized operating room (OR) to intensive care unit (ICU) handoffs. This mixed methods study will use a stepped wedge design with randomized roll out to test the effectiveness of a customized protocol for structuring communication between clinicians in the OR and the ICU. The study will be conducted in twelve ICUs (10 adult, 2 pediatric) based in five United States academic health systems. Contextual inquiry incorporating implementation science, systems engineering, and human factors engineering approaches will guide both protocol customization and identification of protocol implementation determinants. Implementation mapping will be used to select appropriate implementation strategies for each setting. Human-centered design will be used to create a digital toolkit for dissemination of study findings. The primary implementation outcome will be fidelity to the customized handoff protocol (unit of analysis: handoff). The primary effectiveness outcome will be a composite measure of new-onset organ failure cases (unit of analysis: ICU).DiscussionThe HATRICC-US study will customize, implement, and evaluate standardized procedures for OR to ICU handoffs in a heterogenous group of United States academic medical center intensive care units. Findings from this study have the potential to improve postsurgical communication, decrease adverse clinical outcomes, and inform the implementation of other evidence-based practices in critical care settings.Trial registrationClinicalTrials.gov identifier: NCT04571749. Date of registration: October 1, 2020.

Protocol for a two-arm pragmatic stepped-wedge hybrid effectiveness-implementation trial evaluating Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship (ENCOMPASS)

BackgroundSepsis survivors experience high morbidity and mortality, and healthcare systems lack effective strategies to address patient needs after hospital discharge. The Sepsis Transition and Recovery (STAR) program is a navigator-led, telehealth-based multicomponent strategy to provide proactive care coordination and monitoring of high-risk patients using evidence-driven, post-sepsis care tasks. The purpose of this study is to evaluate the effectiveness of STAR to improve outcomes for sepsis patients and to examine contextual factors that influence STAR implementation.MethodsThis study uses a hybrid type I effectiveness-implementation design to concurrently test clinical effectiveness and gather implementation data. The effectiveness evaluation is a two-arm, pragmatic, stepped-wedge cluster randomized controlled trial at eight hospitals in North Carolina comparing clinical outcomes between sepsis survivors who receive Usual Care versus care delivered through STAR. Each hospital begins in a Usual Care control phase and transitions to STAR in a randomly assigned sequence (one every 4 months). During months that a hospital is allocated to Usual Care, all eligible patients will receive usual care. Once a hospital transitions to STAR, all eligible patients will receive STAR during their hospitalization and extending through 90 days from discharge. STAR includes centrally located nurse navigators using telephonic counseling and electronic health record-based support to facilitate best-practice post-sepsis care strategies including post-discharge review of medications, evaluation for new impairments or symptoms, monitoring existing comorbidities, and palliative care referral when appropriate. Adults admitted with suspected sepsis, defined by clinical criteria for infection and organ failure, are included. Planned enrollment is 4032 patients during a 36-month period. The primary effectiveness outcome is the composite of all-cause hospital readmission or mortality within 90 days of discharge. A mixed-methods implementation evaluation will be conducted before, during, and after STAR implementation.DiscussionThis pragmatic evaluation will test the effectiveness of STAR to reduce combined hospital readmissions and mortality, while identifying key implementation factors. Results will provide practical information to advance understanding of how to integrate post-sepsis management across care settings and facilitate implementation, dissemination, and sustained utilization of best-practice post-sepsis management strategies in other heterogeneous healthcare delivery systems.Trial registrationNCT04495946. Submitted July 7, 2020; Posted August 3, 2020.

Program uptake of a parent-tailored telephone smoking cessation counselling: An examination of recruitment approaches.

INTRODUCTIONRecently, a Dutch proactive parent-tailored telephone smoking cessation counselling program, Smoke-free Parents (SFP), was demonstrated to be effective in helping parents to quit smoking. This study aimed to examine the program’s uptake and the costs of two recruitment approaches (i.e. healthcare vs mass media) for SFP. In addition, parent’s barriers to participating in SFP and the characteristics of participating parents were assessed.METHODSAs part of an effectiveness-implementation hybrid trial, 402 smoking parents were recruited via healthcare settings and mass media for an informal, proactive, and free phone call with a smoking cessation counsellor about SFP (the Netherlands, September 2016 – September 2018). Parents were asked whether they wanted to participate in SFP. If parents refused, reasons for decline and additional information (e.g. educational level) were collected.RESULTSResults revealed that 26.4% of the recruited parents participated in SFP. Although the program uptake of parents recruited via mass media was slightly, but not significantly, higher than via healthcare (27.3% vs 26.8%, p=0.92), the healthcare approach resulted in lower costs per participant (€99.62 vs €205.72). Smoking cessation counsellors were unable to reach almost one-third (32.7%) of the parents after they had agreed to be called about SFP.CONCLUSIONSThe present study showed that more than a quarter of all recruited parents participated in SFP and that the mass media approach and healthcare approach can be used to recruit parents for SFP. To increase the number of parents participating in SFP, it is important to overcome the identified barriers that prevent parents from participating.

Adapting Safety Check as a Universal Suicide Prevention Strategy in Pediatric Primary Care

The presence of unlocked firearms in the home is associated with increased risk of suicide and unintentional injury in youth. We adapted an evidence-based program for promoting safe firearm storage, Safety Check, to enhance its acceptability as a universal suicide prevention strategy in pediatric primary care. We applied ADAPT-ITT, an established adaptation framework, to guide iterative program adaptation with ongoing input from key stakeholders. The present study describes 2 phases of ADAPT-ITT: the Production phase (generating adaptations) and the Topical Experts phase (gathering stakeholder feedback on adaptations). After generating proposed program adaptations based on 3 inputs (stakeholder feedback collected in a prior study, the behavioral science literature, and best practices in pediatric medicine), we elicited feedback from stakeholders with firearm expertise. The adaptations included changes such as clarifying firearm ownership will not be documented in the medical record and offering follow-up reminders. We also crowdsourced feedback from 337 parents to select a new name and program logo. Saturation was reached with 9 stakeholders. Feedback confirmed the value of adaptations that: 1) considered context (eg, reason for ownership), 2) promoted parent autonomy in decision-making, and 3) ensured privacy. The most preferred program name was Suicide and Accident prevention through Family Education (SAFE) Firearm. Guided by an established adaptation framework that prioritized multistage stakeholder feedback, adaptations to the original Safety Check were deemed acceptable. We plan to test the SAFE Firearm program as a universal suicide prevention strategy in pediatric primary care via a hybrid effectiveness-implementation trial.

A hybrid implementation-effectiveness randomized trial of CYP2D6-guided postoperative pain management

Purpose:Cytochrome P450 2D6 (CYP2D6) genotype-guided opioid prescribing is limited. The purpose of this type 2 hybrid implementation-effectiveness trial was to evaluate the feasibility of clinically implementing CYP2D6-guided post-surgical pain management and determine that such an approach did not worsen pain control.Methods:Adults undergoing total joint arthroplasty were randomized 2:1 to genotype-guided or usual pain management. For participants in the genotype-guided arm with a CYP2D6 poor (PM), intermediate (IM), or ultra-rapid metabolizer (UM) phenotype, recommendations were to avoid hydrocodone, tramadol, codeine, and oxycodone. The primary endpoints were feasibility metrics and opioid use; pain intensity was a secondary endpoint. Effectiveness outcomes were collected 2-weeks post-surgery.Results:Of 282 patients approached, 260 (92%) agreed to participate. In the genotype-guided arm, 20% had a high-risk (IM/PM/UM) phenotype, of whom 72% received an alternative opioid versus 0% of usual care participants (p<0.001). In an exploratory analysis, there was less opioid consumption (200 [104-280] vs. 230 [133-350] morphine milligram equivalents; p=0.047) and similar pain intensity (2.6 ± 0.8 vs. 2.5 ± 0.7; p=0.638) in the genotype-guided vs. usual care arm, respectively.Conclusion:Implementing CYP2D6 to guide post-operative pain management is feasible and may lead to lower opioid use without compromising pain control.

Effects of the Family Check-Up 4 Health on Parenting and Child Behavioral Health: A Randomized Clinical Trial in PrimaryCare.

The Family Check-Up 4 Health (FCU4Health) is an adaptation of the Family Check-Up (FCU) for delivery in primary care settings. While maintaining the original FCU's focus on parenting and child behavioral health, we added content targeting health behaviors. This study evaluated whether the adapted FCU maintained positive effects on parenting (positive behavior support, limit setting, parental warmth) and child behavioral health (self-regulation, conduct problems, emotional problems). Pediatric (6-12years) primary care patients with a BMI ≥ 85th%ile (n = 240) were recruited from primary care clinics in Phoenix. Children were 75% Latino, 49% female, and 73% Medicaid recipients. This type 2 effectiveness-implementation hybrid trial compared families randomized to FCU4Health (n = 141) or usual care (n = 99). FCU4Health was delivered over a period of 6months. This study focuses on a priori secondary outcomes included parenting and child behavioral health targets of the original FCU, assessed at baseline and 3, 6, and 12months. Significant improvements were found for the FCU4Health condition, compared to usual care, in parenting from baseline to the 3-month assessment [β = .17 (.01; .32)]. Parenting predicted improvements in child self-regulation at 6-months [β = .17 (.03; .30)], which in turn predicted reductions in conduct problems [β = - .38 (- .51; - .23)] and emotional problems [β = - .24 (- .38; - .09)] at 12 months. Ethnicity and language of delivery (English or Spanish) did not moderate these effects. The FCU4Health can improve parenting and child behavioral health outcomes when delivered in primary care.Trial RegistrationTrial registration number: NCT03013309 ClinicalTrials.gov.

Mobile App-Based Intervention for Pregnant Women With Stress Urinary Incontinence: Protocol for a Hybrid Effectiveness-Implementation Trial.

BackgroundStress urinary incontinence (SUI) is a common source of distress among women during and after pregnancy. It has a negative effect on quality of life but with poor care-seeking. Mobile health (mHealth) may be a promising solution with potential advantages. However, there is uncertainty whether a mobile app is effective for SUI symptom improvement during and after pregnancy. The implementation is also unclear. We developed an app named UIW (Urinary Incontinence for Women) aimed at improving perinatal incontinence.ObjectiveThe objective of this study is to evaluate the effectiveness of the UIW app-based intervention in improving SUI symptoms among pregnant women and explore the facilitators and barriers to using the UIW app to help refine and optimize the intervention.MethodsThis study is a hybrid effectiveness-implementation trial with a randomized controlled trial alongside a mixed-methods process evaluation according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Pregnant women with SUI (n=336) will be recruited from a university-affiliated hospital in China. They will be randomly allocated (1:1) to either the intervention group that receive usual care plus UIW app or control group that receive usual care alone. The intervention period will last 2 months. The 5 dimensions of the RE-AIM framework will be evaluated at recruitment (-T1), baseline (T0), immediately after intervention (T1), 42 days after delivery (T2), 3 months after delivery (T3), and 6 months after delivery (T4) through project documents, online questionnaires and a pelvic floor muscle training diary, surface electromyography, log data in the background management system, and qualitative interviews. Data analysis will follow the intention-to-treat principle. Descriptive statistics, t tests, chi-square tests, and a linear mixed model will be used to analyze the quantitative data. Deductive and inductive content analysis will be used to analyze the qualitative data.ResultsThe effectiveness-implementation trial started in June 2020, trial recruitment was completed in October 2020, and the intervention will last for a 2-month period. Completion of the 6-month follow-up will be in July 2021, and we anticipate that the results of this study will be published in December 2021.ConclusionsThis study will evaluate both effectiveness and implementation of the UIW app-based intervention among pregnant women. The hybrid effectiveness-implementation trial design according to the RE-AIM framework with a mixed-methods approach will give valuable insights into the effects as well as facilitators and barriers to the implementation that will influence the effects of the UIW app-based intervention.Trial RegistrationChinese Clinical Trial Registry ChiCTR1800016171; http://www.chictr.org.cn/showproj.aspx?proj=27455International Registered Report Identifier (IRRID)PRR1-10.2196/22771

Kentucky Women's Justice Community Opioid Innovation Network (JCOIN): A type 1 effectiveness-implementation hybrid trial to increase utilization of medications for opioid use disorder among justice-involved women

The opioid crisis has disproportionately affected women, but research on approaches to increase initiation of medications for opioid use disorder (MOUD) among women is limited. The Kentucky Justice Community Opioid Innovation Network (JCOIN) will implement a type 1 hybrid effectiveness and implementation trial to examine an innovative MOUD pretreatment model using telehealth (alone and in combination with peer navigators) for justice-involved women in transition from jail to the community. The overall goal of the project is to increase initiation and maintenance of MOUD among high-risk justice-involved women during community reentry to reduce opioid relapse and overdose. This project and other studies through the JCOIN network have the potential to significantly impact the OUD treatment field by contributing empirical evidence about the effectiveness and implementation of innovative technologies to increase initiation and maintenance of MOUD during a critical, high-risk time of community reentry among vulnerable, justice-involved individuals in both urban and nonurban communities.

Improving mental health care for unaccompanied young refugees through a stepped-care approach versus usual care+: study protocol of a cluster randomized controlled hybrid effectiveness implementation trial

BackgroundMore than half of the unaccompanied young refugees (UYRs) resettled in Europe report elevated levels of posttraumatic stress symptoms (PTSS) and comorbid symptoms. Earlier studies have highlighted the effectiveness of the trauma-focused preventive group intervention “Mein Weg” (English “My Way”), and the feasibility of trauma-focused cognitive behavioral therapy (TF-CBT) for UYRs. Both interventions are deemed to be empirically supported treatments (ESTs). However, UYRs seldom receive ESTs or, in fact, any treatment at all. In view of the high need and the limited treatment resources available, a stepped-care approach is indicated but has not been evaluated so far. The purpose of this trial is to compare the stepped-care approach BETTER CARE with usual care enhanced with screening and indication (usual care+).MethodsIn a cluster randomized controlled trial involving N = 540 UYRs living in up to N = 54 child and youth welfare service (CYWS) facilities, BETTER CARE will be compared with usual care+. We will randomize clusters comprising a CYWS facility with at least one eligible psychotherapist. BETTER CARE consists of step (1) screening and indication and either step (2) preventive trauma-focused group intervention “Mein Weg” delivered by trained CYWS staff or step (3) TF-CBT delivered by trained community therapists and supported by trained translators if necessary. Participants will be assessed 6 and 12 months after randomization. The primary outcome is the severity of PTSS after 12 months. Secondary outcomes are depressive and anxiety symptoms, quality of life, and proxy reported PTSS. Furthermore, drug use, health costs, benefits, and long-term effects on integration/acculturation will be assessed.DiscussionThe trial will directly integrate a stepped-care approach into existing structures of the German child welfare and (mental) health system. It could, therefore, serve as a blueprint for how to implement ESTs for UYRs. If successful, screening, prevention, and intervention will be sustainably implemented in CYWS in southern Germany.Trial registrationGerman Clinical Trials Register DRKS00017453. Registered on 11 December 2019.

Implementing Mobile Health-Enabled Integrated Care for Complex Chronic Patients: Patients and Professionals' Acceptability Study.

BackgroundIntegrated care (IC) can promote health and social care efficiency through prioritization of preventive patient-centered models and defragmentation of care and collaboration across health tiers, and mobile health (mHealth) can be the cornerstone allowing for the adoption of IC.ObjectiveThis study aims to assess the acceptability, usability, and satisfaction of an mHealth-enabled IC model for complex chronic patients in both patients and health professionals.MethodsAs part of the CONNECARE Horizon 2020 project, a prospective, pragmatic, 2-arm, parallel, hybrid effectiveness-implementation trial was conducted from July 2018 to August 2019 in a rural region of Catalonia, Spain. Home-dwelling patients 55 years and older with chronic conditions and a history of hospitalizations for chronic obstructive pulmonary disease or heart failure (use case [UC] 1), or a scheduled major elective hip or knee arthroplasty (UC2) were recruited. During the 3 months, patients experienced an mHealth-enabled IC model, including a self-management app for patients, a set of integrated sensors, and a web-based platform connecting professionals from different settings or usual care. The Person-Centered Coordinated Care Experience Questionnaire (P3CEQ) and the Nijmegen Continuity Questionnaire (NCQ) assessed person-centeredness and continuity of care. Acceptability was assessed for IC arm patients and staff with the Net Promoter Score (NPS) and the System Usability Scale (SUS).ResultsThe analyses included 77 IC patients, 58 controls who completed the follow-up, and 30 health care professionals. The mean age was 78 (SD 9) years in both study arms. Perception of patient-centeredness was similarly high in both arms (usual care: mean P3CEQ score 16.1, SD 3.3; IC: mean P3CEQ score 16.3, SD 2.4). IC patients reported better continuity of care than controls (usual care: mean NCQ score 3.7, SD 0.9; IC: mean NCQ score 4.0, SD 1; P=.04). The scores for patient acceptability (UC1: NPS +67%; UC2: NPS +45%) and usability (UC1: mean SUS score 79, SD 14; UC2: mean SUS score 68, SD 24) were outstanding. Professionals’ acceptability was low (UC1: NPS −25%; UC2: NPS −35%), whereas usability was average (UC1: mean SUS score 63, SD 20; UC2: mean SUS score 62, SD 19). The actual use of technology was high; 77% (58/75) of patients reported physical activity for at least 60 days, and the ratio of times reported over times prescribed for other sensors ranged from 37% for oxygen saturation to 67% for weight.ConclusionsThe mHealth-enabled IC model showed outstanding results from the patients’ perspective in 2 different UCs but lacked maturity and integration with legacy systems to be fully accepted by professionals. This paper provides useful lessons learned through the development and assessment process and may be of use to organizations willing to develop or implement mHealth-enabled IC for older adults.

Virtual Reality Job Interview Training in Transition Services: Results of a Single-Arm, Noncontrolled Effectiveness-Implementation Hybrid Trial.

This study reports the results of a single-arm non-controlled, Type 3 hybrid effectiveness-implementation trial evaluating virtual reality job-interview training (VR-JIT) delivered in five pre-employment transition programs comprising 15 schools, 10 administrators, 23 teachers, and 279 youth ages 16-21 years receiving special education pre-employment transition services. Fidelity, expected implementation feasibility, and teacher and student acceptance of VR-JIT were high. Youth completed virtual interviews over six to eight weeks (M = 10.8, SD = 7.4). At the six-month follow-up, teachers reported that youth using VR-JIT had employment rates higher than current national employment rates for youth with disabilities. A multinomial logistic regression revealed VR-JIT engagement was associated with greater employment rates by six-month follow-up (OR=1.63, p=0.002). This study provides promising evidence that VR-JIT may be feasibly implemented with high fidelity in special education pre-employment transition services and can potentially enhance employment outcomes among transition-age youth receiving special education services.

Technology and implementation science to forge the future of evidence-based psychotherapies: the PRIDE scale-up study

ObjectiveTo report the interim results from the training of providers inevidence-based psychotherapies (EBPs) and use of mobile applications.Design and SettingThe Partnerships in Research to Implement and Disseminate Sustainable and Scalable...