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✪ Is telemedicine the answer to rural expansion of medication treatment for opioid use disorder? Early experiences in the feasibility study phase of a National Drug Abuse Treatment Clinical Trials Network Trial

Authors:

Yih-Ing Hser, Allison J. Ober, Alex R. Dopp, Chunqing Lin, Katie P. Osterhage, Sarah E. Clingan, Larissa J. Mooney, Megan E. Curtis, Lisa A. Marsch, Bethany McLeman, Emily Hichborn, Laurie S. Lester, Laura-Mae Baldwin, Yanping Liu, Petra Jacobs, & Andrew J. Saxon

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2021

Read the full text in the open access journal Addiction Science & Clinical Practice

Abstract:

Telemedicine (TM) enabled by digital health technologies to provide medical services has been considered a key solution to increasing health care access in rural communities. With the immediate need for remote care due to the COVID-19 pandemic, many health care systems have rapidly incorporated digital technologies to support the delivery of remote care options, including medication treatment for individuals with opioid use disorder (OUD). In responding to the opioid crisis and the COVID-19 pandemic, public health officials and scientific communities strongly support and advocate for greater use of TM-based medication treatment for opioid use disorder (MOUD) to improve access to care and have suggested that broad use of TM during the pandemic should be sustained.

Nevertheless, research on the implementation and effectiveness of TM-based MOUD has been limited. To address this knowledge gap, the National Drug Abuse Treatment Clinical Trials Network (CTN) funded (via the NIH HEAL Initiative) a study on Rural Expansion of Medication Treatment for Opioid Use Disorder (Rural MOUD; CTN-0102) to investigate the implementation and effectiveness of adding TM-based MOUD to rural primary care for expanding access to MOUD. In preparation for this large-scale, randomized controlled trial incorporating TM in rural primary care, a feasibility study is being conducted to develop and pilot test implementation procedures.

In this commentary, we share some of our experiences, which include several challenges, during the initial two-month period of the feasibility study phase. While these challenges could be due, at least in part, to adjusting to the COVID-19 pandemic and new workflows to accommodate the study, they are notable and could have a substantial impact on the larger, planned pragmatic trial and on TM-based MOUD more broadly. Challenges include low rates of identification of risk for OUD from screening, low rates of referral to TM, digital device and internet access issues, workflow and capacity barriers, and insurance coverage. These challenges also highlight the lack of empirical guidance for best TM practice and quality remote care models.

With TM expanding rapidly, understanding implementation and demonstrating what TM approaches are effective are critical for ensuring the best care for persons with OUD.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Prevention of cervical cancer through two HPV-based screen-and-treat implementation models in Malawi: Protocol for a cluster randomized feasibility trial

Authors:

Jennifer H. Tang, Jennifer S. Smith, Shannon McGue, Luis Gadama, Victor Mwapasa, Effie Chipeta, Jobiba Chinkhumba, Erik Schouten, Bagrey Ngwira, Ruanne Barnabas, Mitch Matoga, Maganizo Chagomerana & Lameck Chinula

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2021

Read the full text in the open access journal Pilot and Feasibility Studies

Abstract:

Background

Cervical cancer is the leading cause of cancer incidence and mortality among Malawian women, despite being a largely preventable disease. Implementing a cervical cancer screening and preventive treatment (CCSPT) program that utilizes rapid human papillomavirus (HPV) testing on self-collected cervicovaginal samples for screening and thermal ablation for treatment may achieve greater coverage than current programs that use visual inspection with acetic acid (VIA) for screening and cryotherapy for treatment. Furthermore, self-sampling creates the opportunity for community-based screening to increase uptake in populations with low screening rates. Malawi’s public health system utilizes regularly scheduled outreach and village-based clinics to provide routine health services like family planning. Cancer screening is not yet included in these community services. Incorporating self-sampled HPV testing into national policy could address cervical cancer screening barriers in Malawi, though at present the effectiveness, acceptability, appropriateness, feasibility, and cost-effectiveness still need to be demonstrated.

Methods

We designed a cluster randomized feasibility trial to determine the effectiveness, acceptability, appropriateness, feasibility, and budget impact of two models for integrating a HPV-based CCSPT program into family planning (FP) services in Malawi: model 1 involves only clinic-based self-sampled HPV testing, whereas model 2 includes both clinic-based and community-based self-sampled HPV testing. Our algorithm involves self-collection of samples for HPV GeneXpert® testing, visual inspection with acetic acid for HPV-positive women to determine ablative treatment eligibility, and same-day thermal ablation for treatment-eligible women. Interventions will be implemented at 14 selected facilities. Our primary outcome will be the uptake of cervical cancer screening and family planning services during the 18 months of implementation, which will be measured through an Endline Household Survey. We will also conduct mixed methods assessments to understand the acceptability, appropriateness, and feasibility of the interventions, and a cost analysis to assess budget impact.

Discussion

Our trial will provide in-depth information on the implementation of clinic-only and clinic-and-community models for integrating self-sampled HPV testing CCSPT with FP services in Malawi. Findings will provide valuable insight for policymakers and implementers in Malawi and other resource-limited settings with high cervical cancer burden.

Trial registration

ClinicalTrials.gov identifier: NCT04286243. Registered on February 26, 2020.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Implementation Determinants and Outcomes of a Technology-Enabled Service Targeting Suicide Risk in High Schools: Mixed Methods Study

Authors:

Molly Adrian, Jessica Coifman, Michael D. Pullmann, Jennifer B. Blossom, Casey Chandler, Glen Coppersmith, Paul Thompson, & Aaron R. Lyon

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2020

Read the full text in the open access journal JMIR Mental Health

Abstract:

Background

Technology-enabled services (TESs), which integrate human service and digital components, are popular strategies to increase the reach and impact of mental health interventions, but large-scale implementation of TESs has lagged behind their potential.

Objective

This study applied a mixed qualitative and quantitative approach to gather input from multiple key user groups (students and educators) and to understand the factors that support successful implementation (implementation determinants) and implementation outcomes of a TES for universal screening, ongoing monitoring, and support for suicide risk management in the school setting.

Methods

A total of 111 students in the 9th to 12th grade completed measures regarding implementation outcomes (acceptability, feasibility, and appropriateness) via an open-ended survey. A total of 9 school personnel (school-based mental health clinicians, nurses, and administrators) completed laboratory-based usability testing of a dashboard tracking the suicide risk of students, quantitative measures, and qualitative interviews to understand key implementation outcomes and determinants. School personnel were presented with a series of scenarios and common tasks focused on the basic features and functions of the dashboard. Directed content analysis based on the Consolidated Framework for Implementation Research was used to extract multilevel determinants (ie, the barriers or facilitators at the levels of the outer setting, inner setting, individuals, intervention, and implementation process) related to positive implementation outcomes of the TES.

Results

Overarching themes related to implementation determinants and outcomes suggest that both student and school personnel users view TESs for suicide prevention as moderately feasible and acceptable based on the Acceptability of Intervention Measure and Feasibility of Intervention Measure and as needing improvements in usability based on the System Usability Scale. Qualitative results suggest that students and school personnel view passive data collection based on social media data as a relative advantage to the current system; however, the findings indicate that the TES and the school setting need to address issues of privacy, integration into existing workflows and communication patterns, and options for individualization for student-centered care.

Conclusions

Innovative suicide prevention strategies that rely on passive data collection in the school context are a promising and appealing idea. Usability testing identified key issues for revision to facilitate widespread implementation.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Lay Counselor Perspectives of Providing a Child-Focused Mental Health Intervention for Children: Task-Shifting in the Education and Health Sectors in Kenya

Authors:

Shannon Dorsey, Rosemary D. Meza, Prerna Martin, Christine L. Gray, Noah S. Triplett, Caroline Soi, Grace S. Woodard, Leah Lucid, Cyrilla Amanya, Augustine Wasonga and Kathryn Whetten

University of Washington affiliated authors are displayed in bold.

Published: December 2019

Read the full text in the open access journal Frontiers in Psychiatry

Abstract:

The global mental health treatment gap has increasingly been addressed using task-shifting; however, very little research has focused on lay counselors’ perspectives on the acceptability, feasibility, and appropriateness of mental health interventions in specific government-supported sectors that might scale up and sustain mental health care for children and adolescents. In western Kenya, these sectors include Education and Health.

Data come from a large hybrid effectiveness-implementation study examining implementation practices and policies in either or both sectors that support successful implementation of a child-focused intervention, Trauma-focused Cognitive Behavioral Therapy (TF-CBT), for children and adolescents who had experienced parental death. We examined lay counselors’ self-report of acceptability, feasibility, and appropriateness of TF-CBT. Lay counselors were teachers (n = 30) from the Education sector and Community Health Volunteers (CHVs; n = 30) from the Health sector, who were part of Sequence 1 of a large stepped-wedge, cluster randomized trial.

Lay counselor self-report surveys included reflective and formative measurement of acceptability, feasibility, and appropriateness administered after lay counselors in both sectors had experience delivering the locally-adapted, group-based TF-CBT intervention. Descriptive statistics (means, standard deviations) were used to understand counselors’ perspectives stratified by sector.

Both teachers and CHVs endorsed high acceptability, feasibility, and appropriateness of TF-CBT, with lay counselors’ responses on items from the formative measures providing some insight into specific aspects of acceptability, feasibility, and appropriateness that may be important to consider when planning for implementation support.

These early findings suggest that both sectors may hold promise for task-shifting of mental health care for children and adolescents but also underline the importance of considering the multiple facets of these three implementation outcomes as well as lay counselor context (Education vs. Health).

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ An evaluation of a common elements treatment approach for youth in Somali refugee camps

Authors:

L. K. Murray, B. J. Hall, S. Dorsey, A. M. Ugueto, E. S. Puffer, A. Sim, A. Ismael, J. Bass, C. Akiba, L. Lucid, J. Harrison, A. Erikson, and P. A. Bolton

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2018

Read the full text in the open access journal Global Mental Health

Excerpt:

Introduction

Children, defined as any boy or girl under 18 years, make up almost half of the world’s refugee population (United Nations High Commissioner for Refugees, 2016) and are exposed to challenges, traumas and stressors at the individual, family, and community levels that increase their risk for mental health problems (Barenbaum et al., 2004; Betancourt & Khan, 2008; Reed et al., 2012). These may include forced migration, forced labor, witnessing of murder and mass killings, lack of food and shelter, rape, torture, loss and separation from family, recruitment and use by armed forces, physical abuse, and family and sexual violence (Lustig et al., 2004; Office of the Special Representative of the Secretary-General for Children & Armed Conflict et al., 2009). Overlaid on potentially traumatic events are the daily, chronic stressors caused by displacement and associated with living in the camp environment – lack of basic needs, crowded and unsafe living conditions, and interpersonal conflict, among others (Layne et al., 2010; Miller & Rasmussen, 2010).

Children affected by these types of traumas and stressors present with a wide range of mental health symptoms, including those associated with posttraumatic stress (PTS), depression, anxiety, conduct problems, risk behaviors (e.g., alcohol or drug use), and distress associated with grief reactions (Barenbaum et al., 2004; Lustig et al., 2004; Sagi-Schwartz, 2008; Attanayake et al., 2009; Okello et al., 2013[for review], Morgos et al., 2008; Fernando et al., 2010; Miller & Rasmussen, 2010; Reed et al., 2012; Meyer et al., 2013; Newnham et al., 2015). Prevalence is difficult to study in these contexts; however, most studies find higher rates of mental health problems among displaced children compared with non-displaced populations (Goldstein et al., 1997; Paardekooper et al., 1999; Tousignant et al., 1999; Morgos et al., 2008; Bronstein & Montgomery, 2011; Reed et al., 2012).

There remains limited evidence on the effectiveness of interventions to treat mental health problems of children in refugee settings in low- and middle-income countries (LMICs). Some studies suggest that cognitive–behavioral-based treatments can be effective for reducing mental health symptoms in refugee children (Bolton et al., 2007; Layne et al., 2010). Relatedly, some eclectic psychosocial programs have been tested with conflict-affected populations, and show an impact on outcomes such as self-esteem or hope, but not mental health (Tol et al., 2014). Studies have generally utilized focal disorder treatments – or treatments focused on one disorder or cluster of symptoms. For example, Layne and colleagues used a treatment developed for posttraumatic stress disorder (PTSD) and grief (Layne et al., unpublished treatment manual) and Bolton and team (2007) used a treatment developed for depression (Interpersonal Therapy for depression; IPT). In contrast to this focal disorder treatment model where everyone receives the same elements in the same order, in common elements approaches providers learn elements that can be combined in different ways (elements used, order, dose) to treat a range of common mental health symptoms, and how to handle comorbidity (e.g., depression, trauma, anxiety co-occurrence) (Chorpita et al., 2005; Weisz et al., 2011; Weisz et al., 2012; Murray et al., 2014a). This approach is potentially more efficient and sustainable in both high-income countries (Mansell et al., 2008; Weisz et al., 2011; Weisz et al., 2012) and in LMICs (Bolton et al., 2014; Murray et al., 2014a; Ventevogel, 2015; Weisz et al., 2015) because it does not require providers to learn multiple interventions. Additionally, in settings with high rates of disorder comorbidity, such as in refugee populations, a model that can address multiple disorders may also be more appropriate (Murray & Jordans, 2016).

Current project

This paper reports on: (1) an evaluation of a common elements treatment approach (CETA) (Bolton et al., 2007; Bolton et al., 2014; Murray et al., 2014a; Weisz et al., 2015) developed for comorbid presentations of depression, anxiety, post traumatic stress, and/or externalizing symptoms among children in three Somali refugee camps on the Ethiopian/Somali border; and (2) an evaluation of implementation factors including acceptability, applicability/fit, feasibility and treatment facilitators, and barriers from the perspective of staff of the implementing partner organization, lay providers, and families who engaged in…

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ The impact of inter-organizational alignment (IOA) on implementation outcomes: evaluating unique and shared organizational influences in education sector mental health

Authors:

Aaron R. Lyon, Kelly Whitaker, Jill Locke, Clayton R. Cook, Kevin M. King, Mylien Duong, Chayna Davis, Mark D. Weist, Mark G. Ehrhart, & Gregory A. Aarons

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2018

Read the full text in the open access journal Implementation Science

Abstract:

Background

Integrated healthcare delivered by work groups in nontraditional service settings is increasingly common, yet contemporary implementation frameworks typically assume a single organization—or organizational unit—within which system-level processes influence service quality and implementation success. Recent implementation frameworks predict that inter-organizational alignment (i.e., similarity in values, characteristics, activities related to implementation across organizations) may facilitate the implementation of evidence-based practices (EBP), but few studies have evaluated this premise. This study’s aims examine the impact of overlapping organizational contexts by evaluating the implementation contexts of externally employed mental health clinicians working in schools—the most common integrated service delivery setting for children and adolescents. Aim 1 is to estimate the effects of unique intra-organizational implementation contexts and combined inter-organizational alignment on implementation outcomes. Aim 2 is to examine the underlying mechanisms through which inter-organizational alignment facilitates or hinders EBP implementation.

Methods/design

This study will conduct sequential, exploratory mixed-methods research to evaluate the intra- and inter-organizational implementation contexts of schools and the external community-based organizations that most often employ school-based mental health clinicians, as they relate to mental health EBP implementation. Aim 1 will involve quantitative surveys with school-based, externally-employed mental health clinicians, their supervisors, and proximal school-employed staff (total n = 120 participants) to estimate the effects of each organization’s general and implementation-specific organizational factors (e.g., climate, leadership) on implementation outcomes (fidelity, acceptability, appropriateness) and assess the moderating role of the degree of clinician embeddedness in the school setting. Aim 2 will explore the mechanisms through which inter-organizational alignment influences implementation outcomes by presenting the results of Aim 1 surveys to school-based clinicians (n = 30) and conducting semi-structured qualitative interviews. Qualitative data will be evaluated using an integrative inductive and deductive approach.

Discussion

The study aims are expected to identify intra- and inter-organizational constructs that are most instrumental to EBP implementation success in school-based integrated care settings and illuminate mechanisms that may account for the influence of inter-organizational alignment. In addition to improving school-based mental health, these findings will spur future implementation science that considers the relationships across organizations and optimize the capacity of implementation science to guide practice in increasingly complex systems of care.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness–implementation trial (Raising Healthy Children study)

Authors:

Justin D. Smith, Cady Berkel, Neil Jordan, David C. Atkins, Shrikanth S. Narayanan, Carlos Gallo, Kevin J. Grimm, Thomas J. Dishion, Anne M. Mauricio, Jenna Rudo-Stern, Mariah K. Meachum, Emily Winslow and Meg M. Bruening

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2018

Read the full text in the open access journal Implementation Science

Abstract:

Background

Pediatric obesity is a multi-faceted public health concern that can lead to cardiovascular diseases, cancers, and early mortality. Small changes in diet, physical activity, or BMI can significantly reduce the possibility of developing cardiometabolic risk factors. Family-based behavioral interventions are an underutilized, evidence-based approach that have been found to significantly prevent excess weight gain and obesity in children and adolescents. Poor program availability, low participation rates, and non-adherence are noted barriers to positive outcomes. Effective interventions for pediatric obesity in primary care are hampered by low family functioning, motivation, and adherence to recommendations.

Methods

This (type II) hybrid effectiveness–implementation randomized trial tests the Family Check-Up 4 Health (FCU4Health) program, which was designed to target health behavior change in children by improving family management practices and parenting skills, with the goal of preventing obesity and excess weight gain. The FCU4Health is assessment driven to tailor services and increase parent motivation. A sample of 350 families with children aged 6 to 12 years who are identified as overweight or obese (BMI ≥ 85th percentile for age and gender) will be enrolled at three primary care clinics [two Federally Qualified Healthcare Centers (FQHCs) and a children’s hospital]. All clinics serve predominantly Medicaid patients and a large ethnic minority population, including Latinos, African Americans, and American Indians who face disparities in obesity, cardiometabolic risk, and access to care. The FCU4Health will be coordinated with usual care, using two different delivery strategies: an embedded approach for the two FQHCs and a referral model for the hospital-based clinic. To assess program effectiveness (BMI, body composition, child health behaviors, parenting, and utilization of support services) and implementation outcomes (such outcomes as acceptability, adoption, feasibility, appropriateness, fidelity, and cost), we use a multi-method and multi-informant assessment strategy including electronic health record data, behavioral observation, questionnaires, interviews, and cost capture methods.

Discussion

This study has the potential to prevent excess weight gain, obesity, and health disparities in children by establishing the effectiveness of the FCU4Health and collecting information critical for healthcare decision makers to support sustainable implementation of family-based programs in primary care.

Trial registration

NCT03013309 ClinicalTrials.gov
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Psychometric assessment of three newly developed implementation outcome measures

Authors:

Bryan J. Weiner, Cara C. Lewis, Cameo Stanick, Byron J. Powell, Caitlin N. Dorsey, Alecia S. Clary, Marcella H. Boynton and Heather Halko

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2017

Read the full text in the open access journal Implementation Science

Abstract:

Background

Implementation outcome measures are essential for monitoring and evaluating the success of implementation efforts. Yet, currently available measures lack conceptual clarity and have largely unknown reliability and validity. This study developed and psychometrically assessed three new measures: the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM).

Methods

Thirty-six implementation scientists and 27 mental health professionals assigned 31 items to the constructs and rated their confidence in their assignments. The Wilcoxon one-sample signed rank test was used to assess substantive and discriminant content validity. Exploratory and confirmatory factor analysis (EFA and CFA) and Cronbach alphas were used to assess the validity of the conceptual model. Three hundred twenty-six mental health counselors read one of six randomly assigned vignettes depicting a therapist contemplating adopting an evidence-based practice (EBP). Participants used 15 items to rate the therapist’s perceptions of the acceptability, appropriateness, and feasibility of adopting the EBP. CFA and Cronbach alphas were used to refine the scales, assess structural validity, and assess reliability. Analysis of variance (ANOVA) was used to assess known-groups validity. Finally, half of the counselors were randomly assigned to receive the same vignette and the other half the opposite vignette; and all were asked to re-rate acceptability, appropriateness, and feasibility. Pearson correlation coefficients were used to assess test-retest reliability and linear regression to assess sensitivity to change.

Results

All but five items exhibited substantive and discriminant content validity. A trimmed CFA with five items per construct exhibited acceptable model fit (CFI = 0.98, RMSEA = 0.08) and high factor loadings (0.79 to 0.94). The alphas for 5-item scales were between 0.87 and 0.89. Scale refinement based on measure-specific CFAs and Cronbach alphas using vignette data produced 4-item scales (α’s from 0.85 to 0.91). A three-factor CFA exhibited acceptable fit (CFI = 0.96, RMSEA = 0.08) and high factor loadings (0.75 to 0.89), indicating structural validity. ANOVA showed significant main effects, indicating known-groups validity. Test-retest reliability coefficients ranged from 0.73 to 0.88. Regression analysis indicated each measure was sensitive to change in both directions.

Conclusions

The AIM, IAM, and FIM demonstrate promising psychometric properties. Predictive validity assessment is planned.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**