Accounting for quality improvement during the conduct of embedded pragmatic clinical trials within healthcare systems: NIH Collaboratory case studies

Embedded pragmatic clinical trials (ePCTs) and quality improvement (QI) activities often occur simultaneously within healthcare systems (HCSs). Embedded PCTs within HCSs are conducted to test interventions and provide evidence that may impact public health, health system operations, and quality of care. They are larger and more broadly generalizable than QI initiatives, and may generate what is considered high-quality evidence for potential use in care and clinical practice guidelines. QI initiatives often co-occur with ePCTs and address the same high-impact health questions, and this co-occurrence may dilute or confound the ability to detect change as a result of the ePCT intervention. During the design, pilot, and conduct phases of the large-scale NIH Collaboratory Demonstration ePCTs, many QI initiatives occurred at the same time within the HCSs. Although the challenges varied across the projects, some common, generalizable strategies and solutions emerged, and we share these as case studies. KEY LESSONS: Study teams often need to monitor, adapt, and respond to QI during design and the course of the trial. Routine collaboration between ePCT researchers and health systems stakeholders throughout the trial can help ensure research and QI are optimally aligned to support high-quality patient-centered care

Testing the Question-Behavior Effect of Self-Administered Surveys Measuring Youth Drug Use

Concern that asking about a specific behavior could elicit that behavior is often cited as a reason that communities and schools should not administer surveys about youth drug use. In this study, we investigated if this question-behavior effect exists related to substance use. We examined if simply asking a student about their current drug use leads to an increase in drug use 1 year later. This study tests the validity of the question-behavior effect on youth drug use in a longitudinal panel of 2,002 elementary school students. The sample of students was drawn from the Community Youth Development Study, a community-randomized test of the Communities That Care prevention system. If the prevalence of self-reported drug use in sixth grade in a sample surveyed in fifth and sixth grades was higher than in an accretion sample surveyed only in sixth grade, the difference could indicate a question-behavior effect. Results from logistic regression analyses did not provide any evidence of a question-behavior effect on 30-day or lifetime prevalence of alcohol, tobacco, inhalant, or marijuana use reported in sixth grade. Asking youth about drug use in a survey did not increase the rates of self-reported drug use measured 1 year later. The absence of evidence of a question-behavior effect should ease concerns of communities and schools when administering surveys asking youth about their drug use

Standards of Evidence for Conducting and Reporting Economic Evaluations in Prevention Science

Over a decade ago, the Society for Prevention Research endorsed the first standards of evidence for research in preventive interventions. The growing recognition of the need to use limited resources to make sound investments in prevention led the Board of Directors to charge a new task force to set standards for research in analysis of the economic impact of preventive interventions. This article reports the findings of this group's deliberations, proposes standards for economic analyses, and identifies opportunities for future prevention science. Through examples, policymakers' need and use of economic analysis are described. Standards are proposed for framing economic analysis, estimating costs of prevention programs, estimating benefits of prevention programs, implementing summary metrics, handling uncertainty in estimates, and reporting findings. Topics for research in economic analysis are identified. The SPR Board of Directors endorses the "Standards of Evidence for Conducting and Reporting Economic Evaluations in Prevention Science.

Economic Evaluation Design within the HEAL Prevention Cooperative

The rapid rise in opioid misuse, disorder, and opioid-involved deaths among older adolescents and young adults is an urgent public health problem. Prevention is a vital part of the nation’s response to the opioid crisis, yet preventive interventions for those at risk for opioid misuse and opioid use disorder are scarce. In 2019, the National Institutes of Health (NIH) launched the Preventing Opioid Use Disorder in Older Adolescents and Young Adults cooperative as part of its broader Helping to End Addiction Long-term (HEAL) Initiative ( https://heal.nih.gov/ ). The HEAL Prevention Cooperative (HPC) includes ten research projects funded with the goal of developing effective prevention interventions across various settings (e.g., community, health care, juvenile justice, school) for older adolescent and young adults at risk for opioid misuse and opioid use disorder (OUD). An important component of the HPC is the inclusion of an economic evaluation by nine of these research projects that will provide information on the costs, cost-effectiveness, and sustainability of these interventions. The HPC economic evaluation is integrated into each research project’s overall design with start-up costs and ongoing delivery costs collected prospectively using an activity-based costing approach. The primary objectives of the economic evaluation are to estimate the intervention implementation costs to providers, estimate the cost-effectiveness of each intervention for reducing opioid misuse initiation and escalation among youth, and use simulation modeling to estimate the budget impact of broader implementation of the interventions within the various settings over multiple years. The HPC offers an extraordinary opportunity to generate economic evidence for substance use prevention programming, providing policy makers and providers with critical information on the investments needed to start-up prevention interventions, as well as the cost-effectiveness of these interventions relative to alternatives. These data will help demonstrate the valuable role that prevention can play in combating the opioid crisis

Parent-focused prevention of adolescent health risk behavior: Study protocol for a multisite cluster-randomized trial implemented in pediatric primary care

Evidence-based parenting interventions play a crucial role in the sustained reduction of adolescent behavioral health concerns. Guiding Good Choices (GGC) is a 5-session universal anticipatory guidance curriculum for parents of early adolescents that has been shown to reduce substance use, depression symptoms, and delinquent behavior. Although prior research has demonstrated the effectiveness of evidence-based parenting interventions at achieving sustained reductions in adolescent behavioral health concerns, public health impact has been limited by low rates of uptake in community and agency settings. Pediatric primary care is an ideal setting for implementing and scaling parent-focused prevention programs as these settings have a broad reach, and prevention programs implemented within them have the potential to achieve population-level impact. The current investigation, Guiding Good Choices for Health (GGC4H), tests the feasibility and effectiveness of implementing GGC in 3 geographically and socioeconomically diverse large integrated healthcare systems. This pragmatic, cluster randomized clinical trial will compare GGC parenting intervention to usual pediatric primary care practice, and will include approximately 3750 adolescents; n = 1875 GGC intervention and n = 1875 usual care. The study team hypothesizes that adolescents whose parents are randomized into the GGC intervention arm will show reductions in substance use initiation, the study\u27s primary outcomes, and other secondary (e.g., depression symptoms, substance use prevalence) and exploratory outcomes (e.g., health services utilization, anxiety symptoms). The investigative team anticipates that the implementation of GGC within pediatric primary care clinics will successfully fill an unmet need for effective preventive parenting interventions. Trial registration: Clinicaltrials.govNCT04040153

Research Priorities for Economic Analyses of Prevention: Current Issues and Future Directions

In response to growing interest in economic analyses of prevention efforts, a diverse group of prevention researchers, economists, and policy analysts convened a scientific panel, on “Research Priorities in Economic Analysis of Prevention” at the 19(th) annual conference of the Society for Prevention Research. The panel articulated four priorities that, if followed in future research, would make economic analyses of prevention efforts easier to compare and more relevant to policymakers, and community stakeholders. These priorities are: (1) increased standardization of evaluation methods, (2) improved economic valuation of common prevention outcomes, (3) expanded efforts to maximize evaluation generalizability and impact, as well as (4) enhanced transparency and communicability of economic evaluations. In this paper we define three types of economic analyses in prevention, provide context and rationale for these four priorities as well as related sub-priorities, and discuss the challenges inherent in meeting them