The National Institute on Drug Abuse (NIDA), in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA), has recently released a Request for Information (RFI) for the HEALing Communities Study, part of National Institute of Health (NIH)’s Helping to End Addiction Long-term (HEAL) Initiative in response to the opioid crisis.
NIDA, in partnership with SAMHSA, is exploring options for conducting a multi-site national research effort in up to three communities to develop and test approaches for the systematic implementation and sustainability of an integrated set of evidence-based interventions across healthcare, behavioral health, justice systems, state and local governments, and community organizations to prevent and treat opioid misuse and OUD. The goals are to decrease fatal and non-fatal overdoses, decrease the incidence of OUD and related infectious diseases (e.g. Hepatitis C and HIV), increase the number of individuals receiving medication-assisted treatment (MAT), increase the proportion retained in treatment beyond 6 months, and increase the number of individuals receiving needed recovery support services. This research would be a part of the NIH Helping to End Addiction Long-term (HEAL) Initiative. The HEALing Communities Study will test the implementation of an integrated set of addiction prevention and treatment approaches in an array of settings in up to three communities affected by the opioid crisis. Through this study, NIDA and SAMHSA aim to define effective strategies to reduce opioid overdose and overdose death, while increasing the number of individuals receiving medication-assisted treatment and the number retained in treatment and receiving needed recovery support services.
Despite the availability of multiple effective evidence-based interventions and practices, most Americans at risk for or suffering from an OUD do not receive appropriate prevention and treatment services. Simultaneously, opioid overdose rates continue to increase.
This Request For Input (RFI) seeks input on the design, study outcomes, and necessary partnerships and infrastructure for this multi-site research effort. The RFI is focused on the use, misuse, abuse of opioids and Opioid Use Disorders (OUD). Opioids include prescription and illicit opioids, such as heroin, illicitly manufactured fentanyl, and related analogs. Opioid Use Disorder (OUD) refers to the clinical diagnosis defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
This RFI solicits input from the extramural research community and public stakeholders. NIDA and SAMHSA especially seek input on study elements such as, but not limited to:
- Definition for “heavily affected communities” be defined, including geospatial/geopolitical definitions to provide consistent boundaries for a multi-site study
- Research designs that might be appropriate to accomplish the overall goals of the study
- Estimating effect size and effect size expected in relation to candidate outcomes: rates of non-fatal and fatal overdose; prevalence and incidence of opioid misuse, OUD and Hepatitis C; percent of patients screened for opioid misuse and OUD and who received a brief intervention or were referred to treatment; percent of patients initiated on MAT and retained in medication treatment beyond 6 months; rates of naloxone distribution and overdose reversals; opioid analgesic and benzodiazepine prescription rates; and implementation of prevention programs
- Baseline data that should be captured, existing sources for this data, and challenges that might exist with quality of existing data
- Length of integrated set of evidence-based interventions needed to be in place before expecting a meaningful change in outcomes, and which combination of interventions should be implemented in communities with different characteristics
- Confounding variables that need to be considered
- Potential threats to internal and external study validity and the strategies that could be deployed to mitigate threats
- Strategies that can help the Coordinating Center overcome barriers to the facilitation of collaboration and coordination activities across Research Centers with regard to data harmonization, collection, integration, cleaning, analyses, and creating datasets for sharing with the research community at large
Target metrics feasible for outcomes, candidate outcomes could include, but are not limited to those listed above: rates of non-fatal and fatal overdose; prevalence and incidence of opioid misuse, OUD and Hepatitis C; percent of patients screened for opioid misuse and OUD and who received a brief intervention or were referred to treatment; percent of patients initiated on MAT and retained in medication treatment beyond 6 months; rates of naloxone distribution and overdose reversals; opioid analgesic and benzodiazepine prescription rates; and implementation of prevention programs
- Best ways to gather reliable data related to candidate outcomes listed above>
Integrated Evidence-based Interventions:
- Essential interventions for an evidence based integrated approach to opioid prevention and treatment services, including policies and practices
- Definition for How could “evidence based or evidence informed”
- Measuring and assuring fidelity to an evidence-based integrated approach to opioid prevention and treatment services, including policies and practices
- Strategies and resources necessary, including training and technical assistance, to have meaningful penetration of the evidence-based integrated approach to opioid prevention and treatment services in a single community
- Economic questions included as part of the study to inform systems and policy change
- Implementation research questions included to develop best practices for replication in other communities impacted by the opioid crisis
- Data collected to help develop metrics for determining the quality of an integrated approach to opioid prevention and treatment services, including policies and practices
- Examples of prior implementation research studies that highlight implementation tools that can be used to replicate and scale up integrated approaches
Infrastructure, Partnerships, Collaboration:
- Research, prevention, and treatment infrastructure and partnerships are needed to support a community-based pragmatic trial assessing the impact of an evidence-based integrated approach to opioid prevention and treatment services
- Best approach to fostering collaboration and meaningful participation between state, county, and local governments; community stakeholders; medical/clinical service providers; and researchers
- Construction a research initiative with the highest likelihood of having sustainable prevention and treatment services
- Data would be of most interest to state and community partners
Submit your responses no later than July 20!
Learn more about this RFI and how to submit input.