Request for Information (RFI): The HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis

Notice Number: NOT-DA-18-023

Key Dates
Release Date: June 29, 2018
Response Date: July 20, 2018

Related Announcements
RFA-DA-19-016
RFA-DA-19-017

Issued by
National Institute on Drug Abuse (NIDA)
Substance Abuse and Mental Health Services Administration (SAMHSA)

Purpose

This RFI is for information and planning purposes only, and should not be construed as a solicitation or an obligation on the part of the Federal Government, the National Institutes of Health (NIH), or the National Institute on Drug Abuse (NIDA).  The NIH does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.

Terminology:  This 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).

Problem Statement:  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.

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 (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative).

Information Requested:  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:

Study Design:

  • 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 

Outcomes:

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 

Health Economics:

  • Economic questions included as part of the study to inform systems and policy change

Implementation Research:

  • 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

How to Submit a Response:

Responses will be accepted until July 20, 2018 , via e-mail to: OpioidRFI@nida.nih.gov.  Please mark your responses with the RFI identifier NOT-DA-18-023 Responses are expected to be no longer than approximately 2000 words.

Respondents will receive an automated e-mail confirmation acknowledging receipt of their response but will not receive individual feedback.

Any identifiers (e.g. names, institutions, e-mail addresses, etc.) will be removed when responses are compiled.  Only the processed, anonymized results will be shared internally with NIDA and NIH program staff and participating leadership across the Department of Health and Human Services, as appropriate.  Nonetheless, no proprietary information should be submitted.

Inquiries

Please direct all inquiries to:

Redonna K. Chandler, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-1470
Email: redonna.chandler@nih.gov