83 FR 30756 - Request for Information on the HEALing Communities Study: Developing and Testing an Integrated Approach To Address the Opioid Crisis

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 126 (June 29, 2018)

This Request for Information (RFI) is intended to gather broad public input on the conduct of a multi-site national research effort 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 Opioid Use Disorders (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.

[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30756-30757]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-14031]



[[Page 30756]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information on the HEALing Communities Study: 
Developing and Testing an Integrated Approach To Address the Opioid 
Crisis

AGENCY: National Institutes of Health; Substance Abuse and Mental 
Health Services Administration, HHS.

ACTION: Notice.

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SUMMARY: This Request for Information (RFI) is intended to gather broad 
public input on the conduct of a multi-site national research effort 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 Opioid Use Disorders (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.

DATES: The RFI is open for public comment for a period of 21 days. 
Comments must be received by July 20, 2018 to ensure consideration.

ADDRESSES: Comments must be submitted electronically to the following 
email address: [email protected].

FOR FURTHER INFORMATION CONTACT: Please direct all inquiries to Redonna 
K. Chandler, Ph.D., National Institute on Drug Abuse; Phone: 301-443-
1470; email: [email protected].

SUPPLEMENTARY INFORMATION: 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), the National Institute on Drug Abuse 
(NIDA), or the Substance Abuse and Mental Health Services 
Administration (SAMHSA). 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 OUD. Opioids include prescription and illicit opioids, 
such as heroin, illicitly manufactured fentanyl, and related analogs. 
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:
     How can ``heavily affected communities'' be defined, 
including geospatial/geopolitical definitions to provide consistent 
boundaries for a multi-site study?
     What research designs might be appropriate to accomplish 
the overall goals of the study?
     How can effect size be estimated and what effect size 
might be 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?
     What baseline data should be captured, what are potential 
existing sources for this data, and what challenges might exist with 
quality of existing data?
     How long would an integrated set of evidence-based 
interventions need to be in place before expecting a meaningful change 
in outcomes, and which combination of interventions should be 
implemented in communities with different characteristics?
     What confounding variables need to be considered?
     What are potential threats to internal and external study 
validity and what strategies could be deployed to mitigate threats?
     Are there particular 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:
     What target metrics would be 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?
     What is the best way to gather reliable data related to 
candidate outcomes listed above?
     What are essential interventions for an evidence-based 
integrated approach to opioid prevention and treatment services, 
including policies and practices?
     How could ``evidence-based or evidence-informed'' be 
defined?
     How can fidelity to an evidence-based integrated approach 
to opioid prevention and treatment services, including policies and 
practices be measured?
     What strategies and resources would be necessary, 
including training and technical assistance, to have meaningful 
penetration of the evidence-

[[Page 30757]]

based integrated approach to opioid prevention and treatment services 
in a single community?
    Health Economics:
     What economic questions should be included as part of the 
study to inform systems and policy change?
    Implementation Research:
     What implementation research questions should be included 
to develop best practices for replication in other communities impacted 
by the opioid crisis?
     What data should be collected to help develop metrics for 
determining the quality of an integrated approach to opioid prevention 
and treatment services, including policies and practices?
     Are there examples of prior implementation research 
studies that highlight implementation tools that can be used to 
replicate and scale up integrated approaches?
    Infrastructure, Partnerships, Collaboration:
     What 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?
     What is the best approach to fostering collaboration and 
meaningful participation between state, county, and local governments; 
community stakeholders; medical/clinical service providers; and 
researchers?
     How do we construct a research initiative with the highest 
likelihood of having sustainable prevention and treatment services?
     What data would be of most interest to state and community 
partners?
    Responses to this RFI are voluntary and may be submitted 
anonymously. Please do not include any personally identifiable or other 
information that you do not wish to make public. Proprietary, 
classified, confidential, or sensitive information should not be 
included in responses. Comments submitted will be compiled for 
discussion and shared internally with NIDA, SAMHSA, NIH program staff, 
and participating leadership across the Department of Health and Human 
Services, as appropriate. Any personal identifiers (personal names, 
email addresses, etc.) will be removed when responses are compiled.
    This RFI is for informational and planning purposes only and is not 
a solicitation for applications or an obligation on the part of the 
United States Government to provide support for any ideas identified in 
response to it. Please note that the United States Government will not 
pay for the preparation of any information submitted or for use of that 
information.

    Dated: June 25, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2018-14031 Filed 6-28-18; 8:45 am]
 BILLING CODE 4140-01-P