Skip to navigation bar Skip to breadcrumbs Skip to page content Skip to comments area
clear place holder
Envelope icon E-mail Updates Teal square Text size:  a A A
You are here: HomePublic Comments and NominationsOpportunity for Public CommentDraft Research Plan : Draft Research Plan

Draft Research Plan

Draft Research Plan for Prevention of Opioid Use Disorder: Interventions

This opportunity for public comment expired on January 16, 2019 at 8:00 PM EST

Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

Send Us Your Comments

In an effort to maintain a high level of transparency in our methods, we open our draft Research Plans to a public comment period before we publish the final version.

Comment period is not open at this time.

Draft: Preface

This review will address patient- and clinician-level interventions to prevent opioid use disorder in persons not currently using opioids. In light of other evidence-based opioid prescribing guidelines (and their supporting systematic reviews), the USPSTF review will not include key questions (KQs) on the effectiveness and harms of interventions aimed at persons currently being prescribed opioids for pain management. Instead, interventions aimed at risk mitigation in persons taking opioids for pain management will be addressed in a contextual question.

Draft: Proposed Analytic Framework

Figure 1 is an analytic framework that depicts the three Key Questions to be addressed in the systematic review. The figure illustrates how interventions to prevent opioid use disorder in persons not currently using opioids may result in improved health and related outcomes including mortality, opioid-related morbidity, and opioid use disorder (Key Question 1), and behavioral outcomes including opioid use, frequency and/or quantity of opioid use, and prescription misuse (Key Question 2). Additionally, the figure addresses whether interventions to prevent opioid use disorder in persons not currently using opioids may results in any harms (Key Question 3).

Draft: Proposed Key Questions to Be Systematically Reviewed

  1. Do interventions to prevent opioid use disorder that are feasible for implementation in or referred from primary care improve patient health outcomes in persons not currently using opioids?
  2. Do interventions to prevent opioid use disorder that are feasible for implementation in or referred from primary care prevent the initiation of unnecessary opioid use, reduce the amount of opioid use, or prevent prescription misuse in persons not currently using opioids?
  3. What are the harms of interventions to prevent opioid use disorder that are feasible for implementation in or referred from primary care in persons not currently using opioids?

Draft: Proposed Contextual Questions

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What system- or practice-level interventions can help implement effective interventions to prevent opioid use disorder in primary care among persons not currently using opioids?
  2. What is the state of the evidence on interventions to prevent prescription misuse, opioid use disorder, or both in persons currently being prescribed opioids for pain management?

Draft: Proposed Research Approach

The Proposed Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Report. Criteria are overarching as well as specific to each of the KQs.

  Include Exclude
Condition Any opioid use, including illicit opioid use, prescription opioid misuse, and opioid use disorder Use of nonopioid drugs and other substances (alcohol, tobacco)
Aim Prevention of prescription misuse and opioid use disorder in persons not currently using opioids through the avoidance or minimization of exposure to prescribed opioids and avoidance of nonmedical opioid use (defined as use of illicit opioids or nonmedical use of prescription opioids) altogether
  • Prevention of prescription misuse and opioid use disorder in persons currently being prescribed opioids for pain management through risk mitigation strategies to promote judicious prescribing of opioids
  • Screening/early detection and treatment for opioid misuse and opioid use disorder (included in a separate USPSTF review)
  • Interventions aimed at preventing overdose and complications in persons with opioid use disorder (included in a separate USPSTF review)
Population
  • Adolescents and adults not currently using opioids, including persons presenting with acute or chronic pain
  • Subpopulations of interest include:
    • Persons with a mental health comorbid condition
    • Persons with prior substance use disorder
    • Adolescents and young adults (ages 12 to 25 years)
    • Older adults (age 65 years and older)
    • Women of reproductive age and pregnant women
  • Clinicians seeing patients who may present for pain management (see “Intervention” below)
  • Children (younger than age 12 years)
  • Persons currently being prescribed opioids for pain management
  • Persons with a current opioid use disorder
  • Persons being managed for postoperative acute pain
Intervention
  • Single or multicomponent interventions to prevent prescription misuse and opioid use disorder that are targeted to individual patients or clinicians (multicomponent interventions with system- or practice-level components will be considered if a component is targeted directly at individual patients or clinicians)
  • Interventions aimed at persons not currently using opioids, including persons with and without pain:
    • Education-based or behavioral interventions to prevent any nonmedical opioid use (including illicit opioid use)
    • Education-based or behavioral interventions to reduce initiation (or amount) of prescribed opioids for acute or chronic pain management, including interventions to optimize the use of effective nonopioid treatment for pain management
    • Education-based or behavioral interventions to reduce initiation of illicit opioids in adults
    • Education-based or behavioral interventions to prevent diversion of prescribed opioids through safe storage or appropriate disposal practices
    • Risk assessment prior to the initiation of prescribing opioids for acute or chronic pain management (includes checking prescription drug monitoring programs, urine drug tests)
  • Interventions to prevent prescription misuse and opioid use disorder in persons currently being prescribed opioids for chronic pain management, including risk monitoring (ongoing risk assessment); includes checking prescription drug monitoring programs, urine drug tests, opioid or treatment agreements, and abuse deterrent formulations
  • Policy-level interventions (e.g., legislation, community-wide programs)
  • Screening/early detection and treatment for nonmedical drug use, including behavioral and medication-based treatment (included in a separate USPSTF review)
  • Interventions aimed at preventing fatal opioid overdose (e.g., naloxone) and treatment of opioid use disorder (included in a separate USPSTF review)
  • System- or practice-level interventions to facilitate implementation of interventions to prevent prescription opioid misuse or opioid use disorder
Comparator
  • No intervention or usual care
  • Waitlist control
  • Attention control (e.g., intervention is similar in format and intensity but on a different content area)
Active intervention
Outcomes KQ 1 (Health, social, and other outcomes):

Health outcomes:

  • All-cause mortality
  • Drug-related mortality (intentional and unintentional)
  • Opioid use disorder and DSM-IV abuse or dependence (including severity of disorder)
  • Drug-related morbidity (including but not limited to: mental health disorder, STI/HIV transmission, hepatitis B or C virus transmission, unintended pregnancy/pregnancy complications, deep bacterial abscess, endocarditis, respiratory infection, cardiovascular complications, stroke, seizure, endocrinological complications)
  • Drug-related injury
  • Nonfatal overdose
  • Quality of life

Social and other outcomes:

  • Health care utilization (including drug treatment)
  • Social and legal outcomes (e.g., incarceration, criminal activity, violence, driving under the influence)

KQ 2 (Patient behavioral outcomes):

  • Opioid use (e.g., any use, frequency of use, quantity of use)
  • Prescription misuse

KQ 3 (Harms):

  • Any serious intervention-related harms
  • Unintended consequences (e.g., paradoxical changes in function or quality of life)
  • Clinician behavioral outcomes (e.g., prescribing practices, adherence to prescribing guidelines)
  • Patient or clinician satisfaction, knowledge, or self-efficacy
Outcome assessment timing KQs 1, 2: At least 3 months after baseline measurement

KQ 3: No restrictions on timing of outcome measurement

KQs 1, 2: Less than 3 months after baseline measurement
Study design KQs 1, 2: Randomized, controlled trials; nonrandomized controlled trials; and prospective or retrospective cohort studies with concurrent selection of control cohorts

KQ 3: Trials, prospective or retrospective cohort studies, and case-control studies (for rare events)

Time-series studies, pre-post studies, cross-sectional studies, case studies, case series

Note: If limited studies with included study designs, may consider ecologic studies or large cohort studies using historical control groups

Country Studies conducted in countries categorized as “Very High” on the United Nations Human Development Index (as defined by the United Nations Development Programme and based on 2015 indicators) Studies conducted in countries not categorized as “Very High” on the 2015 Human Development Index
Publication language English Languages other than English
Study quality Fair- or good-quality studies Poor-quality studies (according to design-specific USPSTF criteria)

Abbreviations: DSM=Diagnostic and Statistical Manual of Mental Disorders; HIV=human immunodeficiency virus; STI=sexually transmitted infection.

Current as of: December 2018

Internet Citation: Draft Research Plan: Prevention of Opioid Use Disorder: Interventions. U.S. Preventive Services Task Force. December 2018.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/interventions-to-prevent-opioid-use-disorder

USPSTF Program Office   5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857