Medication Assisted Treatment (MAT) Delivery for Pregnant Women with Substance Abuse Disorders Involving Prescription Opioids and/or Heroin Town Hall Webinar Washington, DC July 12, 2017 at 12:00pm ET
Agenda I. Welcome and Introductions Submitting Questions: II. About PCORI III. Topic Background Submit questions via the and PFA Overview chat function in GoToWebinar IV. Patient and Stakeholder Engagement Ask a question via phone at the end of the presentation V. LOI Process and Review VI. Resources and Q&A 2
Welcome Steven Clauser, PhD, MPA Program Director Healthcare Delivery and Disparities Research 3
Today’s Presenters Greg Martin Perrinne Kelley, MPA Els Houtsmuller, PhD Jeanne Murphy, PhD, CNM Deputy, Chief Engagement and Administrator Program Officer Associate Director Dissemination Officer Contracts Management Healthcare Delivery and Healthcare Delivery and Office of the Chief Engagement Disparities Research Disparities Research and Dissemination Officer 4
Introduction to PCORI Els Houtsmuller, PhD Associate Director Healthcare Delivery and Disparities Research
PCORI • An independent, non-profit [501-(c)(1)] research institute authorized by Congress in 2010 and governed by a 21- member Board of Governors representing the entire healthcare community
Our Mission and Strategic Goals PCORI helps people make informed healthcare decisions, and improves healthcare delivery and outcomes, by producing and promoting high- integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader healthcare community. Our Strategic Goals: Increase quantity, quality, and timeliness of useful, trustworthy research information available to support health decisions Speed up the implementation and use of patient-centered outcomes research evidence Influence research funded by others to be more patient-centered 7
Our Focus Comparative Effectiveness Research • Compares two or more interventions that are evidence-based or in widespread use • Is performed in real-world populations and settings • Patient-centered: -Engages patients and key stakeholders throughout the research process -Answers questions that matter to patients and other clinical decision makers 8
Topic Background and PFA Overview Els Houtsmuller, PhD Associate Director Healthcare Delivery and Disparities Research
Pathway for this Funding Announcement Stakeholders proposed topic to PCORI; PCORI staff reviewed PCORI IHS Advisory Panel reviewed PCORI engaged stakeholders PCORI staff and Science Oversight Committee further refined topics PCORI Science Oversight Committee reviewed and approved PCORI Board of Governors reviewed and approved topic for targeted PFA (May 8, 2017)
Rationale for This Targeted PFA • Prevalence of opioid use by pregnant women has increased dramatically; associated with potentially serious maternal, fetal, and neonatal risks • Medication-Assisted Treatment (MAT; maintenance therapy with opiate agonist [methadone, buprenorphine] plus psychosocial services) improves: maternal, pregnancy-related, birth and infant outcomes • Buprenorphine is safer than methadone, improves birth outcomes, reduces neonatal withdrawal compared with methadone • Pregnancy may motivate women to seek treatment, but there are treatment barriers: stigma (treatment setting and treatment type), lack of access, legal consequences • Buprenorphine can be offered in physician’s office (Drug Addiction Treatment Act), but requires qualification and delivery is not widespread • Provider barriers include concerns re: lack of expertise, of adequate support, of mental health providers 11
Models of MAT Delivery for Pregnant Women Existing models • Vary by integration : – Integrated prenatal care, OBOT, addiction medicine, psychosocial service Co-located prenatal care, OBOT, collaboration with community psychosocial services – Prenatal care by clinician, referral to opioid use disorder treatment (usual care) • Offer remote support for providers: – Hub and spoke o Core components spokes: prenatal care and OBOT by clinician o More or less resource-intensive – Induction and stabilization (in methadone clinic or hospital vs office-based) – Psychosocial services (medical management vs referral; group vs individual) 12
Targeted PFA Goal The goal of this targeted PFA is to generate evidence regarding the comparative effectiveness of different models of MAT delivery to pregnant women with Opioid Use Disorder (OUD) 13
Proposed Research Questions & Study Details 1. What is the comparative effectiveness of alternative models for comprehensive OUD treatment delivery on maternal and neonatal outcomes in pregnant and post-partum women with different levels of addiction severity? – Comprehensive care includes prenatal care, medication- assisted treatment, psychosocial care 2. What is the comparative effectiveness of remotely supported OUD treatment delivery to pregnant women that includes more versus less resource-intense approaches to induction and psychosocial support for office-based opioid treatment, in terms of maternal and neonatal outcomes? 14
Proposed Research Question & Study Details (cont.) Population: Pregnant women with OUD as defined by the DSM-5, and infants born to women with OUD. While Medicaid insurance covers close to 50% of US births, applications that include women with private insurance and uninsured women will also be considered responsive. Interventions and Comparators: Treatment delivery models that vary by integration, including - Integrated prenatal care, addiction medicine, and psychosocial services - Co-located prenatal care and office-based opioid treatment; collaboration with community psychosocial services - Prenatal care by clinician, referral to OUD treatment, or opioid treatment and referral to prenatal care (usual care) Models offering remote support for providers, e.g. ‘Hub and Spoke’ models, with varying levels of support for clinician 15
Proposed Research Question & Study Details (cont.) • Outcomes: • Addiction specific outcomes (e.g. illicit drug use, relapse, treatment entry, treatment retention, post-partum treatment continuation, patient quality of life, anxiety/depression) • Pregnancy and neonatal outcomes (e.g. preterm birth, pregnancy complications, birthweight, neonatal complications, Neonatal Abstinence Syndrome (NAS)) • Time: – Studies up to 4 years; Repeated assessments to measure maternal and neonatal outcomes during pregnancy as well as 3-months post-partum 16
Proposed Research Question & Study Details (cont.) • Study Design: Large RCTs with sufficient sample size or well justified observational studies – Interested in heterogeneity of treatment effects among subgroups (e.g., addiction severity, low income or disadvantage) • Setting(s): Community-based settings, places where office- based opioid treatment is offered • Proposed Research Commitment: Up to 4 studies, up to $4M per study (total direct costs) 17
Research Activities Not Supported • The Medication Assisted Treatment Delivery for Pregnant Women with Substance Use Disorders PFA will NOT support the following types of studies: • Pilot studies • Efficacy trials • Cost-effectiveness analyses • Direct comparisons of the costs of care between two or more alternative approaches • Development of clinical prediction or prognostication tools • Evaluation of new or existing decision-support tools • Studies of the natural history of disease, instrument development, pharmacodynamics, and fundamental science of biological mechanisms 18
Budget Parameters • PCORI has allocated a total of up to $16 million for this PFA • The proposed budget for studies under this initiative may be up to $4 million in direct costs – At the LOI stage, the only necessary budget information is the total amount requested – PCORI may consider funding larger studies if investigators submit a strong rationale at the LOI stage • The maximum project period is 4 years (three year studies are also encouraged) • Note that PCORI funding does not cover clinical healthcare costs 19
Patient and Stakeholder Engagement Greg Martin Deputy, Chief Engagement and Dissemination Officer Office of the Chief Engagement and Dissemination Officer
Patient-Centeredness vs. Patient and Stakeholder Engagement Patient-Centeredness • Does the LOI mention outcomes (both benefits and harms) important to patients? • Are the interventions being proposed for comparison available to patients now? Patient Engagement • Does the LOI mention intent to build an interdisciplinary study team that includes appropriate patient and stakeholder representation in consultation with PCORI? 21
What PCORI looks for when reviewing LOIs Evidence of appropriate engagement of relevant stakeholders and researchers • Funding applicants are expected to consult with patients and other stakeholders on their decisional dilemma and evidence needs or to reference previously documented decisional dilemmas in preparation for the submission of LOIs • Identify the patients and stakeholders you consulted in determining that the proposed study addresses their evidentiary needs for decision-making and indicate your commitment to continuing to engage them actively in the conduct of the study.
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