Psychosocial Interventions with Office-Based Opioid Treatment for Opioid Use Disorder Cycle 2 2018 Applicant Town Hall Webinar Washington, DC August 8, 2018 at 12:00pm ET
Agenda I. Welcome and Introductions II. About PCORI III. PFA Overview IV. Patient and Stakeholder Engagement V. Administrative Overview VI. Merit Review VII. Tips for Success and Resources VIII.Q&A 2
Today’s Presenters Andrea Brandau Els Houtsmuller Denese Neu Program Officer Associate Director Engagement Officer Healthcare Delivery and Healthcare Delivery and Public and Patient Engagement Disparities Research Disparities Research Carolyn Mohan Ashton Ferrara Merit Review Officer Administrator Merit Review Contracts Management 3
Agenda I. Welcome and Introductions II. About PCORI III. PFA Overview IV. Patient and Stakeholder Engagement V. Administrative Overview VI. Merit Review VII. Tips for Success and Resources VIII.Q&A 4
About PCORI Els Houtsmuller Associate Director, Science 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 6
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 7
Agenda I. Welcome and Introductions II. About PCORI III. PFA Overview IV. Patient and Stakeholder Engagement V. Administrative Overview VI. Merit Review VII. Resources and Q&A 8
Targeted PFA Goal The goal of this targeted PFA is to generate evidence regarding the comparative effectiveness of psychosocial interventions for patients with opioid use disorder (OUD) who receive office-based opioid treatment (OBOT) 9
PICOTS Population: Patients who receive office-based opioid treatment with buprenorphine Interventions and Comparators: Studies may compare different levels of intensity (e.g., different frequencies, group vs individual format, combinations of interventions), and different durations of efficacious interventions. Proposed studies should compare two or more approaches that include interventions that are • documented to be efficacious or in common use, and that are well characterized to facilitate replication and dissemination efforts. 10
PICOTS Continued Outcomes • Treatment adherence/retention, patient function, illicit opioid use, other drug use, emergency department visits, overdose, provider satisfaction, and provider stress Time Studies up to 4 years • Periodic outcome assessments; at least one year of patient follow-up • Setting Community-based settings, places where office-based opioid treatment is offered • 11
Study Considerations • Large randomized controlled trials (RCTs) or well justified observational studies; sufficient sample size • Interested in heterogeneity of treatment (HTE) effects among subgroups (e.g., addiction severity, low income or disadvantage) • Urban, low-income, and racial-ethnic minority populations • Studies should propose interventions that are or can be made available to most patients • Stepped-care and needs-based approaches rather than straightforward comparisons of interventions 12
Research Activities Not Supported • This PFA will NOT support: • 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 13
Budget Parameters • PCORI has allocated a total of up to $25 million for this PFA • The proposed budget for studies under this initiative may be up to $4 million in direct costs • The maximum project period is 4 years (three year studies are also encouraged) • NOTE : PCORI funding does not cover clinical healthcare costs 14
Agenda I. Welcome and Introductions II. About PCORI III. PFA Overview IV. Patient and Stakeholder Engagement V. Administrative Overview VI. Merit Review VII. Tips for Success and Resources VIII.Q&A 15
Patient and Stakeholder Engagement Denese Neu Engagement Officer Public and Patient Engagement
Patients and Other Stakeholders Patient/ Consumer Caregiver/F amily Purchaser Member of Patient Payer Clinician PCORI Community Patient/ Caregiver Industry Advocacy Org Hospital/ Policy Health Maker System Training Institution 17
Patient-Centeredness vs. Patient Engagement • Patient-Centeredness • Addresses outcomes (both benefits and harms) that important to patients and caregivers. • The interventions proposed for comparison are currently available. • Patient and Stakeholder Engagement • Demonstrates active engagement between the research staff, patients, caregivers and other stakeholders. • Involves relevant organizations, patients, and caregivers through existing relationships or presents a logical and reasonable plan to establish these partnerships. 18
Evidence of Appropriate Engagement Patients/Caregivers and Other Stakeholders • Explain consultation with patients/caregivers and other stakeholders on their decisional dilemma and evidence needs or reference previously documented decisional dilemmas. • Identify the patient/caregivers and stakeholders who helped determine that the proposed study addresses their evidentiary needs for decision-making. • Demonstrate commitment to actively engaging these partners throughout the conduct of the study.
Planning for Engagement Insights and Decision-making Formulating the research questions; Selecting outcomes; Defining the characteristics of • study participants, comparators and outcomes; Providing feedback/problem-solving during conduct of the study; Designing plans for dissemination of study results Roles Identifying the partners; Aligning partners with key activities to optimize experience; • Strategy for managing the engagement activity and processes Structure Organizing the activity (e.g., Study Advisory Committee; Patient Advisory Panel); • Addressing national goals as well as local needs; Frequency of meetings; Collaboration between committees and research team
Budgeting Tips • Financial compensation of partners • Expenses of partners (transportation, childcare, caregiver) • Budgeting for program staff dedicated to engagement tasks • Costs of engagement meetings and events (travel, food, AV) • Additional time and resource to incorporate partner feedback into various project process
The Engagement Rubric The rubric is intended to provide guidance to applicants, merit reviewers, awardees, and engagement/program officers (for creating milestones and monitoring projects) regarding engagement in the conduct of research. It is divided into three segments: Planning the Study Conducting the Study Disseminating the Study Results
Engagement Resources PCORIs “Engagement Rubric:” http://www.pcori.org/sites/default/files/Engagement- • Rubric.pdf Sample Engagement Plans: http://www.pcori.org/sites/default/files/PCORI-Sample- • Engagement-Plans.pdf Compensation Framework: http://www.pcori.org/sites/default/files/PCORI-Compensation- • Framework-for-Engaged-Research-Partners.pdf Engagement Budgeting: http://www.pcori.org/sites/default/files/PCORI-Budgeting-for- • Engagement-Activities.pdf Engagement in Research Webpage: http://www.pcori.org/funding-opportunities/what-we- • mean-engagement PCORI’s Methodology Standards PC -1 to PC-4: https://www.pcori.org/research- • results/about-our-research/research-methodology/pcori-methodology-standards
Agenda I. Welcome and Introductions II. About PCORI III. PFA Overview IV. Patient and Stakeholder Engagement V. Administrative Overview VI. Merit Review VII. Tips for Success and Resources VIII.Q&A 24
Administrative Overview Ashton Ferrara Administrator Contracts Management
LOI and Application • Full applications have been invited based on the information provided in the LOI • Changes to the following require PCORI’s approval: • Principal Investigator • Institution • Research question(s) • Specific Aims • Study Design • Comparators 26
Research Plan Template Research Strategy: Maximum 15 pages in length • Provide all information requested, as outlined in the template: • • Specific Aims • Background • Significance • Study Design or Approach • Study Population(s) Research Team & Environment: 2 pages • Describe the research team’s capabilities to accomplish the goals of the • proposed research project and the appropriateness of the research environment to conduct the study 27
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