Suicide Prevention: Brief Interventions for Youth Applicant Town Hall September 10, 2020 12:00pm – 1:00pm EST
Agenda I. Welcome and Introductions II. About PCORI III. PFA Overview IV. Patient and Stakeholder Engagement Submit questions via the Question box V. Administrative Overview in GoToWebinar VI. Merit Review VII. Key Dates and Resources VIII. Q&A 2
Today’s Presenters Els Houtsmuller Julie Kennedy Lesch Rhonda Stewart Laura Sheahan Elizabeth Zofkie Associate Director Senior Engagement Officer Contract Administrator Merit Review Officer Program Associate Healthcare Delivery & Public & Patient Program Support & Program Support & Healthcare Delivery & Disparities Research Engagement Information Management Information Management Disparities Research 3
II. About PCORI 4
Why PCORI? For all the advances it produces, research still has not answered many • questions patients face. People want to know which treatment or approach is best for them . • Patients, their clinicians, and other stakeholders, need information about • what works best for whom. 5
Our Mission PCORI helps people make informed health care decisions, and improves health care delivery and outcomes, by funding comparative effectiveness research that is guided by patients, caregivers, providers, and the broader health care community, and that produces high integrity, evidence-based information. 6
III. PFA Overview 7
Targeted PFA Overview • Priority Research Question: What is the comparative effectiveness of different evidence-based and/or widely used brief interventions to reduce suicidality and improve outcomes for youth ages 15 to 24? • Interested in culturally adapted approaches for underserved populations with increased rates of suicidality (LGBTQ, American Indian/Native Alaskan, Black, Latina, rural, individuals with disabilities) Total Direct Costs: Up to $10 million Maximum Project Period: 5 years • PCORI has allocated a total of up to $30 million for this Targeted Funding Announcement 8
PICOTS Population Youth (15-24) requiring intervention for suicidality, but not continuous monitoring, based on clinical assessment Intervention/ Head to head comparisons of evidence-based or widely used brief Comparators interventions and/or culturally adapted brief interventions Outcomes Primary: Suicidal ideation, self-harm, engagement in mental health care Secondary: functional measures, school participation, employment, skills to manage suicidality, connectedness, quality of life, healthcare utilization (hospital or ED use) Timing Studies up to 5 years; Up to 12-month follow-up Setting Primary care, emergency care, schools, mobile crisis units, community- based settings where youth may receive crisis or mental health care, home, inpatient care, juvenile detention centers 9
Cultural Adaptation Cultural Adaptation (cultural centering, tailoring) of interventions is associated with improved outcomes • Should address barriers for, and be endorsed by, target population • May include specific elements (language, icons, family involvement, rituals); specific settings or staff; involvement of people with lived experience; telehealth (apps, text-based, web- based, phone call, video calls); other • May compare adaptation approaches, adapted vs non-adapted interventions 10
Heterogeneity of Treatment Effects (HTE) Multi-component approaches • (outreach, screening, identification, brief intervention, care coordination, f/u) may be proposed based on evidence for/use of components • Heterogeneity of Treatment Effects (HTE) What works best for whom? Requires large heterogenous sample Smaller studies focusing on subgroups 11
Research We Do Not Fund PCORI does not fund efficacy studies • or research that will produce… clinical practice guidelines • coverage recommendations • payment or policy recommendations • or that includes cost effectiveness analyses • direct comparisons of the costs of care between two or more alternative • approaches NOTE: Cost to patients may be included 12
Intervention Costs In general, PCORI will not cover costs for study interventions (procedures, treatments, diagnostics, or other clinical care) to be compared in the research project. o Sustainability 13
PCORI Methodology Standards Research funded by PCORI must adhere to the PCORI Methodology Standards, which represent minimal requirements for the design, conduct, analysis, and reporting of patient-centered outcomes research. The 65 standards can be grouped into 2 broad categories and 16 topic areas: Cross-Cutting Standards Design-Specific Standards • Formulating Research Questions • Data Registries • Data Networks • Patient Centeredness • Causal Inference Methods* • Data Integrity & Rigorous Analyses • Adaptive & Bayesian Trial Designs • Preventing/Handling Missing Data • Studies of Medical Tests • Heterogeneity of Treatment Effects • Systematic Reviews • Research Designs Using Clusters • Studies of Complex Interventions • Qualitative Methods • Mixed Methods Research *The first standard for Causal Inference Methods (CI-1) • Individual Participant-Level Data Meta-Analysis is considered cross-cutting and applicable to all (IPD-MA) PCOR/CER studies. 14
IV. Patient and Stakeholder Engagement
Patients and Other Stakeholders Patient/ Consumer Caregiver/ Family Purchaser Member of Patient Clinician Payer PCORI Community Patient/ Caregiver Industry Advocacy Org Hospital/ Policy Health Maker System Training Institution 16
Patient-Centeredness vs. Patient Engagement • Patient-Centeredness • Addresses outcomes (both benefits and harms) that are important to patients • The interventions proposed for comparison are currently available to patients or can be made available • Study design is low-burden to participants • Patient and Stakeholder Engagement • Patients and stakeholders are partners in research, not only “subjects” • Active and meaningful partnership between scientists, patients, and other stakeholders with the purpose of improving feasibility, acceptability and relevance • Forms of engagement include: input, consultation, collaboration, shared leadership • Can occur by building upon existing relationships, or developing clear plans for active and meaningful partnership between scientists, patients, and other stakeholders 17
“Research Done Differently” PCORI’s research has shown that engagement makes meaningful differences in studies: Forsythe LP, Carman KL, et al. Patient Engagement In Research: Early Findings From The Patient-Centered Outcomes Research Institute. Health Aff (Millwood). 2019 Mar;38(3):359-367; PCORI Board of Governors Meeting, December 9, 2019, https://www.pcori.org/sites/default/files/PCORI-Board-Meeting-Presentation-Slides-120919.pdf, p. 32-69 18
Demonstration of Appropriate Engagement of Relevant Patients and Other Stakeholders • Applicants are expected to consult with patients and other stakeholders on their decisional dilemma and evidence needs, or reference previously documented decisional dilemmas, and describe how this consultation informed the proposed research project. • Applications should identify patients and stakeholders consulted in determining that the proposed study addresses their evidentiary needs for decision-making and indicate how patients and stakeholders will be actively engaged as partners throughout the conduct of the study. 19
V. Administrative Overview
Using the PCORI Online System • Register as a New User and create your LOI as soon as possible • Please note that the PI and AO cannot be the same person • Please only use Chrome, Safari, and Firefox browsers to access the system https://pcori.force.com/engagement PCORI Online Training Slides PCORI Online Application Cheat Sheet PCORI Online Training Resources 21
Letters of Intent to Apply: Eligibility to Submit Any private sector (non-profit or for-profit) research organization. • Any public sector research organization (university or college hospital or healthcare • system, laboratory or manufacturer, unit of local, state, or federal government). Non-domestic components of organizations based in the US and foreign organizations • may apply, as long as there is demonstrable benefit to the US healthcare system and US efforts in the area of patient-centered research can be clearly shown. Individuals are not permitted to apply. • 22
Letter of Intent (LOI): Requirements An LOI is required and must be submitted prior to the deadline • To submit an LOI, download the PFA-specific Letter of Intent Template from the • Funding Center to begin your LOI. You must answer all questions within the 2-page limit • Do not upload additional documents as part of your LOI. Letters of endorsements or • support are not accepted at this stage. Only those LOIs deemed most responsive (programmatically and administratively) to this • tPFA will be invited to submit a full application. 23
VI. Merit Review
Merit Review Process 25
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