Suicide Prevention: Brief Interventions for Youth

Applicant Town HallSeptember 10, 202012:00pm – 1:00pm EST

I. Welcome and Introductions

II. About PCORI

III. PFA Overview

IV. Patient and Stakeholder Engagement

V. Administrative Overview

VI. Merit Review

VII. Key Dates and Resources

VIII. Q&A

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Agenda

Submit questions

via the Question box

in GoToWebinar

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Today’s Presenters

Els Houtsmuller

Associate Director Healthcare Delivery & Disparities Research

Julie Kennedy Lesch

Senior Engagement Officer Public & Patient

Engagement

Rhonda Stewart

Contract AdministratorProgram Support &

Information Management

Laura Sheahan

Merit Review OfficerProgram Support &

Information Management

Elizabeth Zofkie

Program AssociateHealthcare Delivery & Disparities Research

II.

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About PCORI

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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.

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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.

III.

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PFA Overview

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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?

• PCORI has allocated a total of up to $30 million for this Targeted Funding Announcement

Total Direct Costs: Up to $10 million Maximum Project Period: 5 years

• Interested in culturally adapted approaches for underserved populations with

increased rates of suicidality (LGBTQ, American Indian/Native Alaskan, Black,

Latina, rural, individuals with disabilities)

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PICOTS

Population Youth (15-24) requiring intervention for suicidality, but not continuous

monitoring, based on clinical assessment

Intervention/

Comparators

Head to head comparisons of evidence-based or widely used brief

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

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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

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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

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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

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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

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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

• Formulating Research Questions

• Patient Centeredness

• Data Integrity & Rigorous Analyses

• Preventing/Handling Missing Data

• Heterogeneity of Treatment Effects

Design-Specific Standards

• Data Registries

• Data Networks

• Causal Inference Methods*

• Adaptive & Bayesian Trial Designs

• Studies of Medical Tests

• Systematic Reviews

• Research Designs Using Clusters

• Studies of Complex Interventions

• Qualitative Methods

• Mixed Methods Research

• Individual Participant-Level Data Meta-Analysis

(IPD-MA)

*The first standard for Causal Inference Methods (CI-1)

is considered cross-cutting and applicable to all

PCOR/CER studies.

IV.

Patient and Stakeholder Engagement

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Patients and Other Stakeholders

PCORI

Community

Patient/

ConsumerCaregiver/

Family Member of

Patient

Clinician

Patient/

Caregiver Advocacy

Org

Hospital/

Health System

Training Institution

Policy

Maker

Industry

Payer

Purchaser

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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

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“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

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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.

V.

Administrative Overview

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• 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

Using the PCORI Online System

https://pcori.force.com/engagement

PCORI Online Training Slides

PCORI Online Application Cheat Sheet

PCORI Online Training Resources

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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.

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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.

VI.

Merit Review

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Merit Review Process

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Application Review

Applications are reviewed against six criteria:

1. Potential for the study to fill critical gaps in

evidence

2. Potential for study findings to be adopted into

clinical practice and improve delivery of care

3. Scientific merit (research design, analysis,

outcomes)

4. Investigator(s) and environment

5. Patient-centeredness

6. Patient and stakeholder engagement

Each application is

reviewed by scientists,

patients, and other

stakeholders who

together provide

content, statistical, and

clinical trial expertise.

VII.

Key Dates & Resources

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Key Dates

LOI Deadline September 29, 2020 by 5:00pm EST

Application Deadline January 12, 2021 by 5:00pm EST

Merit Review April 2021

Awards Announced July 2021

Earliest Start Date November 2021

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Resources

Refer to the funding opportunities page in our Funding Center (http://www.pcori.org/funding-opportunities) for the following resources:

• PFA and Submission Instructions

• PCORI Online User Manuals

• General Applicant FAQs: https://help.pcori.org/hc/en-us/categories/200010230-Applicant-Resources

• PCORI Online: https://pcori.force.com/engagement/

• Research Methodology: http://www.pcori.org/node/4020

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Engagement-Specific Resources

Please visit PCORI's website for updated content and resources on the Public and Patient Engagement pages: www.pcori.org/engagement, including:

• The value of engagement and planning for effective engagement in research

• Definitions and examples of different stakeholders

• Budgeting for Engagement Activities

• Compensation Framework for Engaged Research Partners

• Engagement Rubric

• PCORI in Practice Webinar Series

• Updated Engagement Plan template

• Engagement in Health Research Literature Explorer

• PCOR Engagement Tool and Resource Repository

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Where can I find help?

Visit pcori.org/apply

▪ Submission Instructions

▪ FAQs

▪ PCORI Online User Manuals

▪ Sample Engagement Plans

Schedule a Call with a Program Officer

▪ Submit a request at pcori.org/content/research-inquiry

▪ Call 202-627-1884 (programmatic inquiries)

▪ E-mail sciencequestions@pcori.org

Contact our Helpdesk

▪ E-mail pfa@pcori.org

▪ Call 202-627-1885 (administrative and technical

inquiries)

VIII.

Q&A

Ask a question via the question box in GoToWebinar

If we are unable to address your question during this time,

e-mail the Helpdesk at pfa@pcori.org.

www.pcori.org

@pcori

/PCORInstitute

PCORI

/pcori

Contact Information

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202.827.7700

info@pcori.org

Thank you