PCORI Funding Announcement: Implementation of Effective Shared Decision Making Approaches in Practice Settings Town Hall Cycle 2 2017 September 19, 2017
Agenda I. Welcome II. About PCORI III. Dissemination and Implementation Program Goals IV. PFA Overview V. Program Requirements VI. Administrative Requirements VII. Applicant Resources Submit questions via the Q&A box VIII. Questions
Today’s Presenters Joanna Siegel Chris Gayer Arielle Gorstein Program Director Senior Program Officer Program Associate D&I Program D&I Program D&I Program
Welcome to the SDM PFA Town Hall Joanna Siegel, ScD Director, Dissemination & Implementation
The Need for PCORI’s Work • Traditional healthcare research has not answered many of the questions patients face. • People want to know which preventive, diagnostic, or treatment option is best for them. • Patients and their clinicians need information they can understand and use.
Our Mission PCORI helps people make informed healthcare decisions, and improves healthcare delivery and outcomes, by producing and promoting evidence from research guided by patients, caregivers, and the broader healthcare community.
Our Mandate “The purpose of the Institute is to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis... … and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of the medical treatments, services...” --from PCORI’s authorizing legislation
PCORI Dissemination and Implementation Program What is the goal of the D&I Program? • The D&I Program is charged with heightening awareness of the results of PCORI-funded research, and with advancing efforts to put these findings into practice to improve healthcare delivery and health outcomes. • Dissemination and implementation of PCORI-Funded Patient-Centered Outcomes Research Results 8
Implementation of SDM - PFA Overview: Program Requirements Chris Gayer, PhD Senior Program Officer Dissemination and Implementation Program
PFA Overview: Implementation of Effective Shared Decision Making Approaches in Practice Settings Objective of the PFA: • Promote the targeted implementation Available Funds and and systematic uptake of SDM in Duration healthcare settings • $6.5M for this cycle In this PFA we seek to fund: • Up to $1.5M in direct • Active, multi-component approaches to costs per project implementing effective SDM strategies • Projects should be • That address existing barriers and completed within 3 years obstacles to uptake and maintenance…. • So that these interventions are effectively and sustainably integrated into practice
Background • SDM is effective* : – Systematic Reviews have established the positive effect of shared decision making approaches on patient knowledge, understanding of risks and benefits, and increased confidence in decisions • Recognition of importance of SDM has grown in recent years*: – ACA language explicitly promotes SDM – Washington State legislation promotes SDM – National Quality Forum recently published certification standards based on international standards for patient decision aids/tools – CMS has started requiring SDM as a precondition for payment, for two treatment choices *See supporting citations in the PFA
Background However, uptake of SDM in clinical practice remains relatively low • “[D]espite these policy developments and the existence of over 100 randomized controlled trials that have demonstrated the efficacy of these interventions*, their adoption into mainstream clinical practice has yet to be established, and their impact when used in routine workflows requires evaluation* .” The purpose of this PFA is to help bridge the gap between SDM evidence and SDM practice *See supporting citations in the PFA
Shared Decision Making Strategy Definition For this PFA, PCORI defines an SDM strategy as… an intervention or approach that draws on and presents available evidence to inform patients of available treatment options and their risks and benefits, and either engages patients in a decision-making process that reflects their values with their clinician, or promotes their ability to engage in such a process
Essential Characteristics of Projects SDM Strategy: • Is consistent with the definition on the previous slide • Has been developed and tested responsibly and rigorously • Has demonstrated effectiveness on patient, caregiver or health care provider decision making using well-accepted metrics PCORI will not consider as sufficient interventions for which testing has been limited to tool validation, usability, or satisfaction.
Essential Characteristics of Projects Implementation Strategy: • A comprehensive, multi-component implementation strategy • Guided by an established conceptual model or framework • Guided by evidence regarding the implementation of evidence-based practices and interventions • Incorporates the perspectives and experiences of patients and stakeholders , including individuals living with the disease or condition of interest and front-line staff, care providers and leadership of host delivery settings
Implementation Activities We Do Not Fund We do not fund projects that propose to: • Establish efficacy or effectiveness of shared decision making strategies or to study the comparative effectiveness of multiple shared decision making strategies • Implement evidence that does not include a PCORI-funded CER or methods study SDM approach and/or result • Translate or adapt a shared decision making approach without actively implementing it • Develop or validate a new tool or system for patients or clinicians without the primary purpose of actively implementing evidence
Merit Review Criteria 1. Importance of research results in the context of the existing body of evidence 2. Readiness of the research results for dissemination 3. Technical merit of the proposed dissemination or implementation project (project design, outcomes, and evaluation) 4. Project personnel and environment 5. Patient-centeredness 6. Patient and stakeholder engagement
SDM Implementation PFA Overview : Administrative Requirements
Eligibility Project Focus: Projects must propose either 1. To implement a shared decision making (SDM) strategy that was formally tested and demonstrated to be effective in the context of a PCORI research award or 2. An implementation project that will incorporate new PCORI CER evidence into an existing, tested shared decision making strategy, and then implement the updated shared decision making strategy in a practice setting
Eligibility Applicants: Applicants must either 1. Be the principal investigator of the original PCORI-funded research project, the findings from which are incorporated into the proposed implementation project or 2. Provide a letter of support from the principal investigator of the original PCORI-funded research project, the findings from which are incorporated into the proposed implementation project
Eligibility Timing : Applicants must propose to implement PCORI results that are available at the time of the application due date. Specifically… 1. A draft final research report (DFRR) pertaining to the original PCORI research award must have been accepted for entry into the peer review process by PCORI or 2. A manuscript reporting the PCORI results being proposed for implementation must have been formally accepted for publication by a peer-reviewed scientific journal before the application due date for this announcement NOTE: Applicants may submit the mandatory LOI before PCORI has accepted the DFRR for peer review, and before a scientific journal has accepted a manuscript.
Complete a Mandatory Letter of Intent (LOI) • LOIs are competitive ; only applicants whose LOIs are deemed most responsive to this limited PFA will be invited to submit a full application • LOIs are a mandatory prerequisite for submission of a full application – Applicants who fail to submit a letter of intent will not be permitted to submit a full application to the corresponding award cycle • LOIs will be screened by a minimum of two PCORI staff for responsiveness, to ensure compliance with administrative guidelines, and to determine whether the applicant should be invited to submit a full application – Nonresponsive LOIs and those not adhering to administrative guidelines will not be invited to submit a full application 3 page limit (does not include references)
Key Information Key Information Cycle: Cycle 2 2017 Full Announcement: Implementation of Deadlines: Effective Shared Decision Making Approaches Letters of Intent: October 2, 2017 in Practice Settings Applications: January 10, 2018 Status: OPEN Timeline: Online System Opens September 1, 2017 Merit Review: March 2018 Awards Announced: August 2018 Applicant Town Hall Session: September 19, Earliest Start Date: October 2018 2017 Funding Level: $1,500,000 total direct costs. Letter of Intent (LOI): Competitive Funds available up to: $6,500,000 per cycle Project Period: 3 years maximum
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