PCORI Funding Announcement: Implementation of Effective Shared Decision Making Approaches in Practice Settings Town Hall Cycle 2 2018 July 11, 2018
Agenda I. Welcome II. PFA Overview & Requirements III. Administrative Requirements IV. Applicant Resources V. Questions Submitting Questions: Submit questions via the Questions box in the GoToWebinar control panel
Today’s Presenters Joanna Siegel Michelle Henton Bill Lawrence Program Director Sr. Program Associate Sr. Clinical Advisor Dissemination and Dissemination and Office of the Chief Implementation Program Implementation Program Engagement and Dissemination Officer
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 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 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. 7
Implementation of Effective Shared Decision Making (SDM) Approaches in Practice Settings In this PFA, our goals are to: Increase the uptake of shared decision making approaches in • practice Promote the use of PCORI evidence for supporting patients in • making informed decisions about their care.
Implementation of SDM – PFA Overview & Program Requirements Michelle Henton, MA Senior Program Associate 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 three 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 implementation 3. Technical merit of the proposed 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 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 *Applicants that are proposing to implement an SDM strategy that was formally tested and demonstrated to be effective in the context of a PCORI research award must be the Principal Investigator (PI) of the original PCORI funded research project, or be a member of the original PCORI-funded research project team.
Eligibility Requirements If proposing to implement an SDM strategy tested in the context of a PCORI award… The Principal Investigator must have submitted a draft final research • report (DFRR) pertaining to the original PCORI research award, and that DFRR must have been accepted for entry into the peer review process by PCORI, or 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.
Eligibility Requirements If proposing to implement PCORI CER evidence into a tested SDM strategy… The applicant (may be a non-PCORI awardee) must choose from a list of findings of PCORI awardees whose DFRRs have • been accepted for entry into the peer review process. A full list of eligible projects can be found here (and incorporate these findings into their tested SDM strategy)
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. New to this cycle: Resubmission section • 3 page limit (does not include references)
Key Information
Applicant Resources
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