implementation of effective shared decision making ... · town hall. cycle 2 2017 . pcori funding...
TRANSCRIPT
Town HallCycle 2 2017
PCORI Funding Announcement: Implementation of Effective Shared
Decision Making Approaches in Practice Settings
September 19, 2017
I. Welcome
II. About PCORI
III. Dissemination and Implementation Program Goals
IV. PFA Overview
V. Program Requirements
VI. Administrative Requirements
VII. Applicant Resources
VIII. Questions
Agenda
Submit questions via the Q&A box
Today’s Presenters
Chris GayerSenior Program Officer
D&I Program
Joanna SiegelProgram Director
D&I Program
Arielle GorsteinProgram Associate
D&I Program
Welcome to the SDM PFA Town Hall
Joanna Siegel, ScDDirector, 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.
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 Mission
Our Mandate
“The purpose of the Institute is to assist patients, clinicians, purchasers, and policy-makers in making informed health decisionsby 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...
--from PCORI’s authorizing legislation
… and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of the medical treatments, services...”
PCORI Dissemination and Implementation Program
8
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
Implementation of SDM - PFA Overview:Program Requirements
Chris Gayer, PhDSenior Program OfficerDissemination and Implementation Program
PFA Overview: Implementation of Effective Shared Decision Making Approaches in Practice Settings
Objective of the PFA:
• Promote the targeted implementation and systematic uptake of SDM in healthcare settings
In this PFA we seek to fund:
• Active, multi-component approaches to implementing effective SDM strategies
• That address existing barriers and obstacles to uptake and maintenance….
• So that these interventions are effectively and sustainably integrated into practice
Available Funds and Duration
• $6.5M for this cycle
• Up to $1.5M in direct costs per project
• Projects should be completed within 3 years
• 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
Background
*See supporting citations in the PFA
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
Background
*See supporting citations in the PFA
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
Shared Decision Making Strategy Definition
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
Essential Characteristics of Projects
PCORI will not consider as sufficient interventions for which testing has been limited to tool validation, usability, or satisfaction.
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
Essential Characteristics of Projects
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
Implementation Activities We Do Not Fund
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
Merit Review Criteria
SDM Implementation PFA Overview:Administrative Requirements
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.
Eligibility
• 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
Complete a Mandatory Letter of Intent (LOI)
3 page limit (does not include references)
Key Information
Key Information
Cycle: Cycle 2 2017
Full Announcement: Implementation of Effective Shared Decision Making Approaches in Practice Settings
Deadlines:Letters of Intent: October 2, 2017Applications: January 10, 2018
Status: OPENOnline System Opens September 1, 2017
Timeline:Merit Review: March 2018Awards Announced: August 2018
Applicant Town Hall Session: September 19, 2017
Earliest Start Date: October 2018
Letter of Intent (LOI): CompetitiveFunding Level: $1,500,000 total direct costs.
Funds available up to: $6,500,000 per cycle Project Period: 3 years maximum
Applicant Resources
Arielle Gorstein, MPHProgram Associate, Dissemination & Implementation
• Lack of detail regarding evidence to be incorporated or implemented
• Proposing to develop the implementation plan as part of the project
• No demonstration that key personnel have SDM and D&I experience
• Focusing on developing, testing, or validating the SDM approach that will be implemented
Issues to Avoid
1. If you are a PCORI awardee…
– Make plans to submit a high quality DFRR or manuscript ASAP.
– If you’re not ready, wait for the next cycle!
2. If you are NOT a PCORI awardee…
– Review the lists of PCORI results that are ready for implementation:
• DFRRs that have been accepted for entry into the peer review process
• Publications in peer-reviewed scientific journals
– Contact the PCORI PI to get a letter of support
3. Email [email protected] to set up a call with a Program Officer from the D&I team
What Should I be Doing Now if I Want to Apply?
1. Will the Implementation of SDM PFA be made available in a future cycle?
2. Can I submit an LOI to the D&I Limited Competition PFA and the Implementation of SDM PFA?
3. Where can I access a list of PCORI-funded research projects that have accepted DFRR’s or peer-reviewed publications pertaining to their primary research results?
4. Does the principal investigator from the original PCORI study have to the be the principal investigator for the application submitted to this PFA?
List of all Frequently Asked Questions can be found here:
• https://help.pcori.org/hc/en-us/sections/115000554724-Dissemination-and-Implementation-Limited-PCORI-Funding-Announcement-
Frequently Asked Questions
Finding the FAQs
1. Click on “Applicant Resources”
Finding the FAQs
2. Click on “FAQs for Applicants” under “Submit Your Application”
Finding the FAQs
This is what you will see
Finding the FAQs
3. Scroll down to “Implementation of Effective Shared Decision Making Approaches in Practice Settings PFA”
Applicant Resources: Where Can I Find Help?Visit pcori.org/apply, then click on the SDM Implementation Funding announcement link for: Application Guidelines FAQs PCORI Online User Manuals
For technical assistance: PCORI Helpdesk: [email protected]
For assistance from the PCORI D&I program team [email protected]
Q&A
Ask a question via the Q&A box
If we are unable to address your question during this time, e-mail the Helpdesk at [email protected]