PCORI Funding Announcement: Implementation of Effective Shared - - PowerPoint PPT Presentation

Town Hall Cycle 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 Gayer Senior Program Officer D&I Program Joanna Siegel Program Director D&I Program Arielle Gorstein Program Associate 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.

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 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...

• -from PCORI’s authorizing legislation

… and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness

• f 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, 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

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
• bstacles 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

• n 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

• ptions 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

• r

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

• r

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

• r

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, 2017 Applications: January 10, 2018 Status: OPEN Online System Opens September 1, 2017 Timeline: Merit Review: March 2018 Awards Announced: August 2018 Applicant Town Hall Session: September 19, 2017 Earliest Start Date: October 2018 Letter of Intent (LOI): Competitive Funding 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, MPH Program 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 DisseminationQuestions@pcori.org 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: pfa@pcori.org

For assistance from the PCORI D&I program team

• Disseminationquestions@pcori.org

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 disseminationquestions@pcori.org