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

Town Hall Cycle 2 2018

PCORI Funding Announcement: Implementation of Effective Shared Decision Making Approaches in Practice Settings

July 11, 2018

I. Welcome II. PFA Overview & Requirements

• III. Administrative Requirements
• IV. Applicant Resources

V. Questions

Agenda

Submit questions via the Questions box in the GoToWebinar control panel

Submitting Questions:

Today’s Presenters

Joanna Siegel Program Director Dissemination and Implementation Program Michelle Henton

• Sr. Program Associate

Dissemination and Implementation Program Bill Lawrence

• Sr. Clinical Advisor

Office of the Chief 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...

• -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

7

The D&I Program is charged with heightening awareness of the results

• f PCORI-funded research, and with advancing efforts to put these

findings into practice to improve healthcare delivery and health

• utcomes.

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 Effective Shared Decision Making (SDM) Approaches in Practice Settings

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

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

• f 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

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

• f 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
• r 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 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

Merit Review Criteria

SDM Implementation PFA Overview : Administrative Requirements

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

*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

• f the original PCORI-funded research project team.

Eligibility

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,

• r
• 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)

Eligibility Requirements

• 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

Complete a Mandatory Letter of Intent (LOI)

3 page limit (does not include references)

Key Information

Applicant Resources

1. Lack of detail regarding evidence to be incorporated or implemented 2. Proposing to develop the implementation plan as part of the project 3. No demonstration that key personnel have SDM and implementation experience 4. Not providing enough information about your tested SDM approach,

• r focusing on developing, testing, or validating the SDM approach

that will be implemented 5. Lack of detail on the implementation activities, the shared decision making strategy and how it works, and evaluation plans 6. Not including the stakeholders who will be essential to the success

• f your project

Concerns When Submitting an LOI and Application

1. If you are a PCORI awardee…… – Make plans to submit a high quality DFRR or manuscript ASAP. 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

3. Review the PCORI Online applicant trainings to familiarize yourself with the online submission process 4. 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. Can I submit an LOI to the Implementation Limited Competition PFA and the Implementation of SDM PFA? 2. Does the principal investigator from the original PCORI study have to the be the principal investigator for the application submitted to this PFA?

Frequently Asked Questions

Applicant Resources: Where Can I Find Help?

Visit pcori.org/funding-opportunities, then click on the Implementation of Effective Shared Decision Making Approaches funding announcement link for: ▪ Application Guidelines ▪ FAQs ▪ Required LOI/Application Templates ▪ Additional Applicant Resources For technical assistance ▪ PCORI Helpdesk: pfa@pcori.org For programmatic assistance ▪ Disseminationquestions@pcori.org

Q&A

Ask a question via the question box in the GoToWebinar control panel

If we are unable to address your question during this time, e-mail the D&I Helpdesk at disseminationquestions@pcori.org