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I. General Requirements for Engagement Awards

This section includes language that is specific to PCORI’s requirements for programmatic responsiveness under this funding announcement. Applicants should use this section as guidance when preparing their full proposals. For information related to administrative and technical requirements for application submission, please consult the Engagement Award Submission Instructions for Special Cycle 2021.

Engagement Award Priorities

The Engagement Award program supports PCORI’s Engagement Imperative—defined in our Strategic Plan—and provides a platform to increase engagement in research, that is, the meaningful involvement of patients, caregivers, clinicians, and other healthcare stakeholders throughout the research process. We expect projects selected for an Engagement Award to result in tools and resources that may be useful to other awardees for increasing patient and/or other stakeholder engagement in PCOR/CER, PCORI, and the broader PCOR community. We are committed to using and broadly sharing this information. Please see the PCORI Engagement Tool and Resource Repository for examples of what this can look like.

Categories of Nonresponsiveness

Applications will be considered nonresponsive for an Engagement Award if they propose:

• Projects solely intended to increase patient engagement in health care or healthcare systems rather than healthcare research
• Projects to design or test healthcare interventions
• Activities that involve the use of a drug or medical device
• Development of clinical practice guidelines, care protocols, or decision support tools
• Development of coverage, payment, or policy recommendations or guidelines
• Projects related to quality measures, quality improvement, or engagement around quality measures
• Projects to recruit and enroll patients for clinical trials
• Projects that only involve patients as subjects (individuals enrolled into a study as participants)
• Research studies including randomized controlled trials, observational studies, and pragmatic clinical studies
• Development or maintenance of a registry, or recruitment to participate in a registry
• Projects designed solely to validate tools or instruments not created through a PCORI-funded project
• Writing research proposals or completing grant applications, grantmaking
• Projects focused solely on social determinants of health, with no focus on patient-centered outcomes research/comparative clinical effectiveness research (PCOR/CER)
• Planning for dissemination or dissemination initiatives without including PCORI-funded research or related products
• Implementation of PCORI findings in a clinical practice setting (PCORI funds dedicated implementation efforts through the Limited PCORI Funding Announcement: Implementation of PCORI-Funded Patient-Centered Outcomes Research Results)
• Projects or meetings without a clear focus on patient-centered outcomes research/comparative clinical effectiveness research (PCOR/CER)

Avoiding Redundancy

PCORI encourages potential applicants to review funded projects at pcori.org. We intend to balance our funded portfolio to achieve synergy and avoid redundancy where possible.

Required Education of Key Personnel on the Protection of Human Subject Participants

PCORI requires that all applicants adhere to the National Institutes of Health (NIH) policy on education in the protection of human subject participants. This applies to all individuals listed as key personnel in the application. The policy and FAQs are available on the NIH website.

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II. Special Cycle: Building Capacity for PCOR/CER in Intellectual and Developmental Disabilities

The Engagement Award program is now accepting full proposals for the Special Cycle: Building Capacity for PCOR/CER in Intellectual and Developmental Disabilities, a research support—not research—special funding opportunity for projects up to two years in duration and up to $250,000 in total costs. The length of the project period and budget amount must be justified by the level of activity that will occur during the project and all projects must be at least 18 months in duration.

Overview of Building Capacity for PCOR/CER

PCORI’s reauthorizing legislation in 2019 included two new research priority areas, one of which centers on individuals with intellectual and developmental disabilities (IDD). These new priority areas provide more focused opportunities for engaging diverse stakeholders and facilitating PCOR/CER that is critical in understanding and addressing the needs of those impacted by these conditions.

Developmental disabilities are chronic disabilities that originate at birth or in the developmental period and cause impairment in physical, learning, language, and/or behavioral areas. Intellectual disabilities, which fall under the umbrella term of developmental disabilities, involve limitations to cognitive function (reasoning, learning, problem solving) and adaptive behavior. Not all developmental disabilities include limitations in cognitive ability.

This Engagement Award funding announcement offers an opportunity for organizations and community groups to build capacity and skills for patient-centered outcomes research and comparative clinical effectiveness research (PCOR/CER) in IDD, as well as understand the impact of stakeholder engagement within different settings and stakeholder groups focused on this special area of interest.

In the context of the Engagement Awards program, capacity building to support research refers to the following types of projects:

• Projects that support organizations with strong ties to patients, caregivers, clinicians, and/or other stakeholders who have a connection to, expertise in, or lived experience related to the focus area to equip them to engage as partners in PCOR/CER. These projects will focus on building the knowledge, competencies, and abilities of their community to be meaningful partners with researchers throughout the research process from topic selection through design and conduct of research to dissemination or implementation of results.
• Activities might include, but are not limited to:
  • Educating and training stakeholders on the fundamentals of PCOR/CER; establishing a sustainable collaborative or learning community; engaging stakeholders to identify important patient-centered outcomes, prioritize PCOR/CER topics or themes, and/or develop a research agenda; capturing stakeholder perspectives on emerging PCOR/CER needs and barriers/facilitators to patient-centered research.
    • Applicants may wish to consider utilizing PCORI’s Research Fundamentals, a free, on-demand, comprehensive training that offers different ways to learn about the health research process and be involved in patient-centered outcomes research.
  • Multi-stakeholder convenings, meetings, and conferences that include patients, caregivers, researchers, clinicians, purchasers, payers, health system leaders, and other stakeholders.
  • Convenings designed with the active involvement of patient and community groups and organizations to bring diverse stakeholders together around a central focus or theme that unifies stakeholders.
  • Convenings that include one or more of the following priority/focus areas: (a) facilitating discussion around patient-centered research design and development of PCOR, (b) sharing engagement methods, and/or (c) dissemination of research findings.
• Projects that strengthen the skills of researchers to be better partners with patients and other stakeholders involved in PCOR/CER.
  • Applicants must clearly explain how the capacity that is developed through an award will be applied to existing or planned PCOR/CER partnership opportunities.
• Projects that support the expansion of use or adoption of existing engagement tools and resources whenever possible, rather than develop new products and tools. Projects may implement available tools, processes, or programs, alone or in combination, in a new population or geographic area—for example, a new network of clinicians, patient advocates, and academic researchers.
  • If this project is using a PCORI-funded engagement tool/resource, applicants should identify the existing engagement tool/resource that this project will be scaling or adopting by listing the: (a) Tool Name, (b) Project Title, (c) Project Lead Name, (d) URL to project page. Applicants should anticipate seeking a letter of support from the tool/resource originator should a full application be invited.
  • Applicants should identify and describe all tools/trainings/programs that will be used as part of the project, as well as share the evidence base for the resources that will be used.

Funding Priorities for Special Cycle: IDD

This special funding opportunity will support projects that enable organizations and communities to develop their capacity and skills to participate across all phases of the PCOR/CER process, as described above, on topics related to IDD health outcomes. This is an opportunity to address the need to build capacity for stakeholder engagement in PCOR/CER in IDD in areas that would benefit from further research such as:

• Addressing health equity and advancing IDD health outcomes for vulnerable populations, such as addressing institutional racism, building workforce capacity to provide appropriate and culturally competent care; matching high-risk individuals to specialty care and services; addressing social determinants of health and/or risk factors and conditions that disproportionally affect vulnerable populations
• Leveraging community-based and patient-centered models of care delivery
• Challenges related to clinical care delivery, coordination, and access, such as identifying and addressing risk factors for adverse health outcomes; treating chronic comorbid conditions; timing of key provider encounters; and transitions in care
• Telehealth solutions
• Transition to adulthood
• Caregiver needs and access to wraparound support
• Patient needs and preferences

Other relevant topics related to IDD health outcomes with appropriate justification are welcomed.

We expect that projects selected for an Engagement Award will further PCORI’s goals of promoting the relevance of research to target audiences and the uptake of research results by end users. We are committed to using and sharing successful approaches.

The information and learnings generated by Engagement Award projects must be generalizable; they must be of interest or use not just to the applicant organizations but to others doing related work. The learnings and information will be made public so they can have a broader impact. Please see the PCORI Engagement Tool and Resource Repository for examples of what this can look like.

Submitting a Successful Application

Successful applications will include:

• Applicants should consider alternative plans for any convening activities within the project, should an in-person meeting not be feasible. Please consult PCORI’s Applicant and Awardee FAQs Related to COVID-19 to ensure your proposed project adheres to PCORI’s guidance related to applicant pre-award concerns.
  • PCORI is aware that there is an evolving context around the COVID-19 pandemic. We are committed to working with awardees to adapt projects and processes to the evolving context during this time so that deliverables are implemented fully as per the executed contract.
• Rationale that there is a need for additional patient and/or stakeholder capacity to participate in IDD-related PCOR/CER with a clear and direct link to participation in research opportunities.
• The intended impact of the proposed project.
• The organization’s relationship to the population and/or context and track record in engagement.
• Commitment from the patient and/or stakeholder communities to be involved in the project and clear patient and/or stakeholder involvement/leadership in all stages of the proposed work.
• Evaluation metrics for assessing the success of the engagement strategies.
• Plans for sustainability/next steps after the project period has ended. Future funding from PCORI should not be assumed. If the project does not lend itself to sustained activities after the project period concludes, provide justification.
• If using or adopting a PCORI-funded engagement tool or resource:
  • Description of the engagement tool(s) or resource(s) selected and justification for its continued and expanded use. Provide information about prior use/implementation of the tool(s) or resource(s), including any data on its effectiveness to build capacity for patient and stakeholder engagement in PCOR/CER.
  • Approval to use and, if applicable, adapt tool(s) and resource(s) from the relevant copyright owner of the tool(s) and/or resource(s) in the form of a written letter of support with the full proposal submission. This will typically be from the awardee institution of the original PCORI award. The relevant owner must grant the applicant rights to the engagement tool(s)/resource(s) sufficient to carry out the project.

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III. Project Evaluation

Applicants must include a completed Evaluation Reporting Tool as a deliverable at the end of the project period. The Evaluation Reporting Tool provides a template to collect information about Engagement Awards that can help with evaluation of our portfolio, as well as evaluation of individual projects. This reporting tool should be taken into consideration during proposal development and uploaded at the end of the project period with the Final Deliverable Milestone. Awardees may use a different evaluation framework if there is one that is more aligned with their project proposal, subject to PCORI approval. Applicants adopting such an approach must identify the proposed alternate evaluation framework in their application.

The goal of this reporting tool is to ensure a standard set of reported information for Engagement Awards. Given the difficulty in applying metrics and a standard set of indicators around engagement best practices, this tool provides a baseline of outcomes to report on in Engagement Award projects.

At a minimum, evaluation plans should document the reach (in absolute numbers) of the engagement effort among the targeted end users and settings.

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IV. Review Process

Applying for this award is a one-stage process unlike applying for other Engagement Awards. A full proposal is required at the time of submission. An LOI is not required. Specific requirements and guidance to complete a successful application are found in the full funding announcement, submission instructions, and submission checklist.

Proposals must be submitted by the application deadline of May 24, 2021 at 5 pm ET. PCORI may request additional information from the applicant after the initial review of the full proposal. PCORI aims to provide a final programmatic approval decision on the full proposal, via email, within 10 weeks of the application deadline. If the full proposal is programmatically approved, a PCORI staff member will coordinate arrangements to begin budgetary review and contracting negotiations.

To select high-quality patient-centered projects, PCORI’s Engagement and Contract Management and Administration teams and internal and external subject matter experts (as necessary) will review all applications.

Review Criteria:

1. Program Fit
2. Project Plan and Timeline
3. Qualifications of the Project Lead, Personnel, and Organizational Capabilities
4. Patient and Stakeholder Engagement Plan and Collaborators
5. Past Performance
6. Budget/Cost Proposal

For additional details on the review process, click here.

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V. How To Apply

1. Read the full funding announcement
2. Follow the process outlined in the Submission Instructions
   (A Letter of Intent (LOI) is not required for this PFA.)
3. Submit an application

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VI. Applicant Resources

• Applicant Webinar: March 2, 2021 (Recorded, no registration necessary)
• Applicant Office Hours (Session 1): March 8, 2021 – 12:00-12:30 pm ET
• Applicant Office Hours (Session 2): March 22, 2021 – 12:00-12:30 pm ET
• Applicant Office Hours (Session 3): April 12, 2021 – 12:00-1:00 pm ET
• Special Cycle: IDD PFA (PDF)
• Submission Instructions

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VII. Questions?

If you have any additional questions, please contact PCORI at [email protected] or (202) 370-9312. PCORI will provide a response within three business days.

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