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Section III : Stakeholder Engagement

An Iterative Process

Key Points

  • Identify your stakeholders up front and engage them throughout the research process.  Focus on working “with” a community, not doing research “on” a community.
  • Be open to the possibility that patients and other stakeholders will want to reframe your intervention or study question – in fact you want their active engagement!
  • Stakeholder engagement enhances dissemination and implementation of study results.

Learning Objective:

Explain the iterative process of stakeholder engagement, including the identification of stakeholders, informed engagement and plan development. 

Engagement Defined

The Centers for Disease Control and the Agency for Toxic Substances and Disease Registry defined community engagement as: 

… the process of working collaboratively with groups of people who are affiliated by geographic proximity, special interests, or similar situations with respect to issues affecting their well-being.

 (CDC, 1997)

The Clinical and Translational Science Awards Consortium has stated that “community engagement is a blend of science and art”. 

•    Scientific principles of engagement are derived from the disciplines of sociology, psychology, social work, organizational development, and political science.  Organizing concepts are described in the scientific literature on community participation, community mobilization, constituency building, community psychology, and cultural influences.
•    The art of engagement comes from the understanding, skill and sensitivity used to apply and adapt the science in order to meet the interests of the community and the purpose for the engagement.

Principles of Community Engagement (2nd Edition) is an excellent guide for understanding definitions and organizing concepts of community engagement.  It provides an excellent resource for researchers wanting to incorporate engagement into the research process.  Engagement can be labor-intensive, requiring dedicated resources including: time, funding, and people with the appropriate skills. This primer also provides guidance for managing organization support for community engagement.

Engagement Informs Pragmatic Research

HOW ENGAGEMENT INFORMS PRAGMATIC RESEARCH

The Patient-Centered Outcomes Research Institute (PCORI) provides cross-cutting standards for PCOR which cannot be met without engaging patients and stakeholders. 

STANDARDS FOR FORMULATING RESEARCH QUESTIONS

Identify specific populations and health decision(s) affected by the research:

To produce information that is meaningful and useful to people when making specific health decisions, research proposals and protocols should describe 3 components:
The specific health decision the research is intended to inform.
The specific population for whom the health decision is pertinent.
How study results will inform the health decision.

Measure outcomes that stakeholders notice and care about:

Identify and include outcomes the population of interest notices and cares about (e.g., survival, function, symptoms, health-related quality of life) and that inform an identified health decision. Define outcomes clearly, especially for complex conditions or outcomes that may not have established clinical criteria. 


Provide information that supports the selection of outcomes as meeting the criteria of “patient-centered” and “relevant to decision makers,” such as patient and decision-maker input from meetings, surveys, or published studies. Select outcomes based on input directly elicited from patient informants and people representative of the population of interest, either in previous studies or in the proposed research.

 

STANDARDS ASSOCIATED WITH PATIENT-CENTEREDNESS

Engage people representing the population of interest and other relevant stakeholders in ways that are appropriate and necessary in a given research context.

 

People representing the population of interest include individuals who have the condition or who are at risk of the condition and, as relevant, their surrogates or caregivers. Other relevant stakeholders may include clinicians, administrators, policy makers, or others involved in healthcare decision making. 

 

Stakeholders can be engaged in the processes of:

 

Formulating research Questions

Defining essential characteristics of study participants, comparators and outcomes;

Identifying and selecting outcomes that the population of interest notices and cares about (e.g., survival, function, symptoms, health-related quality of life) and that inform decision making relevant to the research topic;

Monitoring study conduct and progress; and

 

Designing/suggesting plans for dissemination and implementation activities.

When applicable, research proposals should describe how these stakeholders will be identified, recruited, and retained. If engagement is not necessary or appropriate, explain why.

Identify Your Stakeholder: The Seven P's Framework:

This framework can be used to identify stakeholders in patient-centered and comparative effectiveness research (Concannon, et al) can be a useful framework for identifying stakeholders for pragmatic trials.

PATIENTS AND THE PUBLIC

Current and potential consumers of patient-centered health care and population focused public health, their caregivers, families and patient and consumer advocacy organizations.

PROVIDERS

Individuals and organizations that provide care to patients and populations.

PURCHASERS

Employers, the self-insured, taxpayers and other entities responsible for underwriting the costs of health care or health services.

PAYERS

Insurers, Medicaid and Medicare, state insurance exchanges, individuals with deductibles, and others responsible for reimbursement of interventions or episodes of care.

POLICY MAKERS

The White House, Department of Health and Human Services, Congress, states, professional associations, and other policy-making entities.

PRODUCT MAKERS

Electronic health record and related technology companies; drug and device manufacturers; and other affected healthcare product producers.

PRINCIPAL INVESTIGATORS

Other researchers and funding agencies.
Boot Camp Translation

Developing an Engagement Plan

PCORI has published general guidance regarding engagement in the conduct of PCOR research.  The Engagement Plan instructs applicants, merit reviewers, awardees and engagement/program officers.  

Planning the Study

Describe how patient and stakeholder partners will participate in study planning and design.

Conducting the Study

Describe how patient and stakeholder partners will participate in the study conduct.

Disseminating the Study Results

Describe how patient and stakeholder partners will be involved in plans to disseminate study findings, and ensure that findings are communicated in understandable, usable ways.

Using PCOR Engagement Principles

•    Reciprocal Relationships in decision-making
•    Co-learning through training and educational opportunities
•    Partnership where value is reflected in fair financial compensation and time commitment
•    Trust, Transparency, Honesty

 

Local and National Resources

CCTSI
A core which facilitates Community-Based Participatory Research, educates and connects investigators and communities, develops programs to improve relationships and build trust between academicians and communities, and makes funds available for community engagement and research.
PCORI Engagement Awards Program
A program to advance patient-centered outcomes research.  The program provides targeted funding to groups of patients, clinicians and others across the healthcare community.

Other Resources

​​​Boot Camp Translation for Patient-centered Outcomes

Elaine Morrato, DrPH, MPH, CPH

An introduction to Stakeholder Engagement from the CRISP Pragmatic Trials Workshop September 15, 2014

An Overview on Engament

Kim Bailey, PCORI Engagement Officer

An Overview on Stakeholder Engagement, from PCORI engagement officer Kim Bailey at the 2014 CRISP Pragmatic Trials Workshop.

Key Takeaways

Click To Reveal Flipcard Answer

When is the most critical stage of stakeholder involvement for the research process?

Identify your stakeholders up front and engage them throughout the research process.  Focus on working “with” a community, not doing research “on” a community.

What benefits may arise from active engagement of patients and stakeholders?

It benefits researchers to be open to the possibility that patients and other stakeholders will want to reframe (and potentially improve) your intervention or study question. Engagement can also enhance disseminationa and implementation of results!

What are some key standards for formulating research questions?

  • Identify specific populations and health decision(s) affected by research
  • Measure outcomes that stakeholders notice and care about
  • Engage people representing the population of interest and other relevant stakeholders in ways that are appropriate and necessary in a given research context

What are the 7 P's of the framework used to identify stakeholders?

  • Patients and the Public
  • Providers
  • Purchasers
  • Payers
  • Policy Makers
  • Product Makers
  • Principal Investigators

References

Click Each Reference to View the Abstract and Download Full Texts.
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