Letters of Intent for this PCORI funding announcement were due Tuesday, February 14, 2017. Those selected to submit a full application were notified by Wednesday, March 15, 2017. Full applications were due Wednesday, May 17, 2017, by 5:00 p.m. (ET)

Table of Contents Summary Introduction Background Research of Interest Evidence to Action Network

Summary

PCORI seeks to fund projects that address critical knowledge gaps in the communication and dissemination process—both the communication and dissemination of research results to patients, their caregivers, and clinicians, and the communication between patients, caregivers, and clinicians—in the service of enabling patients and caregivers to make the best-possible decisions in choosing among available options for care and treatment.

Funds Available: $8 million

Maximum Project Budget (Total Direct Costs): $1.5 million

Maximum Research Project Period: Three years

Budget/Time Limits: Applicants must submit a Greater Than Time/Budget Request with their LOI if the proposed project’s budget or duration exceeds limits specified in this announcement.

Return to the Broad PCORI Funding Announcements page for key dates.

Introduction

Knowledge needs to be strengthened about how to communicate optimally and facilitate the effective use of patient-centered outcomes research (PCOR) and comparative clinical effectiveness research (CER) findings by patients, caregivers, and healthcare professionals. Well-documented barriers exist to the rapid transfer of evidence. Informed healthcare decisions require innovative and effective strategies to make existing PCOR/CER evidence available to patients and providers in real-world settings. Moreover, the information needs to be understandable to improve decision making.

The Communication and Dissemination Research Program invites applications that study the comparative effectiveness of communication and dissemination strategies. We are looking for strategies aimed at informing and empowering patients, caregivers, and other healthcare decision makers so that they know what questions to ask and have the information needed to provide support in shared decision making.

This announcement is designed to solicit applications that include:

• The direct comparison of two or more health communication and dissemination interventions or strategies, each of which has established efficacy or is in widespread use
• Research conducted in real-world, clinical care settings and situations
• Proposed research questions and health outcomes that will matter to the patient population, their caregivers, and family members under study, and that will help to guide their healthcare decisions

Research appropriate for this PCORI Funding Announcement (PFA) includes:

• Communication strategies to promote the use of health and healthcare CER evidence by patients and clinicians
• Dissemination strategies to promote the use of health and healthcare CER evidence by patients and clinicians
• Explanation of uncertain health and healthcare CER evidence to patients and clinicians

Note: Proposed research that includes “usual care” as the control condition or one arm of an intervention trial should explain clearly how the term “usual care” is defined, assessed, and justified as an appropriate comparator.

Research not appropriate for this PFA includes:

• Applications that focus on the development, testing (establishing efficacy), and validation of individual decision aids and tools
• Applications that include a formal cost-effectiveness analysis
• Applications that directly compare the costs of care of two or more alternative approaches to providing care
• Applications that include creation of clinical practice guidelines or clinical pathways

See Categories of Nonresponsiveness for a more detailed explanation and examples of topics that will be considered nonresponsive.

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Background

Making an informed healthcare choice requires critically assessing the potential benefits and harms of the options within the context of the patient’s personal characteristics, conditions, and preferences.^[1],[2] The environment in which patients, caregivers, and their providers communicate is also evolving rapidly to include a wide array of available health information and communication applications. These tools can help fill critical information gaps, but are often confusing and difficult to use. The type of healthcare decisions being made is an important determinant of the appropriate information needed and of the best vehicle for providing it. (For example, the informational needs of a patient weighing options for treating high blood pressure will differ from those of a patient facing a terminal cancer diagnosis with complicated treatment options.) Furthermore, patients and caregivers want information that does not necessarily deliver decisions or tell them what to do, but instead informs them of the relevant trade-offs and facilitates improved decision making in collaboration with their healthcare team.

Clear communication approaches and active dissemination of PCOR/CER research findings to all audiences (in easy-to-understand formats) are critical to increasing the awareness, consideration, adoption, and use of these data by patients, caregivers, and healthcare providers.^[3] This PFA focuses on three key areas: (1) communication strategies, (2) dissemination strategies, and (3) explaining uncertainty.

Communication strategies to promote the use of health and healthcare CER evidence by patients and clinicians

Translating existing scientific research into accessible and usable formats that clearly outline the risks and benefits of various healthcare options for patients, caregivers, and healthcare providers is an important research area in clinical and community-based settings. In clinical care, shared decision making and decision-support interventions are two of the primary ways in which medical evidence is translated into a usable format for patients, families, and caregivers. Understanding the best ways to communicate, while addressing numeracy and health literacy, is fundamental to communicating PCOR/CER effectively via shared decision making.^[4],[5],[6] For example, the integration of patient decision support, electronic health records, and associated patient systems holds considerable promise, but little evidence is available to guide best practices.

Research gaps identified in a systematic review included the need for more head-to-head comparisons of communication strategies.³ For example, more CER is needed to determine how shared decision making and decision-support interventions perform using different media, what level of information and detail they require, how they perform in different patient subpopulations, and how they can reflect new evidence and remain current. In addition, CER is needed to determine whether using efficacious applications of newer conceptual approaches to decision making—such as use of gist representation approaches in evidence communication or using behavioral economic strategies to improve healthcare decisions—can improve patients’ and clinicians’ use of evidence in decision making compared to more traditional methods.^[7] Furthermore, most of the CER research to date consists of comparisons of communication strategies relative to “usual care.” In most cases, it is difficult to determine what “usual care” is or how it differs from “standard of care.” Therefore, proposed research that includes “usual care” as the control condition or one arm of an intervention trial should explain clearly how the term “usual care” is defined, assessed, and justified as an appropriate comparator.

Effective communication skills of patients and healthcare providers are important for the optimal use of CER results. Research on doctor-patient communication has focused primarily on the doctor-patient dyad, but little is known about other health professionals who communicate with patients and play a critical role in the patient care experience. Moreover, additional information is needed on how family involvement and family dynamics affect communication and the decision-making process. Applicants should consider broadening their focus beyond the patient-clinician dyad by recognizing that patient-centered care and communication are characterized by a complex web of communication among patients, caregivers, and a variety of healthcare professionals with whom they interact during different stages of the care continuum (pre-diagnosis to end-of-life).^[8]

Dissemination strategies to promote the use of health and healthcare CER evidence by patients and clinicians

The dissemination of CER information to patients, caregivers, and providers (in clinical and community-based settings) is an area that has not received sufficient research attention. Dissemination is defined as the active and targeted approach of spreading evidence-based interventions to potential adopters and the target audience through determined channels using planned strategies.^[9] The goals of dissemination are to increase the reach of information, motivation and ability of patients, caregivers, and providers to use and apply evidence. The goals of dissemination research are to make such efforts more effective in accomplishing these aims.³ Dissemination research is the scientific study of targeted distribution of information and intervention materials to a specific public health or clinical practice audience, or individual patients. The intent is to understand how best to spread and sustain knowledge and the associated evidence-based interventions. Little is known about the comparative effectiveness of dissemination methods and approaches for achieving these goals.

Although more research is needed to identify the most-effective approaches for disseminating CER results to healthcare providers, with the goals of sustained changes in clinical practice and effective dissemination to patients of results that enable behavior changes (e.g., adherence and self-care), CER includes evaluation of alternative strategies for dissemination and implementation itself. In other words, dissemination can be the subject of CER and not just an approach to publicize the CER findings. This area has continued to evolve and includes the development and application of new study designs. Effectiveness-Implementation hybrid designs blend the design components of clinical effectiveness trials (e.g., proven interventions introduced in real-world settings) and the implementation strategy. Dissemination studies using such hybrid designs have the potential to speed and improve the translation of clinical intervention uptake; identify more effective implementation strategies; and provide more useful information for patients, stakeholders, researchers and decision makers.^[10],[11] Three types of hybrid designs have been identified, and vary according to the emphasis placed on testing the intervention versus the implementation. Hybrid Type 1 tests the effects of a clinical intervention on relevant outcomes while observing and gathering information on its potential for implementation in a real-world situation; Hybrid Type 2 balances attention to the effectiveness of the clinical intervention and the implementation strategy that supports the interventions; and Hybrid Type 3 tests an implementation intervention and strategy while observing and gathering information on the clinical intervention’s impact on relevant outcomes. ¹⁰

Explaining uncertain health and healthcare CER evidence to patients and clinicians

Risk and uncertainty are ubiquitous in healthcare. Like most decisions, many healthcare decisions have consequences and involve uncertainties and trade-offs. A significant gap exists in the limited research on risk communication generally, and with underserved individuals and those with limited health literacy and numeracy in particular. Research is also lacking in effective methods for communicating risk to healthcare providers and enabling them to use the information effectively. A seminal publication on patient-centered communication from the National Cancer Institute identified managing uncertainty as a core function of patient-clinician communication.⁷ Uncertainty creates many challenges, including the following: (1) determining whether preventive services and treatments should be implemented in clinical practice; (2) determining for whom and in what settings services and treatments should be implemented; and (3) communicating evidence so that consumers can make informed decisions.³ A systematic review identified research gaps that revealed a need for analyses that identify and prioritize uncertainties that should be communicated; methods that measure and provide a better understanding of uncertainties as they pertain to risks, practice recommendations, and other types of evidence; and standardized language used to communicate uncertainties in clinical evidence. The systematic review also revealed a need for formal systems used to rate uncertainty arising from clinical evidence that incorporates the patient perspective to ensure comprehensibility, meaningfulness, and appropriate use.^[12]

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Research of Interest

The Communication and Dissemination Research Program seeks to fund investigator-initiated CER that includes, but is not limited to, the following:

Communication Strategies

• Compare strategies that increase knowledge of how to communicate complex information to patients and caregivers.
• Identify and compare practices that increase understanding of the tension between strongly held beliefs and contrary evidence, and those practices’ impact on the shared decision-making process.
• Compare strategies meant to generate conversations between patients and providers about what is appropriate and necessary treatment (e.g., Choosing Wisely)—based on patients’ preferences and conditions—to improve patient satisfaction with their decision process and enable them to use the best-available evidence.
• Compare strategies and methods that optimize communication among the patient, family/caregiver, and healthcare team (e.g., role of family member or caregiver in patient-provider, patient-caregiver, and healthcare team interactions).
• Compare the influence of family, friends, and other patients on healthcare decisions that occur outside the healthcare setting.
• Compare strategies in situations where there is not a single “right” choice (e.g., preference-sensitive decisions) to improve patients’ satisfaction with their decision process and to enable them to use the best-available evidence.

Dissemination Strategies

• Compare CER dissemination strategies while evaluating the potential for implementation in real-world settings (e.g., hybrid effectiveness-implementation design trial).
• Compare and identify best practices of dissemination and translation techniques to facilitate shared decision making in everyday practice.
• Identify the most-effective approaches to disseminating CER results to healthcare providers, with the goals of sustained changes in clinical practice and effective dissemination to patients of results that enable behavior changes (e.g., self-care).
• Understand how strategies used in public health communication and social marketing can be adapted to disseminate CER results and to identify creative ways of combining multiple communication channels to increase CER exposure.

Explaining Uncertainty

• Compare strategies for conveying uncertainty associated with health and healthcare evidence that increase the likelihood that patients and caregivers will understand the information, incorporate it into decision making, and evaluate personal trade-offs.
• Compare strategies to reduce the cognitive burden required to understand complex numeric and risk-related information, and to improve understanding of the potential outcomes and improve decision making.
• Compare the effectiveness of health literacy- and numeracy-sensitive health communication strategies that relay risks and benefits of health decisions so that individuals can make sound healthcare decisions.
• Compare interventions that help patients and families or caregivers facing difficult medical decisions in which the outcomes are ambiguous or uncertain to improve their understanding of the outcomes and facilitate their decision making.

PCORI is interested in understanding the role of shared decision making and established, effective decision aids in communicating and implementing PCOR/CER. Applications focused on developing, testing (establishing efficacy), and validating individual decision aids and tools will be considered nonresponsive to this PFA.

PCORI expects the efficacy or effectiveness of each intervention to be known. Interventions that have documented efficacy or effectiveness in similar situations may be used—with adaptation if necessary— if the efficacy is well-documented (e.g., with multiple trials or with a systematic review), and sufficiently strong rationale for why the intervention would be expected to be efficacious in the proposed new setting(s) and/or population(s) is provided. If an intervention is to be adapted, PCORI expects the majority of the proposed time and budget to aim at establishing comparative effectiveness rather than adapting and validating the interventions.

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Evidence to Action Networks

PCORI is interested in ensuring communication and engagement between awardees with similar needs and interests and end-users to help refine and improve the research, and to facilitate dissemination of research findings that will help patients and the public make better-informed healthcare decisions. To meet this goal, PCORI has set up Evidence to Action Networks (E2AN), whereby we facilitate engagement among awardees and cross-learning between projects and teams comprised of researchers, patients, caregivers, and other stakeholders. PCORI also facilitates exchanges between awardees and end-users (e.g., patients, caregivers and other stakeholders, such as payers, employers and purchasers, clinicians, professional societies, policy makers, and training institutions) for disseminating and implementing important research findings.

Awardees are encouraged to participate in E2ANs if they become available on a specific topic relevant to their research.

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