Keywords
clinical decision support - patient engagement - codesign - patient and caregiver
partnerships - implementation - information security - privacy
Background and Significance
Background and Significance
The pandemic surrounding infection from severe acute respiratory syndrome coronavirus
2 (SARS-CoV-2 and the condition known as coronavirus disease [COVID]) has heightened
awareness of the importance of scientific research to guide decision-making for health
care, personal safety, and prevention of acute and chronic illnesses. Decision-making
around prevention has included a focus on vaccination, but some populations face tremendous
uncertainty when deciding whether or when to receive the vaccination. For example,
people who are immunocompromised face uncertainty around the response to vaccination
and length of protection. In March of 2021, when preliminary results of a large prospective
cohort study revealed low antibody response to COVID vaccination among immunocompromised
patients, patient activists in the transplant, chronic kidney disease, dialysis, and
immunocompromised communities sought advice from the medical community and from each
other.[1] Here we loosely define patient activists as those directly and indirectly impacted
by a health challenge, who are knowledgeable about those challenges, and who openly
speak about their stories locally and nationwide to help others in similar situations.
Media and local/national leaders often listen to patient activists. In one city, a
local news outlet published a high-level summary of some of the study's data, which
frightened many patients in and around the city and left hospital staff overwhelmed
and scrambling to respond to calls and emails.[2] Both patients and clinicians could have understood and navigated this uncertainty
together with shared decision-making (SDM) if they had been given the right tools.
Other than media stories and a few tweets with links to papers, no tools were available
to share study data between clinical teams and their patients, to help patients, families
or the activist community get proper, timely, information, or to provide decision
support about what to do with this information, if anything. The feeling of being
panicked with nowhere to turn and no direct line of support causes helplessness to
fall over even the most engaged people. Patients and their families also took to social
media and were forced to share extremely personal information, risking the privacy
and security of such information. In situations like these, health care decision-making
can be fraught with uncertainty and is an opportunity for SDM using decision support
tools.
Patient-centered clinical decision support (CDS) is an emerging area for tool development.[3] Meeting the CDS “Five Rights” (i.e., the right information to the right people in
the right channels and right formats at the right times) in areas of uncertainty requires
sensitivity to and awareness of patient desires, values, capabilities, and limitations.[4] Well-designed, patient-responsive CDS, therefore, necessitates a thorough understanding
of these patient-centered elements, which can be gained through a partnership with
patients throughout the CDS development and implementation process, including its
initial design.[5] Partnering with patients and caregivers is even more important for CDS intended
to support SDM, particularly as patient activists and the general public become more
knowledgeable about privacy and information security.
Advancing the uptake of best evidence into practice through CDS and learning how to
best incorporate patient perspectives have been a priority for the Agency for Healthcare
Research and Quality (AHRQ) since the agency launched its CDS initiative in 2016.[6] The initiative is a multicomponent program that encompasses public, web-based infrastructure
for sharing interoperable CDS, research grants that use CDS to disseminate evidence
into practice at scale, and stakeholder engagement. Engaging stakeholders has taken
the form of learning collaboratives, such as the Patient-Centered CDS Learning Network
(PCCDS LN) and the recently awarded CDS Innovation Collaborative (CDSiC).[7]
[8] This article describes how patient activists have positively impacted the AHRQ CDS
initiative to advance patient-centered CDS. The patient activists developed models
for patient partnership, which have spurred continued innovation and exploration of
CDS codesign. The material presented here is based on content originally presented
as a panel by the authors at AMIA's 2021 Clinical Informatics Conference. While patient
engagement, even coproduction, in CDS may not be novel, such engagement could be more
widespread, varied, creative, and range from beginning to end of the project or product.
This includes research and artifact governance, artifact content, design, testing,
and dissemination. Engagement and coproduction are complex, not for the faint of heart,
yet doable.
Objectives
Our objective was to share approaches for patient partnership in the codesign of CDS
and to inspire developers to begin exploring relationships with patient and caregiver
communities.
Methods
Description of the Team
Potential pathways for meaningfully engaging patients and caregivers within AHRQ's
CDS program originated with two patient activists working with AHRQ and AHRQ's contractor.
One patient activist is a patient with multiple sclerosis, care partner for several
family members' end-of-life journeys, a nurse for over 40 years, an informaticist,
a quality improvement leader, a mentor to leaders and advocates, and a weekly blogger
and podcaster for more than 7 years at www.health-hats.com/pod. The other patient activist is a stakeholder inclusion consultant and cybersecurity
professional, former patient editor at The British Medical Journal, and the current
Board President of the American Living Organ Donor Fund. He is also a Patient-Centered
Outcomes Research Institute (PCORI) ambassador, a Medicine X ePatient Scholar, a member
of the Information Technology Advisory Committee of the United Network for Organ Sharing
Board of Directors, and Board Secretary of the Light Collective.
Approaches for Engaging Patient and Caregiver Communities to Inform Clinical Decision
Support Codesign
The patient activists advocated approaches that could engage patient/caregiver communities
broadly to provide suggestions and directions for codesign. These approaches and how
they were made inclusive of patients and caregiver communities are described here
and summarized in [Table 1]. Approaches took advantage of existing mechanisms and channels to which the patient
activists already had access.
Table 1
Approaches for engaging patient and caregiver communities to inform clinical decision
support codesign
|
Approach
|
Description
|
Results
|
|
Virtual focus groups
|
Engaged advocacy teams working on topics such as chronic pain management and reducing
opioid use, including a task force of the Patient Family Advisor Network
|
Enhanced training materials to help clinicians assess patient readiness for shared
decision-making and for actions potentially recommended by the CDS
|
|
Social media
|
Multiple tweets and posts on various platforms asking for feedback, suggestions, and
follow up discussion
|
Over 1,000 hits, 30 substantive comments, and 4 advisors joining CDS projects because
of outreach through social media
|
|
Agile software development
|
Assigned stories include patient activists that are also reported on during end of
cycle meetings
|
Consistent check that prioritized tasks lead to features and functionality important
to patient and caregiver perspective
|
|
Consideration of privacy and security
|
Review of materials (e.g., reports, implementation guides, Web site content, descriptions
of technical architecture, and proposed policies) to indicate attention to privacy
and cybersecurity issues that may be of concern for consumers (patients).
|
Better understanding and priority-setting for explaining the importance of and transparency
around technical and non-technical approaches for meeting these concerns, even if
technical approaches were sound
|
Abbreviation: CDS, clinical decision support.
Virtual focus groups. One of the approaches was to raise the topic of CDS in the context of a task force
of an existing Patient and Family Advisor (PFA) Network.[9] This task force, which had been meeting for 18 months, consisted of eight people
from across the country who served as patient/family advisors to inpatient and outpatient
health care institutions on issues related to chronic pain. Over the course of 3 months
and three sessions, the task force saw wireframes of a patient-facing pain management
CDS application and provided feedback about design, scope of material, choices offered,
and gaps that current technology overlooked or was unprepared to fill. One such gap
assumed that patients and clinicians had a shared understanding of “personal goals”
and the data that might fill clinician free-text fields corresponding to patient goals.
Social media. Feedback from the PFA Network focus group emphasized that pain management decisions
often depend on patient goals and priorities. While the tool under review asked about
goals, the focus group thought that people had variation in understanding of what
personal goals meant and how to formulate goals. In response, and to help the clinical
teams, the task force collaborated to develop brief instructional adjunct YouTube
videos about dealing with chronic pain and about how people might share their pain
goals with their clinical teams.[10] Similarly, invitations to provide input on the topic of patient-centered CDS took
place through social media accounts that were already established and followed by
members of the patient activist community. One tweet pointed to a web page that offered
additional information and invited people to respond and comment.
Agile software development. The agile software development (i.e., iterative and adaptive approach to project
management) took place in the context of the AHRQ CDS Connect project, which built
a web-based, prototype repository for publicly sharing interoperable CDS resources
and developed new standards-based CDS as an exemplar content for the repository.[11] The project operated on 2-week cycles and included patient activist participation
in task planning for software engineering, testing, and implementation, with decisions
documented during each 2-week cycle.
Assessment of privacy and cybersecurity. A patient activist reviewed multiple resources produced by the CDS program to assess
attention to privacy and cybersecurity as areas of particular importance to patients
and patient activists. The patient activist review was both a technical and methodological
review of how privacy and cybersecurity were described in materials such as user guides,
descriptive programmatic materials (e.g., project profiles on the internet), and material
presented at scientific conferences. The CDS artifacts produced by the CDS Connect
project met all local privacy and security requirements at pilot implementation sites.
Results
Each of the approaches for engaging patient and caregiver communities, through the
patient activists, resulted in new CDS resources, altered processes within projects,
or built new relationships that provided additional patient perspective as delineated
in [Table 1]. In the CDS Connect project, the additional interest resulted in the formation of
a patient partnership subgroup of its public clinician- and researcher-focused work
group dedicated to exploring goals, methods, and measures for partnering for the codesign
of CDS. The collective discussion and proposed materials developed in the subgroup
were summarized and shared with the larger work group for their feedback. The proposed
materials covered three domains identified as being helpful for those in CDS development
and implementation who would like to involve patients and caregivers: (1) an overview
of patient partnering, (2) lessons learned when partnering with patients and caregivers,
and (3) areas to explore to make patient and caregiver partnering more feasible as
a standard practice.
The technical review of privacy and cybersecurity did reveal varying levels of understanding
on the part of implementers using cybersecurity protocols, at least in how those protocols
were described in available materials (e.g., presentation slides). In addition, projects
could have further leveraged principles of privacy by design.
At the program level, lessons learned informed the design and creation of the new
CDSiC that will continue to advance the concept of patient-centered CDS. The lessons
learned centered on information sharing and access, as well as the recognition that
patient and caregiver perspectives can be influential at numerous points in the development
and implementation of CDS. Panelists and work group members also identified challenges
to including patient and caregiver perspectives: (1) patient/caregiver identification
across domains that are often siloed (e.g., cost, clinical evidence, and policy),
(2) the need for manageable feedback loops to continue including patient/caregiver
perspective after the initial implementation of CDS, and (3) availability of trainings,
including relationship building, for inclusion of patients and caregivers. With efforts
like the new CDSiC, these lessons and challenges will continue to be explored and
shared with the stakeholder community.
Discussion
The incorporation of patient and caregiver perspectives into the design and implementation
of CDS gives CDS the greatest potential to positively influence health, especially
in situations appropriate for SDM. This case study summarizes successful approaches
taken by patient activists to work within a federal program that is advancing patient-centered
CDS on a national scale.
Patient and caregiver engagement has been pursued by varying degrees by other initiatives,
notably by PCORI and the All of Us campaign.[12]
[13] The concept of patient-centered CDS, however, is new, and even less is known about
specific strategies tailored toward codesign of CDS.[14] There are several themes among the strategies described. One is the preference toward
iterative or sustained engagement. The iterative nature of agile software development,
for example, made multiple opportunities for engagement possible, and importantly,
the results of that engagement are visible on an ongoing basis in terms of artifacts
(e.g., software code and clinician-facing material) generated from cycle to cycle.
This led to improved training materials and improved user interfaces for clinicians
who face often difficult conversations with patients about managing their chronic
pain. Importantly, changes to the software design and/or implementation strategies
(e.g., the training materials) were documented into decision logs as sourced from
patient activist input. One noted aspect for future research is the added component
of privacy and cybersecurity in the development of CDS and engagement with patients.
Greater attention to principles of privacy by design and participation by community
stakeholders who can provide expert input on the privacy and cybersecurity components
should be considered.
Iterative, sustained processes for meaningful patient and caregiver participation
are important because progress is likely to be incremental or slow. Most health care
communities are just learning how to operationalize patient and caregiver engagement,
and the concept may be particularly foreign to information technology teams. Typical
CDS applications, for example, because they are intended for clinical applications
such as electronic health records, are designed for clinical end-users, not directly
for patients or caregivers. However, CDS intended for clinical end-users (e.g., Statin Use for the Primary Prevention of CVD in Adults: Patient-Facing CDS Intervention) may benefit the most by participatory codesign. The need for attention to patient
values, preferences, and goals may be obvious for applications clearly targeted for
patient audiences, but attention to the same values, preferences, and goals may also
be extremely important for applications designed for clinical teams.
Another theme is the recognition that all strategies are dependent upon and should
continue to build trust between clinicians, patients, and caregivers. As CDS systems
continue to grow in number (e.g., number of rules and clinical recommendations on
which they are based), complexity (e.g., artificial intelligence), and types of technologies
employed (e.g., integration with sensors and other devices), patients and caregivers
are more likely to trust those systems if partnership with patients during their design
is robust and transparent.[15] Trust was a major factor identified by patients and caregivers in the PCCDS LN.[16]
Ensuring trust, however, requires the ability to measure trust. One of our key limitations
was the lack of a published framework to measure meaningful patient and caregiver
engagement during CDS design (e.g., recognition of the need for appropriateness to
CDS for patients, but not necessarily including patients).[17] Recently, AHRQ launched the CDSiC, which has several patient activists in key roles
to advance a research agenda for measuring trust and patient-centeredness of CDS,
among other important areas in the field of CDS. If successful, the CDSiC will build
upon the approaches described here and will provide a measurement framework to study
the impact of participatory, patient-centered design of CDS. Without a framework to
measure meaningful patient/caregiver engagement, it will be difficult for researchers
and implementers to know whether the degree of partnership with patient and caregiver
communities is sufficient on a project or program level basis.[18] A framework would also help health care and CDS development teams engage patient
and caregiver networks (e.g., organized groups of advisors) or individual patients
and caregivers. Another limitation of our study was the number of patient activists
who developed and implemented the approaches taken by the federal program. Additional
experts on patient and caregiver perspective may have led to different or additional
approaches.
Developing a more profound understanding of each other's expertise, life experiences,
and contexts enabled the federal program to more meaningfully partner with patients
and caregivers. Further, learning together what worked and what did not as the partnership
grew made us better equipped to describe effective patient and caregiver partnerships
to others in our respective spheres of influence. For this we are grateful.
Clinical Relevance Statement
Clinical Relevance Statement
Exploring ways to codesign CDS with patients and caregivers has the potential for
more impactful and meaningful CDS that is sensitive to patients' and caregivers' needs,
values, and preferences.
Multiple Choice Questions
Multiple Choice Questions
-
How can relationships with patients and caregivers help frontline informaticists and
informatics leaders in their day-to-day operations?
-
Build trust and breakdown inequities
-
Support understanding and adoption of evidence-based practice
-
Foster improved workflows with enhanced relevance, findability, speed, and standards
-
All of the above
Correct Answer: The correct answer is option d. Relationships with patients and caregivers can help
frontline informaticists and informatics leaders in their day-to-day operations in
myriad ways. Building trust and breaking down inequities creates an opportunity for
successful decision-making regarding care needs (Answer A). Specifically, this trust
supports understanding and adoption of evidence-based practices, particularly in situations
such as during the COVID pandemic where evidence may be limited (Answer B). The trust
and consideration of evidence build to foster improved workflows with enhanced relevance,
findability, speed, and standards (Answer C). Ultimately, this relationship building
has several benefits to frontline stakeholders (Answer D, correct answer).
-
What is an example of a challenge to shared-decision making through health information
security such as CDS?
-
Barriers to information security and interoperability
-
Cannot be done without technology
-
No repository of evidence-based guidelines
-
Everyone wants to share decisions
Correct Answer: The correct answer is option a. SDM is never easy, but its integration into clinical
practice becomes even more challenging when technology is introduced. One challenge
is that organizations build proprietary systems, datasets, algorithms, etc., and some
organizations choose to not share data or connect their systems. This leads to patient
accessibility issues. In this same line of development, information security becomes
a barrier as well. Patients need and want to have their privacy and confidentiality
preserved and know that any shared information is secure, available, handled properly.
Information integrity is a top priority. Answers b through d are incorrect because
SDM can be successful without technology (b), there are repositories of evidence-based
guidelines available, and SDM requires a personal approach where one size may not
fit all (d).
