Key concepts and background

As one moves from governance to the actual integration of ePROs into clinical practice, there are specific guidelines and steps to take to achieve integration. In this section, we focus on the unique considerations that we believe are important for successfully integrating ePROs into clinical care. The guidelines in this section assume that organization-wide activities, such as ePRO governance and culture-building efforts, are already underway within your health system. For further information, refer to the Governance section.

Although this section will provide some basic introduction to the concepts of workflow design and modeling, change management, and implementation, for more in-depth information on these concepts, please refer to the Tools and Resources section. The guidelines proposed in this section draw from current evidence and real-world learnings from implementing ePROs across diverse settings.

The intersection of workflow and health information technology

Introducing the implementation of new technology into a healthcare setting is difficult and requires significant workflow planning and redesign to be successful. The amount of workflow redesign required will depend on the existing processes and the context where care is provided (i.e., the current state), including workflow, staffing, physical environment, and organizational culture.

For the purposes of this section, we define integration as the broad goal of incorporating ePROs into clinical care. An ePRO implementation can be considered the set of processes a team undertakes to integrate ePROs within a specific setting. Lastly, we define workflow as the repeatable patterns of activities that enable the use of ePROs in practice.

Designing workflows to support scale

The ongoing work conducted in healthcare settings depends on complex systems of people, processes, facilities, and technology. Scaling new tools across healthcare environments can exacerbate complexity and highlight broader challenges around balancing customization with standardization. When integrating ePROs into clinical care, one must appreciate that the current web of patient care and management processes is a complex adaptive system that is constantly changing in response to the broader environment and actions of individuals within it. Viewing ePRO integration from a complex systems perspective is important for ensuring ePRO workflows and implementation processes have the flexibility to respond to this dynamic, emergent environment.

There are a number of approaches to designing and modeling workflows for health information technology (HIT) implementation, and this section will remain agnostic to any particular recommendation for how project teams should proceed. Instead, we have utilized Structured Analysis and Design Technique (SADT) to present the common components that translate across ePRO workflows in different clinical settings.

Briefly, SADT is one approach to workflow modeling based in systems engineering that examines commonalities across diverse workflows for the same process (Marca & McGowan, 1988; Multic et al, 2020; IEEE Computer Society, 1998). The strategy used to construct SADT models is hierarchical aggregation and decomposition. Aggregation is used to hide details and complexity; decomposition reveals lower-level component processes. In this way, you can examine the complete workflow at the level of detail most appropriate for the questions or designs to be addressed. Figure 3A shows the template for SADT modeling, which includes the core workflow activity (or function to be accomplished) and the associated inputs, outputs, controls, and mechanisms that influence how that step is completed. The benefit of SADT models is that they identify the common workflow components that must be in every implementation, creating a workflow blueprint that individual settings can then customize for their unique environment. For a health system, this can be particularly valuable as the SADT model provides a template that can aid governance and leadership teams in comparing complex workflows across individual clinical sites.

In this section’s guidelines, we will present workflow recommendations that draw from an SADT model developed for ePRO implementation. Note that it is not necessary for readers to understand how to develop SADT models; the ePRO model we present can be used as a template to support the design and customization of workflows within your setting. If you are interested in learning more about the SADT modeling method, please refer to Workflow Recommended Resources in the Tools and Resources section.

Managing implementation in practice

Every health IT project starts with a project implementation plan organized as a sequence of project phases or stages. Commonly accepted project implementation phases include plan, design, develop, implement, and sustain (see Figure 3B) (Canada Health Infoway, 2013). Your organization may define these phases differently, so we recommend you align with the current practice within your organization.

As part of the implementation process, project teams should establish a detailed project plan, utilize evidence-based implementation methods whenever possible, and engage in change management throughout the implementation process.

It is also important to acknowledge that ePRO tool implementation should bring together a variety of different disciplines, including clinical, IT and informatics, health system administrators, staff, and patients. These stakeholders may not all use the same language for how they approach concepts around functionality, workflow, and care delivery experience, so project leaders may need to establish common understanding.

Change management

When introducing ePROs to a clinical setting, the impact of the associated changes on the organization and the work and people involved must be considered. Change management is a necessary component of any HIT initiative. Any changes to existing processes in health systems necessarily entail a need to understand organizational culture and climate, resistance to change, and change management. The practice of change management (Kotter & Cohen, 2002; Cohen, 2005) focuses on:

• engaging the right people to lead change  
• explicitly communicating the objectives of the changes
• adequately planning and organizing the sequences of activities involved
• mobilizing leadership to support the change process

Evaluating implementation process and effectiveness

Managing the implementation process can often involve efforts to identify, diagnose, and address implementation barriers that influence user adoption of new practices. There are many evidence-based methods and tools that can guide implementation planning, facilitation, monitoring, and evaluation.  Some examples from both healthcare practice and research include:

• Lean Management, a set of performance improvement tools which can guide teams in optimizing complex workflows to enhance system performance (What is LEAN? [Lean Enterprise Institute] nd)
• IHI Model for Improvement, which can guide teams in accelerating improvements via facilitating change on a small scale using Plan-Do-Study-Act cycles (Improving Health and Healthcare Worldwide [Institute for Healthcare Improvement] nd)
• Proctor’s Outcomes for Implementation Research Model, which can provide a framework for aligning outcomes across implementation process, care delivery, and patient experience (Proctor et al, 2011)
• Consolidated Framework for Implementation Research (CFIR) Framework, which can guide identification of implementation factors that impact adoption and outcomes (Damschroder et al, 2009)
• Non-adoption, Abandonment, Scale-up, Spread, Sustainability (NASSS) framework, which can guide teams in diagnosing and addressing challenges with non-adoption, abandonment, and sustainability of new HIT interventions (Greenhalgh et al, 2017)

The approach your team takes will depend on the prior experience and culture of your organization and goals for ePRO use, however we recommend leveraging existing evidence-based practice in implementation facilitation and evaluation whenever feasible.

Please visit Recommended Resources in the Tools and Resources section for more resources related to Change Management, Workflow, and Implementation and Evaluation.

The Integration Guidelines: What to Expect

This section provides direction and information on the design and implementation of ePRO tools used in clinical practice. These guidelines cover recommendations to support the nuances of ePRO implementation throughout the phases of implementation planning, design, execution, and sustainment.

The first guideline focuses on understanding how PROM data will be used at the point of care, recognizing that there are many different use cases and applications of PROMs to clinical decisions. The next three guidelines advise on workflow, technology, and user engagement strategies to support ePRO use in practice. The last guideline of the section provides recommendations to sustain ePRO use via continuous learning. It is essential to understand that:

• The sequence in which you undertake the outlined steps may shift, depending on your practice context (e.g., size, type, budgets, and deadlines).
• These guidelines are organized in a temporal sequence, but some of the activities may overlap or occur simultaneously.
• You may need to use these guidelines in concert with your health system’s internal policies, procedures, and guides.
• This chapter will address some broad principles that will apply across different settings, acknowledging that nuances will exist for different environments.

In addition to the references cited throughout this section, we have provided an additional Supplemental Bibliography of resources that informed this work and may be useful to readers.