A guide to research partnerships for pragmatic clinical trials

Build partnerships

Several of the demonstration trial partnerships began with prior studies, ranging from feasibility studies to full trials that needed to be translated to new settings. In the US, researchers and healthcare organization collaborators connect through varied mechanisms including consortia such as the HMO Research Network or the Clinical and Translational Science Awards Consortium supported by the National Institutes of Health. Other countries and regions may have similar structures for fostering collaboration, such as the Academic Health Science Networks or the Collaborations for Leadership in Applied Health Research and Care in the UK.

A challenge to collaboration is that researchers and healthcare system representatives must understand and respect each others’ needs, objectives, and work culture. Interviewees said that the healthcare organization should have a culture that values research, measurement, and evidence, while researchers must understand healthcare system priorities and processes.12 For example, in the REDUCE MRSA trial, the collaborators had shared interests in preventing healthcare associated infections but needed to develop mechanisms to work together to design an effective trial. These mechanisms included Hospital Corporation of America developing a team for research and academic affairs to work with other external partners. This team meets regularly to evaluate progress on current research but also to evaluate and design new studies of mutual interest. This relationship then fostered additional studies such as the ABATE Infection trial (table 1⇑). Collaborators who are “boundary spanners” with both research and clinical experience are valuable because they facilitate the communication between researchers and clinical partners that is necessary for conducting a pragmatic trial and translating its results to usual care.13 14 The next step is defining the research questions that drive the study.

Select the research topic

Pragmatic trials answer questions that are relevant to patients, providers, and healthcare organizations.2 Questions might originate from academia, delivery systems, professional organizations, patient-clinician alliances, the public health community, or the general public. The National Institute for Health Research and the James Lind Alliance in the UK both offer mechanisms for prioritizing research that is most wanted by patients. The research topic for several of the Health Care Systems Collaboratory demonstration projects arose from discussions with healthcare system managers. For example, the PPACT study (table 1⇑) emerged from what seemed like an intractable problem to patients, clinicians, and researchers about how to control chronic pain.

Assess feasibility

To be feasible, pragmatic trials must potentially add value to the healthcare system. Without this element, researchers are unlikely to receive the necessary clinical and operational commitment for the study. Therefore, research topics should fit a healthcare system’s need for (1) results that decision makers might use to improve care and patient outcomes, (2) integration with clinic workflow, (3) relatively low entry costs, and (4) positive, or at least little negative, impact on productivity and the healthcare system’s finances. Not all trials will meet all criteria. A limitation is that some trials must substantially disrupt clinical workflow; however, these trials can be feasible with effective joint planning and a potentially large clinical payoff. For example, in the REDUCE MRSA trial, the practical experience of the academic investigators as medical directors of infection prevention programs and the health system quality improvement experience of the Hospital Corporation of America co-investigators enabled the creation of functional and efficient changes to workflow to implement either targeted or universal decolonization that were not only acceptable by management and clinicians but were used for enduring implementation and dissemination after the trial results were known. Pragmatic trials must watch for conflicts with delivery system quality improvement projects. For example, for a demonstration trial embedded in a delivery system that was transitioning to a new electronic health record, researchers and delivery system representatives cooperated to limit changes in the electronic health record that might affect the study.

Pilot phases are particularly important to understand the best study process, resources, and management to move work into everyday workflow.15 All of the Collaboratory demonstration projects were funded as pilots in order to assess feasibility of full implementation. Even for previously successful research partnerships, an objective pre-assessment of the healthcare system’s capabilities for the proposed study is essential. Critical questions include:

• Are sufficient patient numbers and data available for the analysis?

• Can data be collected at all clinical sites?

• How do the sites vary in services and capabilities?

• Can the system’s regulatory and administrative infrastructure support approval and oversight by ethics committees and review boards?

• Will the intervention add long-term value to the system?

If the pre-assessment process reveals a poor fit between a healthcare system and a planned study, the system cannot participate, although researchers can maintain relationships with its management for future studies and dissemination.

Involve stakeholders in design

A successful pragmatic clinical trial requires engagement and input from all levels of a healthcare system. Pragmatic trials give clinical staff a professional development opportunity to practice research skills and participate in quality improvements.16 17 However, clear communication between researchers and clinical personnel about processes, expectations, and roles and goals is essential (table 2⇓), since the collaboration is often a new experience for all parties. All collaborators should acknowledge competing priorities and differences in work culture.18 For example, researchers may discount the ongoing quality improvement work in healthcare systems as not rigorous, while frontline clinicians may perceive research as slow, expensive, inflexible, or not clinically relevant. As described earlier, the REDUCE MRSA trial developed a successful trial by working closely with staff who were already designated as quality improvement champions about how to implement and monitor the protocol. Weekly steering committee and analytic calls were used to maintain communication across multiple stakeholders.

Getting the attention of busy managers is challenging, especially before funding is assured. Researchers approaching healthcare organization managers to propose research embedded in clinical practice should highlight advantages such as the potential for gains in patient outcomes, staff efficiency, or health information technology (IT) improvements, along with congruence with other organization-wide priorities. After getting leadership buy-in, interviewees recommended networking to find people throughout the organization with the knowledge, interest, and authority to contribute to the study, as well as the time to maintain regular contact with researchers.

Researchers we interviewed stated that clinical staff, healthcare system managers, and researchers need to work together to optimize design and implementation of the study protocol. This is especially important during design and piloting. Staff and managers know how to best use existing health IT, workflow, clinical procedures, and local champions to make study participation easier for clinical staff. For example, based on provider input, one demonstration project moved data collection from a study website to an existing clinical system, another changed an intervention from group to individual therapy, and a third shifted implementation responsibilities from doctors to pharmacists.

Research teams may also need to involve clinical managers and frontline staff to identify additional costs of the study. These might include wear and tear on medical devices, use of additional supplies and services, time and effort to collect additional data, or the need for additional staff or providers. In the UK, for example, clear demarcation and calculation of which costs are the responsibility of the researcher and which are the responsibility of the healthcare service are standard parts of grant applications to national funders. In countries with multiple payers, operational staff can prevent double billing and advise research teams about sustainability, such as who will pay for intervention costs when the trial ends.

Health IT staff are increasingly crucial to pragmatic trials because of the growing use of electronic health records in research. In our experience, many studies experienced challenges making additions or alterations to the electronic health record. These were resolved either by consulting with clinical IT staff or by changing study plans.

Implement the study into workflow

To facilitate study implementation by clinical staff, trial procedures should mimic normal clinical practices and use existing resources as much as possible. Because pragmatic clinical trials occur in the context of dynamic real-world care, researchers need to be prepared to adapt studies based on stakeholder input or changes in the care environment. Ideally this happens during a pilot phase but likely will continue even as the study is under way. Flexibility in adapting to specific clinical situations will improve study protocol compliance by clinicians and facilitate the long term sustainability of tested interventions.

Planning for sustainability from the beginning of a study lays a foundation for implementing and spreading successful changes, including establishing a sustainable funding model.14 A limitation of research embedded in practice is that researchers must consider how to remove or adapt an intervention if data indicate that it is not effective. This part of the study is facilitated by communicating tailored results to all groups involved in the study, including patients and their families.