Table 2

 Typical roles and goals of healthcare system participants in pragmatic clinical trials

ParticipantsRolesGoalsOther considerations
Frontline clinical staffHelp formulate and carry out study protocolAdd study to workflow while maintaining high-quality patient care. Produce evidence to improve patient care and clinical decision makingStaff should be engaged without interrupting their work and should receive tailored reports on study progress and findings
Leadership (senior management)Promote and support study throughout the delivery systemValue: better patient outcomes, cost effectiveness, efficiencyIdeally, support is at all levels, but buy-in from top leaders is critical
Business operationsEnsure study integration with HCS billingCompliance with regulations, avoid revenue lossThis factor is typically complex due to local variations
IT staffAdapt EHR for study protocol and data collection; advise on feasibility of protocol; maintain functionality beyond the studyEHR and patient portal features that patients and clinicians useIT staff, in particular, often have competing demands and resource limits
Operational managersTranslate study objectives into clinical workflow changesEnsure study success with minimal clinical disruptionThe research team must be flexible and realize that local considerations for this group include patient outcomes
Clinic championsLiaison between HCS and researchersIntegration and sustainability of study interventionChampions should have local credibility and be rewarded and recognized, especially for improving patient outcomes
ResearcherPropose, design, and adapt study for HCS. Translate clinical issues into researchable questions.Answer research questions and positively impact public healthExpect the unexpected and be prepared to be flexible and to learn.

HCS=healthcare system. IT=information technology. EHR=electronic health record.