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Table 2 Stakeholder questions for designing provider-focused trials to match the overall purpose and intent of the trial

From: Designing provider-focused implementation trials with purpose and intent: introducing the PRECIS-2-PS tool

Stakeholder group

Questions

Research team

• What is the current evidence base for various provider-focused strategies? What still needs to be tested?

• How many organizations (e.g., clinics, hospitals) are needed to be adequately powered to answer the primary research question? What is the likelihood that some clinics may drop out or close down and additional clinics could be recruited into the trial?

• What type of RCT (e.g., cluster, stepped-wedge) is optimal for answering the research question(s)?

• What analytic approach is best-equipped to answer the research question? What back-up approaches are feasible yet still rigorous if critical aspects of the trial (e.g., sample size of organizations, provider turnover) unexpectedly change during the trial?

Healthcare professionals

• What topic areas are most important to healthcare professionals within the context of service provision, scope of work, and patients’ needs?

• What provider-focused strategies might be most effective and feasible given competing demands or intractable barriers that significantly constrict practice change?

• What outcomes are most important to healthcare professionals within the context of their needs, patients’ needs, and professional standards?

• What types of patient-focused interventions are healthcare professionals most interested in implementing or de-implementing?

• What elements of the local environment (e.g., context) will be important to incorporate into trial design?

• How are healthcare professionals supported in making changes to care delivery?

Information technology and/or monitoring and surveillance experts and systems

• What type of information technology systems or monitoring and surveillance models are currently available (e.g., vendor for electronic health records, digital dashboard designs)?

• What changes to the information technology system or monitoring and surveillance model might be possible during and/or after the trial (e.g., order sets, shared decision-making tool, audit and feedback options)?

Quality improvement managers, technical assistance teams

• What resources are currently used to support implementation-as-usual?

• Could the proposed provider-focused strategies be packaged and delivered by quality improvement managers or technical assistance teams (or other support, funding, or change management entities; e.g., technical assistance services offered by professional associations or public health agencies) during and/or after the trial? If not, who else could deliver the strategies (e.g., develop and continually update implementation toolkits, host trainings, provide external coaching)?

Healthcare delivery system leaders, public health directors

• Are the proposed provider-focused strategies feasible and acceptable?

• For healthcare systems, what is the anticipated return-on-investment for delivering strategies and the downstream impact on patient outcomes relative to other potential sources of revenue, accreditation, or requirements for healthcare reimbursement?

• For public health systems, can these strategies be applied to implement or de-implement additional or alternative health practices as disease topics or community health needs change over time?

• If needed, would additional resources be made available to scale and sustain the provider-focused strategies after the trial?

  1. *All stakeholders would discuss and agree on the overall purpose and intent of the trial. Subsequent discussions and decision-making for all PRECIS-2-PS domains would be consistent with the overall purpose and intent of the trial along the explanatory-pragmatic continuum