Table 2.

Possible Challenges and Solutions for Pilots for ePCT, by RAPT Domain

RAPT domain and definition	Possible challenge	Possible focus of a pilot for an ePCT
1. Implementation protocol: Is the protocol sufficiently detailed to be replicated?	Investigators may be uncertain as to how to implement an existing protocol using an embedded approach and how to measure fidelity.	Partner with HCS provider sites to test the feasibility of staff incorporating the protocol into their workflow; have supervisors review routinely captured clinical notes to ascertain fidelity to the protocol and implementation.
2. Evidence: To what extent does the evidence base support intervention’s efficacy?	At a minimum, a pilot must start with an intervention previously tested in a randomized clinical trial and be efficacious. Investigators may want to test the intervention in a new setting.	Evaluate the feasibility of conducting an ePCT by consulting with leadership and staff methods of randomization, sample size, and other design considerations.
3. Risk: Is it known how safe the intervention is?	At a minimum, an intervention’s risks must be known and low and plan to monitor risks.	Develop a plan to record and address any adverse event (e.g., if a patient falls).
4. Feasibility: To what extent can the intervention be implemented under existing conditions?	Investigators may be engaging with new partners or sites or using embedded methods for the first time.	Evaluate feasibility of the intervention when implemented by provider staff at partner sites, if and how changes in policy or practice impact implementation.
5. Measurement: To what extent can the intervention’s outcome be captured?	Administrative and clinical data may not capture outcomes of interest or be readily accessible to researchers.	Identify measures used by HCSs; examine how new measures can be integrated into routine workflow. Use mixed methods to overcome measurement limitations.
6. Cost: How likely is the intervention to be economically viable?	Prior studies may have limited data on cost-effectiveness or policies and practices that impact cost-effectiveness may have changed.	Consult with stakeholders to identify potential resource issues, including staff time for training and implementation, and derive business case for intervention.
7. Acceptability: How willing are providers to adopt the intervention?	At a minimum, an intervention must be acceptable to HCS partners. However, often acceptability is ascertained by engaging HCS leaders and not the frontline staff responsible for implementation.	Conduct qualitative interviews with provider staff responsible for implementing the intervention, supervisors, and leadership.
8. Alignment: To what extent does the intervention align with external stakeholders’ priorities?	Stakeholders may have previously stated that an intervention aligns with priorities, but priorities can change over time as new policies and practices are enacted.	Incorporate stakeholder-engaged methods to obtain ongoing input as to how intervention processes align with stakeholder values, goals, and mission.
9. Impact: How useful will the intervention’s results be to different stakeholders?	Questions about how results of the pilot study can inform care or policy.	Incorporate stakeholder-engaged methods to develop active dissemination strategies for key audiences.

Abbreviations: ePCT, embedded pragmatic clinical trial; HCS, healthcare system; RAPT, Readiness Assessment for Pragmatic Trials.