At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, a team of experts shared key decisions about whether or not to integrate digital tools into the electronic health record (EHR). The panel, moderated by Steve George of the NIH Collaboratory Coordinating Center, explained that the decision hinges on 4 critical factors: complexity, institutional governance, requirements for integration, and involvement of personnel.

Complexity

Complexity depends on the number of participating systems, the type of healthcare systems (such as private clinics, federally qualified health centers, and academic medical centers), and the number of EHR vendors involved. Complexity is also driven by the level of integration required: sending a result or message is fairly easy, while embedding a decision support application within a screen is more difficult.

For more, see the Living Textbook chapter on Intervention Delivery and Complexity.

Institutional Governance

Institutional governance varies by health system. There may be single or multiple review committees, long wait times for implementation and deployment, or multiple levels of approval needed (including corporate and C-suite), all of which can impact possible EHR integration and timelines.

Requirements for Integration

Panelists suggested that investigators weigh whether the trial or intervention requires EHR integration for meaningful results or if integration would just be nice to have. If EHR integration is required, are there pieces that could be removed or deferred if implementation timelines are delayed?

Involvement of Personnel

Finally, the panelists suggested that researchers should be prepared to account for the human factors that affect intervention uptake, fidelity, and sustainability.

Key Questions

• If the intervention requires someone to push a button or click on something, does that role or person exist at each institution?
• Has there been buy-in from sites to assess whether the intervention is compatible with clinical workflows to ensure fidelity?
• What types of updates or modifications are necessary over time? Will sites need to do additional work after the initial implementation? If so, are there plans for handling site IT staff turnover?

The panelists included Keith Marsolo, chair of the EHR Core, Mike Ho, co–principal investigator (PI) for Nudge, Andrea Cheville, PI for NOHARM, and Michele Balas, co-PI for BEST-ICU.

This summer, we are sharing highlights from the 2025 Annual Steering Committee Meeting. Access the complete collection of meeting materials.