The benefits of eSource, where trial data remains electronic from start through data lock, are well understood. They include the elimination of transcription errors (shown by Nham et al to be 10x more accurate), reduction in duplicitous effort, reduced monitoring requirements and easier query resolution.
With clinic EHR adoption nearing 90%, digital datapoints should be easy to come by and eSource should be a step away, so why haven’t trials swiftly transitioned to eSource? Barriers to eSource are more complex to understand than its benefits. They can be considered in three categories.
- Behavior change. eSource requires digital data entry at the bedside, often through a tablet. Some clinics resist adding a tablet to their workflow. This can be through technophobia, but more often its because some other tablet activity is already required for the clinic’s EHR system, and this creates a duplicate task.
- Technical barriers. Integration with the clinics’ EHR systems could make eSource easy, trouble is in a 20-site study a sponsor might need to integrate ten different EHR systems. Even where integration is technically possible, getting site IT participation within a set startup timeline is unlikely. This problem compounds when histories from referring clinics are required.
- Policy Barriers. Assuming technical integration is overcome, a sponsor may encounter different EHR record release policies across the 20 site studies such as:
• No releases allowed (only transcription with over-the-shoulder verification permitted)
• Only redacted paper records allowed for release
• Limited onsite login access permitted
• Remote login access permitted
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Since each site in this study will surface at least one of these three barriers, what are sites doing today to get around them? Sites turn to paper “shadow charts,” where printed versions of EHR records, emails and digital faxes act as ways to assemble a record that would normally be fragmented across different data sources or locked behind a policy-restricted EHR.
In fact, of the 100+ sites Florence Healthcare interviewed in 2014, over 90% have used paper copies of EHR systems to create duplicate, paper-based source records of digital charts in order to get past the barriers mentioned above. This stops eSource in its tracks
So what’s to be done? One approach could be to require behavior change, create technical integrations and create policy change.
Another is to bring paper shadow charts into a digital workflow.
Digitizing shadow charts is easier than you might think. Most shadow charts are printed from a digital source, and that same printing step can be replaced with a digital step. This avoids barrier #1, the behavior change barrier. Further, this approach sidesteps the integration and policy barriers, too. Users create and manage individual documents rather than relying on weighty integrations, and release policies align with those long established in the paper world.
Florence Healthcare has built the world’s best system for moving past Paper Shadow Charts and creating a bridge to eSource.
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