Table 2.

Intersection of study processes, clinical processes, and CPRS/VISTA functionality as implemented for this POCCT

RCT process	Clinical process	CPRS/VISTA functionality
Identify eligible subjects	Clinician begins to order insulin regimen for patients with diabetes	Customizable order menu displays randomization option (see figure 1)
Educating interested clinicians/patients about study	Clinician reads CPRS/VISTA study option on order menu and discusses with patient and both agree to consider enrolment	Consult sent to study nurse. Health factor created to track clinician and patient consideration
Documentation of consent/non-consent	Study nurse reviews informed consent using official, paper-based HIPAA authorization and informed consent forms	Health factors capture agreement to consent/non-consent or record review-only consent allowing electronic tracking. A progress note is added to the medical record for consented patients
Randomization	N/A	A computed finding calls the MUMPS randomization routine
Intervention	Clinician receives an alert to sign unsigned order	An order set is automatically created based on the results of the computed finding. A CPRS alert is created and sent to the clinician
Data collection	N/A	Periodic pulls from the CPRS/VISTA databases provide longitudinal data collection

CPRS, computerized patient record system; HIPAA, Health Insurance Portability and Accountability Act; POCCT, point-of-care clinical trial; VISTA, veterans health information systems and technology architecture.