An Electronic Registry to Improve Adherence to Active Surveillance Monitoring at a Safety-net Hospital

We aim to implement and evaluate a health information technology (HIT) registry at an urban,
public delivery system. We will use systems engineering methodologies to design, develop, and
implement the platform. The platform will be implemented in the Urology clinic that cares for
patients with prostate cancer. We are conducting a prospective non-randomized pilot study
that will follow men who choose active surveillance as a management strategy for prostate
cancer. We aim to assess the impact of the HIT registry on patient monitoring and adherence.

The HIT platform seeks to improve the monitoring and alerting functionality of existing
systems. Specifically, it replaces paper-based or ineffective computer-based systems
previously used by the clinic to monitor its active surveillance patients. It will be
implemented clinic-wide for all patients being monitored by an active surveillance protocol.
The platform is approved for clinical use and research by the San Francisco Health Network
and the University of California, San Francisco.

Research involves materials that are collected for nonresearch purposes, as well as low-risk
research employing survey, interview, focus group, program evaluation, and human factors
methodologies. We will solicit structured feedback from registry users designed to
continuously evaluate and improve performance in a clinical area to reduce patient safety
gaps. Patient medical records will be reviewed, but patients monitored on the registry will
not be contacted by researchers.

Procedures are in place to monitor the registry. First, quality assurance is performed by the
research team, information technology analysts in the San Francisco Health Network, as well
as by the third-party software provider. This includes checking that data in the platform
matches source data, such as data entered in the electronic health record. In addition, users
are audited on a weekly basis. A data dictionary defining variables used in the platform
exists and is updated as needed. The HIT platform users include clinicians who are
responsible for monitoring patients on active surveillance for prostate cancer. Patients who
are enrolled in the active surveillance program will be added to the registry by a clinician.
The research team will support the clinicians in data analysis, although this will be
performed with population-level, de-identified data. However, if unmediated adverse events
are identified by the research team, the research team will alert the clinicians
appropriately. The research team will also develop training materials and conduct training
sessions to ensure that all clinicians responsible for monitoring patients on active
surveillance are provided with up-to-date resources and accessible support. The HIT platform
is designed to supplement, but not replace, the existing electronic health record. Data on
the registry will be validated with source data and users will still engage with the source
data and electronic health record as appropriate clinically and operationally.

Inclusion Criteria:

- Patients who elect to be managed by Active Surveillance for prostate cancer by the
Urology Clinic

Exclusion Criteria: