Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/13/2018
Start Date:June 1, 2018
End Date:May 2023
Contact:Sarah Lisker
Email:sarah.lisker@ucsf.edu
Phone:415-206-6609

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To implement and evaluate a health information technology platform designed to support the
management of patients with head and neck cancer in an urban, publicly-funded outpatient
setting. This is an observational study; researchers will not assign specific interventions
to study participants.

The investigators aim to implement and evaluate a health information technology (HIT)
registry at an urban, public delivery system. The investigators will not assign specific
interventions to the study participants, but rather observationally assess the effect of the
HIT registry, designed to support routine medical care, on participants.

The investigators will use systems engineering methodologies to design, develop, and
implement the platform. The platform will be implemented in the Otolaryngology - Head and
Neck Surgery clinic that cares for patients with head and neck cancers. The study will assess
patient outcomes and evaluate the time it takes for patients to progress through key
treatment and post-treatment milestones before and after the HIT tool is implemented. The
investigators will use models controlling for secular trend to estimate the effect of the
tool on improving timely and successful completion of guideline-based care processes.

The HIT platform seeks to improve the monitoring and alerting functionality of existing
systems. Specifically, it replaces paper-based systems previously used by the clinic to
monitor its head and neck cancer patients. It will be implemented clinic-wide for all
patients being treated for head and neck cancers. The investigators are not assigning a
specific intervention to patients, but rather supporting the clinic and health system in the
development of a population management platform that improves routine care processes. The
platform is approved for clinical use and research by the San Francisco Health Network and
the University of California, San Francisco.

The HIT platform users are clinicians who are responsible for monitoring patients with head
and neck cancer and agree to partner with the investigators to improve monitoring processes.
The clinicians involved may be asked to voluntarily participate in surveys, interviews, focus
groups, and program evaluations. 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, and software engineers. This includes
checking that data in the platform matches source data, such as data entered in the
electronic health record. In addition, the platform users are audited on a weekly basis. A
data dictionary defining variables used in the platform exists and is updated as needed.
Patients will be added to the registry by a clinician if they are diagnosed with head and
neck cancer. 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
immediately. 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 with head and neck surgery monitored by the Otolaryngology - Head and Neck
Surgery Clinic

Exclusion Criteria:
We found this trial at
1
site
1001 Potrero Avenue
San Francisco, California 94110
Phone: 415-206-6609
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San Francisco, CA
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