Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion:
Urmimala Sarkar

Description

Summary

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.

Details

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.

Keywords

Head and Neck Neoplasms head and neck cancer health information technology patient safety adherence ambulatory outpatient human factors vulnerable populations chronic disease Registry

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients with head and neck surgery monitored by the Otolaryngology - Head and Neck Surgery Clinic

You CAN'T join if...

Location

  • Zuckerberg San Francisco General Hospital and Trauma Center accepting new patients
    San Francisco California 94110 United States

Lead Scientist

  • Urmimala Sarkar
    Urmimala Sarkar MD, MPH is Associate Professor of Medicine at UCSF in the Division of General Internal Medicine, Associate Director of the UCSF Center for Vulnerable Populations, and a primary care physician at Zuckerberg San Francisco General Hospital’s Richard H. Fine People's Clinic. Dr. Sarkar’s research focuses on innovating for health equity.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03546322
Study Type
Observational [Patient Registry]
Last Updated