Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers
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|ClinicalTrials.gov Identifier: NCT03546322|
Recruitment Status : Active, not recruiting
First Posted : June 6, 2018
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment|
|Head and Neck Neoplasms||Other: Registry|
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||802 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||June 2024|
Head and neck cancer patients monitored on registry
Patients who are diagnosed with head and neck cancer and monitored by the Otolaryngology - Head and Neck Surgery clinic at Zuckerberg San Francisco General Hospital and Trauma Center will be included in this group. The intervention is the implementation of a registry, designed to replace existing paper-based systems for tracking patients. All head and neck cancer patients monitored by the clinic will be included.
- Workup and Treatment Planning - Primary Outcome [ Time Frame: From date of diagnosis to first date of treatment, assessed up to 5 years ]Time from diagnosis to initiation of treatment
- Treatment - Primary Outcome [ Time Frame: 5 years ]Proportion of patients that complete tumor board treatment recommendations
- Workup and Treatment Planning - Secondary Outcome #1 [ Time Frame: From date of diagnosis to presentation at tumor board, assessed up to 5 years ]Time from diagnosis to presentation at tumor board
- Workup and Treatment Planning - Secondary Outcome #2 [ Time Frame: From date of diagnosis to date of dental evaluation for patients undergoing radiation treatment, assessed up to 5 years ]Time from diagnosis to dental evaluation
- Workup and Treatment Planning - Secondary Outcome #3 [ Time Frame: From date of diagnosis to date of first visit with oncology clinic, assessed up to 5 years ]Time from diagnosis to first visit in oncology clinics
- Treatment - Secondary Outcome [ Time Frame: 6 weeks ]Proportion of patients who complete post-treatment radiation
- Loss to follow-up [ Time Frame: 5 years ]Proportion of patients who are lost to follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546322
|United States, California|
|Zuckerberg San Francisco General Hospital and Trauma Center|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Urmimala Sarkar, MD, MPH||University of California, San Francisco|