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

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ClinicalTrials.gov Identifier: NCT03546322
Recruitment Status : Recruiting
First Posted : June 5, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Urmimala Sarkar, University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment
Head and Neck Neoplasms Other: Registry

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
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 : May 2019
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Registry
Head and neck cancer patients monitored on registry
Other: 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.




Primary Outcome Measures :
  1. 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

  2. Treatment - Primary Outcome [ Time Frame: 5 years ]
    Proportion of patients that complete tumor board treatment recommendations


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Treatment - Secondary Outcome [ Time Frame: 6 weeks ]
    Proportion of patients who complete post-treatment radiation

  5. Loss to follow-up [ Time Frame: 5 years ]
    Proportion of patients who are lost to follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with head and neck cancer monitored by the Otolaryngology - Head and Neck Surgery clinic at the Zuckerberg San Francisco General Hospital and Trauma Center
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

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


Contacts
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Contact: Sarah Lisker 415-206-6609 sarah.lisker@ucsf.edu
Contact: Urmimala Sarkar, MD, MPH 415-206-4273 urmimala.sarkar@ucsf.edu

Locations
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United States, California
Zuckerberg San Francisco General Hospital and Trauma Center Recruiting
San Francisco, California, United States, 94110
Contact: Sarah Lisker    415-206-6609    sarah.lisker@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Urmimala Sarkar, MD, MPH University of California, San Francisco

Additional Information:

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Responsible Party: Urmimala Sarkar, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03546322     History of Changes
Other Study ID Numbers: P30HS023558-1
P30HS023558 ( U.S. NIH Grant/Contract )
First Posted: June 5, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Urmimala Sarkar, University of California, San Francisco:
head and neck cancer
health information technology
patient safety
adherence
ambulatory
outpatient
human factors
vulnerable populations
chronic disease

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms