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Head and Neck NeoplasmsNCT03546322

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

An observational study of Head and Neck Neoplasms, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Neoplasms
What is being tested?
Registry
How many people
802 participants
Where
1 siteUnited States
Study dates
1 Jun 2018to 30 Mar 2022
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Zuckerberg San Francisco General Hospital and Trauma Center

    San Francisco, California, 94110

Other trials in United States

About this study

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.

Read the 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.

Being tested
Registry
Keywords
head and neck cancer, health information technology, patient safety, adherence, ambulatory, outpatient, human factors, vulnerable populations, chronic disease
Medical subject headings
Head and Neck Neoplasms, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RegistryOther

    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.

Study groups in NCT03546322
Study groupRoleWhat they receive
RegistryHead and neck cancer patients monitored on registry
Receives: Other: Registry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Workup and Treatment Planning - Primary Outcome

    Time from diagnosis to initiation of treatment

    Measured: From date of diagnosis to first date of treatment, assessed up to 5 years

  2. Treatment - Primary Outcome

    Proportion of patients that complete tumor board treatment recommendations

    Measured: 5 years

Secondary outcomes (5)
  1. Workup and Treatment Planning - Secondary Outcome #1

    Time from diagnosis to presentation at tumor board

    Measured: From date of diagnosis to presentation at tumor board, assessed up to 5 years

  2. Workup and Treatment Planning - Secondary Outcome #2

    Time from diagnosis to dental evaluation

    Measured: From date of diagnosis to date of dental evaluation for patients undergoing radiation treatment, assessed up to 5 years

  3. Workup and Treatment Planning - Secondary Outcome #3

    Time from diagnosis to first visit in oncology clinics

    Measured: From date of diagnosis to date of first visit with oncology clinic, assessed up to 5 years

  4. Treatment - Secondary Outcome

    Proportion of patients who complete post-treatment radiation

    Measured: 6 weeks

  5. Loss to follow-up

    Proportion of patients who are lost to follow-up

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2018
  2. Study start1 Jun 2018
  3. Primary completion30 Mar 2022
  4. Study completion30 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
802 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03546322
Sponsor's protocol ID
P30HS023558-1
Other IDs
P30HS023558
Status last verified
Jun 2022
First submitted
10 May 2018
Last updated
1 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hickey MD, Lisker S, Brodie S, Vittinghoff E, Russell MD, Sarkar U. Customized registry tool for tracking adherence to clinical guidelines for head and neck cancers: protocol for a pilot study. Pilot Feasibility Stud. 2020 Feb 7;6:16. doi: 10.1186/s40814-020-0552-0. eCollection 2020.

    PubMed 32047648

Questions about this trial

What is this clinical trial studying?

An observational study of Head and Neck Neoplasms, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Workup and Treatment Planning - Primary Outcome (time frame: From date of diagnosis to first date of treatment, assessed up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03546322, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.

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