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.
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
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.
- Conditions
- Head and Neck Neoplasms
- 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 group | Role | What they receive |
|---|---|---|
| Registry | Head 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.
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
Treatment - Primary Outcome
Proportion of patients that complete tumor board treatment recommendations
Measured: 5 years
Secondary outcomes (5)
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
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
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
Treatment - Secondary Outcome
Proportion of patients who complete post-treatment radiation
Measured: 6 weeks
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.
- First posted6 Jun 2018
- Study start1 Jun 2018
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Urmimala Sarkar, MD, MPH, Principal investigator, University of California, San Francisco
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT03546322
- Acronym / sponsor ID
- P30HS023558-1
- Conditions
- Head and Neck Neoplasms
- Keywords
- head and neck cancer, health information technology, patient safety, adherence, ambulatory, outpatient, human factors, vulnerable populations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Registry | – | Other: RegistryHead and neck cancer patients monitored on registry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- Patients with head and neck surgery monitored by the Otolaryngology - Head and Neck Surgery Clinic
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RegistryPatients 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. | Other | Registry |
Primary outcome
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
5 secondary outcomes
Workup and Treatment Planning - Secondary Outcome #1
Time frame: From date of diagnosis to presentation at tumor board, assessed up to 5 years
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
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
Treatment - Secondary Outcome
Time frame: 6 weeks
Loss to follow-up
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Derived from this study: PubMed 32047648Hickey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urmimala Sarkar, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
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.