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

NCT03546322 | Completed

• 2 other identifiers: P30HS023558-1P30HS023558
• Study Type: observational
• Target: 802
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms

Keywords

head and neck cancer; health information technology; patient safety; adherence; ambulatory; outpatient; human factors; vulnerable populations; chronic disease

Outcome Measures

Primary Outcomes (2)

• Workup and Treatment Planning - Primary Outcome

  Time from diagnosis to initiation of treatment

  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

  5 years

Secondary Outcomes (5)

• Workup and Treatment Planning - Secondary Outcome #1

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

• Workup and Treatment Planning - Secondary Outcome #2

  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

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

• Treatment - Secondary Outcome

  6 weeks

• Loss to follow-up

  5 years

Study Arms (1)

Registry

Head and neck cancer patients monitored on registry

Other: Registry

Interventions

Registry OTHER

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.

Registry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of California, San Francisco: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

Location

Related Publications (1)

• 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.

  PMID: 32047648 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Chronic Disease

Interventions

Registries

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Urmimala Sarkar, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: June 6, 2018
• Study Start: June 1, 2018
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)