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

27. juni 2022 opdateret af: University of California, San Francisco
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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

802

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • California
      • San Francisco, California, Forenede Stater, 94110
        • Zuckerberg San Francisco General Hospital and Trauma Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Registry
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Workup and Treatment Planning - Primary Outcome
Tidsramme: From date of diagnosis to first date of treatment, assessed up to 5 years
Time from diagnosis to initiation of treatment
From date of diagnosis to first date of treatment, assessed up to 5 years
Treatment - Primary Outcome
Tidsramme: 5 years
Proportion of patients that complete tumor board treatment recommendations
5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Workup and Treatment Planning - Secondary Outcome #1
Tidsramme: From date of diagnosis to presentation at tumor board, assessed up to 5 years
Time from diagnosis to presentation at tumor board
From date of diagnosis to presentation at tumor board, assessed up to 5 years
Workup and Treatment Planning - Secondary Outcome #2
Tidsramme: 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
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
Tidsramme: 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
From date of diagnosis to date of first visit with oncology clinic, assessed up to 5 years
Treatment - Secondary Outcome
Tidsramme: 6 weeks
Proportion of patients who complete post-treatment radiation
6 weeks
Loss to follow-up
Tidsramme: 5 years
Proportion of patients who are lost to follow-up
5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Urmimala Sarkar, MD, MPH, University of California, San Francisco

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2018

Primær færdiggørelse (Faktiske)

30. marts 2022

Studieafslutning (Faktiske)

30. marts 2022

Datoer for studieregistrering

Først indsendt

10. maj 2018

Først indsendt, der opfyldte QC-kriterier

1. juni 2018

Først opslået (Faktiske)

6. juni 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juni 2022

Sidst verificeret

1. juni 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P30HS023558-1
  • P30HS023558 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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