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Population-Based Patient-Centric Care: Comprehensive Preventive Cancer Screening Using Health IT (TopCare)

2. oktober 2014 oppdatert av: Steven Atlas, Massachusetts General Hospital

Technology for Optimizing Population Care in a Resource-limited Environment

Although there is considerable evidence that current health IT can improve certain elements of care, the most effective and efficient implementation of health IT systems for primary care population management are not currently known. Indeed, while many systems currently take a "case-management" approach to identify and address clinical care issues for high risk patients, no systems to our knowledge apply a risk-based approach that accounts both for adverse clinical outcome risk (e.g. breast cancer in a woman who has not had indicated screening for 4 years) and for clinical process risk (e.g. the likelihood that a specific patient will ignore a reminder letter and would therefore benefit from direct phone or in person contact). The investigators propose to directly test the hypothesis that implementing a health IT platform that 1) provides novel risk-based decision support using data derived from the electronic health record (EHR) and 2) leverages each clinician's unique knowledge of his or her patient panel will result in more effective and more efficient population-based primary care. The investigators will test this hypothesis in a practice-randomized clinical trial of preventive cancer screening within our primary care Practice-Based Research Network (PBRN).

Studieoversikt

Detaljert beskrivelse

In prior NIH-funded research, the investigators have demonstrated the efficacy of an IT-based population management system to improve breast cancer screening (NCI R21 CA121908). The investigators will expand our current IT platform from this single function (breast cancer screening) to a package of cancer prevention actions (breast, cervical, and colorectal cancer screening) and examine the added benefit of population-level preventive cancer care that is directed by specific clinician knowledge of individual patient needs. Moreover, rather than compare our system to currently sub-optimal "usual care" practice, our goal is to test whether the impact of our intervention exceeds the current state-of-the-art of IT-based population management. Therefore, control group practices will receive augmented standard care defined as a population-level reminder system with automated patient contacts.

In augmented standard care control practices, the investigators will implement a system that includes: 1) a population-based perspective to identify all eligible patients overdue for screening, 2) an automated, centralized process to contact selected patients by letter, 3) a result management system that automatically tracks test scheduling and completion, 4) a web-based, easily accessible tool allowing practice personnel to contact patients not completing testing, and 5) use of patient navigators for high risk patients not responding to initial outreach. In the control arm, the process of escalating the reminder intervention from a letter, to contact by phone call, to a patient navigator, will occur in a standard algorithmic fashion without provider input. While not yet the standard of care nationwide, prior studies have proven the efficacy of such an approach. In intervention practices, the investigators will enhance augmented standard care by implementing a novel system that will enable physicians and clinical population managers to individualize care for each patient in their panel using tools to classify and organize patients by their clinical attributes. The investigators hypothesize that this personalized identification of patients by both their clinical outcome and clinical process risk status will improve the efficacy and efficiency of resource allocation decisions. The key additions to the health IT system for intervention practices will be: 1) a clinical systems IT platform to organize and present clinical data for each clinician's patient panel, 2) an accessible Web-based tool allowing clinicians (physicians and clinical population managers) to view, organize, and investigate their patient panels, and 3) a simple process where the clinician can make a tailored screening decision and designate the method of clinical intervention based upon the patient's risk profile.

Studietype

Intervensjonell

Registrering (Faktiske)

103870

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Breast cancer: Women 42-74 years old
  • Cervical cancer: Women 21-65 years old
  • Colorectal cancer: Women and men 52-75 years old

Exclusion Criteria:

  • Breast cancer: History of bilateral mastectomy in their EHR
  • Cervical cancer: History of total hysterectomy in their EHR
  • Colorectal cancer: History of total colectomy in their EHR

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: TopCare Intervention

The TOP-CARE intervention will be based on a medical informatics platform that:

  1. Identifies all patients eligible for any of the three cancer screening programs
  2. Links patients with a specific clinician
  3. Offers a visit-independent method for clinicians to review panels of their eligible patients
  4. For patients due for one or more cancer screenings, clinicians will access a web-based informatics tool to:

    1. Screen their panel based upon risk
    2. Defer patients, document exclusions, and update the EHR
    3. Order a screening test with patient information material based upon the patient's risk profile and automatically initiate the process of:

      1. Informing the patient by letter of the need to schedule a test, educating the patient with respect to the benefits of cancer screening, and properly documenting the transaction in the patient's EHR, or
      2. Referral to a patient navigator for patients most likely to benefit from this more intensive approach
We will be evaluating the system in practices where providers are involved in determining to contact a patient, including the most appropriate outreach method, compared with practices where the system is fully automated without provider input.
Aktiv komparator: Augmented Standard Care
In augmented standard care control practices, we will implement a system that includes: 1) a population-based perspective to identify all eligible patients overdue for screening, 2) an automated, centralized process to contact selected patients by letter, 3) a result management system that automatically tracks test scheduling and completion, 4) a web-based, easily accessible tool allowing practice personnel to contact patients not completing testing, and 5) use of patient navigators for high risk patients not responding to initial outreach. In the control arm, the process of escalating the reminder intervention from a letter, to contact by phone call, to a patient navigator, will occur in a standard algorithmic fashion without provider input.
We will be evaluating the system in practices where providers are involved in determining to contact a patient, including the most appropriate outreach method, compared with practices where the system is fully automated without provider input.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cancer completion for all eligible cancers
Tidsramme: 1 year
Average cancer screening test completion rate over the 1-year follow-up period for each eligible patient in all eligible cancers (breast, cervical, colorectal)
1 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
% of patients completing all eligible cancer screenings
Tidsramme: 1 year
Percentage of patients completing all eligible cancer screening modalities at 1-year follow-up will be compared between study arms
1 year
Primary outcome in specified patient subgroups
Tidsramme: 1 year
  1. Eligible population: prevalent (overdue at baseline) or incident (become overdue during study) cancer screening rates will be compared between study arms.
  2. Patient-physician linkage status: Analyses will be stratified to compare PCP-linked patients between study arms and practice-linked patients between study arms.
  3. Patient risk status: Patients at high risk for not completing screening will be compared between study arms.
1 year
TopCare system measures (intervention practices)
Tidsramme: 1 year
  1. Percentage of providers (PCPs and clinical population managers) in intervention practices using TOP-CARE system and percentage of eligible patients in clinician panel screened
  2. Percentage of providers (practice personnel and patient navigators) in intervention and control practices using TOP-CARE system and percentage of eligible patients assigned to provider who were contacted
  3. Percentage of eligible patients in clinician (PCP and clinical population manager) panel deferred and reasons selected
1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2011

Primær fullføring (Faktiske)

1. juni 2012

Studiet fullført (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først innsendt

10. juni 2011

Først innsendt som oppfylte QC-kriteriene

13. juni 2011

Først lagt ut (Anslag)

14. juni 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

3. oktober 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. oktober 2014

Sist bekreftet

1. oktober 2014

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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