- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01372527
Population-Based Patient-Centric Care: Comprehensive Preventive Cancer Screening Using Health IT (TopCare)
Technology for Optimizing Population Care in a Resource-limited Environment
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02114
- Massachusetts General Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: TopCare Intervention
The TOP-CARE intervention will be based on a medical informatics platform that:
|
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.
|
Aktiver 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Cancer completion for all eligible cancers
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
% of patients completing all eligible cancer screenings
Zeitfenster: 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
Zeitfenster: 1 year
|
|
1 year
|
TopCare system measures (intervention practices)
Zeitfenster: 1 year
|
|
1 year
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Atlas SJ, Zai AH, Ashburner JM, Chang Y, Percac-Lima S, Levy DE, Chueh HC, Grant RW. Non-visit-based cancer screening using a novel population management system. J Am Board Fam Med. 2014 Jul-Aug;27(4):474-85. doi: 10.3122/jabfm.2014.04.130319.
- Zai AH, Kim S, Kamis A, Hung K, Ronquillo JG, Chueh HC, Atlas SJ. Applying operations research to optimize a novel population management system for cancer screening. J Am Med Inform Assoc. 2014 Feb;21(e1):e129-35. doi: 10.1136/amiajnl-2013-001681. Epub 2013 Sep 16.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Uterusneoplasmen
- Genitale Neubildungen, weiblich
- Gebärmutterhalskrankheiten
- Uteruserkrankungen
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Darmerkrankungen
- Darmerkrankungen
- Darmtumoren
- Rektale Erkrankungen
- Gebärmutterhalstumoren
- Kolorektale Neubildungen
Andere Studien-ID-Nummern
- R18HS018161 (US-AHRQ-Zuschuss/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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