- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00365885
Showing Health Information Value in a Community Network
9. Juli 2014 aktualisiert von: Duke University
The purpose of this study is to determine the value of shared health information on care quality and costs when this information is used to notify care providers about concerning health events for patients cared for by a community-based network of providers.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Project Abstract This three-year project will assess the costs and benefits of health information technology (HIT) in an established community-wide network of academic, private and public healthcare facilities created to share clinical information for the purpose of population-based care management of over 16,000 Medicaid beneficiaries in Durham County, North Carolina.
The area of interest for this project is the impact of information-driven interventions on care quality, patient safety and healthcare costs across the diverse stakeholders participating in this collaborative partnership.
In order to asses HIT value rigorously in the context of a production information system that is under continual development, we propose to conduct a randomized controlled trial.
Specifically, we will randomly assign patients by family unit to either a control group or to an intervention group in which they will initially receive one of 3 information-driven interventions.
The interventions include clinical alerts sent to care providers, performance feedback reports presented to clinic managers, and care reminders sent directly to patients.
The content of the interventions will address "concerning" events (e.g., an emergency room encounter for asthma) and care deficiencies (e.g., delinquency on biannual mammogram) identified from the composite set of clinical data in our information system.
To assess the benefits and burdens of the interventions, combinations of the 3 interventions will be sequentially introduced into the study groups over the course of the project.
The analysis will compare groups receiving various combinations of interventions as well as those receiving no interventions.
At baseline and at six-month intervals throughout the course of the study, we will measure emergency department encounter rates, hospitalization rates, HEDIS (Healthcare Effectiveness Data and Information Set) scores, missed appointment rates, glycated hemoglobin levels in diabetics, and patient satisfaction.
Our assessment will look at the societal value of HIT as well as the value for individual stakeholders including patients, providers, payers, purchasers and policy makers.
From these measures, we will assess the costs and benefits of this community-wide effort to promote interoperability of clinical data exchange in order to increase the understanding of HIT value in a community setting.
In our preliminary studies, we have observed a statistically significant 3-fold reduction in repeat ED (Emergency Department) encounter rates using email alerts alone.
The approach used in this project is able to be generalized across geographic areas and healthcare settings and can, therefore, serve to promote the dissemination of HIT to other communities.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
20108
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
North Carolina
-
Durham, North Carolina, Vereinigte Staaten, 27710
- Duke University Medical Center
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Enrollment in the Community Care of North Carolina Medicaid program in Durham County North Carolina
Exclusion Criteria:
-
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Fakultätszuweisung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 1
electronic mail notifications to care managers about sentinel health events
|
computer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients
Andere Namen:
|
Experimental: 2
feedback reports with notifications to clinic managers about sentinel health events
|
computer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients
Andere Namen:
|
Experimental: 3
letters to patients with notifications about sentinel health events
|
computer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients
Andere Namen:
|
Kein Eingriff: 4
electronic mail notifications to care managers about sentinel health events -- generated but withheld
|
|
Kein Eingriff: 5
feedback reports with notifications to clinic managers about sentinel health events -- generated but withheld
|
|
Kein Eingriff: 6
letters to patients with notifications about sentinel health events -- generated but withheld
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Emergency department utilization rates and hospitalization rates
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
ED encounter rates for low severity conditions
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
ED encounter rates for asthma
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
ED encounter rates for diabetes
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Hospitalization rates
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Hospitalization rates for asthma (also PQI)
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Hospitalization rates for diabetes (also PQI)
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Glycemic control (hemoglobin A1c)
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Medication contraindications
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
HEDIS - Preventive services
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
HEDIS - # WCC visits
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
AHRQ Prevention Quality Indicators
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
HEDIS - Asthma and diabetes
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
# of messages triggered for health risks
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
# of messages triggered for barriers to care
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Missed appointment rates
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Primary care appointment rates
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
F/U rates post-partum
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Patient satisfaction instruments (CHAPS)
Zeitfenster: at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
|
at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
|
EuroQoL
Zeitfenster: at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
|
at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
|
Provider opinion surveys
Zeitfenster: At conclusion of study
|
At conclusion of study
|
Costs of ED utilization for all causes
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Costs of ED use for asthma
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Costs of ED use for diabetes
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Costs of ED use for low severity visits
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Hospitalization costs for all causes
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Hospitalization costs for asthma
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Hospitalization costs for diabetes
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Reimbursement for labs+other ancillary services
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Primary care reimbursement
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
ED rates for recurrent ED encounters
Zeitfenster: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: David F Lobach, MD, PhD, Duke University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. August 2006
Primärer Abschluss (Tatsächlich)
1. Juli 2008
Studienabschluss (Tatsächlich)
1. August 2008
Studienanmeldedaten
Zuerst eingereicht
16. August 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
16. August 2006
Zuerst gepostet (Schätzen)
18. August 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
11. Juli 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Juli 2014
Zuletzt verifiziert
1. Dezember 2012
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- Pro00006833
- R01HS015057 (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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