- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00365885
Showing Health Information Value in a Community Network
9 luglio 2014 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
20108
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke University Medical Center
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Enrollment in the Community Care of North Carolina Medicaid program in Durham County North Carolina
Exclusion Criteria:
-
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
Altri nomi:
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Sperimentale: 2
feedback reports with notifications to clinic managers about sentinel health events
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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
Altri nomi:
|
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Sperimentale: 3
letters to patients with notifications about sentinel health events
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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
Altri nomi:
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Nessun intervento: 4
electronic mail notifications to care managers about sentinel health events -- generated but withheld
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Nessun intervento: 5
feedback reports with notifications to clinic managers about sentinel health events -- generated but withheld
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Nessun intervento: 6
letters to patients with notifications about sentinel health events -- generated but withheld
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Emergency department utilization rates and hospitalization rates
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
ED encounter rates for low severity conditions
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.
|
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Medication contraindications
Lasso di tempo: 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.
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HEDIS - Preventive services
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
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# of messages triggered for health risks
Lasso di tempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
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# of messages triggered for barriers to care
Lasso di tempo: 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
Lasso di tempo: 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.
|
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Primary care appointment rates
Lasso di tempo: 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.
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F/U rates post-partum
Lasso di tempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
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Patient satisfaction instruments (CHAPS)
Lasso di tempo: 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.
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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.
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EuroQoL
Lasso di tempo: 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.
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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.
|
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Provider opinion surveys
Lasso di tempo: At conclusion of study
|
At conclusion of study
|
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Costs of ED utilization for all causes
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
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Reimbursement for labs+other ancillary services
Lasso di tempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
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Primary care reimbursement
Lasso di tempo: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
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ED rates for recurrent ED encounters
Lasso di tempo: 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.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: David F Lobach, MD, PhD, Duke University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2006
Completamento primario (Effettivo)
1 luglio 2008
Completamento dello studio (Effettivo)
1 agosto 2008
Date di iscrizione allo studio
Primo inviato
16 agosto 2006
Primo inviato che soddisfa i criteri di controllo qualità
16 agosto 2006
Primo Inserito (Stima)
18 agosto 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
11 luglio 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 luglio 2014
Ultimo verificato
1 dicembre 2012
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- Pro00006833
- R01HS015057 (Sovvenzione/contratto AHRQ degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .