- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00365885
Showing Health Information Value in a Community Network
9. července 2014 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
20108
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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North Carolina
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Durham, North Carolina, Spojené státy, 27710
- Duke University Medical Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Enrollment in the Community Care of North Carolina Medicaid program in Durham County North Carolina
Exclusion Criteria:
-
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 1
electronic mail notifications to care 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
Ostatní jména:
|
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Experimentální: 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
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
|
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Žádný zásah: 4
electronic mail notifications to care managers about sentinel health events -- generated but withheld
|
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Žádný zásah: 5
feedback reports with notifications to clinic managers about sentinel health events -- generated but withheld
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Žádný zásah: 6
letters to patients with notifications about sentinel health events -- generated but withheld
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Emergency department utilization rates and hospitalization rates
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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ED encounter rates for low severity conditions
Časové okno: 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 encounter rates for asthma
Časové okno: 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 encounter rates for diabetes
Časové okno: 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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Hospitalization rates
Časové okno: 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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Hospitalization rates for asthma (also PQI)
Časové okno: 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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Hospitalization rates for diabetes (also PQI)
Časové okno: 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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Glycemic control (hemoglobin A1c)
Časové okno: 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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Medication contraindications
Časové okno: 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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HEDIS - Preventive services
Časové okno: 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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HEDIS - # WCC visits
Časové okno: 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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AHRQ Prevention Quality Indicators
Časové okno: 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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HEDIS - Asthma and diabetes
Časové okno: 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 health risks
Časové okno: 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
Časové okno: 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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Missed appointment rates
Časové okno: 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 appointment rates
Časové okno: 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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F/U rates post-partum
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: At conclusion of study
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At conclusion of study
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Costs of ED utilization for all causes
Časové okno: 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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Costs of ED use for asthma
Časové okno: 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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Costs of ED use for diabetes
Časové okno: 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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Costs of ED use for low severity visits
Časové okno: 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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Hospitalization costs for all causes
Časové okno: 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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Hospitalization costs for asthma
Časové okno: 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.
|
|
Hospitalization costs for diabetes
Časové okno: 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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Reimbursement for labs+other ancillary services
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: David F Lobach, MD, PhD, Duke University
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. srpna 2006
Primární dokončení (Aktuální)
1. července 2008
Dokončení studie (Aktuální)
1. srpna 2008
Termíny zápisu do studia
První předloženo
16. srpna 2006
První předloženo, které splnilo kritéria kontroly kvality
16. srpna 2006
První zveřejněno (Odhad)
18. srpna 2006
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
11. července 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. července 2014
Naposledy ověřeno
1. prosince 2012
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- Pro00006833
- R01HS015057 (Grant/smlouva AHRQ USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .