- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00365885
Showing Health Information Value in a Community Network
9 lipca 2014 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Interwencyjne
Zapisy (Rzeczywisty)
20108
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
North Carolina
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Durham, North Carolina, Stany Zjednoczone, 27710
- Duke University Medical Center
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Enrollment in the Community Care of North Carolina Medicaid program in Durham County North Carolina
Exclusion Criteria:
-
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przypisanie czynnikowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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
Inne nazwy:
|
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Eksperymentalny: 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
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
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Brak interwencji: 4
electronic mail notifications to care managers about sentinel health events -- generated but withheld
|
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Brak interwencji: 5
feedback reports with notifications to clinic managers about sentinel health events -- generated but withheld
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Brak interwencji: 6
letters to patients with notifications about sentinel health events -- generated but withheld
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Emergency department utilization rates and hospitalization rates
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
ED encounter rates for low severity conditions
Ramy czasowe: 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.
|
|
ED encounter rates for asthma
Ramy czasowe: 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
Ramy czasowe: 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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Hospitalization rates
Ramy czasowe: 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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Hospitalization rates for asthma (also PQI)
Ramy czasowe: 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)
Ramy czasowe: 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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Glycemic control (hemoglobin A1c)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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AHRQ Prevention Quality Indicators
Ramy czasowe: 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 - Asthma and diabetes
Ramy czasowe: 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
Ramy czasowe: 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 barriers to care
Ramy czasowe: 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.
|
|
Missed appointment rates
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Patient satisfaction instruments (CHAPS)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: At conclusion of study
|
At conclusion of study
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Costs of ED utilization for all causes
Ramy czasowe: 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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Costs of ED use for asthma
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: David F Lobach, MD, PhD, Duke University
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 sierpnia 2006
Zakończenie podstawowe (Rzeczywisty)
1 lipca 2008
Ukończenie studiów (Rzeczywisty)
1 sierpnia 2008
Daty rejestracji na studia
Pierwszy przesłany
16 sierpnia 2006
Pierwszy przesłany, który spełnia kryteria kontroli jakości
16 sierpnia 2006
Pierwszy wysłany (Oszacować)
18 sierpnia 2006
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
11 lipca 2014
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
9 lipca 2014
Ostatnia weryfikacja
1 grudnia 2012
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- Pro00006833
- R01HS015057 (Grant/kontrakt AHRQ w USA)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .