Title: Comparative Effectiveness of Asthma Interventions Within an AHRQ PBRN
19 kwietnia 2022 zaktualizowane przez: Wake Forest University Health Sciences
Accelerating Implementation of Comparative Effectiveness Findings on Clinical and Delivery Systems by Leveraging AHRQ Networks
The overall goal is to identify best practices for improving health outcomes for patients with asthma using comparative effectiveness research within an Agency for Healthcare Research and Quality (AHRQ) Practice-Based Research Network (PBRN).
This goal will be achieved by completing the following aims: (1) Create a centralized database for comparative effectiveness research on asthma by combining clinical and billing data from one of the largest healthcare systems in the country (Carolinas Healthcare System) with data from the school system, Medicaid, and patient and community-level datasets; (2) Deploy a fully developed integrated approach to asthma management based on the Chronic Care Model; (3) Develop and implement a "shared decision making" approach for asthmatic patients from disadvantaged backgrounds; (4) Implement an electronic data collection system for an existing CDC funded school-based asthma intervention that will allow program evaluation and link school nurses with providers; (5) Evaluate and compare the effectiveness of these three asthma management strategies on: overall healthcare consumption and medical costs; quality of life, school absenteeism and performance; asthma clinical measures; and medication utilization; and (6) Disseminate findings across the state via the statewide PBRN and other network partners.
This project has the potential to impact over 30,000 asthma patients across the Carolinas including many patients from disadvantaged backgrounds.
Przegląd badań
Status
Zakończony
Warunki
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
1040
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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North Carolina
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Charlotte, North Carolina, Stany Zjednoczone, 28207
- Department of Family Medicine
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Charlotte, North Carolina, Stany Zjednoczone, 28207
- CMC Elizabeth Family Medicine
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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
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
all with asthma diagnosis
Exclusion Criteria:
none
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: Badania usług zdrowotnych
- Przydział: Nielosowe
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Komparator placebo: Group A - Usual Care Controls
Group A will consist of 20 primary care clinics who are part of the Carolinas Healthcare System network but have not yet adopted the Electronic Medical Record System.
These practices do use the same billing databases as the remaining clinics, allowing easy identification of asthma patients and their health services utilization patterns.
Data from the billing systems will be used to retrospectively populate a database for these clinics from January 2009 forward.
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No EMR
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Aktywny komparator: Group B - EMR Control Practices
There are currently 65 primary care practices within the Carolinas Healthcare System network that have electronic medical record with decision support (EAP)access at baseline.
These practices will serve as a second level of control for comparison with the intervention groups.
Each of these practices is currently using Cerner PowerChart and at the start of the study and will have access to the asthma decision support tools; an electronically generated Asthma Action Plan (AAP); and a built-in system of population management reports which will be pushed to the practices on an on-going basis to help in patient recall and management.
The EAP approach to care has been developed with input from clinicians, hospital administrators, hospital information services personnel, and Cerner consultants.
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Decision Support, Asthma Action Plans, and Population Management Reporting (EAP)
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Aktywny komparator: C Integrated Approach to Care
There are 10 practices within the Carolinas Healthcare System (CHS) network that have already received additional training for improving outcomes for patients with chronic diseases termed the Integrated Approach to Care (IAC).
This IAC approach developed by CHS is based on the Chronic Care Model (CCM).
The IAC approach includes a heavy emphasis on the use of health information technology that practices receive during the initial EAP rollout.
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Patients within the IAC group will also receive their own copy of an asthma action plan to allow for some degree of self-management support.
In addition, IAC practices receive assistance from a practice coach trained in practice redesign and rapid cycle process improvement.
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Aktywny komparator: Group D - Shared Decision Making (SDM)
This approach has great potential for improved patient outcomes and provides an additional step in the successful implementation of patient self-management.
The research team will develop the SDM intervention during the first 6 months of the study.
In particular, the Shared decision making (SDM) intervention will be designed to be deployed within the 4 large clinics that care for the majority of the community's underserved and disadvantaged patients.
The SDM intervention development will be overseen by the study advisory board and actively recruit providers from within the clinics for feedback about the intervention.
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The research team will develop the SDM intervention during the first 6 months of the study.
The team will model this intervention on the randomized control trial performed by Dr. Sandra Wilson and colleagues within the Kaiser Permanente Clinics in California and Oregon
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Aktywny komparator: School Based Care (SBC)
Activities included: spending individual time with students to assess, treat, and monitor and to educate students in proper asthma management; facilitate access to health care and medicine; and communicate with parents.
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the research team will start an electronic data capture system linking school data and the clinical EMR (Cerner Power Chart) that will be implemented over the first year.
Flow of data between schools and the hospital system will allow the children who have a regular source of care as well as those without a medical home to be treated with a unified asthma program by the school nurse and the hospital system.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Reducing Hospitalizations and Emergency Department Visits
Ramy czasowe: 2011-2013
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Quality goals will be measured by the percentage of patients who reach the goal out of all patients identified with the disease through healthcare system data.
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2011-2013
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Improving Adherence to Medication
Ramy czasowe: 2011-2013
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Quality goals will be measured by the percentage of patients who reach the goal out of all patients identified with the disease.
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2011-2013
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Improve Quality of Life
Ramy czasowe: 2011-2013
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Measured via Survey
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2011-2013
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Reduced School Absenteeism
Ramy czasowe: 2011-2013
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measured with school absenteeism data
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2011-2013
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Improved Self-Efficacy
Ramy czasowe: 2011-2013
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survey
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2011-2013
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Improved School Performance
Ramy czasowe: 2011-2013
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measured by yearly end of grade results
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2011-2013
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Michael F Dulin, MD, PhD, Wake Forest University Health Sciences
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 marca 2011
Zakończenie podstawowe (Rzeczywisty)
1 sierpnia 2017
Ukończenie studiów (Rzeczywisty)
1 sierpnia 2017
Daty rejestracji na studia
Pierwszy przesłany
19 stycznia 2011
Pierwszy przesłany, który spełnia kryteria kontroli jakości
19 stycznia 2011
Pierwszy wysłany (Oszacować)
20 stycznia 2011
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
25 kwietnia 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
19 kwietnia 2022
Ostatnia weryfikacja
1 lutego 2018
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HS10-014
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 .