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Title: Comparative Effectiveness of Asthma Interventions Within an AHRQ PBRN

19 april 2022 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1040

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • North Carolina
      • Charlotte, North Carolina, Verenigde Staten, 28207
        • Department of Family Medicine
      • Charlotte, North Carolina, Verenigde Staten, 28207
        • CMC Elizabeth Family Medicine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

all with asthma diagnosis

Exclusion Criteria:

none

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: 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.
Ander: usual care
No EMR
Actieve vergelijker: 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.
Gedragsmatig: electronic medical record
Decision Support, Asthma Action Plans, and Population Management Reporting (EAP)
Actieve vergelijker: 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.
Ander: Integrated Approach to Care
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.
Actieve vergelijker: 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.
Ander: Shared Decision Making
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
Actieve vergelijker: 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.
Ander: school based care
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Reducing Hospitalizations and Emergency Department Visits
Tijdsspanne: 2011-2013
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.
2011-2013

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Improving Adherence to Medication
Tijdsspanne: 2011-2013
Quality goals will be measured by the percentage of patients who reach the goal out of all patients identified with the disease.
2011-2013
Improve Quality of Life
Tijdsspanne: 2011-2013
Measured via Survey
2011-2013
Reduced School Absenteeism
Tijdsspanne: 2011-2013
measured with school absenteeism data
2011-2013
Improved Self-Efficacy
Tijdsspanne: 2011-2013
survey
2011-2013
Improved School Performance
Tijdsspanne: 2011-2013
measured by yearly end of grade results
2011-2013

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Wake Forest University Health Sciences

Onderzoekers

  • Hoofdonderzoeker: Michael F Dulin, MD, PhD, Wake Forest University Health Sciences

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2011

Primaire voltooiing (Werkelijk)

1 augustus 2017

Studie voltooiing (Werkelijk)

1 augustus 2017

Studieregistratiedata

Eerst ingediend

19 januari 2011

Eerst ingediend dat voldeed aan de QC-criteria

19 januari 2011

Eerst geplaatst (Schatting)

20 januari 2011

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 april 2022

Laatste update ingediend die voldeed aan QC-criteria

19 april 2022

Laatst geverifieerd

1 februari 2018

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HS10-014

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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