Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation (G2P)

8. Mai 2015 aktualisiert von: Public Health - Seattle and King County
The primary hypothesis the investigators will test is that that improving asthma guideline implementation and providing patients with a unified asthma management plan using a multi-component and multilevel intervention will improve patient-centered asthma outcomes compared to health plan case management, passive guideline dissemination and provider education.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The study will use a factorial randomized controlled design to assess the comparative effectiveness of the following interventions among 8 community health centers and 550 patients with:

  • Health plan enhanced intervention plus traditional provider education: Health plans will enhance case management support, monitor medication fills, and increase passive guideline dissemination. Traditional provider education will consist of implementation of the PACE asthma education program. Note that all participants and clinics will receive this intervention. In effect, this will be the base active comparator arm of the study.
  • Home visit intervention: Community health workers will provide in-home tailored asthma support: assess asthma self-management knowledge and skills, conduct a home environmental assessment focused on asthma triggers, and conduct follow-up visits to support patient actions to improve asthma control based on unified asthma management plan.
  • Enhanced clinic intervention with system integration: Clinics will implement a multi-component intervention that includes decision support, audit and feedback, provider and staff education, team-based care, and training and feedback in implementing office spirometry and allergy testing. EHR enhancements and clinic systems redesign will support this work. The EHR will also provide a platform for sharing a common asthma management plan and enhancing communications among care team members (clinicians, CHWs, plan case managers).

All four intervention groups will receive enhanced health plan intervention + provider education. The four study arms will receive the following additional different interventions: (a) usual clinic care; (b) a + home visit, (c) enhanced clinic care + system integration, and (d) c + home visit.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

550

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98104
        • Public Health -- Seattle & King County

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

5 Jahre bis 75 Jahre (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Age 5-75
  • Provider-verified diagnosis of asthma
  • Have uncontrolled asthma
  • Primary language of English,Spanish or Vietnamese
  • Patient of Neighborcare or HealthPoint Health
  • Insured by Molina Healthcare or Community Health Plan of Washington

Exclusion Criteria:

  • Patient planning to leave Neighborcare or Healthpoint Health within the next 12 months
  • Household appearing to be unsafe for a visit by a community health worker
  • Co-existing medical conditions that make asthma control a low priority for patient management or that confound outcome measurement or that preclude participation in self-management
  • Participation in another asthma research study

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Enhanced Clinic+ Unified Management Plan

Patients in study arm will receive:

  • Enhanced Clinic Intervention
  • Enhanced Health Plan
  • Unified Management Plan
Verhalten: Enhanced Clinic+ Unified Management Plan
  • Unified asthma management plan and asthma support team coordination: A support team (clinicians, CHWs and plan care managers) will partner with each patient to develop a single asthma management plan. An EMR will provide a web-based platform for sharing the unified asthma management plan and enhancing communications among care team.
  • Enhanced clinic intervention: Intervention clinics will implement a multicomponent intervention that will include decision support, audit and feedback, provider and staff education, asthma champions, team-based care, and spirometry, all supported by EMR enhancements and clinic systems redesign.
Andere Namen:
  • -Unified Management Plan
  • -Enhanced Clinic Intervention
Aktiver Komparator: CHW Home Visit Only

Patients in study arm will receive:

  • CHW Home Visit
  • Usual clinic care with enhanced health plan
Verhalten: CHW Home Visit Only
-Home visit intervention: Community health workers will provide in-home tailored asthma support: assess asthma self-management knowledge and skills, conduct a home environmental assessment focused on asthma triggers, and conduct follow-up visits to support patient actions to improve asthma control based on unified asthma management plan.
Andere Namen:
  • -CHW Home Visit Intervention
Aktiver Komparator: Enhanced Clinic+ Unified Plan+ CHW

Patients in study arm will receive:

  • CHW Home Visit
  • Enhanced Clinic intervention
  • Enhanced health plan
  • Unified asthma management plan
Verhalten: Enhanced Clinic+ Unified Plan + CHW
  • Unified asthma management plan and asthma support team coordination: A support team will partner with each patient to develop a single asthma management plan. An EMR will provide a web-based platform for sharing the unified asthma management plan.
  • Home visit intervention: Community health workers will provide in-home tailored asthma support and conduct follow-up to support patient actions to improve asthma control based on unified asthma management plan.
  • Enhanced clinic intervention: Intervention clinics will implement a multicomponent intervention that will include decision support, audit and feedback, provider and staff education, asthma champions, team-based care, and spirometry, all supported by EMR enhancements and clinic systems redesign.
Andere Namen:
  • -Enhanced Clinic
  • -CHW Home Visits
  • -Unified Management plan
Kein Eingriff: Usual Care
-Usual clinic care with enhanced healthplan

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Symptom free days
Zeitfenster: 12 Months
Measured by questionnaire: Days without cough, wheeze, chest tightness, shortness of breath, nocturnal wakening from symptoms or activity limitation due to asthma in past 2 weeks.
12 Months
Asthma control
Zeitfenster: 12 Months
Measured by questionnaire and spirometry. Asthma Control Adults: Asthma Control Test and EPR3 categories Asthma Control Children: cACT and EPR3 categories
12 Months
Asthma-related Quality of Life
Zeitfenster: 12 Months

Measured by questionnaire.

Adults:

  • Mini Asthma Quality of Life Questionnaire

Children 7-17:

  • Pediatric Asthma Quality of Life Questionnaire

Children 5-6:

  • Pediatric Asthma Caregiver Quality of Life Scale
12 Months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Nocturnal wakening
Zeitfenster: 12 Months
Measured by questionnaire: Nights wakened in the past two weeks due to asthma.
12 Months
Asthma exacerbations
Zeitfenster: 12 Months
Measured by questionnaire: Need for oral steroids (3+ day course), hospitalization, ED visit or unscheduled clinic visit for worsening asthma in past 12 months
12 Months
Pulmonary function
Zeitfenster: 12 Months
Measured by spirometry: Post-bronchodilator FEV1 and FEV1 /FVC and change in pre-post bronchodilator FEV1 and FEV1 /FVC182 using EasyOne Diagnostic spirometer
12 Months
FeNO (Fractional exhaled Nitric Oxide)
Zeitfenster: 12 Months
Measured by portable handheld device: Online measurement of ppb in exhaled breath at 50 L/s (<25 ppb indicates normal value.)
12 Months
Beta-agonist use
Zeitfenster: 12 Months
Measured by questionnaire and claims data: Days using Beta-agonist medication in past 2 weeks
12 Months
Oral steroid use
Zeitfenster: 12 Months
Measured by questionnaire and claims data: Courses of steroids (3+ day course) in past 12 months
12 Months
Controller use
Zeitfenster: 12 Months
Measured by claims data: Controller to total asthma medication ratio > 0.5
12 Months
Asthma-related urgent health services utilization
Zeitfenster: 12 Month
Measured by questionnaire and administrative data: Urgent clinic visits, emergency department visits, and hospitalizations during past three months and past year
12 Month
Missed work or school days
Zeitfenster: 12 Months
Measured by questionnaire: Number of school or work days missed in past two weeks.
12 Months
General Health Status
Zeitfenster: 12 Months

Measured by questionnaire:

Adults: SF-12 Health Survey Children: SF -10 Health Survey
12 Months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Public Health - Seattle and King County

Mitarbeiter

Patient-Centered Outcomes Research Institute

Ermittler

  • Hauptermittler: James Stout, MD, University of Washington

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Dezember 2014

Primärer Abschluss (Voraussichtlich)

1. Oktober 2016

Studienabschluss (Voraussichtlich)

1. Oktober 2016

Studienanmeldedaten

Zuerst eingereicht

11. Juli 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Juli 2014

Zuerst gepostet (Schätzen)

15. Juli 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

12. Mai 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Mai 2015

Zuletzt verifiziert

1. Juli 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • AS1307-05498

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Asthma

Klinische Studien zur Enhanced Clinic+ Unified Management Plan

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Cote d'Ivoire

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren