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

8 mei 2015 bijgewerkt door: 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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

550

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
    • Washington
      • Seattle, Washington, Verenigde Staten, 98104
        • Public Health -- Seattle & King County

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

5 jaar tot 75 jaar (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

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

  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Enhanced Clinic+ Unified Management Plan

Patients in study arm will receive:

  • Enhanced Clinic Intervention
  • Enhanced Health Plan
  • Unified Management Plan
Gedragsmatig: 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
Actieve vergelijker: CHW Home Visit Only

Patients in study arm will receive:

  • CHW Home Visit
  • Usual clinic care with enhanced health plan
Gedragsmatig: 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
Actieve vergelijker: Enhanced Clinic+ Unified Plan+ CHW

Patients in study arm will receive:

  • CHW Home Visit
  • Enhanced Clinic intervention
  • Enhanced health plan
  • Unified asthma management plan
Gedragsmatig: 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
Geen tussenkomst: Usual Care
-Usual clinic care with enhanced healthplan

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Symptom free days
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Nocturnal wakening
Tijdsspanne: 12 Months
Measured by questionnaire: Nights wakened in the past two weeks due to asthma.
12 Months
Asthma exacerbations
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 12 Months
Measured by questionnaire and claims data: Days using Beta-agonist medication in past 2 weeks
12 Months
Oral steroid use
Tijdsspanne: 12 Months
Measured by questionnaire and claims data: Courses of steroids (3+ day course) in past 12 months
12 Months
Controller use
Tijdsspanne: 12 Months
Measured by claims data: Controller to total asthma medication ratio > 0.5
12 Months
Asthma-related urgent health services utilization
Tijdsspanne: 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
Tijdsspanne: 12 Months
Measured by questionnaire: Number of school or work days missed in past two weeks.
12 Months
General Health Status
Tijdsspanne: 12 Months

Measured by questionnaire:

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

Medewerkers en onderzoekers

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

Sponsor

Public Health - Seattle and King County

Medewerkers

Patient-Centered Outcomes Research Institute

Onderzoekers

  • Hoofdonderzoeker: James Stout, MD, University of Washington

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 december 2014

Primaire voltooiing (Verwacht)

1 oktober 2016

Studie voltooiing (Verwacht)

1 oktober 2016

Studieregistratiedata

Eerst ingediend

11 juli 2014

Eerst ingediend dat voldeed aan de QC-criteria

14 juli 2014

Eerst geplaatst (Schatting)

15 juli 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

12 mei 2015

Laatste update ingediend die voldeed aan QC-criteria

8 mei 2015

Laatst geverifieerd

1 juli 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AS1307-05498

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