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

8. maj 2015 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

550

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Public Health -- Seattle & King County

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

5 år til 75 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Enhanced Clinic+ Unified Management Plan

Patients in study arm will receive:

  • Enhanced Clinic Intervention
  • Enhanced Health Plan
  • Unified Management Plan
Adfærdsmæssigt: 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.
Andre navne:
  • -Unified Management Plan
  • -Enhanced Clinic Intervention
Aktiv komparator: CHW Home Visit Only

Patients in study arm will receive:

  • CHW Home Visit
  • Usual clinic care with enhanced health plan
Adfærdsmæssigt: 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.
Andre navne:
  • -CHW Home Visit Intervention
Aktiv 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
Adfærdsmæssigt: 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.
Andre navne:
  • -Enhanced Clinic
  • -CHW Home Visits
  • -Unified Management plan
Ingen indgriben: Usual Care
-Usual clinic care with enhanced healthplan

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Symptom free days
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Measured by questionnaire:

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Public Health - Seattle and King County

Samarbejdspartnere

Patient-Centered Outcomes Research Institute

Efterforskere

  • Ledende efterforsker: James Stout, MD, University of Washington

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2014

Primær færdiggørelse (Forventet)

1. oktober 2016

Studieafslutning (Forventet)

1. oktober 2016

Datoer for studieregistrering

Først indsendt

11. juli 2014

Først indsendt, der opfyldte QC-kriterier

14. juli 2014

Først opslået (Skøn)

15. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2015

Sidst verificeret

1. juli 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AS1307-05498

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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