Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation (G2P)
8 maj 2015 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
550
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Washington
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Seattle, Washington, Förenta staterna, 98104
- Public Health -- Seattle & King County
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
5 år till 75 år (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Enhanced Clinic+ Unified Management Plan
Patients in study arm will receive:
|
Andra namn:
|
|
Aktiv komparator: CHW Home Visit Only
Patients in study arm will receive:
|
-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.
Andra namn:
|
|
Aktiv komparator: Enhanced Clinic+ Unified Plan+ CHW
Patients in study arm will receive:
|
Andra namn:
|
|
Inget ingripande: Usual Care
-Usual clinic care with enhanced healthplan
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Symptom free days
Tidsram: 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
Tidsram: 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
Tidsram: 12 Months
|
Measured by questionnaire. Adults:
Children 7-17:
Children 5-6:
|
12 Months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Nocturnal wakening
Tidsram: 12 Months
|
Measured by questionnaire: Nights wakened in the past two weeks due to asthma.
|
12 Months
|
|
Asthma exacerbations
Tidsram: 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
Tidsram: 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
|
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FeNO (Fractional exhaled Nitric Oxide)
Tidsram: 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
Tidsram: 12 Months
|
Measured by questionnaire and claims data: Days using Beta-agonist medication in past 2 weeks
|
12 Months
|
|
Oral steroid use
Tidsram: 12 Months
|
Measured by questionnaire and claims data: Courses of steroids (3+ day course) in past 12 months
|
12 Months
|
|
Controller use
Tidsram: 12 Months
|
Measured by claims data: Controller to total asthma medication ratio > 0.5
|
12 Months
|
|
Asthma-related urgent health services utilization
Tidsram: 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
Tidsram: 12 Months
|
Measured by questionnaire: Number of school or work days missed in past two weeks.
|
12 Months
|
|
General Health Status
Tidsram: 12 Months
|
Measured by questionnaire: Adults: SF-12 Health Survey Children: SF -10 Health Survey |
12 Months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: James Stout, MD, University of Washington
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2014
Primärt slutförande (Förväntat)
1 oktober 2016
Avslutad studie (Förväntat)
1 oktober 2016
Studieregistreringsdatum
Först inskickad
11 juli 2014
Först inskickad som uppfyllde QC-kriterierna
14 juli 2014
Första postat (Uppskatta)
15 juli 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
12 maj 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 maj 2015
Senast verifierad
1 juli 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AS1307-05498
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .