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

8 mai 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

550

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Washington
      • Seattle, Washington, États-Unis, 98104
        • Public Health -- Seattle & King County

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

5 ans à 75 ans (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Enhanced Clinic+ Unified Management Plan

Patients in study arm will receive:

  • Enhanced Clinic Intervention
  • Enhanced Health Plan
  • Unified Management Plan
Comportemental: 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.
Autres noms:
  • -Unified Management Plan
  • -Enhanced Clinic Intervention
Comparateur actif: CHW Home Visit Only

Patients in study arm will receive:

  • CHW Home Visit
  • Usual clinic care with enhanced health plan
Comportemental: 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.
Autres noms:
  • -CHW Home Visit Intervention
Comparateur actif: Enhanced Clinic+ Unified Plan+ CHW

Patients in study arm will receive:

  • CHW Home Visit
  • Enhanced Clinic intervention
  • Enhanced health plan
  • Unified asthma management plan
Comportemental: 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.
Autres noms:
  • -Enhanced Clinic
  • -CHW Home Visits
  • -Unified Management plan
Aucune intervention: Usual Care
-Usual clinic care with enhanced healthplan

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Symptom free days
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

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

Measured by questionnaire:

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Public Health - Seattle and King County

Collaborateurs

Patient-Centered Outcomes Research Institute

Les enquêteurs

  • Chercheur principal: James Stout, MD, University of Washington

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2014

Achèvement primaire (Anticipé)

1 octobre 2016

Achèvement de l'étude (Anticipé)

1 octobre 2016

Dates d'inscription aux études

Première soumission

11 juillet 2014

Première soumission répondant aux critères de contrôle qualité

14 juillet 2014

Première publication (Estimation)

15 juillet 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

12 mai 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 mai 2015

Dernière vérification

1 juillet 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AS1307-05498

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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