Skip to main content
Clinical Trials/NCT02190617
NCT02190617
Unknown
Not Applicable

Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation

Public Health - Seattle and King County1 site in 1 country550 target enrollmentDecember 2014
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Public Health - Seattle and King County
Enrollment
550
Locations
1
Primary Endpoint
Symptom free days
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
October 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Symptom free days

Time Frame: 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.

Asthma control

Time Frame: 12 Months

Measured by questionnaire and spirometry. Asthma Control Adults: Asthma Control Test and EPR3 categories Asthma Control Children: cACT and EPR3 categories

Asthma-related Quality of Life

Time Frame: 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

Secondary Outcomes

  • Nocturnal wakening(12 Months)
  • Asthma exacerbations(12 Months)
  • Pulmonary function(12 Months)
  • Beta-agonist use(12 Months)
  • Controller use(12 Months)
  • Missed work or school days(12 Months)
  • General Health Status(12 Months)
  • FeNO (Fractional exhaled Nitric Oxide)(12 Months)
  • Asthma-related urgent health services utilization(12 Month)
  • Oral steroid use(12 Months)

Study Sites (1)

Loading locations...

Similar Trials