Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation
- Conditions
- Asthma
- Interventions
- Behavioral: CHW Home Visit OnlyBehavioral: Enhanced Clinic+ Unified Plan + CHWBehavioral: Enhanced Clinic+ Unified Management Plan
- Registration Number
- NCT02190617
- Lead Sponsor
- Public Health - Seattle and King County
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 550
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description CHW Home Visit Only CHW Home Visit Only Patients in study arm will receive: * CHW Home Visit * Usual clinic care with enhanced health plan Enhanced Clinic+ Unified Plan+ CHW Enhanced Clinic+ Unified Plan + CHW Patients in study arm will receive: * CHW Home Visit * Enhanced Clinic intervention * Enhanced health plan * Unified asthma management plan Enhanced Clinic+ Unified Management Plan Enhanced Clinic+ Unified Management Plan Patients in study arm will receive: * Enhanced Clinic Intervention * Enhanced Health Plan * Unified Management Plan
- Primary Outcome Measures
Name Time Method Symptom free days 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 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 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 Outcome Measures
Name Time Method Nocturnal wakening 12 Months Measured by questionnaire: Nights wakened in the past two weeks due to asthma.
Asthma exacerbations 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
Pulmonary function 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
Beta-agonist use 12 Months Measured by questionnaire and claims data: Days using Beta-agonist medication in past 2 weeks
Controller use 12 Months Measured by claims data: Controller to total asthma medication ratio \> 0.5
Missed work or school days 12 Months Measured by questionnaire: Number of school or work days missed in past two weeks.
General Health Status 12 Months Measured by questionnaire:
Adults: SF-12 Health Survey Children: SF -10 Health SurveyFeNO (Fractional exhaled Nitric Oxide) 12 Months Measured by portable handheld device: Online measurement of ppb in exhaled breath at 50 L/s (\<25 ppb indicates normal value.)
Asthma-related urgent health services utilization 12 Month Measured by questionnaire and administrative data: Urgent clinic visits, emergency department visits, and hospitalizations during past three months and past year
Oral steroid use 12 Months Measured by questionnaire and claims data: Courses of steroids (3+ day course) in past 12 months
Trial Locations
- Locations (1)
Public Health -- Seattle & King County
🇺🇸Seattle, Washington, United States