Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation

Study Overview
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Brief Summary
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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
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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.

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Enhanced Clinic+ Unified Plan + CHW
* Behavioral: Enhanced Clinic+ Unified Management Plan
* Behavioral: CHW Home Visit Only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enhanced Clinic+ Unified Management Plan<br>Patients in study arm will receive: Enhanced Clinic Intervention Enhanced Health Plan Unified Management Plan | Behavioral: Enhanced Clinic+ Unified Management Plan<br>* 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.<br>* Other names: -Enhanced Clinic Intervention;|
| Active Comparator: CHW Home Visit Only<br>Patients in study arm will receive: CHW Home Visit Usual clinic care with enhanced health plan | Behavioral: CHW Home Visit Only<br>* -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.<br>* Other names: -CHW Home Visit Intervention;|
| Active Comparator: Enhanced Clinic+ Unified Plan+ CHW<br>Patients in study arm will receive: CHW Home Visit Enhanced Clinic intervention Enhanced health plan Unified asthma management plan | Behavioral: Enhanced Clinic+ Unified Plan + CHW<br>* 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.<br>* Other names: -Unified Management plan;|
| No Intervention: Usual Care<br>-Usual clinic care with enhanced healthplan | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom free days | 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 | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturnal wakening | Measured by questionnaire: Nights wakened in the past two weeks due to asthma. | 12 Months | 
| Asthma exacerbations | 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 | 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) | 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 | Measured by questionnaire and claims data: Days using Beta-agonist medication in past 2 weeks | 12 Months | 
| Oral steroid use | Measured by questionnaire and claims data: Courses of steroids (3+ day course) in past 12 months | 12 Months | 
| Controller use | Measured by claims data: Controller to total asthma medication ratio > 0.5 | 12 Months | 
| Asthma-related urgent health services utilization | 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 | Measured by questionnaire: Number of school or work days missed in past two weeks. | 12 Months | 
| General Health Status | Measured by questionnaire: Adults: SF-12 Health Survey Children: SF -10 Health Survey | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Guidelines, Community Health Worker