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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Clinic+ Unified Management Plan | Active Comparator | Patients in study arm will receive:
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| CHW Home Visit Only | Active Comparator | Patients in study arm will receive:
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| Enhanced Clinic+ Unified Plan+ CHW | Active Comparator | Patients in study arm will receive:
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| Usual Care | No Intervention | -Usual clinic care with enhanced healthplan |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Clinic+ Unified Plan + CHW | Behavioral |
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| 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:
Children 7-17:
Children 5-6:
| 12 Months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Stout, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health -- Seattle & King County | Seattle | Washington | 98104 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Enhanced Clinic+ Unified Management Plan | Behavioral |
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| CHW Home Visit Only | Behavioral | -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. |
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| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |