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Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02190617
Acronym
G2P
Enrollment
550
Registered
2014-07-15
Start date
2014-12-31
Completion date
2016-10-31
Last updated
2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Guidelines, Community Health Worker

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.

Interventions

BEHAVIORALEnhanced 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.

BEHAVIORALEnhanced 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.

BEHAVIORALCHW 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.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Public Health - Seattle and King County
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Symptom free days12 MonthsMeasured 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 control12 MonthsMeasured by questionnaire and spirometry. Asthma Control Adults: Asthma Control Test and EPR3 categories Asthma Control Children: cACT and EPR3 categories
Asthma-related Quality of Life12 MonthsMeasured 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

MeasureTime frameDescription
FeNO (Fractional exhaled Nitric Oxide)12 MonthsMeasured by portable handheld device: Online measurement of ppb in exhaled breath at 50 L/s (\<25 ppb indicates normal value.)
Beta-agonist use12 MonthsMeasured by questionnaire and claims data: Days using Beta-agonist medication in past 2 weeks
Oral steroid use12 MonthsMeasured by questionnaire and claims data: Courses of steroids (3+ day course) in past 12 months
Nocturnal wakening12 MonthsMeasured by questionnaire: Nights wakened in the past two weeks due to asthma.
Asthma-related urgent health services utilization12 MonthMeasured by questionnaire and administrative data: Urgent clinic visits, emergency department visits, and hospitalizations during past three months and past year
Missed work or school days12 MonthsMeasured by questionnaire: Number of school or work days missed in past two weeks.
General Health Status12 MonthsMeasured by questionnaire: Adults: SF-12 Health Survey Children: SF -10 Health Survey
Controller use12 MonthsMeasured by claims data: Controller to total asthma medication ratio \> 0.5
Asthma exacerbations12 MonthsMeasured by questionnaire: Need for oral steroids (3+ day course), hospitalization, ED visit or unscheduled clinic visit for worsening asthma in past 12 months
Pulmonary function12 MonthsMeasured by spirometry: Post-bronchodilator FEV1 and FEV1 /FVC and change in pre-post bronchodilator FEV1 and FEV1 /FVC182 using EasyOne Diagnostic spirometer

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026