Clinical trial NCT02190617: Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Asthma
Guidelines
Community Health Worker
Lead sponsor: Public Health - Seattle and King County
Sponsor class: OTHER_GOV
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-07-15
Enrollment: 550
Sex: ALL
Minimum age (years): 5
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptom free days
timeFrame: 12 Months
measure: Asthma control
timeFrame: 12 Months
measure: Asthma-related Quality of Life
timeFrame: 12 Months
Secondary outcomes:
measure: Nocturnal wakening
timeFrame: 12 Months
measure: Asthma exacerbations
timeFrame: 12 Months
measure: Pulmonary function
timeFrame: 12 Months
measure: FeNO (Fractional exhaled Nitric Oxide)
timeFrame: 12 Months
measure: Beta-agonist use
timeFrame: 12 Months
measure: Oral steroid use
timeFrame: 12 Months
measure: Controller use
timeFrame: 12 Months
measure: Asthma-related urgent health services utilization
timeFrame: 12 Month
measure: Missed work or school days
timeFrame: 12 Months
measure: General Health Status
timeFrame: 12 Months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Public Health -- Seattle & King County
state: Washington
Study officials:
affiliation: University of Washington
name: James Stout, MD
role: PRINCIPAL_INVESTIGATOR
References: