Asthma Clinical Trial
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:
- 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
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