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Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation

Information source: Public Health - Seattle and King County
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Enhanced Clinic+ Unified Plan + CHW (Behavioral); Enhanced Clinic+ Unified Management Plan (Behavioral); CHW Home Visit Only (Behavioral)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Public Health - Seattle and King County

Official(s) and/or principal investigator(s):
James Stout, MD, Principal Investigator, Affiliation: University of Washington

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Primary outcome:

Symptom free days

Asthma control

Asthma-related Quality of Life

Secondary outcome:

Nocturnal wakening

Asthma exacerbations

Pulmonary function

FeNO (Fractional exhaled Nitric Oxide)

Beta-agonist use

Oral steroid use

Controller use

Asthma-related urgent health services utilization

Missed work or school days

General Health Status

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

Minimum age: 5 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Public Health -- Seattle & King County, Seattle, Washington 98104, United States
Additional Information

Starting date: December 2014
Last updated: May 8, 2015

Page last updated: August 23, 2015

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