Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation
G2P
1 other identifier
interventional
550
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Dec 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2014
CompletedFirst Posted
Study publicly available on registry
July 15, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedMay 12, 2015
July 1, 2014
1.8 years
July 11, 2014
May 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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: * 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
12 Months
Secondary Outcomes (10)
Nocturnal wakening
12 Months
Asthma exacerbations
12 Months
Pulmonary function
12 Months
FeNO (Fractional exhaled Nitric Oxide)
12 Months
Beta-agonist use
12 Months
- +5 more secondary outcomes
Study Arms (4)
Enhanced Clinic+ Unified Management Plan
ACTIVE COMPARATORPatients in study arm will receive: * Enhanced Clinic Intervention * Enhanced Health Plan * Unified Management Plan
CHW Home Visit Only
ACTIVE COMPARATORPatients in study arm will receive: * CHW Home Visit * Usual clinic care with enhanced health plan
Enhanced Clinic+ Unified Plan+ CHW
ACTIVE COMPARATORPatients in study arm will receive: * CHW Home Visit * Enhanced Clinic intervention * Enhanced health plan * Unified asthma management plan
Usual Care
NO INTERVENTION-Usual clinic care with enhanced healthplan
Interventions
* 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.
* 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.
-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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Public Health -- Seattle & King County
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Stout, MD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2014
First Posted
July 15, 2014
Study Start
December 1, 2014
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
May 12, 2015
Record last verified: 2014-07