Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation (G2P)

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.

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Enhanced Clinic+ Unified Management Plan; Behavioral: CHW Home Visit Only; Behavioral: Enhanced Clinic+ Unified Plan + CHW

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.

• Study Type: Interventional
• Enrollment (Anticipated): 550
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enhanced Clinic+ Unified Management Plan; Patients in study arm will receive: Enhanced Clinic Intervention; Enhanced Health Plan; Unified Management Plan	Behavioral: Enhanced 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.; Other Names: -Unified Management Plan; -Enhanced Clinic Intervention
Active Comparator: CHW Home Visit Only; Patients in study arm will receive: CHW Home Visit; Usual clinic care with enhanced health plan	Behavioral: CHW 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.; Other Names: -CHW Home Visit Intervention
Active Comparator: Enhanced Clinic+ Unified Plan+ CHW; Patients in study arm will receive: CHW Home Visit; Enhanced Clinic intervention; Enhanced health plan; Unified asthma management plan	Behavioral: Enhanced 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.; Other Names: -Enhanced Clinic; -CHW Home Visits; -Unified Management plan
No Intervention: Usual Care; -Usual clinic care with enhanced healthplan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Public Health - Seattle and King County
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: James Stout, MD, University of Washington

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 14, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 8, 2015
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Asthma; Guidelines; Community Health Worker
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: AS1307-05498