Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation

Asthma Clinical Trial

— G2P  

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02190617
• Other study ID #: AS1307-05498
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 11, 2014
• Last updated: May 8, 2015
• Start date: December 2014
• Est. completion date: October 2016

Study information

• Verified date: July 2014
• Source: Public Health - Seattle and King County
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 550
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Public Health -- Seattle & King County	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Public Health - Seattle and King County	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Nocturnal wakening	Measured by questionnaire: Nights wakened in the past two weeks due to asthma.	12 Months	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	Beta-agonist use	Measured by questionnaire and claims data: Days using Beta-agonist medication in past 2 weeks	12 Months	No
Secondary	Oral steroid use	Measured by questionnaire and claims data: Courses of steroids (3+ day course) in past 12 months	12 Months	No
Secondary	Controller use	Measured by claims data: Controller to total asthma medication ratio > 0.5	12 Months	No
Secondary	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	Yes
Secondary	Missed work or school days	Measured by questionnaire: Number of school or work days missed in past two weeks.	12 Months	No
Secondary	General Health Status	Measured by questionnaire: Adults: SF-12 Health Survey Children: SF -10 Health Survey	12 Months	No