Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation

NCT ID: NCT02190617

Last Updated: 2015-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

NONE

Study Groups

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Enhanced Clinic+ Unified Management Plan

Patients in study arm will receive:

* Enhanced Clinic Intervention
* Enhanced Health Plan
* Unified Management Plan

Group Type ACTIVE_COMPARATOR

Enhanced Clinic+ Unified Management Plan

Intervention Type BEHAVIORAL

* 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

Patients in study arm will receive:

* CHW Home Visit
* Usual clinic care with enhanced health plan

Group Type ACTIVE_COMPARATOR

CHW Home Visit Only

Intervention Type BEHAVIORAL

-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+ Unified Plan+ CHW

Patients in study arm will receive:

* CHW Home Visit
* Enhanced Clinic intervention
* Enhanced health plan
* Unified asthma management plan

Group Type ACTIVE_COMPARATOR

Enhanced Clinic+ Unified Plan + CHW

Intervention Type BEHAVIORAL

* 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.

Usual Care

-Usual clinic care with enhanced healthplan

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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-Enhanced Clinic -CHW Home Visits -Unified Management plan -Unified Management Plan -Enhanced Clinic Intervention -CHW Home Visit Intervention

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Public Health - Seattle and King County

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Stout, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Public Health -- Seattle & King County

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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AS1307-05498

Identifier Type: -

Identifier Source: org_study_id

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