AsthmaG2PNCT02190617
Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation
A study testing Enhanced Clinic+ Unified Plan + CHW, Enhanced Clinic+ Unified Management Plan and CHW Home Visit Only in people with Asthma, run by Public Health - Seattle and King County at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 5 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Enhanced Clinic+ Unified Plan + CHW, Enhanced Clinic+ Unified Management Plan and CHW Home Visit Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Public Health -- Seattle & King County
Seattle, Washington, 98104
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Enhanced Clinic+ Unified Plan + CHW, Enhanced Clinic+ Unified Management Plan, CHW Home Visit Only
- Keywords
- Asthma, Guidelines, Community Health Worker
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Clinic+ Unified Plan + CHWBehavioural
Also called -Enhanced Clinic, -CHW Home Visits, -Unified Management plan
- 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 PlanBehavioural
Also called -Unified Management Plan, -Enhanced Clinic Intervention
- 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 OnlyBehavioural
Also called -CHW Home Visit Intervention
-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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Clinic+ Unified Management Plan | Active comparator | Patients in study arm will receive:
* Enhanced Clinic Intervention
* Enhanced Health Plan
* Unified Management Plan Receives: Behavioral: Enhanced Clinic+ Unified Management Plan |
| CHW Home Visit Only | Active comparator | Patients in study arm will receive:
* CHW Home Visit
* Usual clinic care with enhanced health plan Receives: Behavioral: CHW Home Visit Only |
| Enhanced Clinic+ Unified Plan+ CHW | Active comparator | Patients in study arm will receive:
* CHW Home Visit
* Enhanced Clinic intervention
* Enhanced health plan
* Unified asthma management plan Receives: Behavioral: Enhanced Clinic+ Unified Plan + CHW |
| Usual Care | No intervention | -Usual clinic care with enhanced healthplan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 12 Months
Secondary outcomes (10)
Nocturnal wakening
Measured by questionnaire: Nights wakened in the past two weeks due to asthma.
Measured: 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
Measured: 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
Measured: 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.)
Measured: 12 Months
Beta-agonist use
Measured by questionnaire and claims data: Days using Beta-agonist medication in past 2 weeks
Measured: 12 Months
Oral steroid use
Measured by questionnaire and claims data: Courses of steroids (3+ day course) in past 12 months
Measured: 12 Months
Controller use
Measured by claims data: Controller to total asthma medication ratio > 0.5
Measured: 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
Measured: 12 Month
Missed work or school days
Measured by questionnaire: Number of school or work days missed in past two weeks.
Measured: 12 Months
General Health Status
Measured by questionnaire:
Adults: SF-12 Health Survey Children: SF -10 Health Survey
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Public Health - Seattle and King County
- Sponsor type
- Other government
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- James Stout, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190617
- Sponsor's protocol ID
- AS1307-05498
- Acronym
- G2P
- Status last verified
- Jul 2014
- First submitted
- 11 Jul 2014
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation
- ClinicalTrials.gov ID
- NCT02190617
- Acronym / sponsor ID
- G2P / AS1307-05498
- Conditions
- Asthma
- Keywords
- Asthma, Guidelines, Community Health Worker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Public Health - Seattle and King CountyOther government
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Dec 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Enhanced Clinic+ Unified Management Plan | Active comparator | Behavioral: Enhanced Clinic+ Unified Management PlanPatients in study arm will receive: * Enhanced Clinic Intervention * Enhanced Health Plan * Unified Management Plan |
| CHW Home Visit Only | Active comparator | Behavioral: CHW Home Visit OnlyPatients in study arm will receive: * CHW Home Visit * Usual clinic care with enhanced health plan |
| Enhanced Clinic+ Unified Plan+ CHW | Active comparator | Behavioral: Enhanced Clinic+ Unified Plan + CHWPatients 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 |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 5-75
- Provider-verified diagnosis of asthma
- Have uncontrolled asthma
- Primary language of English,Spanish or Vietnamese
- Patient of Neighborcare or HealthPoint Health
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Clinic+ Unified Plan + CHWAlso: -Enhanced Clinic, -CHW Home Visits, -Unified Management plan* 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. | Behavioural | Enhanced Clinic+ Unified Plan+ CHW |
| Enhanced Clinic+ Unified Management PlanAlso: -Unified Management Plan, -Enhanced Clinic Intervention* 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. | Behavioural | Enhanced Clinic+ Unified Management Plan |
| CHW Home Visit OnlyAlso: -CHW Home Visit Intervention-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. | Behavioural | CHW Home Visit Only |
Primary outcome
Symptom free days
Time frame: 12 Months
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.
Asthma control
Time frame: 12 Months
Measured by questionnaire and spirometry. Asthma Control Adults: Asthma Control Test and EPR3 categories Asthma Control Children: cACT and EPR3 categories
Asthma-related Quality of Life
Time frame: 12 Months
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
10 secondary outcomes
Nocturnal wakening
Time frame: 12 Months
Asthma exacerbations
Time frame: 12 Months
Pulmonary function
Time frame: 12 Months
FeNO (Fractional exhaled Nitric Oxide)
Time frame: 12 Months
Beta-agonist use
Time frame: 12 Months
Oral steroid use
Time frame: 12 Months
Controller use
Time frame: 12 Months
Asthma-related urgent health services utilization
Time frame: 12 Month
Missed work or school days
Time frame: 12 Months
General Health Status
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Stout, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Clinic+ Unified Plan + CHW, Enhanced Clinic+ Unified Management Plan and CHW Home Visit Only in people with Asthma, run by Public Health - Seattle and King County at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom free days (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.