- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02190617
Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation (G2P)
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Washington
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Seattle, Washington, 미국, 98104
- Public Health -- Seattle & King County
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Enhanced Clinic+ Unified Management Plan
Patients in study arm will receive:
|
다른 이름들:
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활성 비교기: CHW Home Visit Only
Patients in study arm will receive:
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-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.
다른 이름들:
|
활성 비교기: Enhanced Clinic+ Unified Plan+ CHW
Patients in study arm will receive:
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다른 이름들:
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간섭 없음: Usual Care
-Usual clinic care with enhanced healthplan
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Symptom free days
기간: 12 Months
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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.
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12 Months
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Asthma control
기간: 12 Months
|
Measured by questionnaire and spirometry.
Asthma Control Adults: Asthma Control Test and EPR3 categories Asthma Control Children: cACT and EPR3 categories
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12 Months
|
Asthma-related Quality of Life
기간: 12 Months
|
Measured by questionnaire. Adults:
Children 7-17:
Children 5-6:
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12 Months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Nocturnal wakening
기간: 12 Months
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Measured by questionnaire: Nights wakened in the past two weeks due to asthma.
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12 Months
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Asthma exacerbations
기간: 12 Months
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Measured by questionnaire: Need for oral steroids (3+ day course), hospitalization, ED visit or unscheduled clinic visit for worsening asthma in past 12 months
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12 Months
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Pulmonary function
기간: 12 Months
|
Measured by spirometry: Post-bronchodilator FEV1 and FEV1 /FVC and change in pre-post bronchodilator FEV1 and FEV1 /FVC182 using EasyOne Diagnostic spirometer
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12 Months
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FeNO (Fractional exhaled Nitric Oxide)
기간: 12 Months
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Measured by portable handheld device: Online measurement of ppb in exhaled breath at 50 L/s (<25 ppb indicates normal value.)
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12 Months
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Beta-agonist use
기간: 12 Months
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Measured by questionnaire and claims data: Days using Beta-agonist medication in past 2 weeks
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12 Months
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Oral steroid use
기간: 12 Months
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Measured by questionnaire and claims data: Courses of steroids (3+ day course) in past 12 months
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12 Months
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Controller use
기간: 12 Months
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Measured by claims data: Controller to total asthma medication ratio > 0.5
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12 Months
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Asthma-related urgent health services utilization
기간: 12 Month
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Measured by questionnaire and administrative data: Urgent clinic visits, emergency department visits, and hospitalizations during past three months and past year
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12 Month
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Missed work or school days
기간: 12 Months
|
Measured by questionnaire: Number of school or work days missed in past two weeks.
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12 Months
|
General Health Status
기간: 12 Months
|
Measured by questionnaire: Adults: SF-12 Health Survey Children: SF -10 Health Survey |
12 Months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: James Stout, MD, University of Washington
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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