- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01280500
Title: Comparative Effectiveness of Asthma Interventions Within an AHRQ PBRN
2022년 4월 19일 업데이트: Wake Forest University Health Sciences
Accelerating Implementation of Comparative Effectiveness Findings on Clinical and Delivery Systems by Leveraging AHRQ Networks
The overall goal is to identify best practices for improving health outcomes for patients with asthma using comparative effectiveness research within an Agency for Healthcare Research and Quality (AHRQ) Practice-Based Research Network (PBRN).
This goal will be achieved by completing the following aims: (1) Create a centralized database for comparative effectiveness research on asthma by combining clinical and billing data from one of the largest healthcare systems in the country (Carolinas Healthcare System) with data from the school system, Medicaid, and patient and community-level datasets; (2) Deploy a fully developed integrated approach to asthma management based on the Chronic Care Model; (3) Develop and implement a "shared decision making" approach for asthmatic patients from disadvantaged backgrounds; (4) Implement an electronic data collection system for an existing CDC funded school-based asthma intervention that will allow program evaluation and link school nurses with providers; (5) Evaluate and compare the effectiveness of these three asthma management strategies on: overall healthcare consumption and medical costs; quality of life, school absenteeism and performance; asthma clinical measures; and medication utilization; and (6) Disseminate findings across the state via the statewide PBRN and other network partners.
This project has the potential to impact over 30,000 asthma patients across the Carolinas including many patients from disadvantaged backgrounds.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
1040
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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North Carolina
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Charlotte, North Carolina, 미국, 28207
- Department of Family Medicine
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Charlotte, North Carolina, 미국, 28207
- CMC Elizabeth Family Medicine
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
all with asthma diagnosis
Exclusion Criteria:
none
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위화되지 않음
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: Group A - Usual Care Controls
Group A will consist of 20 primary care clinics who are part of the Carolinas Healthcare System network but have not yet adopted the Electronic Medical Record System.
These practices do use the same billing databases as the remaining clinics, allowing easy identification of asthma patients and their health services utilization patterns.
Data from the billing systems will be used to retrospectively populate a database for these clinics from January 2009 forward.
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No EMR
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활성 비교기: Group B - EMR Control Practices
There are currently 65 primary care practices within the Carolinas Healthcare System network that have electronic medical record with decision support (EAP)access at baseline.
These practices will serve as a second level of control for comparison with the intervention groups.
Each of these practices is currently using Cerner PowerChart and at the start of the study and will have access to the asthma decision support tools; an electronically generated Asthma Action Plan (AAP); and a built-in system of population management reports which will be pushed to the practices on an on-going basis to help in patient recall and management.
The EAP approach to care has been developed with input from clinicians, hospital administrators, hospital information services personnel, and Cerner consultants.
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Decision Support, Asthma Action Plans, and Population Management Reporting (EAP)
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활성 비교기: C Integrated Approach to Care
There are 10 practices within the Carolinas Healthcare System (CHS) network that have already received additional training for improving outcomes for patients with chronic diseases termed the Integrated Approach to Care (IAC).
This IAC approach developed by CHS is based on the Chronic Care Model (CCM).
The IAC approach includes a heavy emphasis on the use of health information technology that practices receive during the initial EAP rollout.
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Patients within the IAC group will also receive their own copy of an asthma action plan to allow for some degree of self-management support.
In addition, IAC practices receive assistance from a practice coach trained in practice redesign and rapid cycle process improvement.
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활성 비교기: Group D - Shared Decision Making (SDM)
This approach has great potential for improved patient outcomes and provides an additional step in the successful implementation of patient self-management.
The research team will develop the SDM intervention during the first 6 months of the study.
In particular, the Shared decision making (SDM) intervention will be designed to be deployed within the 4 large clinics that care for the majority of the community's underserved and disadvantaged patients.
The SDM intervention development will be overseen by the study advisory board and actively recruit providers from within the clinics for feedback about the intervention.
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The research team will develop the SDM intervention during the first 6 months of the study.
The team will model this intervention on the randomized control trial performed by Dr. Sandra Wilson and colleagues within the Kaiser Permanente Clinics in California and Oregon
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활성 비교기: School Based Care (SBC)
Activities included: spending individual time with students to assess, treat, and monitor and to educate students in proper asthma management; facilitate access to health care and medicine; and communicate with parents.
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the research team will start an electronic data capture system linking school data and the clinical EMR (Cerner Power Chart) that will be implemented over the first year.
Flow of data between schools and the hospital system will allow the children who have a regular source of care as well as those without a medical home to be treated with a unified asthma program by the school nurse and the hospital system.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Reducing Hospitalizations and Emergency Department Visits
기간: 2011-2013
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Quality goals will be measured by the percentage of patients who reach the goal out of all patients identified with the disease through healthcare system data.
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2011-2013
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Improving Adherence to Medication
기간: 2011-2013
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Quality goals will be measured by the percentage of patients who reach the goal out of all patients identified with the disease.
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2011-2013
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Improve Quality of Life
기간: 2011-2013
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Measured via Survey
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2011-2013
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Reduced School Absenteeism
기간: 2011-2013
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measured with school absenteeism data
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2011-2013
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Improved Self-Efficacy
기간: 2011-2013
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survey
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2011-2013
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Improved School Performance
기간: 2011-2013
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measured by yearly end of grade results
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2011-2013
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Michael F Dulin, MD, PhD, Wake Forest University Health Sciences
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 3월 1일
기본 완료 (실제)
2017년 8월 1일
연구 완료 (실제)
2017년 8월 1일
연구 등록 날짜
최초 제출
2011년 1월 19일
QC 기준을 충족하는 최초 제출
2011년 1월 19일
처음 게시됨 (추정)
2011년 1월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 4월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 4월 19일
마지막으로 확인됨
2018년 2월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .