- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00581711
Improving Otitis Media Care With Clinical Decision Support (OMHIT)
Improving Otitis Media Care With EHR-based Clinical Decision Support and Feedback
연구 개요
상세 설명
Context The high prevalence of Otitis Media (OM) and its enormous cost make it a prime target for cost-effective and evidence-based strategies for disease management.
Objectives
This protocol will prospectively develop a new electronic health record (EHR)-based health information technology (IT) intervention that a) summarizes OM care into clinically meaningful episodes-of-care, b) provides clinical decision support based upon evidence-based guidelines to primary care and ENT physicians working within an integrated physician network that uses a common EHR, and c) tests the additive effects on quality and resource utilization of providing feedback to physicians. The specific aims are:
Aim 1: To develop and pilot test the OM health IT intervention; Aim 2: To examine the overall effect of the health IT intervention and the independent contribution of physician feedback on quality of OM care (primary outcomes); Aim 3: To assess the effects of the intervention on the secondary outcomes of health care resource utilization and clinician adoption of the health IT.
Study Design/Settings/Participants A cluster randomized trial and multi-level statistical modeling will be used to estimate health IT intervention effects on study outcomes. The proposed project will be conducted in the Children's Hospital of Philadelphia's (CHOP) health care system. The heath IT intervention will be tested in the Pediatric Research Consortium (PeRC), which includes 28 primary care practices in the CHOP network, both urban and suburban, and the CHOP ENT clinical sites. Randomization and implementation of the intervention will occur at the practice level. Study outcomes of quality of care and resource utilization will be reported at the levels of the practice, individual practitioner, and episode-of-care (patient-level).
Study Measures Our main study measures include the quality of otitis media care provided during episodes of OM.
Our secondary outcomes include measurement of clinician adoption of the health IT intervention and resource use.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- The Children's Hospital of Philadelphia
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All CHOP primary care pediatric and ENT practice sites are eligible for inclusion in this study. We expect 35,000 patients to receive care for otitis media by CHOP clinicians at these sites during the study period however, they are not the subjects of this research.
Exclusion Criteria:
- There are no exclusion criteria. All CHOP primary care pediatric and ENT sites are eligible for participation. Data for all clinicians providing OM care and data on all OM encounters will be included in our data set.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
간섭 없음: 제어
평상시 관리
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실험적: HIT Intervention without feedback
3-Part Intervention: Training, Otitis Media Episode Grouper, Clinical Decision Support
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A combination of training, an otitis media episode grouper, and clinical decision support.
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실험적: HIT Intervention with feedback
4-Part Intervention: Training, Episode Grouper, Clinical Decision Support, and Physician Feedback.
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A combination of clinician training, an otitis media episode grouper, clinical decision support, and feedback.
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실험적: Feedback only
1 part intervention: Physician Feedback
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Provision of feedback on otitis media quality indicators
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Quality of otitis media care.
기간: 18 Months
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18 Months
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Clinician adoption of intervention and Resource Utilization
기간: 18 months
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18 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Christopher B Forrest, MD, PhD, Children's Hospital of Philadelphia
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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
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. .
3-Part Intervention에 대한 임상 시험
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VA Office of Research and Development모집하지 않고 적극적으로
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Washington University School of MedicineSt. Jude Children's Research Hospital완전한
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University of MichiganNational Institute on Drug Abuse (NIDA)모병
-
University of MichiganNational Institute of Nursing Research (NINR)완전한
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