- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03404999
Clinical-Decision Support to Improve Hypertension Care in Primary Care
Automated Clinical-Decision Support to Improve Hypertension Care Among Overweight Children in Primary Care
Approaches are needed to help primary-care pediatricians address high blood pressure. This study will test whether an electronic health-record-based tool to address high blood pressure is feasible and improves the evaluation and management of high blood pressure in clinical practice. If successful, this approach can be used to address other lifestyle-related and complex health problems (e.g., dyslipidemia and diabetes), then disseminated and used nationwide.
The investigators have developed a new, electronic health-record (EHR)-based tool that is designed to help pediatricians:
IDENTIFY AND DOCUMENT
- when a child's blood pressure is elevated, and
- whether it has been elevated before--including number of prior elevations to document the correct diagnosis (for example, elevated blood pressure, vs. hypertension stage 1, vs. hypertension stage 2), THEN
ORDER the next action(s) needed per guideline-based recommendations, AND per prior actions taken--including:
- laboratories and studies per 2017 updated guidelines
- follow-up interval in primary care
- referral to nephrology, when indicated, and
- patient education on diet/lifestyle modification.
The investigators are working on improving this system further with addition of orders for:
- referral for sleep-apnea testing and treatment, when indicated, and
- blood-pressure medications (for example, initiation, titration, or addition of agents depending on blood-pressure control, comorbid conditions [e.g., diabetes], and risk for pregnancy)
연구 개요
상세 설명
The investigators' data suggest that (1) addressing obesity-related comorbidities (in combination with high BMI/overweight/obesity) and more frequent follow-up are associated with weight-status improvement in overweight (OW) children, (2) that parents rank checking for weight-related health problems as the #1 most important recommended weight-management clinical practice, but that (3) comorbidities are infrequently addressed. Thus, to improve weight status, interventions are needed to improve comorbidity identification, evaluation, and management in primary care. Because the investigators' data suggest that identification of high blood pressure is particularly poor, and that identifying blood-pressure elevations in young children at three separate encounters is complex, they are using existing underutilized data to automate addressing high blood pressure/hypertension in an electronic health record system (EPIC-based), and, if successful, applying the method to other obesity-related comorbidities in primary care.
OF NOTE: in developing and pilot-testing this decision support tool, providers wanted access to it for patients without overweight/obesity. Thus, although the trial was borne out of work in weight-management research, the initial trial will focus on all children irrespective of weight status.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Texas
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Dallas, Texas, 미국, 75390
- University of Texas Southwestern Medical Center, Parkland Medical Center, and (pilot took place at Children's Health)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for Providers: Pediatric primary care providers practicing at participating clinics that have agreed to have the decision-support system implemented.
Exclusion Criteria for Providers:
- Lack of electronic health record
Inclusion Criteria for Children:
- Measured systolic or diastolic blood pressure >=90th % for age/sex, or
- >=120 mmHg systolic or >=80 mmHg diastolic (whichever is lower)
Exclusion Criteria for Children:
- Diagnosis/visit for high blood pressure or hypertension in past 2 years
- Taking anti-hypertensive medication
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: clinical decision support activated
TWO MED ASSIST ALERTS
ONE PROVIDER ALERT
TAILORED ORDERSETS
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Decision support system (see description of hypertension decision support system alerts and order sets for details)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
High blood pressure addressed
기간: 4-month time series analysis
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Proportion of patients with high blood pressure addressed post decision-support implementation (vs.
pre-), defined as proportion of patients with elevated blood pressures or higher who have one or more diagnosis or orders placed to diagnose, evaluate, or manage hypertension.
We will compare the slope of the post- vs. pre-implementation periods to examine change in monthly rate of HTN eval/management (indicated elements ordered/patients eligible) related to decision support that are in excess of secular trends in clinical practice.
In the post-implementation period, the denominator will be determined by tracking patient-level decision-support fires.
In the pre-implementation period, the denominator will be determined by applying the decision-support algorithm to retrospective data in monthly increments to identify patients who would have been eligible.
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4-month time series analysis
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .
clinical decision support에 대한 임상 시험
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Medical University of South CarolinaNational Center for Advancing Translational Sciences (NCATS)완전한
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University of CalgaryAlberta Health services; University of Alberta; Covenant Health완전한
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Beth Israel Deaconess Medical CenterBrigham and Women's Hospital; Clinical Innovations, LLC모병
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Seoul National University HospitalAjou University School of Medicine; Soonchunhyang University Hospital; Saint Vincent's Hospital... 그리고 다른 협력자들완전한
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UConn HealthUniversity of Texas at Austin; Oregon Social Learning Center초대로 등록
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University of Alabama at BirminghamNational Cancer Institute (NCI)모병
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University of PittsburghNational Institute on Minority Health and Health Disparities (NIMHD); University of California... 그리고 다른 협력자들완전한
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University of Alabama at Birmingham완전한
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University of OregonSpecial X Inc.모병부모-자녀 관계 | 육아 | 아동 행동 | 발달 장애 | 개발 지연 | 발달 장애, 아동미국
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Women's College HospitalRyerson University빼는