- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02097355
Using an Online Patient Monitoring System to Improve Care for Children With Chronic Conditions (TriVoxHealth)
Integrated Clinical Information Sharing System: Implementation and Mixed-Methods Evaluation of a Web-based Monitoring and Management System for Patients With Chronic Conditions
연구 개요
상세 설명
TriVox Health is a web-based patient management and monitoring system designed to track patients' disease symptoms and response to therapy over time. TriVox Health enables clinics to use electronic surveys to gather data remotely from multiple responders, including patients, parents/guardians, school personnel and ancillary providers, and view the responses in a timely manner via graphical, tabular, and narrative summary formats.
This quality improvement (QI) initiative will implement TriVox as the standard of care for all patients who receive care for ADHD, asthma, autism, depression, and epilepsy within seven ambulatory specialties at Boston Children's Hospital. Patients and families will use TriVox to report on patient health status and will complete clinically-reTriVoxlevant questionnaires at routine intervals. Providers will use the information collected through TriVox to inform their clinical care of the patient/family.
To evaluate the effectiveness of TriVox, we will conduct a 24-month phased, cluster randomized controlled trial (RCT) where we randomize providers to "active" vs. "delayed-start" to TriVox use, with patients clustered by provider (within specialties) for analytic purposes. Delayed-start providers will crossover to active TriVox use after 12 months. Patients/families will complete additional surveys in order to assess the system's actual or potential effects on patient/family-provider interactions, healthcare utilization and costs.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02115
- Boston Children's Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Pediatric patients with clinical diagnosis of ADHD, asthma, autism, depression, and/or epilepsy
- Patient receives care for these diagnoses from providers in participating ambulatory clinics (Primary Care, Adolescent Medicine, Developmental Medicine, Neurology, Psychiatry)
- Patient's primary caregiver enrolled in TriVox
Exclusion Criteria:
- None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: TriVox Active
Provider using TriVox for clinical care
|
Use TriVox disease modules to manage patients
|
|
간섭 없음: TriVox Delayed-start
Providers not using TriVox for clinical care
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in caregiver-rated disease-specific symptoms
기간: Baseline to 12 months
|
Caregiver-reported ratings on disease-specific symptom rating scale.
For example, Vanderbilt ADHD Parent Rating Scale for ADHD; Asthma Control Test for asthma
|
Baseline to 12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of patients with "red flag" alerts
기간: 1 month
|
Number of patients whose responses to clinical questionnaires trigger a "red flag" alert in ICISS
|
1 month
|
|
Change in caregiver-rated global functioning
기간: Baseline to 12 months
|
Caregiver ratings on modified Clinical Global Assessment Scale
|
Baseline to 12 months
|
|
Experience of care
기간: Baseline and after every ambulatory visit for up to 84 months
|
Participant ratings on Post-Visit Experience of Care Survey
|
Baseline and after every ambulatory visit for up to 84 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Healthcare utilization
기간: 12 months
|
inpatient and ambulatory visits within healthcare system directly related to patient's medical or mental health condition
|
12 months
|
|
Direct out of pocket expenditures
기간: 12 months
|
Out of pocket expenditures directly related to care for child's medical or mental health condition, e.g.
co-pays, prescription costs
|
12 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Eugenia Chan, MD, MPH, Boston Children's Hospital
- 수석 연구원: Eric Fleegler, MD, MPH, Boston Children's Hospital
간행물 및 유용한 링크
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 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- BCH PPQI 52012
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
TriVox for clinical care에 대한 임상 시험
-
Pro-Change Behavior Systems완전한
-
University of AlbertaPublic Health Agency of Canada (PHAC)완전한
-
University of NottinghamEnhanced Recovery After Surgery Group (part of ESPEN)완전한
-
Chestnut Health SystemsNational Institute on Drug Abuse (NIDA)모병
-
Attikon HospitalDepartment of Gastroenterology, Central Clinical School, Monash University완전한
-
University of BirminghamNational Institute for Health Research, United Kingdom알려지지 않은