의학적 복잡성이 있는 어린이를 위한 E-PRIME (E-PRIME)
의학적 복잡성이 있는 아동을 위한 원격 의료를 통한 강화된 1차 진료
Children with medical complexity (CMC) have very high needs for health and support services. CMC have very rare diseases that involve multiple organ systems. As a result, all CMC have multiple chronic conditions and need care from many specialists and services. While there are important benefits to the child and family in living at home, the continuing need for complex medical care places a profound burden on caregivers. Telehealth has long been considered a potential solution to barriers in access to care for children. The purpose of this research is to test whether telehealth can help pediatric primary care providers (PCPs) as they treat, monitor, and manage children with medical complexity (CMC). Additionally, it is to reduce caregiver and child burden as well as improve care coordination between multiple providers.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The specific aims of this study are to: compare the effectiveness of Enhanced Primary Care via Telehealth (E-PRIME) verses usual care in improving child-level appointment and outcome measures; compare the effectiveness of (E-PRIME) verses usual care in reducing caregiver stress and improving caregiver satisfaction in primary care and care coordination services; evaluate how acceptable, appropriate, and feasible E-PRIME is from the perspective of practice providers and staff, and caregivers. Telehealth has long been considered a potential solution to barriers in access to care for children. The purpose of this research is to test whether telehealth can help pediatric primary care providers (PCPs) as they treat, monitor, and manage children with medical complexity (CMC). Additionally, it is to reduce caregiver and child burden as well as improve care coordination between multiple providers.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Winston-Salem, North Carolina, 미국, 27157
- Wake Forest University Health Sciences
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Less than 18 years of age on the date of enrollment (date consented)
- Presence of a chronic condition, defined as a health condition expected to last ≥ 12 months
- Complexity of the condition, defined as needing ongoing care with 4 sub-specialists/ services OR dependent on ≥ 1 technology (e.g. gastrostomy, tracheostomy, oxygen, ventilator, etc.)
Exclusion Criteria:
- CMC whose permanent address is outside of the state of North Carolina
- CMC at a long-term care facility
- CMC who are wards of the state, except when the caregiver is a legal guardian and can consent
- CMC whose caregivers do not speak English or Spanish
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Delayed Enhanced Primary Care (E-PRIME) Group
Children will receive usual care before receiving E-PRIME intervention. |
Usual Care: Interdisciplinary complex care teams help coordinate appointments, facilitate communication between the many specialist providers involved in the child's care, support families, assist with practical needs, and are available as a resource (as consultants) for Primary Care Physicians (PCPs) to care for Children with Medical Complexity (CMC). The complex care teams in tertiary care children's hospital is the focus for providing comprehensive care for CMC. Enhanced Primary Care: The E-PRIME team will support the CMC and their caregivers with navigating the patient access portal and how to use the video visit platform for the telehealth visits. The physician or nurse of the E-PRIME team will create clinical summaries about CMC's visit to specialists and hospital and share this health information about CMC with his/her PCP to help the PCP provide care for CMC at home. A team of telehealth experts will help PCPs in using telehealth in their practice.
다른 이름들:
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실험적: Early Enhanced Primary Care (E-PRIME) Group
Subjects of this arm will receive E-PRIME intervention at the start of enrollment. |
The intervention has the following components: (A) The staff of the E-PRIME team will support the CMC and their caregivers with navigating the patient access portal and how to use the video visit platform for the telehealth visits. (B) The physician or nurse of the E-PRIME team will create clinical summaries about CMC's visit to specialists and hospital and share this health information about CMC with his/her PCP to help the PCP provide care for CMC at home. (C) A team of telehealth experts will help PCPs in using telehealth in their practice.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Days Outside the Home (DOH)
기간: Baseline
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Number of hospital days + ER visit days + number of in-person appointments / child year |
Baseline
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Number of Days Outside the Home (DOH)
기간: Year 1
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Number of hospital days + ER visit days + number of in-person appointments / child year |
Year 1
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Hospitalizations
기간: Year 1
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Number of hospitalizations/100-child years in the two groups. Number of hospitalizations during the observation period will be counted and the rate will be calculated as: [Number of hospitalizations/ observation period in years]*100. Planned admissions (i.e. elective surgeries, procedures, treatments, etc.) will be excluded. |
Year 1
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Number of Emergency Room (ER) visits
기간: Year 1
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Number of ER visits |
Year 1
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Number of Hospital Days
기간: Year 1
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Number of hospital days/observation period in years |
Year 1
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Appointment Completion Rate
기간: Year 1
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Proportion of scheduled appointments that were completed |
Year 1
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Change in Caregiver Burden scores
기간: Month 19
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Caregiver burden will be measured using the 15-item Impact on Family Scale- Revised which as 15 items and 4 domains - financial, family/social, personal strain, and mastery. Scores will range from 15 to 60. The higher the score the greater the impact. |
Month 19
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Change in Caregiver Satisfaction with coordination of care scores
기간: Month 19
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Caregiver satisfaction with coordination of care will be compared between the two groups and measured by the Family Experiences with Coordination of Care survey. Scores will range from 0 to 100 and each item will be measured independently. Higher scores indicate better care (i.e. care plans, coordination, visit summary content, etc.) |
Month 19
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Savithri Nageswaran, MD, Wake Forest University Health Sciences
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- IRB00102234
- TE-2022C3-30607 (기타 식별자: PCORI)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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