- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02585557
Heart Health NOW (Previously Known as FAST PACE NC) (HHN)
Heart Health NOW (Previously Known as Facilitation, Spread, and Translation of Patient-Centered Evidence in North Carolina Practices)
연구 개요
상세 설명
The burden of cardiovascular disease in North Carolina remains large. The latest data available show an annual cardiovascular death rate of 263 per 100,000 explaining almost one-third of deaths in the state. Disease progression is largely determined by several risk factors including elevated blood pressure or cholesterol, not using aspirin for prevention, and tobacco use. Primary care practices as currently organized have been unable to get more than half these patients to achieve recommended targets for risk factor reduction. Small independent practices, in particular, lack resources for enhanced practice support to improve cardiovascular care.
This study will enroll 300 primary care practices to evaluate the effect of primary care support on evidence-based cardiovascular disease (CVD) prevention and organizational change process measures. Each practice will start the trial as a control, receive the intervention at a randomized time point, and then enter a maintenance period 12 months after starting the intervention. All practices will receive 12 months of the intense intervention including onsite quality improvement (QI) facilitation, academic detailing, electronic health record (EHR) support, and, through the North Carolina Health Information Exchange (HIE), a shared statewide utility providing whole population analytics, care gap identification, benchmarking, and an external reporting mechanism which otherwise would not be available to independent practices.
A successful intervention would prove that practice facilitation supported by effective informatics tools is an effective method of translating PCOR findings into practice. Discernible reductions in cardiovascular risk in 300 practices covering over an estimated 900,000 adult patients would likely lead to prevention of thousands of cardiovascular events within 10 years.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Primary care practice in North Carolina with 10 or fewer providers in a single location
- must have implemented an EHR and either be connected to or have agreed to connect to the HIE.
Exclusion Criteria:
- practices with more than 10 providers in a single location
- practices receiving practice facilitation services beyond the usual support provided by Area Health Education Centers (AHEC) or the Community Care of North Carolina (CCNC) program through their parent organization.
- practices without an EHR
- practices where the central practice organization either bars the practice from our program or provides onsite facilitation services equal to or greater than the 4-6 hour standard contact with a QI coach
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: Cluster A
50 practices randomly assigned to start intervention at month 9. Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
|
실험적: Cluster B
50 practices randomly assigned to start intervention at month 11.
Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
|
실험적: Cluster C
50 practices randomly assigned to start intervention at month 12. Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
|
실험적: Cluster D
50 practices randomly assigned to start intervention at month 14.
Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
|
실험적: Cluster E
50 practices randomly assigned to start intervention at month 16.
Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Measurable reduction in arteriosclerotic cardiovascular disease (ASCVD) risk
기간: 18 months
|
By comparing EHR data at baseline and post-intervention, determine whether practice support resulted in discernible reduction in CVD risk.
|
18 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Sam Cykert, MD, UNC Chapel Hill
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
- 15-0479
- 1R18HS023912-01 (미국 AHRQ 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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. .