- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07592598
Simulation-Based Cardiac Point-of-Care Ultrasound Program to Improve Clinical Outcomes in Acute Heart Failure Patients
Co-design and Implementation of a Simulation-Based Cardiac Point-of-Care Ultrasound Program to Improve Clinical Outcomes in Acute Heart Failure Patients
연구 개요
상태
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Rebecca Theophanous, MD, MHSc
- 전화번호: 9196848111
- 이메일: rebecca.theophanous@duke.edu
연구 연락처 백업
- 이름: Maria Manson
- 전화번호: 9196848111
- 이메일: maria.manson@duke.edu
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Emergency medicine provider practicing at the study site, including physician assistants and nurse practitioners
Exclusion Criteria:
- ED nurses and technicians are excluded due to differing ultrasound training needs
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Duke University Hospital emergency medicine physicians and Advanced Practice Providers (APPs)
Co-designed simulation training intervention and clinical practice guidelines implemenation
|
Uses adaptive Experience-Based Co-design (EBCD) to co-design a cardiac POCUS simulation training intervention and implementation strategy for EM clinicians.
The cardiac POCUS training workshop and reinforcement sessions will be co-designed with ED leadership, ultrasound faculty, and key stakeholders.
Participants will then perform cardiac and lung POCUS using standardized clinical practice guidelines (CPG) in AHF patients as part of clinical care.
Clinical practice guidelines will instruct clinicians on how to perform POCUS, save the images, complete worksheets on the archiving platform, and signed so that images are saved to the patient's chart and billed.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Effectiveness of the simulation-based cardiac POCUS (Point-of-Care Ultrasound) training implementation as measured by time-to-diuretic dose in ED (Emergency Department) heart failure patients
기간: 12 months pre and 12 months post-intervention
|
Time-to-diuretics (units in minutes) in patients with a clinical diagnosis of acute heart failure with reduced or preserved ejection fraction.
|
12 months pre and 12 months post-intervention
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Acceptability of the Intervention as measured by the Acceptability of Intervention Measure (AIM)
기간: up to 6 months post-workshop
|
The AIM is scored on a Likert scale from 1 to 5, where a higher score indicates greater acceptability.
|
up to 6 months post-workshop
|
|
Appropriateness of the Intervention as measured by the Intervention Appropriateness Measure (IAM)
기간: up to 6 months post-workshop
|
The IAM is scored on a Likert scale from 1 to 5, where a higher score indicates greater appropriateness.
|
up to 6 months post-workshop
|
|
Feasibility of the Intervention as measured by the Feasibility of Intervention Measure (FIM) survey tool
기간: up to 6 months post-workshop
|
The FIM is scored on a Likert scale from 1 to 5, where a higher score indicates greater appropriateness.
|
up to 6 months post-workshop
|
|
Feasibility of implementing a cardiac point-of-care ultrasound (POCUS) simulation training and clinical practice guidelines for physicians and advanced practice providers (APPs)
기간: 12 months pre and 12 months post-intervention
|
Using a modified framework analysis approach, a team of 3-4 trained research assistants and ultrasound faculty led by an implementation science expert will deductively analyze semi-structured interview content based on IRLM constructs and PROCTOR outcomes, with open inductive coding for data that does not fit into the framework.
A preliminary rapid qualitative deductive analysis will be performed based on audio recordings and meeting notes applied to the PROCTOR dimensions, to determine scope and saturation.
Coding and categorization will be conducted with PROCTOR-templated coding sheets and transferred to NVivo.
|
12 months pre and 12 months post-intervention
|
|
Effectiveness of the simulation-based cardiac POCUS training implementation as measured by the number of clinical POCUS performed in the ED
기간: 12 months pre and 12 months post-intervention
|
To assess the cardiac POCUS simulation training program effectiveness, the investigators will collect pre/post-health record data on the number of clinical POCUS performed in the emergency department pre/post-intervention (from the Butterfly ultrasound archiving system, units in counts/percentages).
|
12 months pre and 12 months post-intervention
|
|
Effectiveness of the simulation-based cardiac POCUS training implementation as measured by image quality review scores
기간: 12 months pre and 12 months post-intervention
|
To assess cardiac POCUS simulation training program effectiveness, the investigators will collect pre/post-health record data on image quality review scores (determine by two ultrasound experts, Likert scale 1-5, where a higher score indicates greater quality).
|
12 months pre and 12 months post-intervention
|
|
Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance as measured by the time to initial cardiology consult
기간: 12 months pre and 12 months post-intervention
|
The investigators will collect electronic health record data on pre/post-intervention time to initial cardiology consult (both from the Epic electronic health record, units in hours).
|
12 months pre and 12 months post-intervention
|
|
Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance as measured by emergency department length-of-stay
기간: 12 months pre and 12 months post-intervention
|
The investigators will collect electronic health record data on pre/post-intervention ED length-of-stay (from the Epic electronic health record, units in hours).
|
12 months pre and 12 months post-intervention
|
|
Clinical impact of the training model on heart failure patients as measured by the number of participants with serious cardiac outcomes
기간: 12 months pre and 12 months post-intervention
|
The investigators will collect pre/post-intervention 30-day serious cardiac outcomes including 30-day mortality, ventilation, new dialysis, myocardial infarction (from the Epic electronic health record, units in counts/percentages).
|
12 months pre and 12 months post-intervention
|
|
Ultrasound Self-efficacy Scale
기간: 6 months
|
Post-workshop assessments will assess participant skills via validated Ultrasound Self-efficacy Scale, which is reported on a scale of 1 to 5. A higher score indicates greater self-efficacy.
|
6 months
|
|
Provider adoption as measured by the number of cardiac/lung POCUS exams performed by each participant for ED acute heart failure patients
기간: 12 months pre and 12 months post-intervention
|
12 months pre and 12 months post-intervention
|
|
|
Ultrasound image interpretation test
기간: 6 months
|
Post-workshop assessments will assess participant skills via validated ultrasound image interpretation tests (knowledge assessment survey, 11 questions multiple choice).
Scores range from 0 to 11, where a higher score indicates greater knowledge.
|
6 months
|
|
Ultrasound Competency Assessment Test (UCAT)
기간: 6 months
|
Post-workshop assessments will assess participant skills via validated ultrasound simulated scenario performance and technical skills using the UCAT.
The score ranges from 1 ("I had to do", total supervisor intervention) to 5 ("I did not need to be there", independent).
Higher scores indicate greater competency.
|
6 months
|
|
Cost-effectiveness as measured by POCUS (Point-of-Care Ultrasound) revenue
기간: 12 months pre and 12 months post-intervention
|
Number of dollars billed at a flat rate for each procedure type from the Butterfly enterprise and hospital clinical billing data archive, units in dollars.
|
12 months pre and 12 months post-intervention
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Rebecca Theophanous, Duke University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Pro00120135
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
All data will be collected in hospital secured platforms including Duke REDCap, the current clinical Butterfly Enterprise POCUS archiving system, and Epic electronic health records. All data will be de-identified at the collection step and kept as de-identified data for our research purposes. Data will be collected in digital format and stored using standardized file types such as .csv, .txt, .docx, .mp3. The total data volume will cover about 175 participants across 2-3 hospital sites.
The research community will have access to data when the award ends. As required by NHLBI, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available and have digital object identifiers (DOI) to aid in findability. The investigators will include the DOI in relevant publications. NHLBI will make decisions about how long to preserve the data.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .