- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01969240
Shared Decision Making in the Emergency Department: Chest Pain Choice Trial (CPC)
Shared Decision Making in the Emergency Department: The Chest Pain Choice Trial
Our long-term goal is to promote evidence-based patient-centered evaluation in the acute setting to more closely tailor testing to disease risk. To compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration, we propose the following:
Test if Chest Pain Choice safely improves validated patient-centered outcome measures in a pragmatic parallel patient randomized trial.
Hypothesis: The intervention will significantly increase patient knowledge, engagement, and satisfaction with no increase in adverse events.
- Test if the decision aid has an effect on healthcare utilization within 30 days after enrollment.
Hypothesis: The intervention will significantly reduce the rate of hospital admission, rate of cardiac testing, and total healthcare utilization.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Sacramento, California, 미국, 95817
- University of California, Davis
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Florida
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Jacksonville, Florida, 미국, 32224
- Mayo Clinic
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Indiana University Hospital: IU
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- Thomas Jefferson University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18+ years of age (at least 18).
- Admitted to emergency department for chest pain.
- Being considered by the treating clinician for admission for cardiac testing.
Exclusion Criteria:
- Ischemic changes on the electrocardiogram not known to be old as determined by the treating clinician in real time.
- Elevated cardiac troponin (cTn) above the 99th percentile reference limit.
- Known coronary artery disease as defined by consensus guidelines on risk stratification studies for emergency department patients with potential acute coronary syndrome (≥ 50% stenosis on cardiac catheterization; prior electrocardiographic changes indicative of ischemia, e.g., ST-segment depression, T-wave inversion, or left bundle branch block; perfusion defects or wall motion abnormalities on previous exercise, pharmacological, or rest imaging studies; previous documentation of acute myocardial infarction; or, if no records are available, patient self-report of coronary artery disease).
- Cocaine use within the previous 72 hours by clinician history.
- Pregnancy.
- Referral to the emergency department by a personal physician for admission.
- Patients who indicate that a hospital different than the site hospital is his or her "hospital of choice" in the event of a return emergency department visit.
- Patients undergoing medical clearance for a detox center or any involuntary court or magistrate order.
- Homelessness, out-of-town residence or other condition known to preclude follow-up.
- Patients in police custody or currently incarcerated individuals.
- Patients who have, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent (or use the decision aid).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Chest Pain Choice Decision Aid
Patients randomized to the decision aid arm.
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The clinician will review the decision aid with the patient.
The decision aid will be used as a tool to facilitate discussion and educate the patient regarding the rationale for their evaluation up to that point in the emergency department visit and their individual risk for a heart attack or pre-heart attack.
The clinician will provide the patient with management options consistent with both the patient's values and preferences and the clinician's level of comfort.
다른 이름들:
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간섭 없음: Usual Care
Patients randomized to the usual care arm (no decision aid used)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Test if Chest Pain Choice Safely Improves Patient Knowledge.
기간: Directly following intervention (on day 1)
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Patient knowledge was measured by immediate post-visit survey that included 8 questions about the patient's risk for acute coronary syndrome and the available management options.
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Directly following intervention (on day 1)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment.
기간: Within 30 days of study enrollment
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We will measure the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days of enrollment.
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Within 30 days of study enrollment
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Test if the Decision Aid Safely Improves Patient Engagement.
기간: Immediately after the intervention (on day 1)
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1) Patient engagement in the decision-making process as measured by the OPTION scale.
The OPTION scale is composed of 12 items with a value of 0-4; they are summed, divided by 48, and then multiplied by 100.
Scores range from 0-100, where higher scores are reflective of higher levels of patient engagement.
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Immediately after the intervention (on day 1)
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Major Adverse Cardiac Event (MACE)
기간: within 30 days of enrollment
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A MACE was defined as acute myocardial infarction, death due to a cardiac or unknown cause, emergency revascularization, ventricular arrhythmia, or cardiogenic shock.
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within 30 days of enrollment
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Total Testing Within 45 Days (a Component of Healthcare Utilization)
기간: 45 days
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In addition to measuring the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days, we measured the total number of tests of any type within 45 days.
Although we pre-specified 30-day healthcare utilization, on further discussion among the investigative team the consensus was that we collected utilization data out to 45 days and reporting testing utilization at 45 days will provide more robust results.
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45 days
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Decisional Conflict
기간: Immediately after the visit (day 1)
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Decisional conflict, which represents the degree of uncertainty patients experience related to feeling uninformed about the management options, is measured by the decisional conflict scale.
The decisional conflict scale includes 16 items that are scored from 0-4; the items are summed, divided by 16, and then multiplied by 25.
The scale is from 0-100, where higher scores are reflective of increased patient uncertainty about the choice.
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Immediately after the visit (day 1)
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Physician Trust
기간: Immediately after the visit (day 1)
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The trust in physician scale consists of 9 items scored from 1-5; the items are subtracted by 1, summed, divided by 9, and then multiplied by 25.
The scale ranges from 0-100, where higher values are reflective of higher levels of patient trust in their physician.
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Immediately after the visit (day 1)
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공동 작업자 및 조사자
스폰서
협력자
수사관
- 수석 연구원: Erik Hess, MD, MSc, Mayo Clinic, Rochester, MN
간행물 및 유용한 링크
일반 간행물
- Hess EP, Hollander JE, Schaffer JT, Kline JA, Torres CA, Diercks DB, Jones R, Owen KP, Meisel ZF, Demers M, Leblanc A, Shah ND, Inselman J, Herrin J, Castaneda-Guarderas A, Montori VM. Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial. BMJ. 2016 Dec 5;355:i6165. doi: 10.1136/bmj.i6165.
- Anderson RT, Montori VM, Shah ND, Ting HH, Pencille LJ, Demers M, Kline JA, Diercks DB, Hollander JE, Torres CA, Schaffer JT, Herrin J, Branda M, Leblanc A, Hess EP. Effectiveness of the Chest Pain Choice decision aid in emergency department patients with low-risk chest pain: study protocol for a multicenter randomized trial. Trials. 2014 May 10;15:166. doi: 10.1186/1745-6215-15-166.
연구 기록 날짜
연구 주요 날짜
연구 시작
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
기타 연구 ID 번호
- 13-001359
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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