- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02411396
Comparison of Patient Centered Outcomes for People With Sickle Cell Disease in the Acute Care Setting (ESCAPED)
Patient Centered Outcomes Research Institute (PCORI) ESCAPED Study: Comparison of Patient Centered Outcomes for People With SCD in the Acute Care Setting
The Emergency Department has been the standard location where patients with Sickle Cell Disease (SCD) go to seek care for the treatment of acute painful events. Vaso- Occlusive Crisis (VOC) is the most common complication of SCD,
The purpose of this study is to compare patient centered outcomes for patients being treated for an uncomplicated VOC in Infusion Centers (IC) and Emergency Departments (ED) in four locations around the United States.
연구 개요
상태
정황
상세 설명
Emergency Department care is marked by long delays, lack of efficacy, and conflict. A sub-specialty Infusion Center staffed by expert clinicians and delivering individualized care can improve care quality while reducing costs. The study will examine whether care provided in an Infusion Center (IC) is more patient centered and efficient than care provided in an Emergency Department (ED) for adults with Sickle Cell Disease (SCD) and uncomplicated Vaso-Occlusive Crisis (VOC).
Sites will prospectively enroll patients in VOC seen in participating centers from either the EDs or the ICs. Specific data from the acute visits (e.g. Times of arrival, time to first dose of analgesic, etc) will be captured. This study will compare: pain management, disposition of subjects (home or admission) and patient experiences of care delivery in both settings. Subjects will complete surveys/questionnaires to asses subjects' experiences in the setting where care was provided.
The four sites to participate in the study are Baltimore, Maryland (Johns Hopkins Hospital), Cleveland, Ohio (Cleveland Medical Center), Milwaukee, Wisconsin (Medical College of Wisconsin), and Baton Rouge, Louisiana (Our Lady of the Lake Hospital). A maximum of 500 subjects will participate in the study. Participants will be enrolled for 18 months.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Louisiana
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Baton Rouge, Louisiana, 미국, 70809
- Our lady of the Lake Hospital
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Ohio
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Cleveland, Ohio, 미국, 44106
- Cleveland Medical Center at University Hospitals
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53201
- Medical College of Wisconsin, Blood Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Confirmed Sickle Cell Disease patients who live within 60 miles of the study center or who already receive regular care at the participating centers.
Exclusion Criteria:
- Stable patients who have been on chronic transfusion therapy and have not had a painful episode within two years of enrollment.
- Patients who are pregnant.
- Patients who are unwilling or unable to sign consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Patients With SCD
Patients treated for uncomplicated VOC in ICs and EDs.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered
기간: Within 6 hours after arrival
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Time is recorded from the time the patient arrives for pain treatment at either the ED or IC until the time the patient is dosed with pain medication administered parenterally.
Guideline recommendations are that patients receive non-oral pain medication within 60 minutes of arrival.
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Within 6 hours after arrival
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Disposition From Acute Care Visit
기간: Day 1 of admission
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Odds for admission to the hospital versus discharge to home (ED vs IC)
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Day 1 of admission
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Pain Reassessment Within 30 Minutes of First Dose of Parenteral Pain Medication Administered
기간: 30 minutes after administration
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Odds of being re-assessed for pain within 30 minutes of receiving first dose of pain medication in ED vs IC.
NHLBI guidelines recommend that patients are re-assessed for adequacy of pain management 30 minutes after receiving pain medication.
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30 minutes after administration
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Patient Reported Satisfaction With Care Received
기간: within 72 hours of acute visit
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Survey to capture patient satisfaction with the quality of care in either the ED or IC.
Validated a new tool to assess satisfaction with care in the acute care setting.
The new tool was developed based on existing tools that assessed several domains: adequacy of pain management, communication with providers, interpersonal aspects of care, provider competence, involvement of family/friends, and access to care.
The final 15 item validated Patient Satisfaction with Pain Management in Sickle Cell Disease (SCD) (PSPS) scale was used to compare satisfaction of care comparing ED to IC acute visits.
Overall mean satisfaction scores ranged from 0-7 with higher scores signifying greater satisfaction
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within 72 hours of acute visit
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Patient Reported Perception of Risk From Visit
기간: within 72 hours of acute visit
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One question on the survey asked patients to rate the overall level of medical safety they felt during their visit to the ED or IC.
Choices for responses: Excellent, Very Good, Good, Fair or Poor.
Excellent and Very Good were determined as having greater feelings of overall safety while patients who chose Good, Fair or Poor were determined having lesser feelings of overall safety.
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within 72 hours of acute visit
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sophie Lanzkron, MD, MHS, Johns Hopkins University, Division of Hematology
간행물 및 유용한 링크
일반 간행물
- Platt OS, Brambilla DJ, Rosse WF, Milner PF, Castro O, Steinberg MH, Klug PP. Mortality in sickle cell disease. Life expectancy and risk factors for early death. N Engl J Med. 1994 Jun 9;330(23):1639-44. doi: 10.1056/NEJM199406093302303.
- Lanzkron S, Carroll CP, Haywood C Jr. The burden of emergency department use for sickle-cell disease: an analysis of the national emergency department sample database. Am J Hematol. 2010 Oct;85(10):797-9. doi: 10.1002/ajh.21807.
- Hassell KL. Population estimates of sickle cell disease in the U.S. Am J Prev Med. 2010 Apr;38(4 Suppl):S512-21. doi: 10.1016/j.amepre.2009.12.022.
- McClish DK, Penberthy LT, Bovbjerg VE, Roberts JD, Aisiku IP, Levenson JL, Roseff SD, Smith WR. Health related quality of life in sickle cell patients: the PiSCES project. Health Qual Life Outcomes. 2005 Aug 29;3:50. doi: 10.1186/1477-7525-3-50.
- Bediako SM. Predictors of employment status among African Americans with sickle cell disease. J Health Care Poor Underserved. 2010 Nov;21(4):1124-37. doi: 10.1353/hpu.2010.0945.
- Lanzkron S, Carroll CP, Hill P, David M, Paul N, Haywood C Jr. Impact of a dedicated infusion clinic for acute management of adults with sickle cell pain crisis. Am J Hematol. 2015 May;90(5):376-80. doi: 10.1002/ajh.23961. Epub 2015 Feb 25.
- Haywood C Jr, Tanabe P, Naik R, Beach MC, Lanzkron S. The impact of race and disease on sickle cell patient wait times in the emergency department. Am J Emerg Med. 2013 Apr;31(4):651-6. doi: 10.1016/j.ajem.2012.11.005. Epub 2013 Feb 4.
- Lanzkron S, Little J, Wang H, Field JJ, Shows JR, Haywood C Jr, Saheed M, Proudford M, Robertson D, Kincaid A, Burgess L, Green C, Seufert R, Brooks J, Piehet A, Griffin B, Arnold N, Frymark S, Wallace M, Abu Al Hamayel N, Huang CY, Segal JB, Varadhan R. Treatment of Acute Pain in Adults With Sickle Cell Disease in an Infusion Center Versus the Emergency Department : A Multicenter Prospective Cohort Study. Ann Intern Med. 2021 Sep;174(9):1207-1213. doi: 10.7326/M20-7171. Epub 2021 Jul 6. Erratum In: Ann Intern Med. 2021 Aug 3;:
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 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. .
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