- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03178513
Post-Acute Physician Home Visit Program
Post-Acute Physician Home Visits: A Randomized Controlled Trial
연구 개요
상태
개입 / 치료
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, 미국, 02130
- Brigham and Women's Faulkner Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Resides within either a 5-mile or 20-minute driving radius of Brigham and Women's Hospital (BWH) or Brigham and Women's Faulkner Hospital (BWFH) emergency room
- Has capacity to consent to study
- >=18 years old
Exclusion Criteria:
- Undomiciled
- In police custody
- Domestic violence screen positive
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Home visit
A participant in this arm will receive a home visit after discharge from the hospital.
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The visit will be entirely patient tailored, last approximately one hour, and at a minimum will entail:
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간섭 없음: Usual Care
A participant in this arm will not receive a home visit after discharge from the hospital.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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New or worsening symptoms
기간: 30 days after discharge from hospital
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"Since you got home from the hospital, have you had any symptoms at all?" If no, stop. If yes, continue. "I'm going to read off a list of symptoms, and I want you to tell me if that symptom is new or has gotten worse since you left the hospital. Please don't include symptoms that have stayed the same since you were in the hospital." For each affirmative, double check if the symptom is new or has gotten worse since getting out of the hospital. Only if new or worse, mark yes. |
30 days after discharge from hospital
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
3개 항목 Care Transition 측정, 점수
기간: 퇴원 후 30일
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퇴원 후 30일
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Total cost, 30-days post discharge
기간: Day of discharge to 30 days later
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Day of discharge to 30 days later
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Total reimbursement, 30-days post discharge
기간: Day of discharge to 30 days later
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Day of discharge to 30 days later
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Primary care provider follow-up within 14 days, y/n
기간: Day of discharge to 14 days later
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Day of discharge to 14 days later
|
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Ability to carry out the discharge plan, score
기간: 30 days after discharge
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I would like to ask you about some more problems that you might have faced after you left the hospital one month ago.
I will read some statements and ask if you agree or disagree.
|
30 days after discharge
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Change in medication list due to home visit, y/n
기간: Day of home visit
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Physician-initiated medication change during home visit
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Day of home visit
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Receipt of prescribed medicines following discharge, y/n
기간: 30 days after discharge
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Pharmacy confirmation
|
30 days after discharge
|
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Unplanned 30-day readmission(s) after index hospitalization, y/n
기간: 30 days after discharge
|
30 days after discharge
|
|
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Unplanned 30-day readmission(s) after index hospitalization, #
기간: 30 days after discharge
|
30 days after discharge
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Global satisfaction with care, score
기간: 30 days after discharge
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Exploratory
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30 days after discharge
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Days at home since discharge, #
기간: 30 days after discharge
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Exploratory
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30 days after discharge
|
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All-cause 30-day readmission(s) after index hospitalization, y/n
기간: 30 days after discharge
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Exploratory
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30 days after discharge
|
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All-cause 30-day readmission(s) after index hospitalization, #
기간: 30 days after discharge
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Exploratory
|
30 days after discharge
|
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Emergency Department (ED) observation stay(s) after index hospitalization, y/n
기간: 30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Emergency Department (ED) observation stay(s) after index hospitalization, #
기간: 30 days after discharge
|
Exploratory
|
30 days after discharge
|
|
Emergency Department (ED) visit(s) after index hospitalization, #
기간: 30 days after discharge
|
Exploratory
|
30 days after discharge
|
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Emergency Department (ED) visit(s) after index hospitalization, y/n
기간: 30 days after discharge
|
Exploratory
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30 days after discharge
|
|
Imaging, #
기간: 30 days after discharge
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Exploratory
|
30 days after discharge
|
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Imaging, y/n
기간: 30 days after discharge
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Exploratory
|
30 days after discharge
|
|
Lab orders, #
기간: 30 days after discharge
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Exploratory
|
30 days after discharge
|
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Lab orders, y/n
기간: 30 days after discharge
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Exploratory
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30 days after discharge
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Physician visits, y/n
기간: 30 days after discharge
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Exploratory
|
30 days after discharge
|
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Physician visits, #
기간: 30 days after discharge
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Exploratory
|
30 days after discharge
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|
Home health utilization, days
기간: 30 days after discharge
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Exploratory
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30 days after discharge
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Home health utilization, y/n
기간: 30 days after discharge
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Exploratory
|
30 days after discharge
|
|
All cause 30-day mortality, y/n
기간: 30 days after discharge
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Exploratory
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30 days after discharge
|
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Unplanned 30-day mortality, y/n
기간: 30 days after discharge
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Exploratory
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30 days after discharge
|
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Change in medication list due to error at discharge, y/n
기간: Visit date
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Exploratory
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Visit date
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Pneumococcal vaccination if appropriate, y/n
기간: 30 days after discharge
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Exploratory
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30 days after discharge
|
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Influenza vaccination if appropriate, y/n
기간: 30 days after discharge
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Exploratory
|
30 days after discharge
|
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Smoking cessation counseling if appropriate, y/n
기간: 30 days after discharge
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Exploratory
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30 days after discharge
|
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Evaluation of ejection fraction as assessed by echocardiogram or other appropriate study, scheduled or completed, if not done within 1 year; y/n
기간: 30 days after discharge
|
Heart failure patients only; Exploratory; appropriate studies include cardiac magnetic resonance imaging, radionuclide ventriculography, single photon emission computed tomography myocardial perfusion imaging, or left ventriculography
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30 days after discharge
|
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Angiotensin converting enzyme inhibitor or angiotensin receptor blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
기간: 30 days after discharge
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Heart failure patients only; Exploratory
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30 days after discharge
|
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Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
기간: 30 days after discharge
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Heart failure patients only; Exploratory
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30 days after discharge
|
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Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
기간: 30 days after discharge
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Heart failure patients only; Exploratory
|
30 days after discharge
|
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Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n
기간: 30 days after discharge
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Heart failure patients only; Exploratory
|
30 days after discharge
|
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Smoking status post-discharge
기간: 30 days after discharge
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Heart failure patients only; Exploratory
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30 days after discharge
|
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Use of inappropriate medications in the elderly, y/n
기간: 30 days after discharge
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Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria
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30 days after discharge
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Time between discharge and visit, days
기간: Date of home visit
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Exploratory
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Date of home visit
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Duration of physician visit, minutes
기간: Date of home visit
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Exploratory
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Date of home visit
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jeffrey Schnipper, MD MPH, Brigham and Women's Hospital
간행물 및 유용한 링크
일반 간행물
- Epstein K, Juarez E, Loya K, Gorman MJ, Singer A. Frequency of new or worsening symptoms in the posthospitalization period. J Hosp Med. 2007 Mar;2(2):58-68. doi: 10.1002/jhm.170.
- Boling PA. Care transitions and home health care. Clin Geriatr Med. 2009 Feb;25(1):135-48, viii. doi: 10.1016/j.cger.2008.11.005.
- Meyer GS, Gibbons RV. House calls to the elderly--a vanishing practice among physicians. N Engl J Med. 1997 Dec 18;337(25):1815-20. doi: 10.1056/NEJM199712183372507.
- Wong FK, Chow SK, Chan TM, Tam SK. Comparison of effects between home visits with telephone calls and telephone calls only for transitional discharge support: a randomised controlled trial. Age Ageing. 2014 Jan;43(1):91-7. doi: 10.1093/ageing/aft123. Epub 2013 Aug 26.
- Branowicki PM, Vessey JA, Graham DA, McCabe MA, Clapp AL, Blaine K, O'Neill MR, Gouthro JA, Snydeman CK, Kline NE, Chiang VW, Cannon C, Berry JG. Meta-Analysis of Clinical Trials That Evaluate the Effectiveness of Hospital-Initiated Postdischarge Interventions on Hospital Readmission. J Healthc Qual. 2017 Nov/Dec;39(6):354-366. doi: 10.1097/JHQ.0000000000000057.
- Wolff JL, Meadow A, Boyd CM, Weiss CO, Leff B. Physician evaluation and management of Medicare home health patients. Med Care. 2009 Nov;47(11):1147-55. doi: 10.1097/MLR.0b013e3181b58e30.
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 (실제)
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
- P000719
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
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. .
Home visit에 대한 임상 시험
-
University of North Carolina, Chapel HillNational Institute of Nursing Research (NINR)모병
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University Health Network, Toronto모병림프종 | 림프 증식 장애 | 유방암 1기 | 유방암 2기 | 대장암 2기 | 대장암 3기 | 유방암 3기 | 대장암 1기 | 두경부암 3기 | 유방암, 0기 | 두경부암 1기 | 두경부암 2기캐나다
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Alberto Pilotto완전한
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Anita Misra-HebertPatient-Centered Outcomes Research Institute; The Cleveland Clinic모병
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)완전한
-
University Hospital, Angers완전한
-
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