Improving Partnerships With Family Members of ICU Patients (IMPACT)
Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial
연구 개요
상세 설명
There is a pressing need to improve the care of critically ill older patients. For critically ill patients who are frequently unable to participate in their own care and decision-making, partnering with their family members is particularly important for improving experiences and outcomes of care for both patients and families. However, the optimal means by which families engage in the role they play, and how best to capacitate them as advocates and partners in care while helping them maintain their own wellbeing, is not known.
The IMPACT trial will evaluate two interventions, each with a separate context, but similar in that they empower and support families; one focused on involvement in care, and the other focused on involvement in decision-making. The first is a nutrition intervention The OPTimal nutrition by Informing and Capacitating family members of best practices (OPTICs) intervention, a multi-faceted strategy to engage and empower family members to advocate for and audit best nutrition practices in their family members. The second is a decision support intervention. The REALISTIC-80 Decision Support Intervention, is a web-based tool (www.myicuguide.com) to support families in shared decision-making about goals of medical treatments.
The investigators propose to conduct a mixed methods multi-centre, open-label, randomized, clinical trial involving 3 groups (2 active interventions and a usual care group). The overall goal of this study is to demonstrate that the multi-faceted nutritional strategies that engage families in care of their family member tested in this trial will increase nutritional intake and optimize physical recovery in older critically ill patients at high nutrition risk.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Arizona
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Phoenix, Arizona, 미국, 85012
- 모병
- Phoenix VA Medical Center
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연락하다:
- Mary Chew
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Missouri
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Saint Louis, Missouri, 미국, 63110-1093
- 모병
- Barnes Jewish Hospital/Washington University
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연락하다:
- Beth Taylor
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Pennsylvania
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Hershey, Pennsylvania, 미국, 17033
- 모병
- Penn State Milton S. Hershey Medical Center
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연락하다:
- Lauren Van Scoy
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Washington
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Vancouver, Washington, 미국, 98686
- 모병
- Legacy Salmon Creek Medical Center
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연락하다:
- Joseph Jura, Dr
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- 모병
- Medical College of Wisconsin
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연락하다:
- Jayshil Patel
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Alberta
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Calgary, Alberta, 캐나다
- 빼는
- University Of Calgary
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Ontario
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Ottawa, Ontario, 캐나다
- 모병
- University of Ottawa
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연락하다:
- Kwadwo Kyeremanteng
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Toronto, Ontario, 캐나다
- 모병
- Sunnybrook Health Science Centre
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연락하다:
- Dominique Piquette
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Toronto, Ontario, 캐나다
- 종료됨
- University Health Network
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Queensland
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Gold Coast, Queensland, 호주
- 모병
- Gold Coast Health
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연락하다:
- Andrea Marshall
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for Patients:
1a) > 60 years of age OR
1b) 55 years to 59 years old with one or more of the following diagnoses:
- Chronic obstructive lung disease - 2 of the 4 of: baseline PaCO2 of > 45 torr, cor pulmonale; respiratory failure episode within the preceding year; forced expiratory volume in 1 sec <0.5 L.
- Congestive heart failure - New York Heart Association class IV symptoms and left ventricular ejection fraction < 25%.
- Cirrhosis - confirmed by imaging studies or documentation of esophageal varices and one of three conditions: a) hepatic coma, b) Child's class C liver disease, or c) Child's class B liver disease with gastrointestinal bleeding.
- Cancer - metastatic cancer or stage IV lymphoma.
- End-stage dementia (inability to perform all ADLs, mutism or minimal verbal output secondary to dementia, bed-bound state prior to acute illness) 2) Have a projected duration of ICU dependency of >72 hours from time of final assessment. We define ICU dependency as the need for one or more of the following:
- Mechanical ventilation
- Non-invasive ventilation
- Renal replacement therapy
- Vasopressors or
- Artificial nutrition because of their underlying illness
Exclusion Criteria for Patients:
- Patients who are not expected to remain alive in ICU for 72 hours after initial screening (physician judgment) or for whom life-sustaining treatments are expected to be withdrawn in the subsequent 72 hours (as sufficient time will be required for implementation of the study interventions)
- Uncomplicated elective surgical patients (regardless of age)
- Patients who have received organ transplantation during this hospitalization
Inclusion Criteria for Family Member:
- 18 years of age or older,
- present and expected to visit regularly (minimum about 3 times a week) while the patient is in hospital
- the nominated or legally appointed substitute decision-maker
- able to communicate in English (verbally and in writing).
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: Nutrition Education Program
Nutrition education for family members of an elderly critically ill patient
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다른 이름들:
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실험적: Decision Support Program
Decision support education for family members of an elderly critically ill patient
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다른 이름들:
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간섭 없음: 평상시 관리
개입 없음
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Nutritional adequacy during the ICU stay
기간: Up to 30 days in ICU
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Up to 30 days in ICU
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Consumption of Oral Nutritional Supplements
기간: First four weeks once on ward
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First four weeks once on ward
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Intake on hospital wards (3 day calorie count)
기간: First four weeks once on ward
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First four weeks once on ward
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Hand grip strength
기간: At or before hospital discharge or up to 90 days
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Hydraulic hand dynamometer
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At or before hospital discharge or up to 90 days
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Use of shared-decision making (OPTION tool)
기간: Within first week in ICU
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Within first week in ICU
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Change in decisional conflict
기간: 1 week
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10-item Decisional Conflict Scale
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1 week
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Family satisfaction with decision-making
기간: 1 week
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1 week
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Overall family satisfaction with ICU
기간: At ICU discharge, an average of 12 days
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At ICU discharge, an average of 12 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Daren Heyland, MD, Clinical Evaluation Research Unit
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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
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