- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00328848
After Discharge Management of Low Income Frail Elderly
After Discharge Management of Low Income Frail Elderly (AD-LIFE)
연구 개요
상태
개입 / 치료
상세 설명
This randomized trial will test the effectiveness of improved clinical practice through comprehensive care management in elderly patients with chronic illness and functional impairment discharged from an acute care hospital. For the intervention group, patient care will be coordinated by a nurse care manager who will perform a comprehensive in home assessment and provide patient education and self management support. The care manager will work with an interdisciplinary team (IT) to develop and implement a plan of care. Evidence based care plans will be implemented in collaboration with the patient, the primary care physician (PCP), the local Area Agency on Aging (AAoA), and other community social agencies. The care manager will provide frequent patient follow up across all providers to ensure integration of medical and social issues. Control patients will be referred to the local AAoA with no IT follow up. Although control patients will receive, through the AAoA, referrals for care and psychosocial support, the absence of a care manager and IT will, we expect, result in functional decline, lower quality of life, and higher health care costs.
The intervention (n=265) and control (n=265) groups will be compared at 1 year on a profile of health and well being using a multiple endpoint global hypothesis testing strategy. The global measure will be comprised of the following 5 domains: function, institutionalization, quality of life, quality of medical management, and quality of self management. Priority populations identified by AHRQ who are targeted in this study include the elderly, patients with chronic illnesses, low income (dual eligible), and patients with disabilities. This study also includes minorities, women, and patients who live in the inner city. Future economic analyses of benefits (for which alternative funding is currently being sought) will inform policy makers about funding care management in AHRQ priority populations.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- > 65 years old
- Confirmed or probable dual eligible
- Have at least one chronic illness (chronic obstructive pulmonary disease [COPD], diabetes, stroke/atrial fibrillation, ischemic heart disease, hypertension, congestive heart failure [CHF], osteoporosis, osteoarthritis) and at least 1 impaired activity of daily living (ADL) 11 or 2 impaired instrumental activities of daily living (IADLs)
- Be discharged home or to a skilled nursing facility (or acute rehabilitation) for a maximum of 8 weeks before being discharged to home
Exclusion Criteria:
- Enrolled in this health system's care management program
- Chemically dependent
- Those with a Mental Status Questionnaire score > 5
- Diagnosed psychosis
- Dialysis
- Terminal diagnosis/hospice
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intervention care management
post dischsrge care management by a nurse care manager who performs in-home vistis and reports to a interdisciplinary team.
Team generates care recommendations based on patient goals.
PCP and care manager implement the care plan that is based on patient goals.
Includes education, behavioral interventions, and coaching.
|
Group Treatment(patient education, self management support, caregiver support)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Function
기간: Length of Study
|
Length of Study
|
|
Quality of life
기간: Duration
|
Duration
|
|
Quality of medical management
기간: Duration
|
Duration
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Mortality
기간: Duration
|
Duration
|
|
Opportunity costs of caregiver time
기간: Duration
|
Duration
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Kyle R Allen, DO, Riverside Health System
간행물 및 유용한 링크
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 (추정)
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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