Clinical trial NCT00328848: After Discharge Management of Low Income Frail Elderly
Official title: After Discharge Management of Low Income Frail Elderly (AD-LIFE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Congestive
Coronary Arteriosclerosis
Atrial Fibrillation
Cerebrovascular Accident
Pulmonary Disease, Chronic Obstructive
Diabetes Mellitus
Hypertension
Osteoarthritis
Osteoporosis
Keywords: patient care management
chronic disease
Lead sponsor: Summa Health System
Sponsor class: OTHER
First posted: 2006-05-22
Enrollment: 530
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether comprehensive post-hospitalization interdisciplinary care management can be an effective care delivery model to improve outcomes in low-income frail elderly.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Function
timeFrame: Length of Study
measure: Quality of life
timeFrame: Duration
measure: Quality of medical management
timeFrame: Duration
Secondary outcomes:
measure: Mortality
timeFrame: Duration
measure: Opportunity costs of caregiver time
timeFrame: Duration
Other outcomes:
Locations:
Study officials:
affiliation: Riverside Health System
name: Kyle R Allen, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen KR, Hazelett SE, Jarjoura D, Wright K, Fosnight SM, Kropp DJ, Hua K, Pfister EW. The after discharge care management of low income frail elderly (AD-LIFE) randomized trial: theoretical framework and study design. Popul Health Manag. 2011 Jun;14(3):137-42. doi: 10.1089/pop.2010.0016. Epub 2011 Feb 15.