After Discharge Management of Low Income Frail Elderly

Hypertension Clinical Trial

Official title:

After Discharge Management of Low Income Frail Elderly (AD-LIFE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328848
• Other study ID #: 1R01HS014539-01A1
• Secondary ID: 1R01HS014539-01A
• Status: Completed
• Phase: N/A
• First received: May 18, 2006
• Last updated: July 16, 2014
• Start date: October 2005
• Est. completion date: April 2013

Study information

• Verified date: July 2014
• Source: Summa Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 66 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Arteriosclerosis
• Atrial Fibrillation
• Cerebrovascular Accident
• Chronic Disease
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Diabetes Mellitus
• Heart Failure
• Heart Failure, Congestive
• Hypertension
• Myocardial Ischemia
• Osteoarthritis
• Osteoporosis
• Pulmonary Disease, Chronic Obstructive
• Stroke

Intervention

Behavioral:
• Behavioral
Group Treatment(patient education, self management support, caregiver support)
• behavioral
patient education, self management support, caregiver support

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Summa Health System

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function		Length of Study	No
Primary	Quality of life		Duration	No
Primary	Quality of medical management		Duration	No
Secondary	Mortality		Duration	No
Secondary	Opportunity costs of caregiver time		Duration	No