After Discharge Management of Low Income Frail Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Susan E. Hazelett, Summa Health System
ClinicalTrials.gov Identifier:
NCT00328848
First received: May 18, 2006
Last updated: July 16, 2014
Last verified: July 2014

May 18, 2006
July 16, 2014
October 2005
April 2013   (final data collection date for primary outcome measure)
  • Function [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Duration ] [ Designated as safety issue: No ]
  • Quality of medical management [ Time Frame: Duration ] [ Designated as safety issue: No ]
  • Functional performance
  • Quality of life
  • Quality of medical management
  • Quality of self-management
  • Institutionalization days
Complete list of historical versions of study NCT00328848 on ClinicalTrials.gov Archive Site
  • Mortality [ Time Frame: Duration ] [ Designated as safety issue: No ]
  • Opportunity costs of caregiver time [ Time Frame: Duration ] [ Designated as safety issue: No ]
  • Mortality
  • Opportunity costs of caregiver time
Not Provided
Not Provided
 
After Discharge Management of Low Income Frail Elderly
After Discharge Management of Low Income Frail Elderly (AD-LIFE)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
  • Heart Failure, Congestive
  • Coronary Arteriosclerosis
  • Atrial Fibrillation
  • Cerebrovascular Accident
  • Pulmonary Disease, Chronic Obstructive
  • Diabetes Mellitus
  • Hypertension
  • Osteoarthritis
  • Osteoporosis
  • Behavioral: Behavioral
    Group Treatment(patient education, self management support, caregiver support)
  • Behavioral: behavioral
    patient education, self management support, caregiver support
Experimental: 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.
Interventions:
  • Behavioral: Behavioral
  • Behavioral: behavioral
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
530
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
66 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00328848
1 R01 HS014539-01A1, 1 R01 HS014539-01A1
Yes
Susan E. Hazelett, Summa Health System
Summa Health System
Not Provided
Principal Investigator: Kyle R Allen, DO Riverside Health System
Summa Health System
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP