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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
  Purpose

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.


Condition Intervention
Heart Failure, Congestive
Coronary Arteriosclerosis
Atrial Fibrillation
Cerebrovascular Accident
Pulmonary Disease, Chronic Obstructive
Diabetes Mellitus
Hypertension
Osteoarthritis
Osteoporosis
Behavioral: Behavioral
Behavioral: behavioral

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: After Discharge Management of Low Income Frail Elderly (AD-LIFE)

Resource links provided by NLM:


Further study details as provided by Summa Health System:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: Duration ] [ Designated as safety issue: No ]
  • Opportunity costs of caregiver time [ Time Frame: Duration ] [ Designated as safety issue: No ]

Enrollment: 530
Study Start Date: October 2005
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Behavioral
Group Treatment(patient education, self management support, caregiver support)
Behavioral: behavioral
patient education, self management support, caregiver support

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

Ages Eligible for Study:   66 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328848

Sponsors and Collaborators
Summa Health System
Investigators
Principal Investigator: Kyle R Allen, DO Riverside Health System
  More Information

Publications:
Responsible Party: Susan E. Hazelett, Investigator, Summa Health System
ClinicalTrials.gov Identifier: NCT00328848     History of Changes
Other Study ID Numbers: 1 R01 HS014539-01A1, 1 R01 HS014539-01A1
Study First Received: May 18, 2006
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Summa Health System:
patient care management
chronic disease

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Cerebral Infarction
Brain Diseases
Brain Infarction
Brain Ischemia
Atrial Fibrillation
Chronic Disease
Coronary Artery Disease
Diabetes Mellitus
Heart Failure
Hypertension
Lung Diseases
Myocardial Ischemia
Osteoarthritis
Osteoporosis
Pulmonary Disease, Chronic Obstructive
Stroke
Arrhythmias, Cardiac
Arterial Occlusive Diseases
Arthritis
Bone Diseases
Bone Diseases, Metabolic
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Coronary Disease
Disease Attributes
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 25, 2014