search
Back to results

After Discharge Management of Low Income Frail Elderly

Primary Purpose

Heart Failure, Congestive, Coronary Arteriosclerosis, Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Behavioral
behavioral
Sponsored by
Summa Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure, Congestive focused on measuring patient care management, chronic disease

Eligibility Criteria

66 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention care management

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Function
    Quality of life
    Quality of medical management

    Secondary Outcome Measures

    Mortality
    Opportunity costs of caregiver time

    Full Information

    First Posted
    May 18, 2006
    Last Updated
    July 16, 2014
    Sponsor
    Summa Health System
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00328848
    Brief Title
    After Discharge Management of Low Income Frail Elderly
    Official Title
    After Discharge Management of Low Income Frail Elderly (AD-LIFE)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2005 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    April 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Summa Health System

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Congestive, Coronary Arteriosclerosis, Atrial Fibrillation, Cerebrovascular Accident, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Hypertension, Osteoarthritis, Osteoporosis
    Keywords
    patient care management, chronic disease

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    530 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention care management
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Behavioral
    Intervention Description
    Group Treatment(patient education, self management support, caregiver support)
    Intervention Type
    Behavioral
    Intervention Name(s)
    behavioral
    Intervention Description
    patient education, self management support, caregiver support
    Primary Outcome Measure Information:
    Title
    Function
    Time Frame
    Length of Study
    Title
    Quality of life
    Time Frame
    Duration
    Title
    Quality of medical management
    Time Frame
    Duration
    Secondary Outcome Measure Information:
    Title
    Mortality
    Time Frame
    Duration
    Title
    Opportunity costs of caregiver time
    Time Frame
    Duration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    66 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kyle R Allen, DO
    Organizational Affiliation
    Riverside Health System
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21323461
    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.
    Results Reference
    background

    Learn more about this trial

    After Discharge Management of Low Income Frail Elderly

    We'll reach out to this number within 24 hrs