After Discharge Management of Low Income Frail Elderly

July 16, 2014 updated by: Susan E. Hazelett, Summa Health System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

530

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Function
Time Frame: Length of Study
Length of Study
Quality of life
Time Frame: Duration
Duration
Quality of medical management
Time Frame: Duration
Duration

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: Duration
Duration
Opportunity costs of caregiver time
Time Frame: Duration
Duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Summa Health System

Investigators

  • Principal Investigator: Kyle R Allen, DO, Riverside Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

May 18, 2006

First Submitted That Met QC Criteria

May 18, 2006

First Posted (Estimate)

May 22, 2006

Study Record Updates

Last Update Posted (Estimate)

July 17, 2014

Last Update Submitted That Met QC Criteria

July 16, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01HS014539-01A1 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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