After Discharge Management of Low Income Frail Elderly
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00328848 |
|
Recruitment Status :
Completed
First Posted : May 22, 2006
Last Update Posted : July 17, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure, Congestive Coronary Arteriosclerosis Atrial Fibrillation Cerebrovascular Accident Pulmonary Disease, Chronic Obstructive Diabetes Mellitus Hypertension Osteoarthritis Osteoporosis | Behavioral: Behavioral Behavioral: behavioral | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 530 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Health Services Research |
| Official Title: | After Discharge Management of Low Income Frail Elderly (AD-LIFE) |
| Study Start Date : | October 2005 |
| Actual Primary Completion Date : | April 2013 |
| Actual Study Completion Date : | April 2013 |
| 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) Behavioral: behavioral patient education, self management support, caregiver support |
- Function [ Time Frame: Length of Study ]
- Quality of life [ Time Frame: Duration ]
- Quality of medical management [ Time Frame: Duration ]
- Mortality [ Time Frame: Duration ]
- Opportunity costs of caregiver time [ Time Frame: Duration ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 66 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328848
| Principal Investigator: | Kyle R Allen, DO | Riverside Health System |
Publications:
| Responsible Party: | Susan E. Hazelett, Investigator, Summa Health System |
| ClinicalTrials.gov Identifier: | NCT00328848 History of Changes |
| Other Study ID Numbers: |
1R01HS014539-01A1 ( U.S. AHRQ Grant/Contract ) 1R01HS014539-01A1 ( U.S. AHRQ Grant/Contract ) |
| First Posted: | May 22, 2006 Key Record Dates |
| Last Update Posted: | July 17, 2014 |
| Last Verified: | July 2014 |
Keywords provided by Susan E. Hazelett, Summa Health System:
|
patient care management chronic disease |
Additional relevant MeSH terms:
|
Diabetes Mellitus Heart Failure Osteoarthritis Lung Diseases Atrial Fibrillation Osteoporosis Chronic Disease Pulmonary Disease, Chronic Obstructive Stroke Arteriosclerosis Coronary Artery Disease Myocardial Ischemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Heart Diseases Cardiovascular Diseases Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Respiratory Tract Diseases Arrhythmias, Cardiac Pathologic Processes Bone Diseases, Metabolic Bone Diseases Disease Attributes Lung Diseases, Obstructive Cerebrovascular Disorders Brain Diseases |