- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00328848
After Discharge Management of Low Income Frail Elderly
After Discharge Management of Low Income Frail Elderly (AD-LIFE)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Group Treatment(patient education, self management support, caregiver support)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Function
Tidsramme: Length of Study
|
Length of Study
|
|
Quality of life
Tidsramme: Duration
|
Duration
|
|
Quality of medical management
Tidsramme: Duration
|
Duration
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Mortality
Tidsramme: Duration
|
Duration
|
|
Opportunity costs of caregiver time
Tidsramme: Duration
|
Duration
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Kyle R Allen, DO, Riverside Health System
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Metabolske sykdommer
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Sykdommer i luftveiene
- Arterielle okklusive sykdommer
- Lungesykdommer
- Muskel- og skjelettsykdommer
- Arytmier, hjerte
- Lungesykdommer, obstruktiv
- Koronar sykdom
- Beinsykdommer
- Bensykdommer, metabolske
- Hjertefeil
- Slag
- Koronararteriesykdom
- Myokardiskemi
- Lungesykdom, kronisk obstruktiv
- Atrieflimmer
- Osteoporose
- Arteriosklerose
Andre studie-ID-numre
- 1R01HS014539-01A1 (U.S.A. AHRQ-stipend/kontrakt)
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