- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01039324
Care Transitions for Complex Patient - Cycle 1 and Cycle 2
Improving Care Transitions for Complex Patients Through Decision Support
The purpose of this study is to improve patient care and safety while decreasing ED visit rates by sending specific information about care transitions related to hospital admission and discharge and emergency department and specialty care visits to primary care practices, care managers and patients with the use of health information technology (HIT) shared across a community-based network of providers.
Cycle 1 focuses on the impact of notices about ED encounters and hospitalizations derived from billing data that are sent to care managers for all 47,000 patients in the Northern Piedmont Community Care Network (NPCCN). Cycle 2 explores the impact of letters sent to patients, and care event reports sent to a patient's medical home in addition to notices sent to care managers about ED encounters, hospitalization and specialty care based on ADT (Admission Discharge Transfer) and billing data on 4,600 patients with complex health needs.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
This three-year project seeks to improve outcomes, quality and coordination of care for patients with complex healthcare needs by facilitating the availability of information following three types of care transitions into the ambulatory care setting. Specific information regarding care transitions will be made available to patients, primary care practitioners and care managers following hospitalizations, emergency department (ED) encounters, and specialty clinic evaluations.
This project will build upon a regional Health Information Exchange (HIE) network created to connect providers serving 47,000 Medicaid beneficiaries across traditional institutional boundaries from both rural and urban settings in a 6-county region in the Northern Piedmont of North Carolina. This network includes 25 ambulatory care practices, 3 federally qualified health centers, 4 rural health clinics, 3 urgent care facilities, 11 government agencies, 5 hospitals and 2 cross-disciplinary care management teams. Within this HIE network, 4,600 patients with complex healthcare needs have been identified.
For this project, a standards-based clinical decision support tool will be utilized in order to ensure that the proposed approach is generalized, portable, and scalable; and routinely available claims and scheduling data will be used as the primary data source. This approach will support both traditional clinic-based models of care as well as new care models including population health management and the use of cross-disciplinary teams.
Under Aim 1, the existing HIE network and decision support tool will be enhanced to enable detection of transitions in care and delivery of timely, patient-specific information regarding these care transitions to patients, primary care clinicians and multidisciplinary care management team members. Under Aim 2, the impact of the proposed approach will be evaluated in a two-cycle randomized controlled trial primarily involving approximately 47000 Medicaid beneficiaries with a special focus on 4600 patients with complex health needs, 309 primary care clinicians, and 31 care management workers. Cycle 1 will assess only daily notices sent to care managers and will use only billing data. Cycle 2 will evaluate all components of the proposed intervention and us both billing and ADT data (see below). For Cycle 1, patients will be randomly assigned by family unit to either receive or not receive email notices sent to their care managers. For Cycle 2 patients will be randomly assigned to one of three groups: 1) information on care transitions sent to patients and their clinic-based caregivers; 2) information sent to patients, their clinic-based caregivers and their care managers; and 3) no information sent. The primary outcome measure will be the overall rate of ED utilization for each study group. Under Aim 3, the economic attractiveness of the proposed approach will be determined. Under Aim 4, the technology and results of this study will be disseminated through public media, publications and presentations. Information-augmented care transitions between sites should result in improved care coordination, higher quality of care, and more appropriate care.
This trial will be deployed in two cycles in order to support the needs of the care management network while the full intervention is developed. Cycle 1 will run from December, 2009 through December, 2010. It will assess the impact of notices about hospital admissions and ED encounters derived from billing data and sent daily to care managers for the 47,000 patients enrolled in NPCCN on the study outcomes. Cycle 2 will run from December, 2010 through December, 2011 and will address AIM 2 of the original grant proposal. For Cycle 2, events detected from ADT and billing data will be generated daily. The events will include hospital admissions, hospital discharges, ED encounters, and specialty care visits. The responses to events will include event summary reports sent to patients' assigned medical homes, letters sent to patients or their guardians, and release of information requests on behalf of a patient's medical home. The response will be generated for 4,600 patients identified as having complex health needs. In addition, notices will be sent to care managers for detected hospital and ED events for all 47,000 patients enrolled in NPCCN. Special priority will be given to patients with complex heath needs.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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North Carolina
-
Durham, North Carolina, Spojené státy, 27710
- Duke University Medical Center (Division of Clinical Informatics)
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- North Carolina Medicaid beneficiary enrolled in the Northern Piedmont Community Care Network (NPCCN)
- Has complex healthcare needs as defined by having two or more IOM (Institute of Medicine) priority conditions (hypertension, coronary artery disease, congestive heart failure, stroke, asthma, diabetes) OR one of the following: moderate to severe mental health diagnosis (schizophrenic disorder, episodic mood disorder, delusional disorder, non-organic psychosis, anxiety, dissociative-somatoform disorder, personality disorder), end-stage renal disease, sickle cell disease
- Continuous enrollment in NPCCN for 10 of the previous 12 months
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Intermediate Intervention (arm #1)
Care transition reports sent to primary care clinics, care transition letters sent to patients, release of information requests about care transitions sent on behalf of primary care clinics.
|
Primary care event reports and patient letters
|
Experimentální: Full Intervention (arm #2)
E-mail notices sent to care managers about care transitions plus care transition reports sent to primary care clinics, care transition reports sent to patients, release of information requests about care transitions sent on behalf of primary care clinics.
|
Primary care event reports, patient letters and care manager notices
|
Experimentální: Control (arm #3)
Subjects assigned to the control group will receive "usual care" which is the standard of care coordination currently existent between patients, providers and care managers.
|
This is the study's control group
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Emergency department encounter rates among patients in the study population.
Časové okno: 6 months
|
6 months
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Emergency department encounter rates for low severity diagnoses among all patients.
Časové okno: 6 months
|
6 months
|
Total emergency department encounter rates among patients for whom intervention was appropriate.
Časové okno: 6 months
|
6 months
|
Total emergency department encounter rates among all patients.
Časové okno: 6 months
|
6 months
|
Hospitalization rates among patients for whom intervention was appropriate.
Časové okno: 6 months
|
6 months
|
Hospitalization rates among all patients.
Časové okno: 6 months
|
6 months
|
Hospital readmission rates within 30 days after hospitalization among patients for whom intervention was appropriate.
Časové okno: 6 months
|
6 months
|
Hospital readmission rates within 30 days after hospitalization among all patients.
Časové okno: 6 months
|
6 months
|
Primary care visit rates among patients following an emergency department encounter or hospitalization for whom intervention was appropriate.
Časové okno: 6 months
|
6 months
|
Primary care visit rates among all patients following an emergency department encounter or hospitalization.
Časové okno: 6 months
|
6 months
|
Rates of completion of medically-indicated post hospitalization studies or procedures among patients for whom intervention was appropriate.
Časové okno: 6 months
|
6 months
|
Rates of completion of medically-indicated post hospitalization studies or procedures among all patients.
Časové okno: 6 months
|
6 months
|
Total medical costs among patients for whom intervention was appropriate.
Časové okno: 6 months
|
6 months
|
Total medical costs among all patients.
Časové okno: 6 months
|
6 months
|
Emergency department costs among patients for whom intervention was appropriate.
Časové okno: 6 months
|
6 months
|
Emergency department costs among all patients.
Časové okno: 6 months
|
6 months
|
Hospitalization costs among patients for whom intervention was appropriate.
Časové okno: 6 months
|
6 months
|
Hospitalization costs among all patients.
Časové okno: 6 months
|
6 months
|
Outpatient costs among patients for whom intervention was appropriate.
Časové okno: 6 months
|
6 months
|
Outpatient costs among all patients.
Časové okno: 6 months
|
6 months
|
Patient satisfaction among patients for whom intervention was appropriate.
Časové okno: 6 months
|
6 months
|
Patient-reported quality of life among patients for whom intervention was appropriate.
Časové okno: 6 months
|
6 months
|
Provider satisfaction among providers with contact with patients for whom intervention was appropriate.
Časové okno: 6 months
|
6 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Eric Eisenstein, DBA, Duke University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Pro00010738
- R18HS017795 (Grant/smlouva AHRQ USA)
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