Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Behaviors and Mental Disorders

Nervous System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Diabetes Mellitus

Depressive Disorder

Mental Disorders

Alzheimer Disease

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Depressive Disorder, Major

Depression

Heart Failure

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Lung Diseases

Cerebrovascular Disorders

Psychotic Disorders

Heart Diseases

Dementia

Brain Diseases

Central Nervous System Diseases

Tauopathies

Neurodegenerative Diseases

Neurocognitive Disorders

Respiratory Tract Diseases

Ischemia

Arteriosclerosis

Arterial Occlusive Diseases

Vascular Diseases

Chronic Disease

Disease Attributes

Schizophrenia

Schizophrenia Spectrum and Other Psychotic Disorders

Familial Alzheimer Disease

Chronic Graft Versus Host Disease

Care coordination, consisting variously (depending on the demonstration site)--nurse telephonic counseling, nurse in-person home visits, home telemonitoring equipment, and physician education and feedback.

Usual care in Medicare fee-for-service from beneficiaries' physicians and other health care providers

Depending on the demonstration site, may consist of nurse telephonic counseling and monitoring, nurse in-person or home visits, home telemonitoring equipment, patient educational materials, patient group educations classes, physician education and feedback.

Care Coordination

Randall S. Brown, Ph.D.

Carol A. Magee, Ph.D.

This is a Congressionally mandated study. In the original study, 16 demonstration programs provided care coordination services to beneficiaries with chronic illness in Medicare's fee-for-service program. A five-year CMS-funded study tested whether the programs can improve patients' use of medical services, improve patients' outcomes and satisfaction with care, and reduce Medicare costs. The study also assessed physicians' satisfaction with the programs.

In 2008 Congress extended the project for two of the original programs--Mercy Medical Center - North Iowa and Health Quality Partners in Pennsylvania--and they will enroll Medicare beneficiaries and provide care coordination services into the spring of 2010.

Mathematica Policy Research, Inc. (MPR) evaluated 16 independent demonstration sites that provide coordinated care interventions to Medicare beneficiaries with chronic illnesses. The rationale for the demonstration is the lack of coordination among the multiple providers typically serving Medicare beneficiaries with chronic illnesses, as well as the adverse consequences of the lack of coordination for the beneficiaries and for Medicare costs. The demonstration sites, selected in early 2001, offered programs designed to improve both the care that patients receive and patients' knowledge of, and adherence with, recommended self-care and behavior. The study estimated the effects of each site on patients' well-being and satisfaction, in addition to the site's effects on the use and cost of Medicare covered services. This analysis relied on a patient survey conducted 6 to 12 months after enrollment, and on Medicare claims data and any data available from the demonstration sites that could enhance the study. The study included two rounds of physician surveys. In each site, eligible applicants were randomly assigned to treatment and control groups. An extensive process analysis was conducted to describe the interventions in detail, with the key goal being an assessment of those factors that account for program success and failure. The study included case studies of each site, program profiles, interim site-specific memos, two interim summary reports, two reports to Congress (based on the interim summary reports), and a final summary report. This original study enrolled 18,277 beneficiaries.

In 2008 Congress extended the study for 2 of the sites, Mercy Medical Center - North Iowa and Health Quality Partners in Pennsylvania, and they will recruit beneficiaries and provide demonstration intervention services through the spring of 2010. Mathematica Policy Research will evaluate the results of this extended demonstration using Medicare claims data and qualitative site visits to the two programs.

Evaluation of Programs of Coordinated Care and Disease Management

Centers for Medicare and Medicaid Services

Mathematica Policy Research, Inc.

Diseases and Abnormalities at or Before Birth

Neoplasms

Arteriovenous Malformations

Congenital Abnormalities

Hemangioma

Vascular Malformations

Cardiovascular Abnormalities

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Patients receive only traditional microsurgical operations in traditional operating theaters or the one-staged hybrid operation theater. No endovascular intervention technique or intraoperative digital subtraction angiography(DSA) will be performed. The DSA will be performed in 3 days after the operation.

Patients receive microsurgical operation under the assistance of intraoperative DSA, endovascular embolization and/or balloon occlusion in the one-staged hybrid operating theater.

An integrated procedure that consists of microsurgery, intraoperative DSA, endovascular intervention techniques and other assistance tools. All the procedures are performed in a one-staged operation without any intermission or any transfer of patients.

one-staged hybrid operation

The classical mode of operations in neurosurgery. The operation is performed with neurosurgical instruments and microscope. Some of assisting tools can be used in the operation, such as neuro-navigation, Doppler probe, neural electrophysiological monitoring and so on. But neither the intraoperative DSA nor endovascular intervention techniques is used in the operation

Traditional microsurgical operation

Shuo Wang, MD

Jun Wu, MD

Guilin Li, MD

Weijian Jiang, MD

Donghai Wang, MD

Chuanfeng Li, MD

Liang Chen, MD

Gao Chen, MD

Complex brain arteriovenous malformations (bAVMs) in ≥3 Spetzler-Martin grades have long been challenges among cerebrovascular diseases. None of the traditional methods, such as microsurgical operation, endovascular intervention, or stereotactic radiotherapy, can completely eliminate complex bAVMs without a risk of neural function deterioration. The multistaged hybrid operation solved part of the challenge but remained risky in the installment procedures and intervals. The one-staged hybrid operation was applied in the surgical treatment of cerebrovascular diseases and proved to be a potentially safe and effective method for curing complex bAVMs. However, lacking the support of high-level evidence, its advantages remain unclear. This study was proposed to validate the benefits and risks of one-staged hybrid operation in the treatment of complex bAVMs, as well as its indications, key technologies, and workflows.

The study is being conducted from Jan 2016 to Dec 2020 with 20 cooperation units. It consists of 2 sets. The registry set is designed as a prospective real-world registry. The trial set is designed as a prospective pragmatic clinical trial, specifically for the patients with perforating arterial feeders. The two sets share a common grouping: the traditional operation group and the one-staged hybrid operation group. The assignment is based on the clinical condition in the registry set and is randomized in the trial set. End points will be evaluated at scheduled time points. The safety and efficiency of one-staged hybrid operation in treating complex bAVMs will be validated.

Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations

Study on Benefits and Risks of Hybrid Operation in the Treatment of Complex Brain Arteriovenous Malformations

any complications that occur within 7 days from the date of operation, including intracranial hemorrhage or infarction, infection of the central nervous system, infection of the respiratory system, cranial nerve deficits, and other symptomatic complications

the bAVMs residue revealed by postoperative DSA or computed tomographic angiography

Ministry of Science and Technology of the People´s Republic of China

Director of Neurosurgery Department

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Programs of Coordinated Care and Disease Management	NCT00627029	Congestive Hear... Diabetes Coronary Artery... Chronic Obstruc... Cancer Cerebrovascular... Alzheimer's Dis... Psychotic Disor... Major Depressio...	Care Coordinati...	-	Mathematica Policy Research, Inc.
Evaluation of Programs of Coordinated Care and Disease Management	NCT00627029	Congestive Hear... Diabetes Coronary Artery... Chronic Obstruc... Cancer Cerebrovascular... Alzheimer's Dis... Psychotic Disor... Major Depressio...	Care Coordinati...	-	Mathematica Policy Research, Inc.
Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations	NCT03774017	Cerebrovascular... Arteriovenous M... Complex; Primar...	one-staged hybr... Traditional mic...	- 70 Years	Ministry of Science and Technology of the People´s Republic of China
Evaluation of Programs of Coordinated Care and Disease Management	NCT00627029	Congestive Hear... Diabetes Coronary Artery... Chronic Obstruc... Cancer Cerebrovascular... Alzheimer's Dis... Psychotic Disor... Major Depressio...	Care Coordinati...	-	Mathematica Policy Research, Inc.

Spots Global Cancer Trial Database for cerebrovascular disease