Clinical trial NCT01629043: Parkinson's Foundation Quality Improvement Initiative
Official title: Parkinson's Foundation Quality Improvement Initiative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's
Quality of Care
Improvement
Mobility
Cognition
Caregiver burden
Center difference
Lead sponsor: National Parkinson Foundation
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 13000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any person who receives medical care for the diagnosis of idiopathic Parkinson's disease at any of the participating Centers is eligible to participate in the Registry. There are no limitations for participation based on age, disease severity or presence of cognitive impairments.

Brief summary: In a recent study it was found that neurologist care for Parkinson's provides a 20% reduction in nursing home placement, hip fracture, and death (Willis 2011). However, as the authors recognized, the investigators don't know what it is about expert care that delivers this benefit. The Parkinson's Foundation's Quality Improvement Initiative was designed to identify the components of great care that yield great outcomes. By capturing demographics, clinical interventions and outcomes over time from multiple centers across the U.S, Canada and internationally, the best care practices from different clinics and different healthcare systems will be analyzed.

Detailed description: In a recent study it was found that neurologist care for Parkinson's provides a 20% reduction in nursing home placement, hip fracture, and death (Willis 2011). However, as the authors recognized, we don't know what it is about expert care that delivers this benefit. The Parkinson's Foundation's Quality Improvement Initiative was designed to identify the components of great care that yield great outcomes. By capturing demographics, clinical interventions and outcomes over time from multiple centers across the U.S, Canada and internationally, the best care practices for improving care, survival, and quality of life from different clinics and different healthcare systems will be analyzed.

The Parkinson's Foundation's QII contains demographic data, information about the patient's Parkinson's disease and other comorbid illness, patient assessments of Parkinson's related physical, emotional and cognitive disability and clinician tests of mobility, memory and cognition. It also includes data on the burden of the disease on caregivers. The tests and questionnaire instruments are currently in regular use in clinical practice. The intent of the registry is not to evaluate the instruments themselves but to collect essential data from previously validated tools.

Registry data will be used to study the relationship between treatment and clinical symptoms of patients with Parkinson's. It will also be used to evaluate and improve care of patients at participating Centers. Through presentation and publication of results, it is hoped that improvement will become more widespread. Important benefits provided by such a Registry may ultimately be to:

* Determine the long term effects of Parkinson's disease and related conditions on quality of life;
* Generate regular reports for Centers including descriptions of their Parkinson's patient populations, treatments utilized at the Center and trends in their patients' outcomes over time;
* Describe differences in current practice across Centers in the care of Parkinson's patients;
* Identify patients who may be candidates for participation in trials of new medications;
* Facilitate or initiate quality improvement efforts intended to enhance survival and/or improve quality of life for Parkinson's disease patients; and
* Publish and otherwise disseminate findings related to most effective treatments to encourage rapid adoption of "best practices."

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with idiopathic Parkinson's disease receiving medical care for the diagnosis of idiopathic Parkinson's disease at any of the participating Centers.

Exclusion Criteria:

Patients who are not willing or won't be able to give written informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute - Muhammad Ali Parkinson Center
state: Arizona
city: Sunnyvale
country: United States
facility: Parkinson's Institute and Clinical Center
state: California
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Parkinson's Disease and Movement Disorders Center
state: Florida
city: Miami
country: United States
facility: University of Miami Parkinson's Disease and Movement Disorders Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Parkinson's Disease and Movement Disorders Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center Parkinson's Disease and Movement Disorder Center
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins Parkinson's Disease and Movement Disorder Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center Parkinson's Disease Movement Disorder Center
state: Massachusetts
city: Golden Valley
country: United States
facility: Struthers Parkinson Center
state: Minnesota
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine Parkinson and movement Disorders Center
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University Parkinson Center
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Parkinson's Disease and Movement Disorder Center
state: Pennsylvania
city: Nashville
country: United States
facility: The Vanderbilt Parkinson Disease Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine Parkinson Disease Center and Movement Disorders Clinic
state: Texas
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Markham
country: Canada
facility: Centre for Movement Disorders
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital Movement Disorders Center
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Nijmegen
country: Netherlands
facility: Parkinson Center Nijmegen at Radboud University Nijmegen Medical Center
Study officials:
affiliation: Vanderbilt University Medical Center
name: Thomas Davis, MD
role: STUDY_CHAIR
affiliation: University of Florida
name: Adolfo Ramirez-Zamora, MD
role: STUDY_CHAIR
affiliation: University of Kansas Medical Center
name: Kelly Lyons, PhD
role: STUDY_CHAIR
References:
citation: Okun MS, Siderowf A, Nutt JG, O'Conner GT, Bloem BR, Olmstead EM, Guttman M, Simuni T, Cheng E, Cohen EV, Parashos S, Marsh L, Malaty IA, Giladi N, Schmidt P, Oberdorf J. Piloting the NPF data-driven quality improvement initiative. Parkinsonism Relat Disord. 2010 Sep;16(8):517-21. doi: 10.1016/j.parkreldis.2010.06.005. Epub 2010 Jul 6.