Parkinson's DiseasePF-QIINCT01629043
Parkinson's Foundation Quality Improvement Initiative
An observational study of Parkinson's Disease, run by National Parkinson Foundation at 24 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- How many people
- 13,000 participants
- Where
- 24 sitesin 4 countries
- Study dates
- Jul 2009to Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with idiopathic Parkinson's disease receiving medical care for the diagnosis of idiopathic Parkinson's disease at any of the participating Centers.
Who cannot join
- Patients who are not willing or won't be able to give written informed consent.
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
United States18 sites
Augusta University
Augusta, Georgia, 30912
Johns Hopkins Parkinson's Disease and Movement Disorder Center
Baltimore, Maryland, 21287
Beth Israel Deaconess Medical Center Parkinson's Disease Movement Disorder Center
Boston, Massachusetts, 02114
Northwestern University Parkinson's Disease and Movement Disorders Center
Chicago, Illinois, 60611
University of Florida Parkinson's Disease and Movement Disorders Center
Gainesville, Florida, 32611
Struthers Parkinson Center
Golden Valley, Minnesota, 55427
Baylor College of Medicine Parkinson Disease Center and Movement Disorders Clinic
Houston, Texas, 77030
University of Kansas Medical Center Parkinson's Disease and Movement Disorder Center
Kansas City, Kansas, 66160
University of Miami Parkinson's Disease and Movement Disorders Center
Miami, Florida, 33136
The Vanderbilt Parkinson Disease Center
Nashville, Tennessee, 37232
NYU Langone Medical Center
New York, New York, 10016
Mount Sinai School of Medicine Parkinson and movement Disorders Center
New York, New York, 10029
University of Pennsylvania Parkinson's Disease and Movement Disorder Center
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute - Muhammad Ali Parkinson Center
Phoenix, Arizona, 85013
Oregon Health and Science University Parkinson Center
Portland, Oregon, 97239
Parkinson's Institute and Clinical Center
Sunnyvale, California, 94085
University of South Florida
Tampa, Florida, 33613
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Canada4 sites
University of Alberta
Edmonton, Alberta
Centre for Movement Disorders
Markham, Ontario
McGill University Health Centre
Montreal, Quebec
Toronto Western Hospital Movement Disorders Center
Toronto, Ontario
Netherlands1 site
Parkinson Center Nijmegen at Radboud University Nijmegen Medical Center
Nijmegen
About this study
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.
Read the 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."
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's, Quality of Care, Improvement, Mobility, Cognition, Caregiver burden, Center difference
- Medical subject headings
- Parkinson Disease, Caregiver Burden
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJul 2009
- Primary completionSep 2022
- Study completionJul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Parkinson Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Davis, MD, Study chair, Vanderbilt University Medical CenterAdolfo Ramirez-Zamora, MD, Study chair, University of FloridaKelly Lyons, PhD, Study chair, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629043
- Sponsor's protocol ID
- Parkinson's Foundation-QII
- Acronym
- PF-QII
- Status last verified
- Jul 2023
- First submitted
- 25 Jun 2012
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20609611
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinson's Foundation Quality Improvement Initiative
- ClinicalTrials.gov ID
- NCT01629043
- Acronym / sponsor ID
- PF-QII / Parkinson's Foundation-QII
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's, Quality of Care, Improvement, Mobility, Cognition, Caregiver burden, Center difference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,000 participants (actual)
- Lead sponsor
- National Parkinson FoundationUniversity, hospital or other
- Study start
- Jul 2009 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Jul 2023 (actual)
- First posted
- 27 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients diagnosed with idiopathic Parkinson's disease receiving medical care for the diagnosis of idiopathic Parkinson's disease at any of the participating Centers.
Key exclusion criteria (1 listed)
- Patients who are not willing or won't be able to give written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Background: PubMed 20609611Okun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Davis, MD study chair
Vanderbilt University Medical Center
Adolfo Ramirez-Zamora, MD study chair
University of Florida
Kelly Lyons, PhD study chair
University of Kansas Medical Center
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by National Parkinson Foundation at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada, Israel, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01629043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.