Investigators/Authors: Mark Guttman, MD, Centre for Movement Disorders; Markham, Canada; Tanya Simuni, MD, Northwestern University, Chicago, IL; Peter Schmidt, Ph.D., Miami, FL.
Objectives:The over-arching objective of the Parkinson’s Outcomes Project is to develop the infrastructure, resources, and evidence necessary to deploy a scalable system to support the provision of efficacious care to everyone with Parkinson’s disease. Over the next year, we intend to advance against two objectives: (1) develop, validate, and test a Parkinson’s severity scale, addressing clinically-measured and patient reported motor and non-motor symptoms of Parkinson’s disease that can be used to associate actual versus expected outcomes; and (2) develop an electronic data capture system to allow clinicians to collect the information necessary to track this severity scale in a patient while providing in real-time a display of any historical data and a comparison with the results in other, similar patients.
Background: The Parkinson’s Outcomes Project is a comparative effectiveness study of Parkinson’s disease designed to compare the care delivered across centers and neurologists who provide care at NPF’s Centers of Excellence. The study, which currently includes almost 7,000 patients followed longitudinally by over 150 neurologists for four years and counting (the average subject has at least one year of follow-up, with 23% followed for over two years), evaluates subject demographics, care, and both patient-reported and clinically measured outcomes with the goal of identifying the care practices that result in better outcomes.
Piloted using a paper form, data collected to-date have shown that the broad vision of the Parkinson’s Outcomes Project requires electronic data collection to provide feed-forward data (i.e., consistent and systematically collected data from past visits presented for review at the current visit) and feedback on how the current subject’s status compares to other similar subjects seen previously.
Methods/Design: The project will start with a modified Delphi process to define the feed-forward, feedback display definition, including the design of the key metrics. Key metrics will be selected with attention to the risk of information overload in a clinical setting that has hampered previous attempts to quantify Parkinson’s. After definition, the investigators will oversee the implementation of this system in a web-based system with a mobile interface. This system will be deployed in clinics as part of a validation study designed to evaluate the feasibility of including such a system in routine care, the usefulness of the metrics selected to clinical decision making, and the correlation between the metrics selected and other commonly-used metrics for the health and clinical status of people with Parkinson’s.
Relevance to Diagnosis/Treatment of Parkinson’s disease: Based on data published in the literature, over 6,000 people die annually from poor Parkinson’s care, due to the fact that the risk-adjusted mortality rate for people with Parkinson’s managed in primary care is 28% higher than that of those managed by a neurologist. These patients are also approximately 25% more likely to break their hip or be placed in a nursing home. Our goal is to help save those lives and prevent these complications and to provide people with Parkinson’s the longest, best life possible.
September 2014 Project Update:
In January, 2014, a set of six key metrics were presented to leaders of NPF Centers of Excellence as the basis for center-center comparisons and as the basis for ongoing evaluation. These six metrics were: health-related quality of life (HRQL), caregiver strain, mobility, cognition, falls, and hospital admissions. To establish their validity for use in informing patients of their relative status, an analytical technique was developed for comparing across diverse patient sets by creating tranches across the population, computing results within each tranche, and then computing an equally-weighted sum across a center’s cohort. Example results from this approach are available on request.
These metrics were subsequently applied to analyze individual results. A software system was developed to select individuals by proximity to a selected candidate by minimizing the norm (equivalent to distance in a carteasian representation) in age and disease duration difference. Using this technique, an arbitrary number of the subjects most similar to the candidate can be selected. To date, the typical number used in comparison sets has been 100, providing good resolution when preparing a percentile scale.
Using this approach, the characteristics of populations and individuals can be compared. First a range of observed outcomes for each variable or a weighted sum of the variables in the comparison patient set is computed. Subsets may be computed to represent patients who do or do not exercise, who are on or not on levodopa or other medications, or other variables. An individual may be compared to the entire comparison set or to the subset that represents that individual’s treatment plan. Then, longitudinal results can be examined to anticipate the effect of a change in the treatment plan. This model has been implemented manually. The coding of this model into an automatic algorithm is the next step.
This study is not yet complete however these results represent the scientific foundation of and, we believe, good progress towards the project goal.
September 2015 Project Update:
Soon after NPF started work on this project, 23andMe was sued by the FDA for providing medical advice. A patient focus group meeting identified little interest in the patient-facing dashboard feature. However, the technology to underly the dashboard concept was completed: given an age, sex, and Parkinson’s duration, software was developed to produce a cohort of 100 closely matched individuals for comparison. Sensitivity analysis resulted in the ratio of the age and duration windows (e.g., +/- 2 years in age, +/- 1 year in duration) being variable depending on duration, where earlier stage patients were better matched across a wider age window but narrower duration window.
Aim 1: Data collection in the Parkinson’s Outcomes Project has continued and the dataset includes over 8,000 individuals and nearly 20,000 clinical evaluations, resulting in the largest clinical study of Parkinson’s disease ever conducted.
Aim 2: While the design of the dashboard was completed and a prototype developed, the dashboard was not constructed. Reports have been made upon request, an automated comparison dashboard has been deferred until a better understanding of the regulatory implications can be developed.
Aim 3: NPF centers of excellence have been provided a report detailing their site’s performance versus other sites. These reports offered detailed information about prescribing patterns, use of DBS, and other clinical parameters and gives a report on each site’s performance across six outcome domains: health-related quality of life, mobility, cognition, falls, caregiver strain, and hospitalizations.
Results: We believe that these results represent good progress towards the overall objectives of the program. It is unfortunate that the Dashboard project was delayed by regulatory concerns, but we believe that the philosophy underlying the dashboard, that of transparency and quality improvement to drive a higher quality of life, is embodied in the over-arching Parkinson’s Outcomes Project. We deeply appreciate the support of the Parkinson’s Unity Walk.
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Investigators/Authors: Janis Miyasaki, MD, Toronto Western Hospital, Toronto, Ontario, Canada
Objectives: (1) To determine which quality of life interventions can provide an improvement in patients’ end-of-life care; (2) To determine whether home palliative care can relieve caregiver burden compared to hospitalization; (3) To determine the best method of pain/discomfort assessments and management for advanced-stage Parkinson’s disease; (4) To identify patient care goals, determine priorities of care, and to design strategies to achieve expected outcomes of care.
Background: For over three years, Dr. Miyasaki has been developing a palliative care program at Toronto Western. In Parkinson’s, the palliative phase of the disease lasts, on average, 2.2 years and is defined by decreased response to dopamine replacement therapy and cognitive decline. As symptomatic therapies fail, palliative care provides comfort in spite of symptom expression. One study found that 42% of patients with advanced disease had difficulties in their daily life that were not being addressed by their healthcare team. Palliative care is intended to address this. Taking a holistic approach to providing comfort to the patient, palliative care focuses on reducing the impact of disease and has been found in study after study to deliver better quality of life to patients in whom symptomatic therapy has decreased efficacy.
Methods/Design: Dr. Miyasaki will expand the existing Toronto Western palliative care program that over the past year delivered 507 visits seen by the multidisciplinary palliative care team. For each patient seen in the palliative care program, the team will evaluate clinical status, patient-reported outcomes, and caregiver strain. These results will be joined with encounter data, patient demographics, and interventions and evaluated on a pre- and post-intervention basis and versus patients who do not participate in the palliative care program.
Relevance to Diagnosis/Treatment of Parkinson’s disease: The suffering associated with advanced Parkinson’s disease as treatments fail and dystonia and other symptoms increasingly result in discomfort and distress is frequently not addressed in clinics. Until we can eliminate Parkinson’s, the impact of advanced disease is an unavoidable consequence of its progression and we need to take steps to improve the lives of patients at every stage of the disease.
September 2014 Project Update:
During the grant period, Dr. Miyasaki left Toronto Western Hospital to join the team at the University of Alberta. The palliative care program remained at the Toronto Western Hospital.
The loss of Dr. Miyasaki has not resulted in a set-back for the palliative care program. Under the new leadership of neurologist Dr. Veronica Bruno and spiritual counselor Rena Arshinoff (Rabi Arshinoff was named by the Jewish Daily Forward as one of America’s Most Inspiring Rabis of 2014), the palliative care program has been able to actively manage 180 patients with late-stage Parkinson’s disease in the past year.
Toronto Western Hospital was identified as a top-performing center for patient outcomes through the Parkinson’s Outcomes Project. As a top-performing center, NPF conducted an in-depth site review including independent raters of the care and systems of care at the center. Evaluators pointed out the palliative care program the number one “Pearl of Care” in their report.
Results: Note that the palliative care program has been operationalized and will be continued.
Palliative Care Clinic Presentations:
Dr Veronica Bruno
Skills Workshop 4413: Palliative care for parkinsonian syndromes. 18th International Congress of Parkinson’s Disease and Movement Disorders in Stockholm, Sweden. June 2014
Parkinson’s Disease and Tzelem Elohim: Helping Patients and Their Families to Maintain the Inborn Image of the Divine. National Association of Jewish Chaplains Conference, January 21, 2013, Scottsdale, Arizona.
Body Image as Sense of Self in Patients with Parkinson’s Disease-Clinical Research Rounds, Toronto Western Hospital, April 19, 2013.
Perceived Factors in the Changed Spousal Relationship in Advanced Movement Disorders From the Perspective of the Healthy Partner: The Role for the Spiritual Component of Palliative Care in Chronic Illness, Lancaster University, September 18, 2013.
Body Image as Sense of Self in Patients with Parkinson’s Disease-Allied Health Parkinsons’ Disease Presentation, Toronto Western Hospital, January 30, 2014.
The Challenge of Progressive Illness: Maintaining Identity and Dignithy in Parkinson’s Patients and Their Families. Canadian Association for Spiritual Care Conference, April 11, 2014, Winnipeg, Manitoba.
September 2015 Project Update:
The palliative care program continues to recruit between three and six patients each week. Their assessment includes a physician assessment, caregiver strain evaluation, and the introduction to the care team of a in-home care liaison (supported by the provincial healthcare system). All patients are supported from recruitment until death and the program typically includes 200 patients actively followed. Patients receive a medical assessment three to four times a year. Because of the challenges faced by this advanced-stage population, grant support for care coordination is critical to its success. The care coordinator’s role is more than just linking patients to diverse professionals, and extends to connecting with families and advocates who can help with community agencies and programs. The program is managed by Dr. Anthony Lang and Dr. Elizabeth Slow, and the care coordination is performed by Deborah Mancini. Using a mixed methods approach, this program was identified as a “pearl” or “a small thing that can have a big impact” by an independent review committee.
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