The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease
Phase: NA
Conditions: Parkinson Disease
Sponsor: Duke University

Research Summary
State your primary study objectives
The purpose of this study is to determine if a “one stop” interdisciplinary benchmark clinic model impacts 
patient engagement with self-care (primary outcome), treatment compliance, caregiver burden, and/or 
clinical outcomes (falls, ER visits/hospitalizations, Parkinson’s disease motor disability) compared to 
standard subspecialty care.
State your secondary study objectives
To develop a single-day comprehensive care clinic for people with Parkinson’s disease, to address care 
fragmentation, increase patient engagement, and improve outcomes.
Travel burden and schedule limitations prevent patients from reaching all necessary skilled therapists with 
training in PD and may negatively impact long term outcomes and engagement with treatment plans.
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Standard Research Summary Template
This is the regular (generic) research summary template which is required  for all regular applications (unless 
your protocol fits under the other research summary templates in this category).  Use of these instructions is 
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Standard Research Summary
Purpose of the Study
Title: The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People with Parkinson 
Disease PI: Kyle Mitchell, M.D.
Version Date: 01/29/2021
Pro00105281
NCT04555720

Objectives & hypotheses to be tested
Does a “one stop” interdisciplinary benchmark clinic model impact patient engagement with self-care 
(primary outcome), treatment compliance, caregiver burden, and/or clinical outcomes (falls, ER visits
/hospitalizations, Parkinson’s disease motor disability) compared to standard subspecialty care?
Background & Significance
Should support the scientific aims of the research
Parkinson’s disease (PD) management is complex, and medication management alone is not sufficient. 
Non-motor complaints are often more disabling than motor symptoms. Neurologists are time-limited in 
their ability to address all aspects of this disease. An interdisciplinary clinic provides comprehensive 
exposure to allied health professionals and immediate interventions, which are already established as 
helpful individually (e.g. physical therapy for falls prevention, speech therapy for aspiration prevention). 
Travel burden and schedule limitations prevent patients from reaching all necessary skilled therapists with 
training in PD and may negatively impact long term outcomes and engagement with treatment plans.
Published studies of interdisciplinary clinics to date have an expert center and community referral model: 
1. see neurologist 2. Get referrals to needed allied health specialties for a later date. This so-called “hub-
and-spoke” care model in the Netherlands improved outcomes and lowered cost [1] but developing a
similar network is challenging in the United States, where geographic distance and competing hospital
networks may fragment care.
We developed a single-day comprehensive care clinic for people with Parkinson’s disease, to address care 
fragmentation, increase patient engagement, and improve outcomes. Patients are evaluated by social 
work, physical therapy, occupational therapy, speech therapy, pharmacy, and a physician’s assistant in a 
scheduled rotation. After these evaluations, the team meets with the physician movement disorders 
specialist for a team discussion of care needs. Following this meeting, the physician meets with the patient 
to summarize the results and discuss ongoing care needs. The benchmark day lasts from around 8AM-1:30 
PM with a built in 45 minutes for lunch from 12:15-1PM.
REFERENCE: [1] Bloem et al. Health Affairs 2017.
Design & Procedures
Describe the study, providing detail regarding the study intervention (drug, device, physical 
procedures, manipulation of the subject or the subject’s environment, etc.). Discuss justifications for 
placebo control, discontinuation or delay of standard therapies, and washout periods if applicable. 
Identify procedures, tests and interventions performed exclusively for research purposes or more 
frequently than standard of care. Include alternative therapies, concurrent therapies discontinued per 
protocol, risk benefit ratio, and use of tissue/specimens. Discuss monitoring during washout periods if 
applicable. Include brief description of follow-up, if any.
Visit 1: 0-3 months before benchmark clinic surveys on day of consent: approximately 30 minutes. 
Physical exam with Parkinson’s disease motor disability score as part of normal clinic visit that day. 
Participants will be randomized on a 1:1 basis to experimental vs control groups after consenting 
and prior to the start of this study visit. Subjects will complete the pre-clinic quality of life, 
treatment adherence, and self-efficacy surveys at this visit.
Visit 2: Benchmark clinic from 8AM-1:30PM: Patients see social work, physical therapy, 
occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes 
each.  Social work and pharmacy visits may be done earlier in the week depending on provider and 
patient availability  After these evaluations, the team meets with the physician movement disorders 
.
specialist for a team discussion of care needs. Following this meeting, the physician meets with the 
patient to summarize the results and discuss ongoing needs and action items and enter appropriate 
referrals and orders. The benchmark day lasts from around 8AM-1:30 PM with a built in 45 minutes 
for lunch from 12:15-1PM.

Visit 3: 3-6 months Follow up study point surveys: approximately 30 minutes. The control group 
will not participate in the benchmark clinic (Visit 2) and instead, their physician movement 
disorders specialist will make allied health referrals as part standard clinical care during a physician 
visit on the same day as study visit 2. They will still complete visit 3.
The control group will not participate in the benchmark clinic (Visit 2) and instead, their physician 
movement disorders specialist will make allied health referrals as part standard clinical care during a 
physician visit on the same day as study visit 1. They will still complete visit 3.
Selection of Subjects
List inclusion/exclusion criteria and how subjects will be identified.
Subjects will be from the patient population with Parkinson's Disease over the age of 30.  Caregivers will 
be required for participation.  All subjects must be able to provide consent.  Subjects will be contacted first 
with the phone script by a study email address.  
Subject Recruitment and Compensation
Describe recruitment procedures, including who will introduce the study to potential subjects. Describe 
how you will ensure that subject selection is equitable and all relevant demographic groups have access 
to study participation (per 45 CFR 46.111(a) (3)). Include information about approximately how many 
DUHS subjects will be recruited. If subjects are to be compensated, provide specific prorated amounts 
to be provided for expenses such as travel and/or lost wages, and/or for inducement to participate.
This study will be discussed with Parkinson's Disease patients when considering referring them to our 
already established benchmark clinic.  All patients already scheduled for an upcoming benchmark clinic 
will be called or emailed to see if they would like to enroll.
Patients who are randomized to standard care will have the opportunity to participate in the benchmark 
clinic within 1 year but not as part of this study.  200 subjects will be enrolled (100 benchmark clinic and 
100 controls for standard of care).  Payment of the subject will be upon completion of visit 2 (the 
benchmark visit or standard visit)  
Subject’s Capacity to Give Legally Effective Consent
If subjects who do not have the capacity to give legally effective consent are included, describe how 
diminished capacity will be assessed. Will a periodic reassessment occur? If so, when? Will the subject 
be consented if the decisional capacity improves?
Subjects with diminished capacity will not be consented.
Study Interventions
If not already presented in #4 above, describe study-related treatment or use of an investigational 
drug or biologic (with dosages), or device, or use of another form of intervention (i.e., either physical 
procedures or manipulation of the subject or the subject’s environment) for research purposes.

There are no study interventions.
Risk/Benefit Assessment
Include a thorough description of how risks and discomforts will be minimized (per 45 CFR 46.111(a) (1 
and 2)). Consider physical, psychological, legal, economic and social risks as applicable. If vulnerable 
populations are to be included (such as children, pregnant women, prisoners or cognitively impaired 
adults), what special precautions will be used to minimize risks to these subjects? Also identify what 
available alternatives the person has if he/she chooses not to participate in the study. Describe the 
possible benefits to the subject. What is the importance of the knowledge expected to result from the 
research?
There are no physical risks associated with this study. Comprehensive interdisciplinary care may help with 
the subjects engagement with Parkinson’s treatment, prevent falls, help with swallowing safety, improve 
voice volume, and improve their ability to care for themselves.  
Costs to the Subject
Describe and justify any costs that the subject will incur as a result of participation; ordinarily, subjects 
should not be expected to pay for research without receiving direct benefit.
Subjects or their insurance provider will be responsible and billed for all costs related to your routine 
medical care, including co-payments and deductibles.
Data Analysis & Statistical Considerations
Describe endpoints and power calculations. Provide a detailed description of how study data will be 
analyzed, including statistical methods used, and how ineligible subjects will be handled and which 
subjects will be included for analysis. Include planned sample size justification. Provide estimated time 
to target accrual and accrual rate. Describe interim analysis including plans to stop accrual during 
monitoring. Phase I studies, include dose escalation schema and criteria for dose escalation with 
definition of MTD and DLT.
The primary outcome is change in composite score on the self-efficacy scale. We will compare within 
subject change in score and differences in changes between control and experimental groups using 
repeated measures ANOVA.
Power calculations were performed using the published mean and SD for the self-efficacy scale. 73 
participants per arm (control/experimental) for a total of 146 participants provides an 80% power to 
detect a 1 point change, which is felt to be a minimal clinically relevant change. We plan to recruit 100 
participants per arm to account for any dropout. The maximum possible capacity of our benchmark clinic is 
250 people per year for logistical/scheduling reasons so our sample size was chosen as a realistic number 
given our power calculation, total capacity, and expected interest of participants.
Secondary outcomes include change in total weekly minutes exercised, change in “engagement score” 
from the patient engagement survey (Likert scale 1-5 choices converted to 0, 25, 50, 75, and 100 to 
calculate composite engagement score as a mean of all Likert scale items), and change in Zarit (caregiver 
burden score). We will also compare total amount of skilled therapy visits, hospitalizations and ER visits, 
falls, and number of contraindicated medication combinations between the groups. All of these analyses 
will also be done using repeated measures ANOVA.
Subgroup analyses for the above outcomes will be performed using MOCA as a measure of baseline 
cognitive status and MDS-UPDRS as a measure of baseline disease severity both performed as linear 
regressions.
All enrolled subjects who complete the study visits will be included for analysis. Eligibility requirements are 
minimal (only need a diagnosis of Parkinson’s disease) and those who do not have a diagnosis of Parkinson’
s disease will not be approached for this study, so we do not anticipate a significant number of ineligible 

participants/screen failures. If for an unforeseen reason a participant is felt to not have a diagnosis of 
Parkinson’s disease by a movement disorders specialist after enrollment, they will be removed from the 
study.
Estimated time to target accrual is 1 year with an accrual rate of 9 participants per arm per month.
RedCap and Duke Box will be used for data storage. A key will be used to link unique identifiers to 
participants responses.  The key will be used to track completion of longitudinal data, as well as to query 
Duke Health medical records for health utilization (e.g. ED visits) as a secondary study outcome. The file 
connecting Study ID with Duke MRN will be encrypted and stored on the Duke Movement Disorders secure 
folder on the neurology private drive and will be password-protected. Only the study investigators will 
have access to this file.