Parkinson's Disease Inpatient Clinical Knowledge and Management
Phase: NA
Conditions: Parkinson Disease
Sponsor: Hackensack Meridian Health

The PICK Study 
 
Parkinson’s Disease Inpatient 
Clinical Knowledge and 
Management 
 
Co-Principal Investigators 
Hooman Azmi, MD 
Claudia Douglas, DNP, RN, APN.C 
Mohammed Quadri, MD 
 
Sub-Investigators 
Francine DeLuise, MSN, RN 
Rose Williams BSMT, MSCRA, CCRP 
Lisa Cocoziello, MSN, RN, APN, CNRN 
Jewell Thomas, Pharm.D. 
Blessy Jacob, Pharm.D 
 
 
Study Sponsor 
Hackensack University Medical Center 
Hackensack, NJ 
 
 
 
 

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Table of Contents 
Protocol Synopsis.............................................................................................................................4 
Statement of Investigator .................................................................................................................7 
Study Contacts .................................................................................................................................8 
Introduction and Background ........................................................................................................10 
Study Purpose and Rationale .........................................................................................................11 
Adherence ............................................................................. Error! Bookmark not defined. 
Smartphone Adherence App ................................................ Error! Bookmark not defined. 
Watch Rx .............................................................................. Error! Bookmark not defined. 
Research Question .........................................................................................................................13 
Hypothesis......................................................................................................................................13 
Primary Objective ..........................................................................................................................13 
Primary Endpoints .........................................................................................................................15 
Secondary Objectives.....................................................................................................................15 
Secondary Endpoints .....................................................................................................................15 
Study Period ................................................................................... Error! Bookmark not defined. 
Method and Data Collection Procedures ....................................... Error! Bookmark not defined. 
Retrospective Study Period .................................................. Error! Bookmark not defined. 
Prospective Study Period ..................................................... Error! Bookmark not defined. 
Enrollment Procedure .................................................................... Error! Bookmark not defined. 
PD Patient Enrollment .......................................................... Error! Bookmark not defined. 
PD Patient Enrollment into WatchRx system.: .................... Error! Bookmark not defined. 
Inclusion Criteria ........................................................................... Error! Bookmark not defined. 
Exclusion Criteria .......................................................................... Error! Bookmark not defined. 
Sample Size Calculation ................................................................ Error! Bookmark not defined. 
Data Analysis .................................................................................................................................20 
Discomforts and Risks ................................................................... Error! Bookmark not defined. 
Benefits .......................................................................................... Error! Bookmark not defined. 
Limitation ....................................................................................... Error! Bookmark not defined. 
Confidentiality ............................................................................... Error! Bookmark not defined. 
References ......................................................................................................................................24 
Appendix A – PD Knowledge Assessment Survey .............................................................28 
Appendix B – PD Inpatient Clinical Knowledge and Management Study (PICK) .............30 
Appendix C – PD Medication Schedule Card ......................................................................33 
Appendix D – Aware in Care Kit ......................................... Error! Bookmark not defined. 

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Appendix E – Educational Information on PD Medication .................................................34 
Appendix F – PICK Data Collection Tool ...........................................................................35 
 
 
 
 
 

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Protocol Synopsis 
PROTOCOL 
NAME 
Parkinson’s Disease Inpatient Clinical Knowledge and Management 
PROTOCOL NO: 
PICK Study: Pro00006159 
CO-PRINCIPAL 
INVESTIGATORS 
Hooman Azmi, MD 
Claudia Douglas, DNP, RN, APN.C 
Mohammed Quadri, MD 
SUB-
INVESTIGATORS 
Francine DeLuise, MSN, RN 
Rose Williams, BSMT, MSCRA, CCRP 
Lisa Cocoziello, MSN, RN, APN, CNRN  
Jewell Thomas, Pharm.D. 
Blessy Jacob, Pharm.D 
SITE AND 
SPONSOR 
Hackensack University Medical Center 
Hackensack, NJ 
RESEARCH 
QUESTION 
Does Parkinson’s Disease Inpatient Clinical Knowledge and 
Management Program and the WatchRx System make a difference in 
the clinician knowledge, customized PD order time and PD medication 
administration time, complications (administered contraindicated 
medication, falls, positive delirium scores, and positive confusion), 
medication error and length of stay during hospitalization? 
HYPOTHESIS 
Ho1: 
Parkinson’s Disease Inpatient Clinical Knowledge and Management 
Program will not make a difference in the clinician knowledge. 
Ha1: 
Parkinson’s Disease Inpatient Clinical Knowledge and Management 
Program will make a difference in the clinician knowledge. 
Ho2: 
Parkinson’s Disease Inpatient Clinical Knowledge and Management 
Program will not make a difference in the customized PD order time 
and PD medication administration time, complications (administered 
contraindicated medication, falls, positive delirium scores, and positive 
confusion), medication error and length of stay during hospitalization. 
Ha2: 
Parkinson’s Disease Inpatient Clinical Knowledge and Management 
Program will make a difference in the customized PD order time and 

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Protocol Synopsis 
PD medication administration time, complications (administered 
contraindicated medication, falls, positive delirium scores, and positive 
confusion), medication error and length of stay during hospitalization. 
Ho3: 
WatchRx System will not make a difference in the customized PD order 
time and PD medication administration time, complications 
(administered contraindicated medication, falls, positive delirium 
scores, and positive confusion), medication error and length of stay 
during hospitalization. 
Ha3: 
WatchRx System will make a difference in the customized PD order 
time and PD medication administration time, complications 
(administered contraindicated medication, falls, positive delirium 
scores, and positive confusion), medication error and length of stay 
during hospitalization. 
STUDY DESIGN 
Two Part Study Design  
 Part 1: Retrospective Phase  
 Part 2: Prospective Phase 
INTERVENTION 
Clinician Education Program, WatchRx system, and enrollment in PD 
registry. 
SAMPLE SIZE 
Patients - 300 in total 
         150 - retrospective phase  
         150 - prospective phase  
 
PRIMARY  
OBJECTIVES 
To measure the difference in knowledge of the clinicians before and  
after completing the Parkinson’s Disease Inpatient Clinical Knowledge 
and Management Program. 
PRIMARY 
ENDPOINTS  
Difference in PD Knowledge assessment score before and after 
Parkinson’s Disease Inpatient Clinical Knowledge and Management 
Program (Appendix I A PD Knowledge assessment score) 

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Protocol Synopsis 
SECONDARY 
OBJECTIVES 
 1. To measure the difference that the Parkinson’s Disease Inpatient 
Clinical Knowledge and Management Program has on PD 
medication administration time, administered contraindicated 
medication, PD medication errors, falls, positive confusion, positive 
delirium scores, and length of stay for PD patients. 
2. To measure the difference that the WatchRx system has on PD 
medication administration time, administered contraindicated 
medication, PD medication errors, falls, positive confusion, positive 
delirium scores, and length of stay for PD patients. 
SECONDARY 
ENDPOINTS 
 Difference in scheduled versus actual PD medication 
administration time  
 Number of medication errors  
 Number of contraindicated medications administered  
 Number of falls  
 Number of positive confusion scores  
 Number of positive delirium scores  
 Length of stay 
STUDY PERIOD 
Retrospective Data Period: January – June 2015  
Prospective Data Period: After the clinicians have completed the 
Parkinson’s disease Inpatient Clinical Knowledge and Management 
Program and the WatchRx Smartwatch is integrated in the medication 
administration for PD medications. 
SPONSOR 
Hackensack University Medical Center 
STATISTICAL 
ANALYSIS PLAN, 
DATABASE,  
DATA ENTRY & 
ANALYSES 
Themba Nyirenda, PhD 
Hackensack University Medical Center 
Research Biostatistician 
Department of Research 
Office: 551-996-8210 
Fax: 201-457-1882 
Email: TNyirenda@HackensackUMC.org 
 

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Statement of Investigator 
Parkinson’s Disease Inpatient Clinical 
Knowledge and management 
An observational, quasi-experimental retrospective and prospective study. 
 
PROTOCOL: PICK VERSION 5 – MAY 9, 2019 
STATEMENT OF INVESTIGATOR(S): 
The Study Site Principal Investigator’s Signature signifies acceptance of the Parkinson’s Disease 
Inpatient Clinical Knowledge and Management (PICK) Study and agrees to participate in the 
study in accordance with the protocol, applicable regulations including informed consent 
requirements, Health Insurance Portability and Accountability Act (1996) and Principal 
Investigator requirements stated in this protocol: 
 
______________________________________       _________________________ 
Hooman Azmi, MD  
 
 
 
 
Date 
Principal Investigator  
 
 
 
 
 
  
 
     
 
 
 
 
______________________________________      ___________________________ 
Claudia Douglas, DNP, RN, APN.C       
Date 
Co-Investigator 
 
 
______________________________________      ___________________________ 
Mohammed Quadri, MD 
     
 
 
 
Date 
Co-Investigator 
 
Hackensack University Medical Center 
 
30 Prospect Avenue  
Hackensack, NJ 07601 
 
 
 

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Study Contacts 
CO-PRINCIPAL INVESTIGATORS 
Hooman Azmi, MD 
Chief Division of Functional and Restorative 
Neurosurgery Chief Division of Neurotrauma 
Department of Neurosurgery Hackensack University 
Office: 201-342-2550 
Fax: 201-342-7171 
 Cell: 917-406-6914 
Email: HAzmi@hackensackUMC.org 
Claudia Douglas, DNP, RN, , 
APN.C 
Director, Institute of EBP & 
Nursing Research 
Patient Care Services 
Office: 551-996-2730 
Cell: 201-913-8591 
Email: 
CDouglas@HackensackUMC.org 
 
Mohammed Quadri, MD, MBA 
Title: Director, Epidemiological Strategy 
Department of Patient Care 
Office: 551-996-2421  
Fax: 551-996-8824 
Cell: 201-310-0477 
Email: mquadri@hackensackUMC.org 
SUB-INVESTIGATORS 
Francine DeLuise, MSN, RN 
Rose Williams BSMT, MSCRA, CCRP 
Lisa Cocoziello, MSN, RN, APN, CNRN 
Jewell Thomas, Pharm.D 
Blessy Jacob, Pharm.D 
STATISTICAL ANALYSIS PLAN AND STATISTICAL ANALYSES 
Themba Nyirenda, PhD 
Hackensack University Medical Center  
Research Biostatistician 
Department of Research 
Office: 551-996-8210 
Fax: 201-457-1882 
Email: TNyirenda@HackensackUMC.org 
STUDY SPONSOR 
Hackensack University Medical Center 
30 Prospect Avenue 
Hackensack, NJ 07601 
 

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Definitions 
Discrete data 
Data with numerical value that is distinct and separate 
MDR 
The Multidisciplinary (MDR) is the clinical infrastructure 
supporting a multidisciplinary/interdisciplinary framework for 
clinical practice promoting a patient-centered, evidence- and value-
based care within a managed care environment 
Dementia 
Assessment 
Method  
Standardized examination used to detect dementia (Mini-Cog)  
Delirium 
Assessment  
Standardized examination used to detect delirium (CAM).  
Unstructured 
data 
Unstructured Data (or unstructured information) refers to 
information that either does not have a pre-defined data model or is 
not organized in a pre-defined manner. Unstructured information is 
typically text-heavy, but may contain data such as dates, numbers, 
and facts. 
 
 

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Introduction and Background 
Parkinson's Disease (PD), the second-most common neurodegenerative disorder after 
Alzheimer's disease is a progressive disorder of the central nervous system affecting movement 
resulting in tremor of the hands, arms, legs, jaw, face, bradykinesia, rigidity of limb, trunk/ 
postural instability, impaired balance and coordination (Kowal, Dall, Chakrabarti, Storm, and 
Jelin, 2013). 
PD prevalence rate in the United States is estimated to be approximately 0.3% (Kowal et al., 
2013) and is ranked the fourteenth leading cause of death (CDC, 2013). Depending on the 
methodology, the national prevalence data on PD is varied and insufficient (McLaughlin, 
Piryatinsky, Epstein-Lubow, Marino, and Friedman, 2014). PD is projected to increase by 4% to 
5% in age 65 and over 85 years respectively (Weintraub, Comella, and Horn, 2008), and is 
associated with high economic burden exceeding $14.4 billion per year (Kowal et al. 2013). 
Admission to the hospital is identified as a major risk factor due to imprecise timing of 
medication administration, disruption of sleep pattern, dietary changes, and unfamiliarity of the 
hospital environment, which all contribute to exacerbation of PD symptoms (Oguh & Videnovic, 
2012; Parkinson’s disease Foundation, 2015). Exacerbation of PD symptoms is also associated 
with higher risk for falls and falls with injury during hospitalization. A study by Chou et al., 
(2011) involving 51 worldwide National Parkinson Foundation Centers found 94% of centers 
were not confident in the care and knowledge hospital professionals provided specific to: PD 
medications, complex drug interactions, contraindications and precise timing of medication 
administration. A survey on medication administration in PD patients found 75% of hospitalized 
patients failed to receive their medications on time (Okun, 2010), thus compromising patient 
care. According to Chou et al. (2011), Martignoni et al. (2004), Michigan Parkinson Foundation 

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(2013) hospital co-morbidities could be improved or prevented by adjustment of PD medication 
and medication adherence, critical in decreasing hospital length of stay. In general, the length of 
stay for patient with PD is 1.45 times higher (Dorsey et al., 2005; McLaughlin et al., 2014) in 
comparison to non- PD patients. 
PD prevalence is projected to double over the next few decades as the size of the elderly population 
increases. This projected growth and anticipated demographic burden has created the impetus for 
Hackensack University Medical Center PD Management Team to create new innovative strategies 
incorporating current best practices and protocols for delivering care and treatment during 
hospitalization in this subset of patient population. 
Study Purpose and Rationale 
It is documented that PD patients are more likely to experience complications during 
hospitalization (Chou et al., 2011; Gerlach et al., 2012). A preponderance of the evidence 
indicate decrease motor function increases the risk for falls and falls with injury, decline in 
mental capacity, the failure to detect depression, and lack of knowledge and expertise on the care 
of PD patients by health care professionals are all contributors leading to the exacerbation of 
complications during acute hospitalization (Ashslok, 2014; Gerlach, Broen, Dombury, Vermeij, 
& Weber 2012; Mondolo, Jahanshahi, Grania, Biasutti, Cacciatori & Benedetto,2006). The root 
cause of the failure to meet the specific therapeutic requirements and overall care needs of PD 
patients during hospital stay is related to failure of health care clinicians to implement current 
evidence-based Parkinson’s specific disease care guidelines (Gerlach et al., 2012; Skelly et al., 
2014). 

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The complexity of PD coupled with the absence of Parkinson specific core knowledge on the care of 
these patients by frontline clinicians ( Gerlach et al, 2012; Thompson, 2015) has led to    the status 
quo of prolonged length of stay (Braga, Pederzoli, Antonini, Beretta, Crespi, 2014; Ramirez et al. 
2015) , deterioration of PD disease symptoms (Ahlskog, 2014; Gerlach, 2012), increased 
psychological and physical morbidity (Soundy, Stubbs, and Roskell, 2014) and subsequent 
reduction in quality of life (Duncan et. al (2014). Timely administration of PD improves 
morbidity, mortality and length of stay (CMS 2014).    
While the goal during hospitalization is to provide, safe and effective high quality care. 74% of 
PD patients receive incorrect medications (Martinez-Ramirez et al, 2015 and are at increased risk 
for developing complications related to medication administration. According to the Institute for 
Safe Medication Practices [ISMP] (2015 p. 19) “patients with PD require strict adherence to an 
individualized timed medication regimen of anti-parkinsonian agents.” Medications must be 
administered on time, based on the patient’s unique schedule. A comprehensive search of the 
literature from 2009 – 2015 found few studies evaluating the impact of focused integrated inter 
and multidisciplinary approach to managing PD patients during hospitalization. In another 
survey, PD patients’ perceptions is that hospital staff lacked understanding of PD, the importance 
of medication timeliness, and appreciation of valuable insights from patients, families and 
caregivers (Oguh & Videnovic, 2012). 
A paradox of the U. S. healthcare system is that it leads the world in medical science and 
technology, yet there is limited application of technology to enhance patient-centered care in the 
hospital setting. In accordance with the Institute of Medicine’s (2001) quality performance goals, 
safety, effectiveness, timeliness, patient-centeredness, efficacy and equity, this study will 
integrate WatchRx system, a medication reminder system. The WatchRx system includes a 

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smartwatch, caregiver app and online web interface which allows clinicians to customize the 
medication administration time and alerts the patient and the nurse when the medication to due to be 
administered. 
This study will conduct research on establishing multidisciplinary clinical guidelines in management 
of PD across the acute care setting. We will further explore the impact of PD medication 
management on patients hospital length of stay and complications associated with mismanagement. 
We intend to create a PD registry for Hackensack University Medical Center, and possibly expand 
across the Hackensack Meridian Health Network in the future. According to the New Jersey 
Assembly Bill 2955, December 2014, patients and/or their designated caregiver must receive 
discharge instructions prior to discharge from the hospital and appropriate referrals for follow-up 
care. This study aligns New Jersey Bill 2955 (2014) mandating the education and preparation of 
designated caregiver in the discharge plan of care of hospitalized PD patients. 
Research Question  
Does Parkinson’s Disease Inpatient Clinical Knowledge and Management Program and the 
WatchRx System make a difference in the clinician knowledge, customized PD order time and 
PD medication administration time, complications (administered contraindicated medicationfalls, 
positive delirium scores, and positive confusion), medication error and length of stay during 
hospitalization? 
Hypothesis 
Ho1: 
Parkinson’s Disease Inpatient Clinical Knowledge and Management Program will not make a 
difference in the clinician knowledge. 

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Ha1: 
Parkinson’s Disease Inpatient Clinical Knowledge and Management Program will make a 
difference in the clinician knowledge. 
Parkinson’s Disease Inpatient Clinical Knowledge and Management Program will not make a 
difference in the customized PD order time and PD medication administration time, 
complications (administered contraindicated medication, falls, positive delirium scores, and 
positive confusion), medication error and length of stay during hospitalization. 
Ha2: 
Parkinson’s Disease Inpatient Clinical Knowledge and Management Program will make a 
difference in the customized PD order time and PD medication administration time, 
complications (administered contraindicated medication, falls, positive delirium scores, and 
positive confusion), medication error and length of stay during hospitalization. 
Ho3: 
WatchRx System will not make a difference in the customized PD order time and PD medication 
administration time, complications (administered contraindicated medication, falls, positive 
delirium scores, and positive confusion), medication error and length of stay during 
hospitalization. 
Ha3: 
WatchRx System will make a difference in the customized PD order time and PD medication 
administration time, complications (administered contraindicated medication, falls, positive 

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delirium scores, and positive confusion), medication error and length of stay during 
hospitalization. 
 
 
Primary Objective 
To measure the difference in knowledge of the clinicians before and after completing the 
Parkinson’s Disease Inpatient Clinical Knowledge and Management Program. 
 Primary Endpoints 
Difference in PD Knowledge assessment score before and after Parkinson’s Disease Inpatient 
Clinical Knowledge and Management Program (Appendix A- PD Knowledge assessment score). 
 Secondary Objectives 
1. To measure the difference that the Parkinson’s Disease Inpatient Clinical Knowledge and 
Management Program has on PD medication administration time, administered 
contraindicated medication, PD medication errors, falls, positive confusion, positive 
delirium scores, and length of stay for PD patients. 
2. To measure the difference that the WatchRx system has on PD medication administration 
time, administered contraindicated medication, PD medication errors, falls, positive 
confusion, positive delirium scores, and length of stay for PD patients. 
Secondary Endpoints  
 Difference in scheduled versus actual PD medication administration time 
 Number of medication errors 

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 Number of contraindicated medications administered 
 Number of falls 
 Number of positive confusion scores 
 Number of positive delirium scores 
 Length of Stay 
Inclusion Criteria 
1. Adult patients diagnosed with primary and secondary diagnosis of Parkinson’s disease 
2. Patient 22 years old and older 
3. Patients admitted to inpatient units and Center for Ambulatory Surgery 
4. Alert and able to follow commands 
5. Patient who agree to participate in the study 
Exclusion Criteria 
1. Patients less than or equal to 21 years of age 
2. Patients who refuse or unable to wear the WatchRx smartwatch 
3. Disoriented and unable to follow commands 
4. Patients who are allergic to silicone, stainless steel and/or latex 
5. Patients positive for Clostridium difficile and/or Candida auris 
Study Period 
Retrospective Data Period: January 2015 – June 2015 
Prospective Data Period: After the clinicians have completed the Parkinson’s Disease Inpatient 
Clinical Knowledge and Management Program and the WatchRx Smartwatch is integrated 
within medication administration for PD medications 
Retrospective Study Period 

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Data collection of adult patients admitted with a primary and secondary diagnosis of Parkinson’s 
disease during January – June 2015. 
 Data will be extracted from the EPIC (current EMR system at Hackensack University 
Medical Center). 
 Business intelligence will run the data and create reports with the specific data points 
mentioned above prior to providing it to the study team for further statistical analysis. 
Data collected from the automatic dispensing cabinet barcoding database will verify accuracy 
and timeliness of medication. 
Prospective Study Period 
Data collection starting after completion of the Parkinson’s Disease Inpatient Clinical 
Knowledge and Management Program for staff nurses, advanced practice nurses (APN), nursing 
assistants, patient care technicians, case managers, adult inpatient physician assistants, 
pharmacists, occupational therapists, physical therapists, nurse educators, and dietitians. 
 Data will be extracted from EPIC and WatchRx records from the Watch Rx Web 
Interface. 
Data collected from the automatic dispensing cabinet barcoding database will verify accuracy 
and timeliness of medication. 
 Unstructured data will be collected by the principle investigator (PI), designees inclusive 
of study staff through focused chart review on 150 patients. 
 Data will be analyzed for objectives and endpoints. 
This data will compare prevalence of medication errors, complications associated with 
administration of contraindicated medications and timing of medications, falls and falls with 

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injury, positive CAM and Mini-Cog Scores, length of stay and cost per case in the study 
population. This phase will also assess the knowledge of the clinicians regarding the basic 
aspects of Parkinson’s Disease inpatient management, the Parkinson’s Disease Inpatient Clinical 
Knowledge and management program and integration of the smartwatch into the PD medication 
management. 
 
 
Parkinson’s Disease Knowledge Assessment Survey (Appendix A)  
 
Parkinson’s Disease Inpatient Clinical Knowledge and Management Program (Appendix B)  
Study Enrollment Procedure 
Patients with Parkinson’s disease (PD) who meet inclusion criteria will be offered the 
opportunity to participate in the study. After obtaining informed consent, the patient will be 
enrolled in the study. 
PD Medication Reconciliation: 
The Principal Investigator (PI) and Transitions of Care (TC) Pharmacists (sub-investigator(s) 
will complete the admission medication reconciliation. 
WatchRx System Enrollment: 
Using Internet Explorer web browser, the Principal Investigator and the TC Pharmacist (sub 
investigator(s) will complete the following: 
 Enter the patient’s information into the WatchRx Inc. Website interface to create the 
patient profile and PD medication regimen 
 Register the patient into WatchRx web interface via website URL by entering the PD 
patient’s name, unit number and room number. 

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 Enter the patient PD medication administration schedule as ordered 
 Assign the WatchRx Smartwatch to the patient 
 Review the WatchRx Smartwatch functions with the patient 
 Review the Aware in Care Kit with the PD patient 
The primary nurse will be asked to wear the WatchRx smartwatch. After obtaining verbal 
consent, the Principal Investigator and TC Pharmacist will review the patient’s PD medication 
schedule in WatchRx smartwatch with the primary nurse. 
The WatchRx web interface will activate reminder alerts from the patient’s WatchRx 
Smartwatch to the primary nurse WatchRx smartwatch. Alerts reminders will send fifteen 
minutes before the PD medication is due. Medication reminder alerts will continue to be sent 
from WatchRx smartwatch worn by the patient to the WatchRx Smartwatch worn by primary 
nurse at 3-minute intervals for a period of 10 minutes or until the PD medication is administered. 
At each end-of-shift and/or at handoff, the WatchRx smartwatch will be cleaned using Super 
SaniClothTM and the nurses will document completion of the WatchRx smartwatch cleaning 
procedure on the WatchRx Smartwatch cleaning log and verify by signing their names 
(Appendix F). 
Sample Size Calculation 
A total of 433 patients were admitted to Hackensack University Medical Center with a diagnosis 
of PD in the year 2014. A convenience sample of 300 patients, 150 patients in the prospective 
phase and 150 patients in the retrospective phase, and approximately 346 clinicians, before and 
after implementing the Parkinson’s Disease Inpatient Clinical Knowledge and Management 
education program will be enrolled in the study. 

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The sample of clinicians will include physician’s assistant, advanced practice nurses, staff 
nurses, nurse educators, case managers, dietitians, pharmacists, physical therapist and 
occupational therapist. (Table 1) 
Categories 
Overall 
population 
Sample 
population 
Percentage 
(Sample 
size)  
Staff Nurses Adult (Inpatient Units)  
1931 
100  
5 % 
Nursing Assistants 
277 
N/A 
 
Patient Care Technicians 
165 
N/A 
 
Advanced Practice Nurses (Adult Inpatient Units) 
107 
87 
81% 
Case Managers(Adult Inpatient Units) 
48 
48 
100% 
Nurse Educator Adult Inpatient  
20 
19 
95% 
Physician’s Assistant Adult Inpatient  
73 
40 
54% 
Dietitians 
17 
17 
100% 
Pharmacists 
119 
12 
11% 
Physical Therapist 
17 
17 
100% 
Occupational Therapists 
6 
6 
100% 
Table 1 
Data Analysis 
The summary of the demographic characteristics will be presented. Continuous variables will be 
summarized using mean (SD) or median (interquartile range) depending on whether or not the 
data follow the normal distribution. Categorical variables will be summarized by frequency 
(percentage). Comparison of continuous variables between any independent groups will be 
examined using two-sided t-test or two-sided Wilcoxon rank sum test, analysis of variance 
(ANOVA) or Kruskal-Wallis test followed by pairwise tests, as appropriate. Categorical 
variables will be examined using Fisher’s exact test or Pearson’s Chi-square test, as appropriate. 
Measurements 

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The following will be documented on a case report form:, demographics (age, sex, and race), 
comorbidities and complications, date of discharge, length of stay, and number of medication 
discrepancies. 
 Subject ID (coded de-identified patient identifier) 
 Demographics (age race, gender) 
 Primary Diagnosis 
 Comorbidities 
 Medication list at admission (Admission Medication Reconciliation) 
o Number of medications at admission 
 Prescribed Medication List (Medication Administration Record) 
o Number of medications during hospitalization 
 Medication list at discharge (Discharge Medication Reconciliation) 
 Complications associated with medication administration 
 Medication Administration Schedule 
o Order Time 
o Patient Falls 
o Number of falls 
o Time of patient falls 
o Injury 
 Length of Stay 
Data Management  
All data in this study will be obtained from multiple sources: EPIC Hyperspace for medical 
record number. A database in Microsoft Office Excel (Microsoft Corporation, Redmond, WA, 

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USA) will be created based on a case report form. Data from the WatchRx smartwatch and the 
WatchRx app will be stored in real time within a secure database. All study data will be imported 
into SAS software where data management programming will be utilized to flag and generate 
queries on out of range data issues until they are resolved. All analysis will be performed using 
SAS version 9.4 (SAS Institute Inc. Cary, NC, USA).  
Discomforts and Risks  
This study involves no more than minimal risks No medical intervention is included as part of 
this study. All patients will be provided and treated as per physician order.  
Benefits  
This study will improve timely administration of medications to PD patients. Patients enrolled in 
the study will have direct monitoring of their medication compliance and adherence. This study 
will improve knowledge of Parkinson’s disease amongst clinicians and better medication 
management of PD patients.  
Limitations  
Limitation 1: Single site  
Limitation 2: Convenience sample  
Confidentiality 
Data will be handled in a confidential manner to meet mandated IT Security standards and to 
prevent loss of privacy. 

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All electronic files will be stored in an encrypted and password-protected database on a secure 
medical center server. Only co-investigators, advanced practice nurses and the data coordinator 
who contact the subjects will have access to information linked to subject identifiers. 
 Each eligible patient will be assigned a study specific identification number (ID#) to 
separate patient information from their specific study data and responses. Any research 
data extracted from participants’ medical records will be recorded in a study specific 
electronic spreadsheet and coded with participants’ ID#’s. The electronic spreadsheet will 
be kept on a password protected computer. 
 The key linking ID numbers to patients’ identifier will be kept on a password-protected 
computer. 
 Publication resulting from this research will not contain any information that could 
potentially identify participants either directly or indirectly. 
 
 
 

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References 
Ashslok,J.R. (2014). Parkinson disease treatment in hospitals and nursing facilities: Avoiding 
pitfalls. Mayo Clinic Proceedings, 89(7), 997-1003. doi:10.1016/j.mayocp.2014.02.018 
Braga, M., Pederzoli, M., Antonini, A., Beretta, F., and Crespi, V. (2014). Reasons for 
hospitalization in PD: A case-control study. Parkinsonism & Relate Disorders, 20(5), 
488-492. doi:10.1016/j.parkreldis.2014.01.022 
Brown MT, Bussell JK. Medication Adherence: WHO Cares? Mayo Clinic Proceedings. 
2011;86(4):304-314. 
Centers for Disease Control. National Vital Statistics Reports: Deaths: Final Data for 2010. May 
2013. Retrieved from:  http://www.cdc.gov/nchs/data/nvsr/nvsr61/nvsr61_04.pdf  
Centers for Medicare and Medicaid. (2011). Interpretative Guidelines for Hospitals 42 
CFR 482.23C 
https://www.cms.gov/RegulationsandGuidance/Guidance/Transmittals/downloads/R77S
OMA.pdf  
Chou, K.l., Zamudio, J., Schmidt, P., Price, CC., Oarashos, SA., Bloem, Okun, M.S. (2011). 
Hospitalization in parkinson disease: A survey of national parkinson foundation centers. 
Parkinsonism & Related Disorder, 17(6), 440-445. doi:10.1016/j.parkreldis.2011.03.002 
Dayer, Lindsey, et al. “Smartphone medication adherence apps: Potential benefits to patients and 
providers: Response to Aungst.” Journal of the American Pharmacists Association, vol. 
53, no. 4, 2013, p. 345., doi:10.1331/japha.2013.13121. 

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Dorsey, E.R., Constantinescu, R., Thompson, J.P., Biglan, K.M., Holloway, R.G., Kieburtz. K., 
Marshall, F.J., Ravina, B.M., Schifitto, G., Sideowf, A., & Tanner, C.M. (2007). 
Projected number of people with parkinson disease in the most populous nations 
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Duncan, GW.,Khoo, TK., Yarnall, AJ. O'Brien, JT., Coleman, SY., Brooks, RA., & Burn, DJ. 
(2014). Health-related quality of life in early PD: The impact of nonmotor symptoms. 
Movement Disorder, 29(2) 195-202. DOI: 10.1002/mds.25664 
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Parkinson’s Disease Patients: Systematic Review. Movement Disorders 26(2). 197 -208. 
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Gerlach, O., Broen, M., van Dombury, P., Vermeij, Ad., & Weber, W. (2012).  
 Deterioration 
of parkinson’lyPDs disease during hospitalization:Survey of 684 patients. BioMed 
Central Neurology 12(3). doi: 10.1186/1471-2377-12-13 
Institute for Safe Medication Practices [ISMP].(2015 Mar12). Delayed administration and 
contraindicated drugs place hospitalized PD patients at risk. ISMP Acute Care 
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Kowal, S.L, Dall, T.M., Chakrabarti. R., Storm, M.V., and Jain, A. (2013). The current and 
projected economic burden of Parkinson's disease in the United States. Mov Disord., 
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C., Nappi, G. and the Parkinson’s Disease Comorbidity Study Group. (2004). Comorbid 

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disorders and hospitalization in parkinson’s disease: A prospective study. Neurological 
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M. S. , E. (2015) Missing Dosages and Neuroleptic Usage May Prolong Length of Stay in 
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diagnosis, and assessment. AmJ Manag Care, 14 (2) 40-48 
 
 

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Appendix A – PD Knowledge Assessment Survey 
 
The PICK Study 
 
Parkinson’s Disease Inpatient 
Clinical Knowledge and 
Management 
Role: 
□ APN 
□ Staff Nurse 
□ Physician 
□ PA 
 
□ Physician Adv
□ Case Manager
□ Pharmacist 
□ Other, specify
  ____________
 
Parkinson’s Disease Knowledge Assessment 
01. 
 Please select the correct 
answer.    
In most cases PD is caused by: 
 a. There is no known cause       
 b. Smoking             
 c. Genetics             
 b. Environmental toxins        
 
06. 
What type of food can interact with the 
adsorption of PD medication?    
 a. Fats              
 b. Carbohydrates             
 c. Protein              
 d. Sugars            
02. 
Which is not a cardinal sign in the 
motor aspect of PD?               
 a. Slowness of movement        
 b. Tremor              
 c. Rigidity of muscles         
 d. Muscle weakness    
07. 
Select the drug which is contraindicated in PD 
patients:               
 a. Quetiapine (Seroquel)               
 b. Haloperidol (Haldol)              
 c. Trimethobenzamide (Tigan)               
 d. Ibuprofen (Motrin)               
03. 
Select the incorrect statement.    
PD is found: 
 a. In all ages             
 b. In all races             
 c. In both genders           
 d. In males only            
 
08. 
Select the correct answer.     
Tremor in PD is most commonly seen in 
patients: 
 a. On action            
 b. On posture            
 c. At rest              
 d. When asleep            
04. 
Please select the correct answer.    
Which neurotransmitter is depleted in 
patients with PD? 
 a. Serotonin            
 b. Acetylcholine          
 c. Dopamine           
 d. Norepinephrine            
09. 
Please select all the correct answers which can 
apply to PD patients:               
 a. Anxiety   
 b. Constipation           
 c. Sexual dysfunction         
 d. Postural hypotension        
 
05. 
Which of the following brand name 
drugs contain levodopa, the precursor 
to dopamine?    
 a. Comtan               
 b. Sinemet               
 c. Symmetrel              
10. 
Select the incorrect answer.    
Nursing care of a patient with PD includes: 
 a. Ensuring contraindicated medications  
   are avoided     
 b. Sitting patient upright for meals    

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 d. Requip     
 c. Restraints for patients with severe 
tremors 
 d. Ensuring medications are given on time  
 
  
Parkinson’s Disease Knowledge Assessment  
11. 
Please select the term which does not 
apply. 
PD is a disease which is:        
 a. Degenerative           
 b. Reversible  
 c. Progressive            
 d. Made worse by stress        
 
16. 
Select the drug which is contraindicated in PD 
patients:               
 a. Metoclopramide (Reglan)               
 b. Acetaminophen             
 c. Ondansetron (Zofran)           
 d. Oxycodone   
 
12. 
Select the correct answer (s).  
Dyskinesia describes involuntary 
chorea-like movements of the head, 
shoulders, trunk or limbs. In PD it:            
 a. is a side effect of medication     
 b. is a symptom of the condition      
 c. requires patient restraint       
 d. it is a precursor to seizures       
 
17. 
Select the incorrect answer 
 a. PD is a form of dementia 
 b. Cognitive slowing can be a side effect of  
   PD meds 
 c. Vivid dreams can occur for patients with  
   PD 
 d. Response to PD meds can be affected by  
   type of food     
 
13. 
Bradyphrenia refers to:     
 a. Hallucinations in PD         
 b. Depression in PD          
 c. Slowness in thinking in PD      
 d. Psychosis in PD          
 
18. 
Delay in PD medication administration can 
lead to all the following except: 
 a. falls 
 b. confusion 
 c. seizures 
 d. dysphagia 
 
14. 
Patients with PD can tolerate missing 
their medications:      
 a. up to 30 minutes         
 b. One hour or more      
 c. No more than fifteen minutes      
 d. can take two doses on the next 
schedule       
19. 
Please select the correct answer(s) 
 a. All PD patients have dementia 
 b. PD patients may have both motor and  
   non-motor symptoms     
 c. Strict adherence to medication timing is  
   not crucial for PD patients 
 d. PD can be diagnosed by a blood test 
 
15. 
Select the incorrect statement.    
 a. The presence of tremor is 
necessary for the diagnosis of PD 
 b. PD can affect any age            
 c. 
PD can be hereditary  
 d. PD medications slow down the 
disease progression 
20. 
Please select which medication is safe in PD  
 a. Meperidine (Demerol) put an R sign for  
   registered trademark 
 b. Prochlorperazine (Compazine) 
 c. Clonazepam (Klonopin) 
 d. Promethazine (Phenergan)    
 
PICK STUDY - PD Clinician Assessment Education Questionnaire  
Adopted with Permission From v06.11.2015 
CONFIDENTIAL 

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Appendix B – PD Inpatient Clinical Knowledge and Management Study (PICK) 
Education Plan Overview 
Prior to launch of the educational plan, there will be Nursing Grand Rounds. The curriculum will 
also be introduced to case managers, pharmacists, physical and occupational therapists and 
dieticians. Clinical Level III and IV registered nurses on each unit will be designated with the 
responsibility of steering the education on the unit. They will be directly supported by Nurse 
Educators and the Department of Neurosurgery clinicians.  
The educational plan will be rolled out by direct testing, education and retesting to each nursing 
unit with distribution via print material and electronic material. Contact hours will be awarded 
for those completing the pre-test, webinar and post-test. 
Step 1: Administration of a Parkinson’s disease knowledge base assessment test to the target 
audience via HOLA.  
Step 2: Introduction of the PD webinar through HOLA. During this step, there will also be 
posters and other educational material available to the units.  
Step 3: Re-administer the Parkinson’s disease knowledge base assessment test to determine 
retention.  
Knowledge Assessment Methodology 
1. Administer Parkinson’s Disease (PD) Pre-test to target audience via HOLA 
(HackensackUMC Online Learning Academy) Learning Management System. Time 
frame for completion: 4 weeks. 
2. Administer PD Webinar to target audience via HOLA followed by Post-test. Time frame 
for completion: 4 weeks. 

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3. Administer a follow-up Post-test to target audience via HOLA 4 months after completion 
of PD webinar. (Time Frame for completion: 4 weeks) 
4. Award contact hours to those completing the pre-test, webinar and post-test. 
5. Develop educational poster on PD to display on all in-patient nursing units. 
6. Coordinate Nursing Grand Rounds on Parkinson’s Disease to include contact hours. 
7. Additional Educational Resources: 
a. PD Nurse Champions 
b. Unit Based Council Chairs 
c. PD Best Practice Alert - EPIC 
Objectives:  
After participating in educational offerings, the (HackensackUMC employed) target audience 
will be able to: 
1. Describe the pathophysiology of Parkinson’s Disease (PD). 
2. Discuss the signs and symptoms of PD. 
3. Identify the treatment options and medications used to manage patients with PD. 
4. Explain the medication contraindications for patients with PD. 
5. Explain the importance of administration of PD medications “On Time Every Time.” 
6. Recognize the complications of not giving PD medications on time 
Target Audience: 
1. Advanced Practice Nurses  
2. Physician’s Assistant (PA) 
3. In-patient registered nurses practicing on: 
a. Medical/Surgical units  

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b. Critical Care units/PACU  
c. Emergency & Trauma Center 
d. Surgical Admission Suite (SAS) 
e. Center for Ambulatory Surgery (CAS). 
4. Case Managers 
5. Pharmacists 
6. Dietitians 
7. Physical Therapist 
8. Occupational Therapist 
 
 

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Appendix C – Aware in Care Kit 
A kit containing useful tools and information for helping PD patients during their hospital visits. 
Includes the following: 
 Parkinson’s Disease ID Wrist Bracelet 
 Medical Alert Card 
 Medication Form 
 PD Fact Sheet 
PD ID Wrist Bracelet 
Designation to be worn at all times in the event of emergency situations and for hospital tracking 
purposes. 
Medical Alert Card 
Includes emergency information. 
Medication Form 
Includes information regarding prescriptions, existing medication regimen and scheduling, and 
other patient information.  
PD Fact sheet 
Information to be shared with hospital staff and included in patient chart. 
 
 
 
 

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Appendix E – Educational Information on PD Medication 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix F – PICK Data Collection Tool 
 
 
 

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Appendix F – PICK WatchRx Smartwatch Nurse Cleaning Log