Parkinson's Disease Inpatient Clinical Knowledge and Management



Status:Active, not recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:22 - Any
Updated:3/27/2019
Start Date:August 1, 2018
End Date:October 1, 2020

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This study will focus on patients with Parkinson's Disease in the adult inpatient units of
Hackensack University Medical Center. We are measuring the effect of a Parkinson's Disease
Inpatient Clinical Knowledge and Management Program on adherence to Parkinson's Disease
medication using a Parkinson's Disease Identification Wrist Band, smartwatch and medication
schedule card

Parkinson's Disease (PD), the second-most common neurodegenerative disorder and is ranked the
fourteenth leading cause of death. PD prevalence rate in the United States is estimated to be
approximately 0.3% 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. PD is
projected to increase by 4% to 5% in age 65 and over 85 years respectively and is associated
with high economic burden exceeding $14.4 billion per year.

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. Parkinson's
disease Foundation, 2015). Hospital length of stay for patient with PD is 1.45 times higher
in comparison to non- PD patients.

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. Hospital co-morbidities could be improved or
prevented by adjustment of PD medication and medication adherence, critical in decreasing
hospital length of stay.

The retrospective phase will be a data collection of adult patients admitted with a primary
and secondary diagnosis of Parkinson's disease during January - June 2015 (6 month period).
There will be 150 patients selected by the principal investigator(s) from chart review. In
addition, the clinicians chosen for the study will complete a Parkinson's Disease Knowledge
Assessment Survey.

The prospective phase will begin 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. There will be 150 patients selected from the adult inpatient units by the
principal investigator(s) that meet the inclusion criteria and confirm through an informed
consent that they will participate in the study.

The selected patients will be registered in a Watch Rx interface via website URL by the
Principal Investigator(s) and the Transition of Care(TC) Pharmacist and required to wear a
Watch Rx smartwatch for the duration of their hospitalization. The Watch Rx Interface will
store all medical information, necessary treatments and daily clinical care for the patient
which is synchronized to the smartwatch on the patient's wrist. The smartwatch will send
alerts to the patient's assigned nurse's iPad through a Watch Rx app for medication
administration, missed PD medications, battery conditions, and enables messaging between the
primary nurse and the patient.

The WatchRx smartwatch will remind when it is time to take the medication. If the Parkinson's
Disease medication is not administered, it sends missed medication reminder alerts to the
nurse. For fixed time medication, the reminder is every 3 minutes up to 10 minutes.

During the prospective phase, the research team will collect data from multiple sources such
as the Watch Rx system, EPIC Hyperspace, and Case Report forms over a 6 month study period.
The data will be calculated by using statistical analysis for the continuous variables and
categorical variables identified from the collection of data. All study data will be imported
into SAS software where data 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 Data will be handled in a confidential manner
to meet mandated IT Security standards and to prevent loss of privacy. 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.

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. Patients participating in the registry will be gain information from the current
research and possibly create a support group amongst themselves. This study will improve
knowledge of Parkinson's disease amongst clinicians and better medication management of PD
patients

Inclusion Criteria:

- Adult patients diagnosed with primary and secondary diagnosis of Parkinson's disease

- Patient 22 years old and older

- Patients admitted to inpatient units

- Patient who are verbally informed and agree to participate in the study

Exclusion Criteria:

- Patients less than or equal to 21 years of age

- Patients who refuse to wear the PD wrist band.

- Patients who verbally refuse enrollment in the PD registry.
We found this trial at
1
site
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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mi
from
Hackensack, NJ
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