Clinical trial NCT03888287: Parkinson's Disease Inpatient Clinical Knowledge and Management
Official title: Parkinson's Disease Inpatient Clinical Knowledge and Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Keywords: PICK study
Impact of Watch Rx
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 477
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The WatchRx is a smartwatch worn on the patient's wrist which receives alerts and notifications for medication administration scheduling as well as intervention messages from a App to the caregiver
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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 a 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 the exacerbation of PD symptoms. Parkinson's disease Foundation, 2015). Hospital length of stay for patients 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 WatchRx 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, North Carolina, 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

Eligibility criteria: 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.

Primary outcomes:
measure: Clinician's Parkinson's Disease Knowledge Assessment Survey Scores
timeFrame: 6 months
Secondary outcomes:
measure: Number of PD Medications Administered on Time (15 Minute Window)
timeFrame: within 15 minutes post PD medication administration time
measure: Number of Patients With Contraindicated Medications Administered.
timeFrame: 6 months
measure: Number Patients With Falls, Falls With Injury, Positive CAM/Mini-cog
timeFrame: 6 Months
measure: Length of Stay in Hospitalized Parkinson's Disease Patients.
timeFrame: 6 months
measure: Number of PD Medications Administered on Time (Within 15 Minute Window)
timeFrame: 15 minutes post assigned medication administration time.
measure: Number of PD Medication Errors After Using the WatchRX System
timeFrame: 6 Months
measure: Number of Falls, Falls Within Injury, Positive CAM Scores, and Positive Mini-Cog Scores After Using the WatchRX System
timeFrame: 6 months
measure: Length of Stay With the WatchRx System
timeFrame: 6 months
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Azmi Hooman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hackensack Meridian Health
name: Mohammed Quadri, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: