Parkinson's Disease Inpatient Clinical Knowledge and Management (PICK)

• ClinicalTrials.gov Identifier: NCT03888287
• Recruitment Status: Terminated
• First Posted: March 25, 2019
• Results First Posted: March 16, 2023
• Last Update Posted: April 18, 2023
• Sponsor: Hackensack Meridian Health
• Information provided by (Responsible Party): Hackensack Meridian Health

Study Description

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

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Device: Watch Rx system; Other: Parkinson's Disease Inpatient Clinical Knowledge and Management Program	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 477 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• 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
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Parkinson's Disease Inpatient Clinical Knowledge and Management
• Actual Study Start Date: August 1, 2018
• Actual Primary Completion Date: January 3, 2022
• Actual Study Completion Date: January 3, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Retrospective Phase; Patients with Parkinson disease before completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program.	Device: Watch Rx system; The Watch Rx system consists of a Watch Rx smartwatch, Watch Rx application and a WatchRx Web Interface. The Watch Rx smartwatch will be worn on the patient's wrist. The smart watch will send alerts to the caregivers through the Watch Rx app when it is time to administer the medication. The Web Interface will be used to store the medical documentations
Experimental: Prospective Phase-Watch Rx system; Patients after completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program who are also assigned to a WatchRx system	Device: Watch Rx system; The Watch Rx system consists of a Watch Rx smartwatch, Watch Rx application and a WatchRx Web Interface. The Watch Rx smartwatch will be worn on the patient's wrist. The smart watch will send alerts to the caregivers through the Watch Rx app when it is time to administer the medication. The Web Interface will be used to store the medical documentations; Other: Parkinson's Disease Inpatient Clinical Knowledge and Management Program; Parkinson's Disease Inpatient Clinical Knowledge and Management Program educates clinical staff and measures difference in knowledge of medication adherence and compliance for hospitalized Parkinson's Disease patients
Experimental: Retrospective Phase - Clinicians; Clinicians, including physician's assistant, advanced practice nurses, staff nurses, nurse educators, case managers, dietitians pharmacists physical therapist and occupational therapist before completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program.	Other: Parkinson's Disease Inpatient Clinical Knowledge and Management Program; Parkinson's Disease Inpatient Clinical Knowledge and Management Program educates clinical staff and measures difference in knowledge of medication adherence and compliance for hospitalized Parkinson's Disease patients
Experimental: Prospective Phase - Clinicians; Clinicians, including physician's assistant, advanced practice nurses, staff nurses, nurse educators, case managers, dietitians pharmacists physical therapist and occupational therapist after completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program.	Other: Parkinson's Disease Inpatient Clinical Knowledge and Management Program; Parkinson's Disease Inpatient Clinical Knowledge and Management Program educates clinical staff and measures difference in knowledge of medication adherence and compliance for hospitalized Parkinson's Disease patients

Outcome Measures

Primary Outcome Measures :

1. Clinician's Parkinson's Disease Knowledge Assessment Survey Scores [ Time Frame: 6 months ]

   Clinician's Parkinson's Disease Knowledge Assessment Survey scores before and after the Parkinson's Disease Inpatient Clinical Knowledge and Management Program.

   A 20-question survey was administered to PD clinicians for a group measurement of PD knowledge. Scores ranged from 0 - 100% and reflected the percentage of clinicians who correctly answered the question. If 70% or more clinicians correctly answered the question, the group was considered knowledgeable on that topic; if <70% of clinicians responded incorrectly, they were considered not knowledgeable on the information that the question assessed. Survey questions addressed three PD areas: 1) medication/treatment, 2) symptoms/diagnosis, and 3) epidemiology/pathophysiology.

Secondary Outcome Measures :

1. Number of PD Medications Administered on Time (15 Minute Window) [ Time Frame: within 15 minutes post PD medication administration time ]
   The number of Parkinson's Disease (PD) medications administered within the 15-minute timeframe at baseline
2. Number of Patients With Contraindicated Medications Administered. [ Time Frame: 6 months ]
   Measure the number of patients who were adminstered contraindicated medications
3. Number Patients With Falls, Falls With Injury, Positive CAM/Mini-cog [ Time Frame: 6 Months ]

   The number of falls, number of falls with injury, and number of patients with positive Confusion Assessment Method (CAM)/Mini-Cog scores) in hospitalized patients.

   Mini-cog is performed on all admitted patients 65 years and older and is a quick screening for "cognitive vital sign" and early dementia detection. The scale classifies patients as being positive or negative for dementia.

   The Confusion Assessment Method (CAM) is performed on all adult admissions at the time of admission with reporting 1) every shift if the first test is positive, or 2) daily if the first test is negative. It improves the detection and recognition of delirium accurately and quickly in clinical and research settings. CAM is documentation of observed patient behavior during brief, structured interviews according to classification of positive or negative for dementia. There are no numerical (minimum or maximum) values assigned.

4. Length of Stay in Hospitalized Parkinson's Disease Patients. [ Time Frame: 6 months ]
   Average length of stay in hospitalized Parkinson's Disease patients
5. Number of PD Medications Administered on Time (Within 15 Minute Window) [ Time Frame: 15 minutes post assigned medication administration time. ]
   Track the difference that the WatchRx system has on scheduled PD medication administration time versus actual PD medication administration time
6. Number of PD Medication Errors After Using the WatchRX System [ Time Frame: 6 Months ]
   The number of contraindicated medications administered to Parkinson's disease patients after using the WatchRX system
7. Number of Falls, Falls Within Injury, Positive CAM Scores, and Positive Mini-Cog Scores After Using the WatchRX System [ Time Frame: 6 months ]
   The number of falls, number of falls with injury, number of positive CAM scores, and number of positive Mini-Cog scores after using the WatchRX system.
8. Length of Stay With the WatchRx System [ Time Frame: 6 months ]
   Parkinson's disease patients' length of stay after using the WatchRx system

Eligibility Criteria

• Ages Eligible for Study: 22 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New Jersey

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Sponsors and Collaborators

Hackensack Meridian Health

Investigators

• Principal Investigator: Azmi Hooman, MD; Hackensack Meridian Health
• Principal Investigator: Mohammed Quadri, MD, MBA; Hackensack Meridian Health

  Study Documents (Full-Text)

Documents provided by Hackensack Meridian Health:

Study Protocol and Statistical Analysis Plan  [PDF] May 9, 2019

More Information

• Responsible Party: Hackensack Meridian Health
• ClinicalTrials.gov Identifier: NCT03888287
• Other Study ID Numbers: Pro00006159
• First Posted: March 25, 2019
• Results First Posted: March 16, 2023
• Last Update Posted: April 18, 2023
• Last Verified: March 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hackensack Meridian Health:

PICK study; Impact of Watch Rx

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases