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

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Watch Rx system
Parkinson's Disease Inpatient Clinical Knowledge and Management Program
Sponsored by
Hackensack Meridian Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring PICK study, Impact of Watch Rx

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hackensack University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Retrospective Phase

Prospective Phase-Watch Rx system

Retrospective Phase - Clinicians

Prospective Phase - Clinicians

Arm Description

Patients with Parkinson disease before completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program.

Patients after completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program who are also assigned to a WatchRx system

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.

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.

Outcomes

Primary Outcome Measures

Clinician's Parkinson's Disease Knowledge Assessment Survey Scores
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

Number of PD Medications Administered on Time (15 Minute Window)
The number of Parkinson's Disease (PD) medications administered within the 15-minute timeframe at baseline
Number of Patients With Contraindicated Medications Administered.
Measure the number of patients who were adminstered contraindicated medications
Number Patients With Falls, Falls With Injury, Positive CAM/Mini-cog
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.
Length of Stay in Hospitalized Parkinson's Disease Patients.
Average length of stay in hospitalized Parkinson's Disease patients
Number of PD Medications Administered on Time (Within 15 Minute Window)
Track the difference that the WatchRx system has on scheduled PD medication administration time versus actual PD medication administration time
Number of PD Medication Errors After Using the WatchRX System
The number of contraindicated medications administered to Parkinson's disease patients after using the WatchRX system
Number of Falls, Falls Within Injury, Positive CAM Scores, and Positive Mini-Cog Scores After Using the WatchRX System
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.
Length of Stay With the WatchRx System
Parkinson's disease patients' length of stay after using the WatchRx system

Full Information

First Posted
August 1, 2018
Last Updated
March 21, 2023
Sponsor
Hackensack Meridian Health
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1. Study Identification

Unique Protocol Identification Number
NCT03888287
Brief Title
Parkinson's Disease Inpatient Clinical Knowledge and Management
Acronym
PICK
Official Title
Parkinson's Disease Inpatient Clinical Knowledge and Management
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Study was put on hold due to COVID and never reopened
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
January 3, 2022 (Actual)
Study Completion Date
January 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health

4. Oversight

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
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
PICK study, Impact of Watch Rx

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
477 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retrospective Phase
Arm Type
Experimental
Arm Description
Patients with Parkinson disease before completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program.
Arm Title
Prospective Phase-Watch Rx system
Arm Type
Experimental
Arm Description
Patients after completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program who are also assigned to a WatchRx system
Arm Title
Retrospective Phase - Clinicians
Arm Type
Experimental
Arm Description
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.
Arm Title
Prospective Phase - Clinicians
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Watch Rx system
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Parkinson's Disease Inpatient Clinical Knowledge and Management Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinician's Parkinson's Disease Knowledge Assessment Survey Scores
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of PD Medications Administered on Time (15 Minute Window)
Description
The number of Parkinson's Disease (PD) medications administered within the 15-minute timeframe at baseline
Time Frame
within 15 minutes post PD medication administration time
Title
Number of Patients With Contraindicated Medications Administered.
Description
Measure the number of patients who were adminstered contraindicated medications
Time Frame
6 months
Title
Number Patients With Falls, Falls With Injury, Positive CAM/Mini-cog
Description
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.
Time Frame
6 Months
Title
Length of Stay in Hospitalized Parkinson's Disease Patients.
Description
Average length of stay in hospitalized Parkinson's Disease patients
Time Frame
6 months
Title
Number of PD Medications Administered on Time (Within 15 Minute Window)
Description
Track the difference that the WatchRx system has on scheduled PD medication administration time versus actual PD medication administration time
Time Frame
15 minutes post assigned medication administration time.
Title
Number of PD Medication Errors After Using the WatchRX System
Description
The number of contraindicated medications administered to Parkinson's disease patients after using the WatchRX system
Time Frame
6 Months
Title
Number of Falls, Falls Within Injury, Positive CAM Scores, and Positive Mini-Cog Scores After Using the WatchRX System
Description
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.
Time Frame
6 months
Title
Length of Stay With the WatchRx System
Description
Parkinson's disease patients' length of stay after using the WatchRx system
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azmi Hooman, MD
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammed Quadri, MD, MBA
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Parkinson's Disease Inpatient Clinical Knowledge and Management

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