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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03888287
Recruitment Status : Active, not recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

Tracking Information
First Submitted Date  ICMJE August 1, 2018
First Posted Date  ICMJE March 25, 2019
Last Update Posted Date March 25, 2019
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • Compare the Parkinson's Disease Inpatient Clinical Knowledge of clinicians before and after the Parkinson's Disease Inpatient Clinical Knowledge and Management Program [ Time Frame: 1 year ]
    Examine the effectiveness of Parkinson's Disease Inpatient Clinical Knowledge and Management Program on PD medication management using a Parkinson's Disease Knowledge Assessment Survey
  • Evaluate the Impact of WatchRx system on PD medication adherence during hospitalization [ Time Frame: 6 months ]
    Track number of medication errors as measured by difference in actual and scheduled PD medication administration time and the number of contraindicated medication administrations.
  • Track adverse events in hospitalized patients [ Time Frame: 6 months ]
    Track adverse events (including number of falls, number of falls with injury, number of patients with positive CAM/Mini-Cog scores, and length of stay) in hospitalized patients before and after implementation of Parkinson's Disease Inpatient Clinical Knowledge and Management Program and the WatchRx system.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • Patients with Early Identification of Parkinson's Disease [ Time Frame: 6 Months ]
    number of patients with early identification of Parkinson's Disease
  • Patients Enrolled in Parkinson's Disease Registry at HackensackUMC [ Time Frame: 6 Months ]
    Parkinson's Disease Registry
  • Trend the prevalence of Parkinson's Disease patients at HackensackUMC [ Time Frame: 6 Months ]
    Identify a trend
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Parkinson's Disease Inpatient Clinical Knowledge and Management
Official Title  ICMJE Parkinson's Disease Inpatient Clinical Knowledge and Management
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 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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Retrospective Phase
    150 patients with Parkinson disease before completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program.
    Intervention: Device: Watch Rx system
  • Experimental: Prospective Phase-Watch Rx system
    150 patients after completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program who are also assigned to a WatchRx system
    Intervention: Device: Watch Rx system
  • Experimental: Retrospective Phase - Clinicians
    346 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.
    Intervention: Other: Parkinson's Disease Inpatient Clinical Knowledge and Management Program
  • Experimental: Prospective Phase - Clinicians
    346 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: Other: Parkinson's Disease Inpatient Clinical Knowledge and Management Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2019)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03888287
Other Study ID Numbers  ICMJE Pro00006159
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hackensack Meridian Health
Study Sponsor  ICMJE Hackensack Meridian Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Azmi Hooman, MD Hackensack Meridian Health
Principal Investigator: Mohammed Quadri, MD, MBA Hackensack Meridian Health
Principal Investigator: Claudia Douglas, DNP Hackensack Meridian Health
PRS Account Hackensack Meridian Health
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP