Trial Outcomes & Findings for Parkinson's Disease Inpatient Clinical Knowledge and Management (NCT NCT03888287)
NCT ID: NCT03888287
Last Updated: 2023-04-18
Results Overview
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.
TERMINATED
NA
477 participants
6 months
2023-04-18
Participant Flow
Participant milestones
| Measure |
Retrospective Phase
Patients with Parkinson's disease before completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program.
|
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
|
Retrospective Phase - Clinicians
Clinicians, including physician's assistants, advanced practice nurses, staff nurses, nurse educators, case managers, dietitians pharmacists physical therapists, and occupational therapists before completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program.
|
Prospective Phase - Clinicians
Clinicians, including physician's assistants, advanced practice nurses, staff nurses, nurse educators, case managers, dietitians pharmacists physical therapists and occupational therapists after completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
131
|
0
|
266
|
80
|
|
Overall Study
COMPLETED
|
131
|
0
|
266
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Information/demographics of clinicians was never collected.
Baseline characteristics by cohort
| Measure |
Retrospective Phase
n=131 Participants
Patients with Parkinson's disease before completion of the Parkinson's Disease Inpatient Clinical Knowledge and Management Program.
|
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
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
76 years
STANDARD_DEVIATION 14.4 • n=99 Participants
|
—
|
76 years
STANDARD_DEVIATION 14.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=99 Participants • Information/demographics of clinicians was never collected.
|
0 Participants
n=107 Participants • Information/demographics of clinicians was never collected.
|
54 Participants
n=206 Participants • Information/demographics of clinicians was never collected.
|
|
Sex: Female, Male
Male
|
77 Participants
n=99 Participants • Information/demographics of clinicians was never collected.
|
0 Participants
n=107 Participants • Information/demographics of clinicians was never collected.
|
77 Participants
n=206 Participants • Information/demographics of clinicians was never collected.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=99 Participants • Demographic data was never collected on clinicians.
|
0 Participants
n=107 Participants • Demographic data was never collected on clinicians.
|
23 Participants
n=206 Participants • Demographic data was never collected on clinicians.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107 Participants
n=99 Participants • Demographic data was never collected on clinicians.
|
0 Participants
n=107 Participants • Demographic data was never collected on clinicians.
|
107 Participants
n=206 Participants • Demographic data was never collected on clinicians.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants • Demographic data was never collected on clinicians.
|
0 Participants
n=107 Participants • Demographic data was never collected on clinicians.
|
1 Participants
n=206 Participants • Demographic data was never collected on clinicians.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants • Demographic data was never collected on clinicians.
|
0 Participants
n=107 Participants • Demographic data was never collected on clinicians.
|
0 Participants
n=206 Participants • Demographic data was never collected on clinicians.
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants • Demographic data was never collected on clinicians.
|
0 Participants
n=107 Participants • Demographic data was never collected on clinicians.
|
4 Participants
n=206 Participants • Demographic data was never collected on clinicians.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • Demographic data was never collected on clinicians.
|
0 Participants
n=107 Participants • Demographic data was never collected on clinicians.
|
0 Participants
n=206 Participants • Demographic data was never collected on clinicians.
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants • Demographic data was never collected on clinicians.
|
0 Participants
n=107 Participants • Demographic data was never collected on clinicians.
|
4 Participants
n=206 Participants • Demographic data was never collected on clinicians.
|
|
Race (NIH/OMB)
White
|
106 Participants
n=99 Participants • Demographic data was never collected on clinicians.
|
0 Participants
n=107 Participants • Demographic data was never collected on clinicians.
|
106 Participants
n=206 Participants • Demographic data was never collected on clinicians.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants • Demographic data was never collected on clinicians.
|
0 Participants
n=107 Participants • Demographic data was never collected on clinicians.
|
0 Participants
n=206 Participants • Demographic data was never collected on clinicians.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=99 Participants • Demographic data was never collected on clinicians.
|
0 Participants
n=107 Participants • Demographic data was never collected on clinicians.
|
17 Participants
n=206 Participants • Demographic data was never collected on clinicians.
|
|
Region of Enrollment
United States
|
131 participants
n=99 Participants
|
—
|
477 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Number of clinicians that completed the pre and post intervention surveys
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.
Outcome measures
| Measure |
Clinicians' Knowledge Before Educational Intervention
n=266 Participants
Average clinician's participant PD score before educational intervention
|
Clinicians' Knowledge After Educational Intervention
n=80 Participants
Average clinician's participant PD score after educational intervention
|
|---|---|---|
|
Clinician's Parkinson's Disease Knowledge Assessment Survey Scores
|
68.50 average knowledge score
Interval 0.0 to 100.0
|
78.75 average knowledge score
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: within 15 minutes post PD medication administration timePopulation: No patients were enrolled in the study after clinician education
The number of Parkinson's Disease (PD) medications administered within the 15-minute timeframe at baseline
Outcome measures
| Measure |
Clinicians' Knowledge Before Educational Intervention
n=2454 Number of scheduled PD medications
Average clinician's participant PD score before educational intervention
|
Clinicians' Knowledge After Educational Intervention
Average clinician's participant PD score after educational intervention
|
|---|---|---|
|
Number of PD Medications Administered on Time (15 Minute Window)
|
678 number of PD meds administered in 15 min
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: No patients were enrolled in the study after clinician education
Measure the number of patients who were adminstered contraindicated medications
Outcome measures
| Measure |
Clinicians' Knowledge Before Educational Intervention
n=131 Participants
Average clinician's participant PD score before educational intervention
|
Clinicians' Knowledge After Educational Intervention
Average clinician's participant PD score after educational intervention
|
|---|---|---|
|
Number of Patients With Contraindicated Medications Administered.
|
21 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Patients were not enrolled after clinical education
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.
Outcome measures
| Measure |
Clinicians' Knowledge Before Educational Intervention
n=93 Participants
Average clinician's participant PD score before educational intervention
|
Clinicians' Knowledge After Educational Intervention
Average clinician's participant PD score after educational intervention
|
|---|---|---|
|
Number Patients With Falls, Falls With Injury, Positive CAM/Mini-cog
Number of falls
|
1 Participants
|
—
|
|
Number Patients With Falls, Falls With Injury, Positive CAM/Mini-cog
Number of falls with injury
|
0 Participants
|
—
|
|
Number Patients With Falls, Falls With Injury, Positive CAM/Mini-cog
Number of patients with positive CAM scores
|
47 Participants
|
—
|
|
Number Patients With Falls, Falls With Injury, Positive CAM/Mini-cog
Number of patients with abnormal mini-cog scores
|
45 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Patients were not enrolled after clinical education
Average length of stay in hospitalized Parkinson's Disease patients
Outcome measures
| Measure |
Clinicians' Knowledge Before Educational Intervention
n=131 Participants
Average clinician's participant PD score before educational intervention
|
Clinicians' Knowledge After Educational Intervention
Average clinician's participant PD score after educational intervention
|
|---|---|---|
|
Length of Stay in Hospitalized Parkinson's Disease Patients.
|
6.1 days
Standard Deviation 6.6
|
—
|
SECONDARY outcome
Timeframe: 15 minutes post assigned medication administration time.Population: No patients were enrolled for the WatchRX system
Track the difference that the WatchRx system has on scheduled PD medication administration time versus actual PD medication administration time
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 MonthsPopulation: No patients were enrolled in the WatchRX system
The number of contraindicated medications administered to Parkinson's disease patients after using the WatchRX system
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: No patient enrollment into 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: No patients were enrolled into the WatchRX system
Parkinson's disease patients' length of stay after using the WatchRx system
Outcome measures
Outcome data not reported
Adverse Events
Retrospective Phase - Watch Rx System
Prospective Phase - Watch Rx System
Retrospective Phase - Clinicians
Prospective Phase - Clinicians
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place