Back to resultsImproved Patient Safety for Acute Restless Medical Patients With Supplemental Observation
Primary Purpose
Delirium
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Camera observation
Sponsored by
About this trial
This is an interventional supportive care trial for Delirium
Eligibility Criteria
Inclusion Criteria:
- Patients over 65 years of age with a CAM score of 2 or higher.
Exclusion Criteria:
- paranoia
- severe dementia
- suicidal
- need for permanent guard
Sites / Locations
- Aalborg Universityhospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Camera observation
No camera observation
Arm Description
Camera observation
No intervention
Outcomes
Primary Outcome Measures
Change in Confusion Assessment Score
Assessed by Confusion Assessment Method (CAM) screening tool. Minimum value is 0, Maximum value is 4. Higher score means higher risk of developing Delirium.
Secondary Outcome Measures
Number of patient falls
Incidence of patient falls observed by the nurse during the observation period.
Discontinuation of accesses
Number of patient discontinuation of e.g. oxygen mask, peripheral venous catheter, bladder catheters
Number of administrations of sedatives
Number of OR administrations and number of IV administrations (specific sedatives e.g. Methylphenidate, Haloperidol, Midazolam).
Full Information
NCT ID
NCT04841122
First Posted
March 25, 2021
Last Updated
October 27, 2021
Sponsor
Aalborg University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04841122
Brief Title
Improved Patient Safety for Acute Restless Medical Patients With Supplemental Observation
Official Title
Improved Patient Safety for Acute Restless Medical Patients With Supplemental Observation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated after 6 months due to recruitment and data collection challenges.
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to investigate whether supplemental camera observation directly linked to the nurse's phone will improve patient safety for acute medical care patients', who are restless, confused or in risk of development of acute delirium. The setting is an acute medical care ward.
The expected result is a reduced incidence of patients with delirious condition, patients who fall or unintentionally remove intravenous access or catheters. Thus, higher patient safety and more efficient patient trajectories are expected, as well as a reduced need for treatment, care and rehabilitation after discharge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Camera observation
Arm Type
Active Comparator
Arm Description
Camera observation
Arm Title
No camera observation
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Device
Intervention Name(s)
Camera observation
Intervention Description
Supplemental camera observation directly linked to the nurse's phone
Primary Outcome Measure Information:
Title
Change in Confusion Assessment Score
Description
Assessed by Confusion Assessment Method (CAM) screening tool. Minimum value is 0, Maximum value is 4. Higher score means higher risk of developing Delirium.
Time Frame
First measurement at admission and second measurement within 24 hours.
Secondary Outcome Measure Information:
Title
Number of patient falls
Description
Incidence of patient falls observed by the nurse during the observation period.
Time Frame
The time the patient is assessed during the observation period.
Title
Discontinuation of accesses
Description
Number of patient discontinuation of e.g. oxygen mask, peripheral venous catheter, bladder catheters
Time Frame
The time the patient is assessed during the observation period.
Title
Number of administrations of sedatives
Description
Number of OR administrations and number of IV administrations (specific sedatives e.g. Methylphenidate, Haloperidol, Midazolam).
Time Frame
The time the patient is assessed during the observation period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over 65 years of age with a CAM score of 2 or higher.
Exclusion Criteria:
paranoia
severe dementia
suicidal
need for permanent guard
Facility Information:
Facility Name
Aalborg Universityhospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improved Patient Safety for Acute Restless Medical Patients With Supplemental Observation
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