Improved Patient Safety for Acute Restless Medical Patients With Supplemental Observation

Delirium Clinical Trial

Official title:

Improved Patient Safety for Acute Restless Medical Patients With Supplemental Observation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04841122
• Other study ID #: N-20200079
• Status: Terminated
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2021
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Device:
• Camera observation
Supplemental camera observation directly linked to the nurse's phone

Locations

Country	Name	City	State
Denmark	Aalborg Universityhospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	First measurement at admission and second measurement within 24 hours.
Secondary	Number of patient falls	Incidence of patient falls observed by the nurse during the observation period.	The time the patient is assessed during the observation period.
Secondary	Discontinuation of accesses	Number of patient discontinuation of e.g. oxygen mask, peripheral venous catheter, bladder catheters	The time the patient is assessed during the observation period.
Secondary	Number of administrations of sedatives	Number of OR administrations and number of IV administrations (specific sedatives e.g. Methylphenidate, Haloperidol, Midazolam).	The time the patient is assessed during the observation period.