Improved Patient Safety for Acute Restless Medical Patients With Supplemental Observation

• Sponsor: Aalborg University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04841122
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.4
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium	Device: Camera observation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Improved Patient Safety for Acute Restless Medical Patients With Supplemental Observation
• Actual Study Start Date: Apr 19, 2021
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Camera observation Camera observation	Device: Camera observation; Supplemental camera observation directly linked to the nurse's phone
No Intervention: No camera observation No intervention

Outcome Measures

Primary Outcome Measures

1. Change in Confusion Assessment Score [First measurement at admission and second measurement within 24 hours.]

   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

1. Number of patient falls [The time the patient is assessed during the observation period.]

   Incidence of patient falls observed by the nurse during the observation period.

2. Discontinuation of accesses [The time the patient is assessed during the observation period.]

   Number of patient discontinuation of e.g. oxygen mask, peripheral venous catheter, bladder catheters

3. Number of administrations of sedatives [The time the patient is assessed during the observation period.]

   Number of OR administrations and number of IV administrations (specific sedatives e.g. Methylphenidate, Haloperidol, Midazolam).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aalborg Universityhospital	Aalborg		Denmark	9000

Sponsors and Collaborators

• Aalborg University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mette Geil Kollerup, Principal investigator and postdoc., Aalborg University Hospital
• ClinicalTrials.gov Identifier: NCT04841122
• Other Study ID Numbers: N-20200079
• First Posted: Apr 12, 2021
• Last Update Posted: Nov 1, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Delirium

Study Results

No Results Posted as of Nov 1, 2021