Screening for Delirium in Older Inpatients

Screening for Delirium in Older Inpatients Using 3D-CAM and 4AT: Protocol for a Randomized Pilot Study

Two-arm parallel-randomized pilot study and to collect data at the Department of Geriatric Medicine at Aalborg University Hospital. The aim is to assess the feasibility of a future randomized controlled study comparing Danish versions of 3D-CAM and 4AT in an acute medical setting. The primary objective is to assess 1) feasibility of obtaining informed consent and recruiting older adults within 24 hours of admission (or surgery) at the Department of Geriatric Medicine, Department of Acute Medicine, or Department of Orthopedic Surgery. Secondary objectives are 2a) to compare feasibility of recruitment and testing in the three different departments, 2b) to inform a preliminary evaluation of validity and reliability of the Danish version of screening instruments, and 2c) to obtain data on variance to support calculating sample size for a full-scale RCT.

Study Overview

• Status: Completed
• Conditions: Delirium in Old Age
• Intervention / Treatment: Diagnostic test: Delirium Screening

Detailed Description

We will recruit participants through a consecutive sampling of all potentially eligible patients. Recruitment will take place in three different settings: the Department of Geriatric Medicine, the Department of Acute Medicine, and the Department of Orthopedic Surgery. One week will be allocated for recruitment in each setting.

Potentially delirious patients often have impaired cognitive status. Therefore, the process of recruitment and informed consent is critically important and poses a central issue of feasibility to be assessed in this study.

It cannot be known with certainty whether patients are delirious prior to inclusion into the study, and even among delirious patients, there are considerable circadian fluctuations (as this is a hallmark of the condition), meaning that patients may have lucid moments during the day where they are cognitively intact and may be able to give informed consent.

Generally, informed consent will be sought from participants when possible. In case they are permanently or temporarily unable to give informed consent, informed consent will be sought from next of kin. Due to the short time in the study for each participant, it is not anticipated that participants will regain the ability to give informed consent during the study. However, if they do, new informed consent will be obtained from the participant. The number of potential participants at each step will be documented to assess problems with feasibility.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Northern Jutland
    • Aalborg, Northern Jutland, Denmark, 9000
      • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age over 80 years
• Admission or surgery within the last 24 hours

Exclusion Criteria:

• Unable to obtain contact to next of kin for informed consent within time-frame

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 3D-CAM screening	Diagnostic test: Delirium Screening; Either 3D-CAM or 4AT
Active Comparator: 4AT screening	Diagnostic test: Delirium Screening; Either 3D-CAM or 4AT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment overall	Measured by counting the number of participants giving informed consent, as well as number of participants in each setting not giving informed consent in each setting over the 3 week period.	3 weeks total

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment in different settings	Comparison of the number of participants (counted) recruited in the Department of Orthopedic Surgery, Geriatric Medicine and Acute Medicine	1 week each
Validity of screening tools	Preliminary results of screening validity of 4A's test and 3D-CAM test comparing sensitivity and specificity	3 weeks total

Collaborators and Investigators

• Sponsor: Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: N-20220026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No