Risk Assessment for Postoperative Delirium (RAPID)

April 24, 2018 updated by: Nicolai Goettel, University Hospital, Basel, Switzerland

Risk Assessment for Postoperative Delirium: Derivation of a Self-Administered Tablet Computer-based Clinical Screening Tool

Postoperative delirium (POD) - a temporary state of confusion - is a frequent complication of surgery, which most commonly occurs in elderly patients. A tablet computer application that may assist preoperative risk screening for POD was developed at the University Hospital Basel in 2014. This study aims to investigate whether the computer program may assess the risk of a patient to develop POD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

Postoperative delirium (POD) - a temporary state of confusion - is a frequent complication of surgery, which most commonly occurs in elderly patients. Depending on the risk profile, 9-87% of patients are affected. Regarding the increasing age of surgical patients, prevention of POD is of even greater importance. New data lead to the assumption that medical preventive strategies may influence the frequency or at least the severity or duration of POD.

Preventive measures in patients at increased risk for developing POD could possibly be administered; however, clinical predictors for POD are rare and/or unspecific. Different scores and test batteries to assess the preoperative risk of POD have been developed, but these tools are time-consuming and require trained personnel.

In 2014, a tablet computer application was developed at the University Hospital Basel with the primary objective to assess the risk of developing POD in surgical patients. The first part records patient details, such as age, level of training, language, sensory impairment, and regular drug intake. The second part tests different cognitive functions, more precisely cognitive self-assessment, temporal orientation, episodic memory, working memory, attention, and executive functions. In contrary to already available tools, this application can be operated by the patient alone without the help of trained staff. It was tested in healthy individuals and patients with mild cognitive impairment and should now be evaluated in a clinical setting.

Study design:

Prospective observational cohort study with a derivation cohort including patients scheduled for elective non-cardiac surgery.

Number of participants:

Patients will be enrolled until a collective of 50 patients with POD is reached. Each study participant in the collective of delirious patients represents 2% in the final analysis. With an expected incidence of POD of 25%, an overall sample size of about 200 patients will be recruited.

Recruitment:

Eligible study participants (patients scheduled for surgery at the University Hospital Basel) will be identified from the appointments calendar of the Anesthesia Preoperative Evaluation Clinic.

Methods:

Before surgery, participating patients perform the tablet computer application to obtain a score. A high score attained in the application suggests a low risk to develop POD. The score is then compared with results of postoperative assessments conducted daily from day 1 after surgery. Outcome measures are the Delirium-Rating-Scale-Revised-98 (DRS-R-98), which can be used to diagnose delirium and assess its severity, the Delirium Observation Screening (DOS) Scale, and the Confusion Assessment Method (CAM). These assessments are repeated for 5 days until the patient is discharged or - if the patient develops delirium - until symptoms have subsided.

Endpoints:

Primary endpoint:

Correlation between the test score attained by the patient in the self-administered computerized test and the incidence of POD.

Secondary endpoint:

Correlation between the test score attained by the patient in the self-administered computerized test and the severity of POD.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective major surgery
  • Age ≥65 years
  • Education ≥7 years
  • Fluency in German language
  • Informed written consent

Exclusion Criteria:

  • Dementia (Mini Mental State Examination (MMSE) <20 points)
  • Surgical intervention that would limit verbal communication
  • Cardiac surgery
  • Thoracic/pulmonary surgery
  • Intracranial surgery
  • Former or present participation in a cognitive research project

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Study cohort
Tablet computer application
Other: Tablet computer application
Preoperatively, all study participants (entire cohort) will perform in the self-administered tablet computer-based tool to assess the risk of developing POD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of POD.
Time Frame: Day 1-5 after surgery.
Incidence of POD, detected by the DRS-R-98.
Day 1-5 after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of POD.
Time Frame: Day 1-5 after surgery.
Severity of POD, measured by the DRS-R-98.
Day 1-5 after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Nicolai Goettel, MD, University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 14, 2015

First Submitted That Met QC Criteria

February 25, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAPID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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