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Risk Assessment for Postoperative Delirium (RAPID)

Primary Purpose

Postoperative Delirium

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Tablet computer application
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Delirium focused on measuring Postoperative delirium, Postoperative cognitive decline, Postoperative cognitive dysfunction, Risk assessment, Tablet computer, Clinical screening tool

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Basel

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study cohort

Arm Description

Tablet computer application

Outcomes

Primary Outcome Measures

Incidence of POD.
Incidence of POD, detected by the DRS-R-98.

Secondary Outcome Measures

Severity of POD.
Severity of POD, measured by the DRS-R-98.

Full Information

First Posted
February 14, 2015
Last Updated
April 24, 2018
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02377115
Brief Title
Risk Assessment for Postoperative Delirium
Acronym
RAPID
Official Title
Risk Assessment for Postoperative Delirium: Derivation of a Self-Administered Tablet Computer-based Clinical Screening Tool
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium
Keywords
Postoperative delirium, Postoperative cognitive decline, Postoperative cognitive dysfunction, Risk assessment, Tablet computer, Clinical screening tool

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study cohort
Arm Type
Other
Arm Description
Tablet computer application
Intervention Type
Other
Intervention Name(s)
Tablet computer application
Intervention Description
Preoperatively, all study participants (entire cohort) will perform in the self-administered tablet computer-based tool to assess the risk of developing POD.
Primary Outcome Measure Information:
Title
Incidence of POD.
Description
Incidence of POD, detected by the DRS-R-98.
Time Frame
Day 1-5 after surgery.
Secondary Outcome Measure Information:
Title
Severity of POD.
Description
Severity of POD, measured by the DRS-R-98.
Time Frame
Day 1-5 after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolai Goettel, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
http://www.guideline.gov/content.aspx?id=24121
Description
Delirium: diagnosis, prevention and management
URL
http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/cardiology/cardiac-risk-stratification-for-noncardiac-surgery/Default.htm
Description
Cardiac Risk Stratification for Noncardiac Surgery

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Risk Assessment for Postoperative Delirium

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