Risk Communication About Post-operative Delirium (POD) and Post-operative Cognitive Dysfunction (POCD)

NCT03953313 | Completed DMC

• 1 other identifier: RISKOMMDELIR
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the awareness of post-operative delirium (POD) and post-operative cognitive dysfunction (POCD), their respective risk factors and effective preparation and treatment options in a pre-clinical sample of patients attending a premedication outpatient clinic (Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Berlin, Germany) prior to elective surgery. The investigators hypothesize that the awareness for POD/POCD as potential risk in consequence of the surgery is very low in patients, and that therefore easy to use measure for prevention are underutilized by patients.

Conditions

Post-operative Delirium; Post-operative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (2)

• Awareness of POD specifically as post-operative complications (Q2)

  A questionnaire is used to assess this outcome measure awareness of POD as post-operative complications. Response to Question: "A possible complication of an operation can be states of confusion, forgetfulness or problems with thinking / speaking, which usually subside within a few hours or days. This is termed "post-operative delirium. Have you ever heard of this complication?": Yes/No

  Prior to elective surgery

• Awareness of POCD specifically as post-operative complications (Q3)

  A questionnaire is used to assess this outcome measure awareness of POCD as post-operative complications. Response to Question: "A possible complication of an operation can be a long-term disruption of thinking and a lower mental capacity, which may last up to several months or even years. This is termed "post-operative cognitive dysfunction". Have you ever heard of this complication?": Yes/No

  Prior to elective surgery

Secondary Outcomes (17)

• Awareness of post-operative complications (Q1)

  Prior to elective surgery

• Estimation about prevalence of POD after elective, non-emergency surgeries (Q4)

  Prior to elective surgery

• Estimation about prevalence of POCD after elective, non-emergency surgeries (Q5)

  Prior to elective surgery

• Estimation about personal risk of developing POD (Q6)

  Prior to elective surgery

• Estimation about personal risk of developing POCD (Q7)

  Prior to elective surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male or female adult patients attending the premedication outpatient clinic Charité University Medicine, CVK, Berlin, Germany in order to attend a (non-cardiac) elective surgery

You may qualify if:

• male or female patients attending the premedication outpatient clinic Charité University Medicine, CVK, Berlin, Germany in order to attend a (non-cardiac) elective surgery
• years or older

You may not qualify if:

• Refusal by the patient

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Claudia Spies, MD. Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 16, 2019
• Study Start: May 3, 2021
• Primary Completion: December 19, 2021
• Study Completion: December 19, 2021
• Last Updated: February 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)