Post-operative DeliriumNCT03953313
Risk Communication About Post-operative Delirium (POD) and Post-operative Cognitive Dysfunction (POCD)
An observational study of Post-operative Delirium and Post-operative Cognitive Dysfunction, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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 … Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Delirium, Post-operative Cognitive Dysfunction
- How many people
- 223 participants
- Where
- 1 siteGermany
- Study dates
- 3 May 2021to 19 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- male or female patients attending the premedication outpatient clinic Charité University Medicine, CVK, Berlin, Germany in order to attend a (non-cardiac) elective surgery
- 18 years or older
Who cannot join
- Refusal by the patient
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin
Berlin, 13353
About this study
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.
Read the detailed description
A post-operative delirium is defined as attentional, consciousness and perceptual deficit occurring after and as a consequence of an operation. These deficits are acute and severe, but usually reversible. A post-operative cognitive dysfunction (POCD) is a serious impediment to cognitive functioning, affecting memory, learning, and cognition, again occurring after and as a consequence of an operation. Both delirium and POCD, of which delirium is predictive, have been recognized in medical science as being associated with major cardiac surgery for a while. However, its prevalence after non-cardiac surgery and its links to mortality have only been quantified relatively recently. These studies show that delirium and POCD are very frequent post-operative complications that often go unrecognized. The prevalence across different age groups varies: younger (18-39) adults and older (60+) adults seem to be particularly at risk of developing early POCD (i.e., POCD at hospital discharge) with one study reporting 36.6% of younger and 41,4% of older adults being affected, as compared to the middle-aged (40-59), 30.4% of which were affected. Late POCD (i.e., POCD three months after hospital discharge) was found to be significantly more common in older adults (12.7%) than in the younger or middle aged population (5.7% and 5.6%, respectively). In intensive care settings, delirium is estimated to occur in up to 82% of patients, POCD in up to 41%.
Importantly, delirium as well as POCD are associated with significant negative effects on health: Investigators report a 1-year mortality rate post-discharge of 10.2% for patients with late POCD. Investigators conducted a meta-analysis of post-discharge mortality, institutionalization and dementia amongst elderly patients and found a 38.0% risk of death for patients with delirium by the time of a 2-year follow-up, compared to a control group with 27.5%; a 33.4% probability of institutionalization a year later as compared to 10.7% in the control; and a 62.5% chance of developing dementia up to 4 years later as compared to 8.1% in the control. These differences were independent of confounders such as age, sex, comorbidity, illness severity, and baseline dementia scores. Other studies report prolonged cognitive impairment over 12 months after surgery and significantly higher rates of job loss associated with POCD.
Note that delirium and POCD are complications that can be managed very well. There are relatively simple ways to prevent delirium or recover from it more quickly. Importantly, patients themselves can do a great deal in the way of preparation for an operation and post-operative behavior to significantly reduce their likelihood of getting delirium / POCD or manage it successfully. Yet, most patients are only made aware of the issue, if at all, during their pre-operative anesthetic consultation, usually the evening before the operation - too late to put many of the important preparatory behaviours into place. Importantly, there is no direct communication channel between general practitioners, who refer the patient, and clinical anesthesiologists who deal with delirium / POCD management. Thus, risk factors for as well as incidence of delirium / POCD after surgeries are likely not passed between these important actors in the health system.
Given its high prevalence and serious impact on mental health, physical health, and socio-economic factors, it is imperative that patients and general practitioners alike are aware of delirium / POCD as well as how to recognize it, how to best prepare for an operation in order to reduce its chance of occurrence, and how to behave in case post-operative delirium or POCD has developed. To the knowledge of the investigators, this is the first study to date assessing the awareness of delirium / POCD, their respective risk factors and effective preparation and treatment options in a pre-clinical sample of the general population. Goal of the study is to assess and quantify the current communication deficit in the healthcare system and thus build up pressure to improve it.
- Medical subject headings
- Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Prior to elective surgery
Secondary outcomes (17)
Awareness of post-operative complications (Q1)
A questionnaire is used to assess this outcome measure awareness of post-operative complications. Response to question "Which of the following symptoms (pain, wound infection, damage to teeth, sepsis, forgetfulness, loss of orientation, thrombosis, attention deficits, nausea, stroke, heart attack, problems with healing of the wound) do you think are possible immediate consequences of an elective operation (e.g. as opposed to an emergency operation)?": Yes/No
Measured: Prior to elective surgery
Estimation about prevalence of POD after elective, non-emergency surgeries (Q4)
Estimation about prevalence of POD. Answer to Question: "Please estimate, after how many of 1000 operations (no emergencies), patients suffer from a post-operative delirium?": Number range in 1000
Measured: Prior to elective surgery
Estimation about prevalence of POCD after elective, non-emergency surgeries (Q5)
Estimation about prevalence of POCD. Answer to Question: "Please estimate, after how many of 1000 operations (no emergencies), patients suffer from a POCD?": Number range in 1000
Measured: Prior to elective surgery
Estimation about personal risk of developing POD (Q6)
A questionnaire is used to assess this outcome measure patients estimation about personal risk of experiencing postoperative delirium after elective surgery. Answer to Question:" Please estimate your personal risk of suffering a post-operative delirium in percentage points!"
Measured: Prior to elective surgery
Estimation about personal risk of developing POCD (Q7)
A questionnaire is used to assess this outcome measure patients estimation about personal risk of experiencing POCD after elective surgery. Answer to Question: "Please estimate your personal risk of suffering from a post-operative cognitive dysfunction three months after the operation in percentage points!"
Measured: Prior to elective surgery
Knowledge about preventive measures to reduce likelihood of developing delirium / POCD (Q8)
A questionnaire is used to assess this outcome measure the knowledge about preventive measures to reduce likelihood of developing pOD / POCD. Answer to question:" Which of the pre-operative measures (bodily hygiene, taking sedatives or anti-depressants, prepare in a calm, quiet environment for the operation, avoid distractions, drink water until 2 hours prior to the operation, a good night's sleep, avoiding contact with animals (e.g., pets), a protein-rich diet, keeping a diary) do you consider effective in preventing a post-operative Delirium or cognitive dysfunction?": Yes/No
Measured: Prior to elective surgery
Knowledge about ways to recover from POD / POCD (Q9)
A questionnaire is used to assess this outcome measure knowledge about ways to recover from POD / POCD. Answer to Question: " If a delirium or post-operative cognitive deficit occurs, which of the following measures (go home as quickly as possible, avoid distractions or disturbances, pain management with medications in the hospital, mental effort (e.g., playing video games, crossword puzzles, etc.), eating healthy food, taking physiotherapy classes, avoiding daylight, request a single-room in Hospital) do you think is most effective in order to recover from it quickly after the operation?: Yes/No
Measured: Prior to elective surgery
Patient-specific risk factors of developing POD / POCD (Q10a)
A questionnaire is used to assess this outcome measure patient-specific risk factors of developing POD / POCD. Answer to Questions: "Your gender?": male or female
Measured: Prior to elective surgery
Patient-specific risk factors of developing POD / POCD (Q10b)
A questionnaire is used to assess this outcome measure patient-specific risk factors of developing POD / POCD. Answer to Questions: "Your age in years?"
Measured: Prior to elective surgery
Patient-specific risk factors of developing POD / POCD (Q10c)
A questionnaire is used to assess this outcome measure patient-specific risk factors of developing POD / POCD. Answer to Questions: "How many different types of medication to you currently take on a regular basis (please also include medications you do not take due to illness or infection, such as regular intake of aspirin)?": 0,1,2,3,4,5 or more
Measured: Prior to elective surgery
Patient-specific risk factors of developing POD / POCD (Q10d)
A questionnaire is used to assess this outcome measure patient-specific risk factors of developing POD / POCD. Answer to Questions: "In the last 10 years, how often have you been operated on?":0,1,2,3,4,5 or more?
Measured: Prior to elective surgery
Patient-specific risk factors of developing POD / POCD (Q10e)
A questionnaire is used to assess this outcome measure patient-specific risk factors of developing POD / POCD. Answer to Questions: "Have you been diagnosed with one or more of the following illnesses / conditions? -Dementia,-Depression,- Physical Disability,- Seeing or Hearing Problems,-Underweight,- Chronic liver or kidney Damage,-Diabetes,-HIV,-Infection,-Alcohol or drug abuse,-Stroke,-Cardio-vascular Problems?"
Measured: Prior to elective surgery
Knowledge of the healthcare system (Q10f)
A questionnaire is used to assess this outcome measure knowledge of the healthcare System. Answer to Question: "Are you employed in a medical or nursing profession?" Yes/No
Measured: Prior to elective surgery
Information transfer in healthcare system (Q11)
A questionnaire is used to assess this outcome measure information transfer in healthcare System. Answer to Question: "If you have had an elective operation before, has your General practitioner or other medical professional made you aware of the possibility of postoperative delirium or cognitive dysfunction as well as measure of prevention, optimal preparation and treatment?": Yes/No
Measured: Prior to elective surgery
(Health) behavioral consequences of POD / POCD knowledge (Q12)
A questionnaire is used to assess this outcome measure (Health) behavioral consequences of POD / POCD Knowledge. Answer to question: "If you have had an elective operation before, would this information about POD / POCD have influenced your decision to do the operation (i.e., would you have not done it in this case)?": Yes/No
Measured: Prior to elective surgery
(Health) behavioral consequences of POD / POCD knowledge (Q13)
A questionnaire is used to assess this outcome measure (Health) behavioral consequences of POD / POCD Knowledge. Answer to question: "Will these informations about POD / POCD influence your future decisions of whether to do an elective surgery or not?": Yes/No
Measured: Prior to elective surgery
(Health) behavioral consequences of POD / POCD knowledge (Q14)
A questionnaire is used to assess this outcome measure (Health) behavioral consequences of POD / POCD Knowledge. Answer to Question: "Will these informations about POD / POCD influence the way in which you will prepare for elective operations in the future?": Yes/No
Measured: Prior to elective surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start3 May 2021
- Primary completion19 Dec 2021
- Study completion19 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative DeliriumStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD. Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953313
- Sponsor's protocol ID
- RISKOMMDELIR
- Status last verified
- Feb 2023
- First submitted
- 10 May 2019
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Communication About Post-operative Delirium (POD) and Post-operative Cognitive Dysfunction (POCD)
- ClinicalTrials.gov ID
- NCT03953313
- Acronym / sponsor ID
- RISKOMMDELIR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 19 Dec 2021 (actual)
- Study completion
- 19 Dec 2021 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A post-operative delirium is defined as attentional, consciousness and perceptual deficit occurring after and as a consequence of an operation. These deficits are acute and severe, but usually reversible. A post-operative cognitive dysfunction (POCD) is a serious impediment to cognitive functioning, affecting memory, learning, and cognition, again occurring after and as a consequence of an operation. Both delirium and POCD, of which delirium is predictive, have been recognized in medical science as being associated with major cardiac surgery for a while. However, its prevalence after non-cardiac surgery and its links to mortality have only been quantified relatively recently. These studies show that delirium and POCD are very frequent post-operative complications that often go unrecognized. The prevalence across different age groups varies: younger (18-39) adults and older (60+) adults seem to be particularly at risk of developing early POCD (i.e., POCD at hospital discharge) with one study reporting 36.6% of younger and 41,4% of older adults being affected, as compared to the middle-aged (40-59), 30.4% of which were affected. Late POCD (i.e., POCD three months after hospital discharge) was found to be significantly more common in older adults (12.7%) than in the younger or middle aged population (5.7% and 5.6%, respectively). In intensive care settings, delirium is estimated to occur in up to 82% of patients, POCD in up to 41%.
Importantly, delirium as well as POCD are associated with significant negative effects on health: Investigators report a 1-year mortality rate post-discharge of 10.2% for patients with late POCD. Investigators conducted a meta-analysis of post-discharge mortality, institutionalization and dementia amongst elderly patients and found a 38.0% risk of death for patients with delirium by the time of a 2-year follow-up, compared to a control group with 27.5%; a 33.4% probability of institutionalization a year later as compared to 10.7% in the control; and a 62.5% chance of developing dementia up to 4 years later as compared to 8.1% in the control. These differences were independent of confounders such as age, sex, comorbidity, illness severity, and baseline dementia scores. Other studies report prolonged cognitive impairment over 12 months after surgery and significantly higher rates of job loss associated with POCD.
Note that delirium and POCD are complications that can be managed very well. There are relatively simple ways to prevent delirium or recover from it more quickly. Importantly, patients themselves can do a great deal in the way of preparation for an operation and post-operative behavior to significantly reduce their likelihood of getting delirium / POCD or manage it successfully. Yet, most patients are only made aware of the issue, if at all, during their pre-operative anesthetic consultation, usually the evening before the operation - too late to put many of the important preparatory behaviours into place. Importantly, there is no direct communication channel between general practitioners, who refer the patient, and clinical anesthesiologists who deal with delirium / POCD management. Thus, risk factors for as well as incidence of delirium / POCD after surgeries are likely not passed between these important actors in the health system.
Given its high prevalence and serious impact on mental health, physical health, and socio-economic factors, it is imperative that patients and general practitioners alike are aware of delirium / POCD as well as how to recognize it, how to best prepare for an operation in order to reduce its chance of occurrence, and how to behave in case post-operative delirium or POCD has developed. To the knowledge of the investigators, this is the first study to date assessing the awareness of delirium / POCD, their respective risk factors and effective preparation and treatment options in a pre-clinical sample of the general population. Goal of the study is to assess and quantify the current communication deficit in the healthcare system and thus build up pressure to improve it.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- male or female patients attending the premedication outpatient clinic Charité University Medicine, CVK, Berlin, Germany in order to attend a (non-cardiac) elective surgery
- 18 years or older
Key exclusion criteria (1 listed)
- Refusal by the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Awareness of POD specifically as post-operative complications (Q2)
Time frame: Prior to elective surgery
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
Awareness of POCD specifically as post-operative complications (Q3)
Time frame: Prior to elective surgery
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
17 secondary outcomes
Awareness of post-operative complications (Q1)
Time frame: Prior to elective surgery
Estimation about prevalence of POD after elective, non-emergency surgeries (Q4)
Time frame: Prior to elective surgery
Estimation about prevalence of POCD after elective, non-emergency surgeries (Q5)
Time frame: Prior to elective surgery
Estimation about personal risk of developing POD (Q6)
Time frame: Prior to elective surgery
Estimation about personal risk of developing POCD (Q7)
Time frame: Prior to elective surgery
Knowledge about preventive measures to reduce likelihood of developing delirium / POCD (Q8)
Time frame: Prior to elective surgery
Knowledge about ways to recover from POD / POCD (Q9)
Time frame: Prior to elective surgery
Patient-specific risk factors of developing POD / POCD (Q10a)
Time frame: Prior to elective surgery
Patient-specific risk factors of developing POD / POCD (Q10b)
Time frame: Prior to elective surgery
Patient-specific risk factors of developing POD / POCD (Q10c)
Time frame: Prior to elective surgery
Patient-specific risk factors of developing POD / POCD (Q10d)
Time frame: Prior to elective surgery
Patient-specific risk factors of developing POD / POCD (Q10e)
Time frame: Prior to elective surgery
Knowledge of the healthcare system (Q10f)
Time frame: Prior to elective surgery
Information transfer in healthcare system (Q11)
Time frame: Prior to elective surgery
(Health) behavioral consequences of POD / POCD knowledge (Q12)
Time frame: Prior to elective surgery
(Health) behavioral consequences of POD / POCD knowledge (Q13)
Time frame: Prior to elective surgery
(Health) behavioral consequences of POD / POCD knowledge (Q14)
Time frame: Prior to elective surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD. Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Delirium and Post-operative Cognitive Dysfunction, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awareness of POD specifically as post-operative complications (Q2) (time frame: Prior to elective surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.