Delirium in Old AgeNCT04355195
Quality Contract: Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)
An observational study of Delirium in Old Age, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
The project "QV-POD-2" is a prolongation based on "QV-POD-1", which was a quality contract program of the IQTIG - Institute for Quality and Transparency in Health Care. The aim is to improve inpatient care for older patients who are undergoing inpatient surgery and thus to specifically reduce the postoperative risk of… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Delirium in Old Age
- How many people
- 18,100 participants
- Where
- 2 sitesGermany
- Study dates
- 20 Apr 2020to Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- Older adult
Study population: Patients aged ≥70 years, male and female, who are receiving surgery
Who may be able to join
- Age ≥ 70 years
- male and female patients
- Patients who are insured with BARMER, HEK, KKH, DAK, TK or hkk Health insurances
- Patients eligible for inclusion: by the patient, preoperatively
- Incapacitated patients for inclusion: Written informed consent by a legal representative
- surgery (elective and not elective)
Who cannot join
- Moribund patients
- Not enough language skills
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
Berlin, 12203
Sascha Treskatsch, MD. Prof., +49 30 450 55 15 22, sascha.treskatsch@charite.de
Sascha Treskatsch, MD, Prof.
- Recruiting
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK) Berlin, Carité - Universitätsmedizin Berlin
Berlin, 13353
Caudia Spies, MD, Pof., +49 30 450 55 11 02, claudia.spies@charite.de
Claudia Spies, MD, Prof.
About this study
Official title: Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)
The project "QV-POD-2" is a prolongation based on "QV-POD-1", which was a quality contract program of the IQTIG - Institute for Quality and Transparency in Health Care. The aim is to improve inpatient care for older patients who are undergoing inpatient surgery and thus to specifically reduce the postoperative risk of delirium. This is achieved through the implementation of evidence-based and consensus-based measures to prevent postoperative delirium in a comprehensive structured concept in routine care. The transparent documentation in an electronic patient file enables the relationships between the symptoms to be depicted in accordance with the clinical circumstances and the genesis of the postoperative delirium to be recorded and treated at an early stage. The content of the additional elements from the routine data (see primary and secondary outcome measures) in QV-POD-2 is analysed internally.
Subproject Retro-Pressure started in August 2022:
Read more
Retrospective, exploratory cohort study using electronic anesthesia and hospital records from Jan 1, 2016 to Jan 1, 2020, including patients ≥70 years undergoing surgery with anesthesia. The objective is to quantify associations between intraoperative blood pressure dynamics-variability, rate of change, relative hypo-/hypertension versus baseline, and time-integrated BP (area under/above reference)-and postoperative organ dysfunction Primary endpoints: Emergence delirium incidence (PACU/ITS) based on Nu-DESC scores and CAM-ICU scores; incidence of postoperative acute renal failure (creatinine and urea levels, as well as urine output); intraoperative blood pressure variation*; intraoperative blood pressure variation rate*; intraoperative blood pressure integral* Secondary endpoints: Blood count (hemoglobin and hematocrit values); intraoperative transfusions of blood reserves Addendum from the ethics amendment vote of 25/07/2022
Subproject Delta-Scan started in August 2022:
Evaluation of brain function using "Delta Scan" Primary objective: Evaluation of the prognostic significance of Delta Scan measurements in relation to postoperative delirium Secondary objectives: Examination of the delirium-related predictive relevance of individual influencing factors (directly but also indirectly through Delta Scan values) and examination of the effect of Delta Scan measurements on standard delirium screening methods. Study and control group's Inclusion criteria: Age >= 70 years and major surgery with anesthesia; additional exclusion criterion in the control group: Inclusion in the QV-POD-1 project (receipt of postoperative preventive measures) Addendum from the ethics amendment vote of 25/07/2022
Subproject started in June,18th, 2026:
For selected patients who are scheduled to undergo a procedure in June, July, August or September 2026 as part of the QV-POD-2 study, a wristband called CardioWatch 287-2 (manufacturer: Corsano Health B.V., Wilhelmina van Pruisenweg 35, 2595 AN The Hague, The Netherlands, loaned by Medtronic, will be etsablished. For same-day surgery patients, monitoring begins before the operation and continues until discharge from the hospital. For pre-hospitalized patients, measurements can begin at least one day before surgery upon request. The recorded values include blood pressure, heart rate, heart rate variability, respiratory rate, oxygen saturation, body temperature, physical activity, and an electrocardiogram once a day.
Subproject started in July, 2026:
Economic analysis conducted by Cellogic as a contract research project-selected clinical trial data from the clinical trial database and selected data from the Institute for the Hospital Payment System (InEK), cost unit accounting, and OPS codes will be evaluated for patients form QV-POD-1
Read the detailed description
The quality contract of the Charité Universitätsmedizin Berlin QV-POD was contractually extended so that the patients of the Charité Universitätsmedizin Berlin can be offered the preventive measures for delirium for another 5 years (07/01/2023 - 06/30/2028). The continuation of the contract is referred to with the short title QV-POD-2. In terms of content, all preventive measures known from QV-POD will be continued.
- Conditions
- Delirium in Old Age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort before training | 500 patients should be asked to participate in the project in the phase of zero value measurement. The documentation of the routine data before the training phase relates to patients aged ≥70 years, male and female, who are undergoing surgery. | |
| Cohort after training 1 | From October 1st, 2020, the documentation of the routine data will begin after the training phase: 2,500 patients in 12 months, each aged ≥70 years, male and female, who will have surgery until the end of the contract on June 30th, 2023. | |
| Cohort after documentation of routine data until June 2023 | From July 1st, 2023, the documentation of the routine data will go on: 2.500 patients in 12 months, each aged ≥70 years, male and female, who will have surgery until the end of the contract on June 30th, 2028. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustainability of implementation rates
QV-POD-2: Sustainability of implementation rates (=Number of patients who underwent delirium screening at least twice a day within the first three days postoperatively / Divisor = All recruited patients) of at least 80% for screening and documentation in the next five years.
Measured: Up to 5 years
Implementation rates
QV-POD-1: Implementation rates (=Number of patients who underwent delirium screening at least twice a day within the first three days postoperatively / Divisor = All recruited patients) of at least 60% for screening and documentation in the first year, at least 70% in the second year and at least 80% in the third year. Addendum to the primary outcome measures from the ethics amendment vote of 25/07/2022)
Measured: Up to 3 years
Secondary outcomes (47)
Sustainability of implementation rates
QV-POD-2: Sustainability of implementation rates (=Number of patients who underwent delirium screening at least twice a day within the first five days postoperatively / Divisor = All recruited patients) of at least 80% for screening and documentation in the next five years
Measured: Up to 5 years
Implementation rates
QV-POD-1: Implementation rates (=Number of patients who underwent delirium screening at least twice a day within the first five days postoperatively / Divisor = All recruited patients) of at least 60% for screening and documentation in the first year, at least 70% in the second year and at least 80% in the third year. Addendum to the secondary outcome measures from the ethics amendment vote of 25/07/2022)
Measured: Up to 5 years
Care level
The care level is taken from hospital records preoperatively and postoperatively
Measured: Up to one year
Routine laboratory
Routine laboratory markers
Measured: The participants are followed up until the end of hospital stay, an expected average of 5 days
Routine vital parameters
Measured: The participants are followed up until the end of hospital stay, an expected average of 5 days
Measurement of cholinesterases
Cholinesterases (point of care testing (POCT) measurements) are measured in the routine
Measured: The participants are followed up until the end of hospital stay, an expected average of 5 days
Intraoperative routine data
Measured: Time of surgery
Postoperative routine data on the ICU, in the recovery room and normal ward
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Drug administration during inpatient treatment
Measured: The participants are followed up until the end of hospital stay, an expected average of 5 days
Routine preventive measures against delirium
Measured: The participants are followed up until the end of hospital stay, an expected average of 5 days
Intraoperative documented peculiarities in patients with delirium
Measured: Time of surgery
Anticholinergic drug intake
Scale to identify the severity of anticholinergic drugs (Level 0 = no anticholinergic effect, Level 1 = mild anticholinergic effect, Level 2 = moderate anticholinergic effect, Level 3 = severe anticholinergic effect). The sum of all levels of the different drugs gives the total load. Higher total loads of anticholinergic drugs are associated with higher anticholinergic drug load. Minimum of the scale is 0. Maximum depends on the sum of each drug level. The more drugs with anticholinergic effect are taken the higher is the anticholinergic drug load.
Measured: The participants are followed up until the end of hospital stay, an expected average of 5 days
Duration of postoperative delirium
Duration of postoperative delirium in all postoperative patients in normal ward, intensive care unit and recovery room is measured in days (a defined day before the start of the training measures, a defined day after the completion of the training measures). Addendum to the secondary outcome measures from the ethics amendment vote of 25/07/2022)
Measured: The participants are followed up until the end of hospital stay, an expected average of 5 days
Incidence of postoperative delirium
Incidence of postoperative delirium in all postoperative patients in normal ward, intensive care unit and recovery room after validated delirium screening tool at two points in time (a defined day before the start of the training measures, a defined day after the completion of the training measures).
Measured: The participants are followed up until the end of hospital stay, an expected average of 5 days
Electroencephalography (EEG) measurement
Objective non-invasive EEG is measured intraoperatively
Measured: During the duration of surgery, an expected average of 2 hours
Infections
Infections according to surgical site infections (SSI) and according to the US Centers for Disease Control and Preventions (CDC).
Measured: The participants are followed up until the end of hospital stay, an expected average of 5 days
Quality of life 1
Health related quality of life is measured by EQ-5D-5L (Patient and Proxy 1)
Measured: Up to one year (18 months)
Post Intensive Care Syndrome (PICS)
The composite outcome measure "PICS" of the patient is measured according to Needham et al 2012: New or worsening physical, cognitive, and/or mental impairments that are collectively called PICS measured by Patient Health Questionnaires (PHQ-4), MiniCog, Animal Naming Test Timed Up-and-Go (TUG), Handgrip strength. The measurements will be performed, when patients present to the outpatient clinic for follow-up examinations.
Measured: Up to one year
Postoperative complications
To evaluate the presence or development of postoperative organ complications during inpatient care
Measured: The participants are followed up until the end of hospital stay, an expected average of 5 days
Analgesia consumption
Concomitant pain medication is recorded
Measured: Up to one year
Postoperative cognitive impairment
Telephone or Video or questionnaire Follow up is offered to every patient with POD three months and one year after their surgery intervention. The aim of Telephone or Video or questionnaire Follow up is to assess to present Neurocognitive disorder (NCD).The Follow up screening tool is based on DSM 5 diagnostic criteria for "mild cognitive disorder". If one of the diagnostic criteria applies, we recommend to visit a neuropsychologist/ memory clinic recommend to visit a neuropsychologist/ memory clinic.
Measured: Up to three months
Depression
Depression is measured by Patient Health Questionnaire-8 (PHQ-8).This scale encompasses eight questions, which can be answered with not at all (0), several days (1), more than half the days (2) and nearly every day (3). The score is the sum of the 8 items. The minimum score is 0 (best outcome) and the heights 24 (worse outcome).
Measured: Up to one year
Anxiety
Anxiety is measured by Generalized Anxiety Disorder Scale-7 (GAD-7).The Assessment method has seven items; each can be answered with not at all (0), several days (1), more than half the days (2) and nearly every day (3). The score is the sum of all items. The minimum and maximum score are 0 (better outcome) and 21 (worse outcome) respectively.
Measured: Up to one year
Physical function
Physical health is measured by the sum scores of the following outcome measurement instruments: Timed Up-and-Go (TUG), Handgrip Strength, 2-Minute Walk Test (2-MWT), Short Physical Performance Battery (SPPB).
Measured: Up to one year
Intensive care unit length of stay
Intensive care unit length of stay is measured in days
Measured: Participants will be followed for the duration of intensive care stay, an expected average of 2 days
Hospital length of stay
Hospital length of stay is measured in days
Measured: The participants are followed up until the end of hospital stay, an expected average of 5 days
Pain levels 1
Pain levels 1 are measured with Numeric Rating Scale (NRS). NRS scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain.
Measured: Up to one year
Pain levels 2
Pain levels 2 are measured with Visual Analog Scale (VAS). VAS scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain.
Measured: Up to one year
Pain levels 3
Pain levels 3 are measured with Assessment of pain in dementia (BESD). BESD: The focus of external observation is on the following behavioral patterns: breathing, negative vocalization, facial expression, body language, and comfort in relation to exertional pain. Observed behaviors are assigned a score from 0 to 2. The range of the score is between 0 and 10, with 10 points indicating the most pronounced pain behavior.
Measured: Up to one year
Pain levels 4
Pain levels 4 are measured through the use of a scale based on behaviour items, the Behavioural Pain Scale (BPS). BPS scale's range from 3 to 12; 3: no pain, high number more pain.
Measured: Up to one year
Pain levels 5
Pain levels 5 are measured through the use of a scale based on behaviour items, the Behavioural Pain Scale - non-intubated (BPS-NI). BPS-NI scale's range from 3 to 12; 3: no pain, high number more pain. In the BPS-NI, the BPS item "Adaptation to the Ventilator" has been replaced by "Vocalization." The BPS-NI can be used, for example, to determine pain status in conscious, delirious patients.
Measured: Up to one year
Disability 1
Disability 1 is measured by Instrumental activities of daily living scale.This scale has 8 categories (ability to use telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for own medications, ability to handle finances). Each has different levels of functioning with a score assigned. The patient circles the item that most closely describes its functional level. The lowest score is 0 (better outcome) and the highest is 8 (worse outcome).
Measured: Up to one year
Disability 2
Disability 2 is measured by Timed up and go test.
Measured: Up to one year
Disability 3
Disability 3 is measured by hand grip strength test
Measured: Up to one year
Anxiety-Score
Faces Anxiety Scale score
Measured: Up to one year
Sedation
Sedation is measured with the Richmond Agitation and Sedation Scale (RASS)
Measured: Up to one year
Person's level of consciousness
The Glasgow Coma Scale (GCS) is a clinical scale used to reliably measure a person's level of consciousness after a brain injury. The GCS assesses a person based on their ability to perform eye movements, speak, and move their body. These three behaviors make up the three elements of the scale: eye, verbal, and motor. A person's GCS score can range from 3 (completely unresponsive) to 15 (responsive). This score is used to guide immediate medical care after a brain injury (such as a car accident) and also to monitor hospitalized patients and track their level of consciousness.
Lower GCS scores are correlated with higher risk of death.
Measured: The participants are followed up until the end of hospital stay, an expected average of 5 days
Permanent medication
Medication at three months compared to baseline is assessed.
Measured: Up to one year
Frailty status
Frequency of frailty is measured by modified Fried criteria (category 1 +2 = pre-frail, category 3 -5 = frail)
Measured: Up to one year
Postoperative oral ingestion
Ingestion is measured by the amount of fluids and solid food.
Measured: The participants are followed up until the end of hospital stay, an expected average of 5 days
Barthelindex
Score of the Barthel Index ranging from 0 to 100 were collected when 0 is the minimum (worst outcome) and 100 is the maximum (best outcome).
Score was reported as mean score of the Barthel Index.
Measured: Up to one year
Patient-related outcome measures (PROMS)
Different tools and questionnaires are combined to measure Patient-related outcome.
Measured: Up to one year
Patient-related experience measures (PREMS)
Patient-reported experiences of health care are measured with a questionnaire.
Measured: Up to one year
Therapy recommendations
Therapy recommendations are documented from patient records.
Measured: Up to one year
Survival
Survival is measured in Patients form QV-POD-2 within 1 year; Survival is measured in patients from QV-POD-1 until 3 months (addendum to the secondary outcome measures from the ethics amendment vote of 28/08/2025) and in patients from QV-POD-2 as Interim analysis of 3-month mortality among QV-POD-2 patients from the recruitment period: July 1, 2023 - December 1, 2025, and then annually in December until the end of the study.
Measured: Up to one year
Establish a real time patient monitoring platform of vital signs
Continous patient monitoring of physiological data - measured by CardioWatch 287-2 during hospital stay.
Measured: 18.06.2026 - 15.09.2026
Economic analysis
Data from the clinical trial database and selected data from the Institute for the Hospital Payment System (InEK), cost unit accounting, and OPS codes form QV-POD-1-patients will be evaluated.
Measured: 01.04.2020 bis 31.12.2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start20 Apr 2020
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delirium in Old AgeStudies 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
- 18,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- BARMER
- 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
- NCT04355195
- Sponsor's protocol ID
- QV-POD-2
- Status last verified
- Aug 2026
- First submitted
- 17 Apr 2020
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yurek F, Zimmermann JD, Weidner E, Hauss A, Dahnert E, Hadzidiakos D, Kruppa J, Kiselev J, Sichinava N, Retana Romero OA, Hoff L, Morgeli R, Junge L, Scholtz K, Piper SK, Gruner L, Harborth AEM, Eymold L, Gulmez T, Falk E, Balzer F, Treskatsch S, Hoft M, Schmidt D, Landgraf F, Marschall U, Holscher A, Rafii M, Spies C. Quality contract 'prevention of postoperative delirium in the care of elderly patients' study protocol: a non-randomised, pre-post, monocentric, prospective trial. BMJ Open. 2023 Mar 6;13(3):e066709. doi: 10.1136/bmjopen-2022-066709.
PubMed 36878649
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)
- ClinicalTrials.gov ID
- NCT04355195
- Acronym / sponsor ID
- QV-POD-2
- Conditions
- Delirium in Old Age
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 18,100 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- BARMER
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 21 Apr 2020 (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 project "QV-POD-2" is a prolongation based on "QV-POD-1", which was a quality contract program of the IQTIG - Institute for Quality and Transparency in Health Care. The aim is to improve inpatient care for older patients who are undergoing inpatient surgery and thus to specifically reduce the postoperative risk of delirium. This is achieved through the implementation of evidence-based and consensus-based measures to prevent postoperative delirium in a comprehensive structured concept in routine care. The transparent documentation in an electronic patient file enables the relationships between the symptoms to be depicted in accordance with the clinical circumstances and the genesis of the postoperative delirium to be recorded and treated at an early stage. The content of the additional elements from the routine data (see primary and secondary outcome measures) in QV-POD-2 is analysed internally.
Subproject Retro-Pressure started in August 2022:
Retrospective, exploratory cohort study using electronic anesthesia and hospital records from Jan 1, 2016 to Jan 1, 2020, including patients ≥70 years undergoing surgery with anesthesia. The objective is to quantify associations between intraoperative blood pressure dynamics-variability, rate of change, relative hypo-/hypertension versus baseline, and time-integrated BP (area under/above reference)-and postoperative organ dysfunction Primary endpoints: Emergence delirium incidence (PACU/ITS) based on Nu-DESC scores and CAM-ICU scores; incidence of postoperative acute renal failure (creatinine and urea levels, as well as urine output); intraoperative blood pressure variation*; intraoperative blood pressure variation rate*; intraoperative blood pressure integral* Secondary endpoints: Blood count (hemoglobin and hematocrit values); intraoperative transfusions of blood reserves Addendum from the ethics amendment vote of 25/07/2022
Subproject Delta-Scan started in August 2022:
Evaluation of brain function using "Delta Scan" Primary objective: Evaluation of the prognostic significance of Delta Scan measurements in relation to postoperative delirium Secondary objectives: Examination of the delirium-related predictive relevance of individual influencing factors (directly but also indirectly through Delta Scan values) and examination of the effect of Delta Scan measurements on standard delirium screening methods. Study and control group's Inclusion criteria: Age >= 70 years and major surgery with anesthesia; additional exclusion criterion in the control group: Inclusion in the QV-POD-1 project (receipt of postoperative preventive measures) Addendum from the ethics amendment vote of 25/07/2022
Subproject started in June,18th, 2026:
For selected patients who are scheduled to undergo a procedure in June, July, August or September 2026 as part of the QV-POD-2 study, a wristband called CardioWatch 287-2 (manufacturer: Corsano Health B.V., Wilhelmina van Pruisenweg 35, 2595 AN The Hague, The Netherlands, loaned by Medtronic, will be etsablished. For same-day surgery patients, monitoring begins before the operation and continues until discharge from the hospital. For pre-hospitalized patients, measurements can begin at least one day before surgery upon request. The recorded values include blood pressure, heart rate, heart rate variability, respiratory rate, oxygen saturation, body temperature, physical activity, and an electrocardiogram once a day.
Subproject started in July, 2026:
Economic analysis conducted by Cellogic as a contract research project-selected clinical trial data from the clinical trial database and selected data from the Institute for the Hospital Payment System (InEK), cost unit accounting, and OPS codes will be evaluated for patients form QV-POD-1
Detailed description
The quality contract of the Charité Universitätsmedizin Berlin QV-POD was contractually extended so that the patients of the Charité Universitätsmedizin Berlin can be offered the preventive measures for delirium for another 5 years (07/01/2023 - 06/30/2028). The continuation of the contract is referred to with the short title QV-POD-2. In terms of content, all preventive measures known from QV-POD will be continued.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort before training | – | –500 patients should be asked to participate in the project in the phase of zero value measurement. The documentation of the routine data before the training phase relates to patients aged ≥70 years, male and female, who are undergoing surgery. |
| Cohort after training 1 | – | –From October 1st, 2020, the documentation of the routine data will begin after the training phase: 2,500 patients in 12 months, each aged ≥70 years, male and female, who will have surgery until the end of the contract on June 30th, 2023. |
| Cohort after documentation of routine data until June 2023 | – | –From July 1st, 2023, the documentation of the routine data will go on: 2.500 patients in 12 months, each aged ≥70 years, male and female, who will have surgery until the end of the contract on June 30th, 2028. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients aged ≥70 years, male and female, who are receiving surgery
Key inclusion criteria (6 listed)
- Age ≥ 70 years
- male and female patients
- Patients who are insured with BARMER, HEK, KKH, DAK, TK or hkk Health insurances
- Patients eligible for inclusion: by the patient, preoperatively
- Incapacitated patients for inclusion: Written informed consent by a legal representative
Key exclusion criteria (2 listed)
- Moribund patients
- Not enough language skills
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
Sustainability of implementation rates
Time frame: Up to 5 years
QV-POD-2: Sustainability of implementation rates (=Number of patients who underwent delirium screening at least twice a day within the first three days postoperatively / Divisor = All recruited patients) of at least 80% for screening and documentation in the next five years.
Implementation rates
Time frame: Up to 3 years
QV-POD-1: Implementation rates (=Number of patients who underwent delirium screening at least twice a day within the first three days postoperatively / Divisor = All recruited patients) of at least 60% for screening and documentation in the first year, at least 70% in the second year and at least 80% in the third year. Addendum to the primary outcome measures from the ethics amendment vote of 25/07/2022)
47 secondary outcomes
Sustainability of implementation rates
Time frame: Up to 5 years
Implementation rates
Time frame: Up to 5 years
Care level
Time frame: Up to one year
Routine laboratory
Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days
Routine vital parameters
Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days
Measurement of cholinesterases
Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days
Intraoperative routine data
Time frame: Time of surgery
Postoperative routine data on the ICU, in the recovery room and normal ward
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Drug administration during inpatient treatment
Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days
Routine preventive measures against delirium
Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days
Intraoperative documented peculiarities in patients with delirium
Time frame: Time of surgery
Anticholinergic drug intake
Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days
Duration of postoperative delirium
Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days
Incidence of postoperative delirium
Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days
Electroencephalography (EEG) measurement
Time frame: During the duration of surgery, an expected average of 2 hours
Infections
Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days
Quality of life 1
Time frame: Up to one year (18 months)
Post Intensive Care Syndrome (PICS)
Time frame: Up to one year
Postoperative complications
Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days
Analgesia consumption
Time frame: Up to one year
Postoperative cognitive impairment
Time frame: Up to three months
Depression
Time frame: Up to one year
Anxiety
Time frame: Up to one year
Physical function
Time frame: Up to one year
Intensive care unit length of stay
Time frame: Participants will be followed for the duration of intensive care stay, an expected average of 2 days
Hospital length of stay
Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days
Pain levels 1
Time frame: Up to one year
Pain levels 2
Time frame: Up to one year
Pain levels 3
Time frame: Up to one year
Pain levels 4
Time frame: Up to one year
Pain levels 5
Time frame: Up to one year
Disability 1
Time frame: Up to one year
Disability 2
Time frame: Up to one year
Disability 3
Time frame: Up to one year
Anxiety-Score
Time frame: Up to one year
Sedation
Time frame: Up to one year
Person's level of consciousness
Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days
Permanent medication
Time frame: Up to one year
Frailty status
Time frame: Up to one year
Postoperative oral ingestion
Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Derived from this study: PubMed 36878649Yurek F, Zimmermann JD, Weidner E, Hauss A, Dahnert E, Hadzidiakos D, Kruppa J, Kiselev J, Sichinava N, Retana Romero OA, Hoff L, Morgeli R, Junge L, Scholtz K, Piper SK, Gruner L, Harborth AEM, Eymold L, Gulmez T, Falk E, Balzer F, Treskatsch S, Hoft M, Schmidt D, Landgraf F, Marschall U, Holscher A, Rafii M, Spies C. Quality contract 'prevention of postoperative delirium in the care of elderly patients' study protocol: a non-randomised, pre-post, monocentric, prospective trial. BMJ Open. 2023 Mar 6;13(3):e066709. doi: 10.1136/bmjopen-2022-066709.
- 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.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium in Old Age, run by Charite University, Berlin, Germany at 2 sites 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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Spies, MD, Prof. (+49 30 450 55 11 02, claudia.spies@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustainability of implementation rates (time frame: Up to 5 years). 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?
On the ClinicalTrials.gov record for NCT04355195, which also lists 1 linked publication.
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 31 Aug 2026.