Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-26 @ 4:24 AM
Study NCT ID:
NCT04355195
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2020-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality Contract: Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Preoperative routine data', 'timeFrame': 'At baseline', 'description': 'Preoperative routine data are medical history, diagnoses, medication, etc.'}, {'measure': 'Patient-specific characteristics', 'timeFrame': 'At baseline', 'description': 'Patient-specific characteristics of patients with delirium'}, {'measure': 'Preoperative risk score for delirium', 'timeFrame': 'At baseline', 'description': 'Development of a risk model with different influencing factors of delirium'}, {'measure': 'Preoperative sober times', 'timeFrame': 'At baseline'}], 'primaryOutcomes': [{'measure': 'Sustainability of implementation rates', 'timeFrame': 'Up to 5 years', 'description': '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.'}, {'measure': 'Implementation rates', 'timeFrame': 'Up to 3 years', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Sustainability of implementation rates', 'timeFrame': 'Up to 5 years', 'description': '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'}, {'measure': 'Implementation rates', 'timeFrame': 'Up to 5 years', 'description': '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)'}, {'measure': 'Care level', 'timeFrame': 'Up to one year', 'description': 'The care level is taken from hospital records preoperatively and postoperatively'}, {'measure': 'Routine laboratory', 'timeFrame': 'The participants are followed up until the end of hospital stay, an expected average of 7 days', 'description': 'Routine laboratory markers'}, {'measure': 'Routine vital parameters', 'timeFrame': 'The participants are followed up until the end of hospital stay, an expected average of 7 days'}, {'measure': 'Measurement of cholinesterases', 'timeFrame': 'The participants are followed up until the end of hospital stay, an expected average of 7 days', 'description': 'Cholinesterases (point of care testing (POCT) measurements) are measured in the routine'}, {'measure': 'Intraoperative routine data', 'timeFrame': 'Time of surgery'}, {'measure': 'Postoperative routine data on the ICU, in the recovery room and normal ward', 'timeFrame': 'The participants are followed up until the end of hospital stay, an expected average of 7 days'}, {'measure': 'Drug administration during inpatient treatment', 'timeFrame': 'The participants are followed up until the end of hospital stay, an expected average of 7 days'}, {'measure': 'Routine preventive measures against delirium', 'timeFrame': 'The participants are followed up until the end of hospital stay, an expected average of 7 days'}, {'measure': 'Intraoperative documented peculiarities in patients with delirium', 'timeFrame': 'Time of surgery'}, {'measure': 'Anticholinergic drug intake', 'timeFrame': 'The participants are followed up until the end of hospital stay, an expected average of 7 days', 'description': '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.'}, {'measure': 'Duration of postoperative delirium', 'timeFrame': 'The participants are followed up until the end of hospital stay, an expected average of 7 days', 'description': '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)'}, {'measure': 'Incidence of postoperative delirium', 'timeFrame': 'The participants are followed up until the end of hospital stay, an expected average of 7 days', 'description': '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).'}, {'measure': 'Electroencephalography (EEG) measurement', 'timeFrame': 'During the duration of surgery, an expected average of 2 hours', 'description': 'Objective non-invasive EEG is measured intraoperatively'}, {'measure': 'Infections', 'timeFrame': 'The participants are followed up until the end of hospital stay, an expected average of 7 days', 'description': 'Infections according to surgical site infections (SSI) and according to the US Centers for Disease Control and Preventions (CDC).'}, {'measure': 'Quality of life 1', 'timeFrame': 'Up to three months', 'description': 'Health related quality of life is measured by EQ-5D-5L'}, {'measure': 'Post Intensive Care Syndrome (PICS)', 'timeFrame': 'Up to one year', 'description': 'The composite outcome measure "PICS" of the patient is measured according to Needham et al 2012: new impairment or worsening of health after intensive care unit stay and at the same time clinically significant distress in at least one of the following outcome measurement instruments: Patient Health Questionnaires (PHQ-9, PHQ-8, PHQ-4), Generalized Anxiety Disorder Scales (GAD-2 and GAD-7), Impact of Event Scale Revised (IES-R), MiniCog, Animal Naming Test, Trail Making Test (TMT-A, TMT-B), Repeatable Battery for the Assessment of Neuropsychological Satus (RBANS), Timed Up-and-Go (TUG), Handgrip Strength, EQ-5D-5L, subjective assessment NRS, WHO Disability Assessment Schedule (WHODAS), Short Physical Performance Battery (SPPB). The Measurement will be performed, when patients present to the outpatient clinic for follow-up examinations. Optionally, the measurement can also be performed via outpatient structures or during a home visit.'}, {'measure': 'Postoperative complications', 'timeFrame': 'The participants are followed up until the end of hospital stay, an expected average of 7 days', 'description': 'To evaluate the presence or development of postoperative organ complications during inpatient care'}, {'measure': 'Analgesia consumption', 'timeFrame': 'Up to one year', 'description': 'Concomitant pain medication is recorded'}, {'measure': 'Postoperative cognitive impairment', 'timeFrame': 'Up to three months', 'description': '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.'}, {'measure': 'Depression', 'timeFrame': 'Up to one year', 'description': '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).'}, {'measure': 'Anxiety', 'timeFrame': 'Up to one year', 'description': '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.'}, {'measure': 'Physical function', 'timeFrame': 'Up to one year', 'description': '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).'}, {'measure': 'Intensive care unit length of stay', 'timeFrame': 'Participants will be followed for the duration of intensive care stay, an expected average of 2 days', 'description': 'Intensive care unit length of stay is measured in days'}, {'measure': 'Hospital length of stay', 'timeFrame': 'The participants are followed up until the end of hospital stay, an expected average of 7 days', 'description': 'Hospital length of stay is measured in days'}, {'measure': 'Pain levels', 'timeFrame': 'Up to one year', 'description': 'Pain levels are measured with validated subjective/objective pain scores.'}, {'measure': 'Disability 1', 'timeFrame': 'Up to one year', 'description': '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).'}, {'measure': 'Disability 2', 'timeFrame': 'Up to one year', 'description': 'Disability 2 is measured by Timed up and go test.'}, {'measure': 'Disability 3', 'timeFrame': 'Up to one year', 'description': 'Disability 3 is measured by hand grip strength test'}, {'measure': 'Anxiety-Score', 'timeFrame': 'Up to one year', 'description': 'Faces Anxiety Scale score'}, {'measure': 'Sedation', 'timeFrame': 'Up to one year', 'description': 'Sedation is measured with the Richmond Agitation and Sedation Scale (RASS)'}, {'measure': "Person's level of consciousness", 'timeFrame': 'The participants are followed up until the end of hospital stay, an expected average of 7 days', 'description': "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.\n\nLower GCS scores are correlated with higher risk of death."}, {'measure': 'Permanent medication', 'timeFrame': 'Up to one year', 'description': 'Medication at three months compared to baseline is assessed.'}, {'measure': 'Frailty status', 'timeFrame': 'Up to one year', 'description': 'Frequency of frailty is measured by modified Fried criteria (category 1 +2 = pre-frail, category 3 -5 = frail)'}, {'measure': 'Postoperative oral ingestion', 'timeFrame': 'The participants are followed up until the end of hospital stay, an expected average of 7 days', 'description': 'Ingestion is measured by the amount of fluids and solid food.'}, {'measure': 'Barthelindex', 'timeFrame': 'Up to one year', 'description': '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).\n\nScore was reported as mean score of the Barthel Index.'}, {'measure': 'Patient-related outcome measures (PROMS)', 'timeFrame': 'Up to one year', 'description': 'Different tools and questionnaires are combined to measure Patient-related outcome.'}, {'measure': 'Patient-related experience measures (PREMS)', 'timeFrame': 'Up to one year', 'description': 'Patient-reported experiences of health care are measured with a questionnaire.'}, {'measure': 'Therapy recommendations', 'timeFrame': 'Up to one year', 'description': 'Therapy recommendations are documented from patient records.'}, {'measure': 'Survival', 'timeFrame': 'Up to one year', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium in Old Age']}, 'referencesModule': {'references': [{'pmid': '36878649', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.\n\nSubproject Retro-Pressure started in August 2022:\n\nRetrospective, 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\n\nSubproject Delta-Scan started in August 2022:\n\nEvaluation 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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged ≥70 years, male and female, who are receiving surgery', 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age ≥ 70 years\n* male and female patients\n* Patients who are insured with BARMER, HEK, KKH, DAK, TK or hkk Health insurances\n* Patients eligible for inclusion: by the patient, preoperatively\n* Incapacitated patients for inclusion: Written informed consent by a legal representative\n* surgery (elective and not elective)\n\nExclusion criteria:\n\n* Moribund patients\n* Not enough language skills'}, 'identificationModule': {'nctId': 'NCT04355195', 'briefTitle': 'Quality Contract: Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)', 'orgStudyIdInfo': {'id': 'QV-POD-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort before training', 'description': '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.'}, {'label': 'Cohort after training 1', 'description': '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.'}, {'label': 'Cohort after documentation of routine data until June 2023', 'description': 'From July 1st, 2023, the documentation of the routine data will go on: 1,700 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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12203', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sascha Treskatsch, MD. Prof.', 'role': 'CONTACT', 'email': 'sascha.treskatsch@charite.de', 'phone': '+49 30 450 55 15 22'}, {'name': 'Sascha Treskatsch, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lennart Junge, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Golschan Asgarpur, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Caudia Spies, MD, Pof.', 'role': 'CONTACT', 'email': 'claudia.spies@charite.de', 'phone': '+49 30 450 55 11 02'}, {'name': 'Claudia Spies, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fatima Halzl-Yürek, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daniel Hadzidiakos, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Laerson Hoff', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maurice Breithaupt, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Antje Kirchstein, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Friedrich Borchers, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Anesthesiology and Intensive Care Medicine (CCM/CVK) Berlin, Carité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Claudia Spies, MD, Prof.', 'role': 'CONTACT', 'email': 'claudia.spies@charite.de', 'phone': '+49 30 450 55 11 02'}], 'overallOfficials': [{'name': 'Claudia Spies, MD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'BARMER', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK/CBF)', 'investigatorFullName': 'Claudia Spies', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}