Quality Contract: Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)
- Conditions
- Delirium in Old Age
- Registration Number
- NCT04355195
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
The project "QV-Delirium" is based on the decision of the Federal Joint Committee (G-BA) from 2017. 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 independent Institute for Quality Assurance and Transparency in Health Care (IQTIG) receives the elements predefined (e.g. incidence of delirium) by IQTIG with which the quality is measured. The content of the additional elements from the routine data (see primary and secondary outcome measures) is merged internally and with BARMER and other health insurance data for a joint evaluation.
Subproject 1:
Preoperative evaluation of systolic and diastolic heart function in patients of the QV delirium cohort:
In this process, this subproject relates to the evaluation of patients during the premedication visit. During the visit, an evaluation of the heart function using TTE should also take place in order to be able to evaluate later whether there is a association between the preoperative cardiac function examined and the development of postoperative delirium. The parameters to be collected are for the systolic heart function (LVEF, TAPSE, rest LV-SV and SVI, LVCO, LVCI LV / RV index, as well as for the diastolic dysfunction according to current recommendations (Nagueh SF et al., 2016) : MV DecT, MV E / A ratio, E'lat, E'sept, E ', E / E', IVRT-LV, S ', A', LAVI, tricuspid valve flow in tricuspid valve insufficiency: TR V max.
Subproject 2 starts in April 2022:
Anonymous quantitative employee (nurses and doctors) survey on the content of the quality contract with regard to employee satisfaction, feasibility, effectiveness, efficiency (cost-benefit balance), acceptance, needs, quality of the introduction, quality of the implementation.
- Detailed Description
The quality contract of the Charité Universitaetsmedizin Berlin QV-POD was contractually extended so that the patients of the Charité Universitaetsmedizin 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 18100
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Delirium Up to 5 years Decrease in the incidence of delirium and / or shortening of the delirium duration (composite endpoint) taking into account the implementation rates of at least 80% for screening and documentation in the next five years.
- Secondary Outcome Measures
Name Time Method Hospital length of stay The participants are followed up until the end of hospital stay, an expected average of 7 days Hospital length of stay is measured in days
Pain levels Up to one year Pain levels are measured by Numeric Rating Scale - Visualized (NRS-V), which ranges from 0 (no pain) to 10 (extreme pain/ worst pain imaginable).
Disability 1 Up to one year 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).
Disability 2 Up to one year Disability 2 is measured by Timed up and go test.
Frailty status Up to one year Frequency of frailty is measured by modified Fried criteria (category 1 +2 = pre-frail, category 3 -5 = frail)
Postoperative oral ingestion The participants are followed up until the end of hospital stay, an expected average of 7 days Ingestion is measured by the amount of fluids and solid food.
Analgesia consumption Up to one year Concomitant pain medication is recorded
Physical function Up to one year 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).
Disability 3 Up to one year Disability 3 is measured by hand grip strength test
Routine preventive measures against delirium The participants are followed up until the end of hospital stay, an expected average of 7 days Care level Up to one year The care level is taken from hospital records preoperatively and postoperatively
Routine laboratory The participants are followed up until the end of hospital stay, an expected average of 7 days Routine laboratory markers
Routine vital parameters The participants are followed up until the end of hospital stay, an expected average of 7 days Measurement of cholinesterases The participants are followed up until the end of hospital stay, an expected average of 7 days Cholinesterases (point of care testing (POCT) measurements) are measured in the routine
Intraoperative routine data Time of surgery Postoperative routine data on the ICU, in the recovery room and normal ward The participants are followed up until the end of hospital stay, an expected average of 7 days Drug administration during inpatient treatment The participants are followed up until the end of hospital stay, an expected average of 7 days Intraoperative documented peculiarities in patients with delirium Time of surgery Anticholinergic drug intake The participants are followed up until the end of hospital stay, an expected average of 7 days 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.
Quality of life 1 Up to three months Health related quality of life is measured by EQ-5D-5L
Pain threshold measurement During the operation Automatic measurement of specific pain is measured by pain tracker
Infections The participants are followed up until the end of hospital stay, an expected average of 7 days Infections according to surgical site infections (SSI) and according to the US Centers for Disease Control and Preventions (CDC).
Postoperative complications The participants are followed up until the end of hospital stay, an expected average of 7 days To evaluate the presence or development of postoperative organ complications during inpatient care
Depression Up to one year 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).
Incidence of postoperative delirium The participants are followed up until the end of hospital stay, an expected average of 7 days 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).
Electroencephalography (EEG) measurement The participants are followed up until the end of hospital stay, an expected average of 7 days Objective non-invasive EEG is measured intraoperatively
Anxiety Up to one year 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.
Intensive care unit length of stay Participants will be followed for the duration of intensive care stay, an expected average of 2 days Intensive care unit length of stay is measured in days
Post Intensive Care Syndrome (PICS) Up to one year 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.
Postoperative cognitive impairment Up to three months 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 visitvisiting a neuropsychologist/ memory clinic.Permanent medication Up to one year Medication at three months compared to baseline is assessed.
Sedation Up to one year Sedation is measured with the Richmond Agitation and Sedation Scale (RASS)
Person's level of consciousness The participants are followed up until the end of hospital stay, an expected average of 7 days 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.Barthelindex Up to one year 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.Patient-related outcome measures (PROMS) Up to one year Different tools and questionnaires are combined to measure Patient-related outcome.
Patient-related experience measures (PREMS) Up to one year Patient-reported experiences of health care are measured with a questionnaire.
Therapy recommendations Up to one year Therapy recommendations are documented from patient records.
Survival Up to one year Anxiety-Score Up to one year Faces Anxiety Scale score
Trial Locations
- Locations (2)
Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK) Berlin, Carité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany