Quality Contract: Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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| Cohort after training From October 1st, 2020, the documentation of the routine data will begin after the training phase: 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, 2023. |
Outcome Measures
Primary Outcome Measures
- Delirium [Up to 3 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 60% for screening and documentation in the first year, at least 70% in the second year and at least 80% in the third year.
Secondary Outcome Measures
- Care level [Up to 3 years]
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 ITS and in the recovery room [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]
- Routine preventive measures against delirium [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.
- 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
- 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).
- Quality of life 1 [Up to three months]
Health related quality of life is measured by EQ-5D-5L
- Post Intensive Care Syndrome (PICS) [Up to three months]
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).
- 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
- Pain threshold measurement [During the operation]
Automatic measurement of specific pain is measured by Dolosys pain tracker
- Analgesia consumption [Up to three months]
Concomitant pain medication is recorded
- Postoperative cognitive impairment [Up to three months]
Telephone or Video Follow up is offered to every patient with POD three months after their operation. The aim of Telephone or Video Follow up is to assess to present 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.
- Depression [Up to three months]
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).
- Anxiety [Up to three months]
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.
- Physical function [Up to three months]
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).
- 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
- 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 three months]
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 three months]
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 three months]
Disability 2 is measured by Timed up and go test.
- Disability 3 [Up to three months]
Disability 3 is measured by hand grip strength test
- Anxiety-Score [Up to three months]
Faces Anxiety Scale score
- Sedation [Up to three months]
Sedation is measured with the Richmond Agitation and Sedation Scale (RASS)
- Person's level of consciousness [Up to three months]
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.
Other Outcome Measures
- Preoperative routine data [At baseline]
Preoperative routine data are medical history, diagnoses, medication, etc.
- Patient-specific characteristics [At baseline]
Patient-specific characteristics of patients with delirium
- Preoperative risk score for delirium [At baseline]
Development of a risk model with different influencing factors of delirium
- Heart function [At baseline]
Heart function is measured by transthoracic echocardiography (TTE)
Eligibility Criteria
Criteria
Inclusion criteria:
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Age ≥ 70 years
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male and female patients
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Patients who are insured with BARMER or hkk Health insurance
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Patients eligible for inclusion: by the patient, preoperatively
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Incapacitated patients for inclusion: Written informed consent by a legal representative
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surgery (elective and not elective)
Exclusion criteria:
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Moribund patients (palliative situation)
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Not enough language skills
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin | Berlin | Germany | 12203 | |
| 2 | Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK) Berlin, Carité - Universitätsmedizin Berlin | Berlin | Germany | 13353 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
- BARMER
Investigators
- Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QV-POD