Clinical trial NCT04355195: Quality Contract: Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)
Official title: Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Delirium in Old Age
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: BARMER
First posted: 2020-04-21
Enrollment: 18100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged ≥70 years, male and female, who are receiving surgery

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.

Eligibility criteria: Inclusion criteria:

* 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)

Exclusion criteria:

* Moribund patients
* Not enough language skills

Primary outcomes:
measure: Delirium
timeFrame: Up to 5 years
Secondary outcomes:
measure: Care level
timeFrame: Up to one year
measure: Routine laboratory
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
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
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
measure: Incidence of postoperative delirium
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Electroencephalography (EEG) measurement
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Infections
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Quality of life 1
timeFrame: Up to three months
measure: Post Intensive Care Syndrome (PICS)
timeFrame: Up to one year
measure: Postoperative complications
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Pain threshold measurement
timeFrame: During the operation
measure: Analgesia consumption
timeFrame: Up to one year
measure: Postoperative cognitive impairment
timeFrame: Up to three months
measure: Depression
timeFrame: Up to one year
measure: Anxiety
timeFrame: Up to one year
measure: Physical function
timeFrame: Up to one year
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
measure: Hospital length of stay
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Pain levels
timeFrame: Up to one year
measure: Disability 1
timeFrame: Up to one year
measure: Disability 2
timeFrame: Up to one year
measure: Disability 3
timeFrame: Up to one year
measure: Anxiety-Score
timeFrame: Up to one year
measure: Sedation
timeFrame: Up to one year
measure: Person's level of consciousness
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Permanent medication
timeFrame: Up to one year
measure: Frailty status
timeFrame: Up to one year
measure: Postoperative oral ingestion
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Barthelindex
timeFrame: Up to one year
measure: Patient-related outcome measures (PROMS)
timeFrame: Up to one year
measure: Patient-related experience measures (PREMS)
timeFrame: Up to one year
measure: Therapy recommendations
timeFrame: Up to one year
measure: Survival
timeFrame: Up to one year
Other outcomes:
measure: Preoperative routine data
timeFrame: At baseline
measure: Patient-specific characteristics
timeFrame: At baseline
measure: Preoperative risk score for delirium
timeFrame: At baseline
measure: Heart function
timeFrame: At baseline
measure: Preoperative sober times
timeFrame: At baseline
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine (CCM/CVK) Berlin, Carité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: