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
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
Moribund patients
Not enough language skills
Patients aged ≥70 years, male and female, who are receiving surgery
Cohort
Prospective
Not listed
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.
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)
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
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)
Care level
The care level is taken from hospital records preoperatively and postoperatively
Routine laboratory
Routine laboratory markers
Preoperative routine data
Preoperative routine data are medical history, diagnoses, medication, etc.
Patient-specific characteristics
Patient-specific characteristics of patients with delirium
Preoperative risk score for delirium
Development of a risk model with different influencing factors of delirium
Preoperative sober times
Click on the lead sponsor to view all of their trials.
Charite University, Berlin, Germany
Lead sponsor
BARMER
Collaborator
