Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18,100
- 试验地点
- 4
- 主要终点
- Sustainability of implementation rates
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Moribund patients
- •Not enough language skills
研究组 & 干预措施
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.
Cohort after documentation of routine data until June 2023
From July 1st, 2023, the documentation of the routine data will go on: 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, 2028.
Cohort after training 1
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.
结局指标
主要结局
Sustainability of implementation rates
时间窗: Up to 5 years
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
时间窗: Up to 3 years
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)
次要结局
- Postoperative complications(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Analgesia consumption(Up to one year)
- Permanent medication(Up to one year)
- Frailty status(Up to one year)
- Postoperative oral ingestion(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Barthelindex(Up to one year)
- Patient-related outcome measures (PROMS)(Up to one year)
- Patient-related experience measures (PREMS)(Up to one year)
- 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)
- Care level(Up to one year)
- Routine laboratory(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- 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)
- 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)
- Anticholinergic drug intake(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Incidence of postoperative delirium(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Infections(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Post Intensive Care Syndrome (PICS)(Up to one year)
- Postoperative cognitive impairment(Up to three months)
- Depression(Up to one year)
- Anxiety(Up to one year)
- Physical function(Up to one year)
- Intensive care unit length of stay(Participants will be followed for the duration of intensive care stay, an expected average of 2 days)
- Hospital length of stay(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Disability 1(Up to one year)
- Disability 3(Up to one year)
- Anxiety-Score(Up to one year)
- Person's level of consciousness(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Pain levels 1(Up to one year)
- Pain levels 2(Up to one year)
- Pain levels 3(Up to one year)
- Pain levels 4(Up to one year)
- Pain levels 5(Up to one year)
- Establish a real time patient monitoring platform of vital signs(18.06.2026 - 18.08.2026)
- Quality of life 1(Up to one year (18 months))
- Routine laboratory(The participants are followed up until the end of hospital stay, an expected average of 5 days)
- Routine vital parameters(The participants are followed up until the end of hospital stay, an expected average of 5 days)
- Measurement of cholinesterases(The participants are followed up until the end of hospital stay, an expected average of 5 days)
- Drug administration during inpatient treatment(The participants are followed up until the end of hospital stay, an expected average of 5 days)
- Routine preventive measures against delirium(The participants are followed up until the end of hospital stay, an expected average of 5 days)
- Anticholinergic drug intake(The participants are followed up until the end of hospital stay, an expected average of 5 days)
- Duration of postoperative delirium(The participants are followed up until the end of hospital stay, an expected average of 5 days)
- Incidence of postoperative delirium(The participants are followed up until the end of hospital stay, an expected average of 5 days)
- Infections(The participants are followed up until the end of hospital stay, an expected average of 5 days)
- Postoperative complications(The participants are followed up until the end of hospital stay, an expected average of 5 days)
- Hospital length of stay(The participants are followed up until the end of hospital stay, an expected average of 5 days)
- Person's level of consciousness(The participants are followed up until the end of hospital stay, an expected average of 5 days)
- Postoperative oral ingestion(The participants are followed up until the end of hospital stay, an expected average of 5 days)
- Economic analysis(01.04.2020 bis 31.12.2025)
- Establish a real time patient monitoring platform of vital signs(18.06.2026 - 15.09.2026)
- Sustainability of implementation rates(Up to 5 years)
- Implementation rates(Up to 5 years)
- Care level(Up to one year)
- Routine laboratory(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- 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)
- 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)
- 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)
- Duration of postoperative delirium(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Incidence of postoperative delirium(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Electroencephalography (EEG) measurement(During the duration of surgery, an expected average of 2 hours)
- Infections(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Quality of life 1(Up to three months)
- Post Intensive Care Syndrome (PICS)(Up to one year)
- Postoperative complications(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Analgesia consumption(Up to one year)
- Postoperative cognitive impairment(Up to three months)
- Depression(Up to one year)
- Anxiety(Up to one year)
- Physical function(Up to one year)
- Intensive care unit length of stay(Participants will be followed for the duration of intensive care stay, an expected average of 2 days)
- Hospital length of stay(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Pain levels(Up to one year)
- Disability 1(Up to one year)
- Disability 2(Up to one year)
- Disability 3(Up to one year)
- Anxiety-Score(Up to one year)
- Sedation(Up to one year)
- Person's level of consciousness(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Permanent medication(Up to one year)
- Frailty status(Up to one year)
- Postoperative oral ingestion(The participants are followed up until the end of hospital stay, an expected average of 7 days)
- Barthelindex(Up to one year)
- Patient-related outcome measures (PROMS)(Up to one year)
- Patient-related experience measures (PREMS)(Up to one year)
- Therapy recommendations(Up to one year)
- Survival(Up to one year)
研究者
Claudia Spies
Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK/CBF)
Charite University, Berlin, Germany