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)

Overview

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 or August 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

Detailed description

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.

Primary outcome measures

• Sustainability of implementation rates [Time frame: Up to 5 years]
• Implementation rates [Time frame: Up to 3 years]

Secondary outcome measures (12)

• Sustainability of implementation rates [Time frame: Up to 5 years]
• Implementation rates [Time frame: Up to 5 years]
• Care level [Time frame: Up to one year]
• Routine laboratory [Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days]
• Routine vital parameters [Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days]
• Measurement of cholinesterases [Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days]
• Intraoperative routine data [Time frame: Time of surgery]
• Postoperative routine data on the ICU, in the recovery room and normal ward [Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days]
• Drug administration during inpatient treatment [Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days]
• Routine preventive measures against delirium [Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days]
• Intraoperative documented peculiarities in patients with delirium [Time frame: Time of surgery]
• Anticholinergic drug intake [Time frame: The participants are followed up until the end of hospital stay, an expected average of 5 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

Germany · 2 centers

• Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedi — Berlin
• Department of Anesthesiology and Intensive Care Medicine (CCM/CVK) Berlin, Carité - Univer — Berlin

Publications

• Yurek F, Zimmermann JD, Weidner E, Hauss A, Dahnert E, Hadzidiakos D, Kruppa J, Kiselev J, Sichinava N, Retana Romero OA, Hoff L, Morgeli R, Junge L, Scholtz K, Piper SK, Gruner L, Harborth AEM, Eymold L, Gulmez T, Falk E, Balzer F, Treskatsch S, Hoft M, Schmidt D, Landgraf F, Marschall U, Holscher A, Rafii M, Spies C. Quality contract 'prevention of postoperative delirium in the care of elderly p PMID 36878649

Identifiers

NCT: NCT04355195 · QV-POD-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗