Quality Contract: Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)

Delirium in Old Age Clinical Trial

Official title:

Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04355195
• Other study ID #: QV-POD-2
• Status: Recruiting
• Start date: April 20, 2020
• Est. completion date: June 2029

Study information

• Verified date: July 2023
• Source: Charite University, Berlin, Germany
• Contact: Claudia Spies, MD, Prof.
• Phone: +49 30 450 55 11 02
• Email: claudia.spies[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18100
• Est. completion date: June 2029
• Est. primary completion date: June 2028
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age
• Emergence Delirium

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin	Berlin
Germany	Department of Anesthesiology and Intensive Care Medicine (CCM/CVK) Berlin, Carité - Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	BARMER

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Preoperative routine data	Preoperative routine data are medical history, diagnoses, medication, etc.	At baseline
Other	Patient-specific characteristics	Patient-specific characteristics of patients with delirium	At baseline
Other	Preoperative risk score for delirium	Development of a risk model with different influencing factors of delirium	At baseline
Other	Heart function	Heart function is measured by transthoracic echocardiography (TTE)	At baseline
Other	Preoperative sober times		At baseline
Primary	Delirium	Decrease in the incidence of delirium and / or shortening of the delirium duration (composite endpoint) taking into account the implementation rates of at least 80% for screening and documentation in the next five years.	Up to 5 years
Secondary	Care level	The care level is taken from hospital records preoperatively and postoperatively	Up to one year
Secondary	Routine laboratory	Routine laboratory markers	The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary	Routine vital parameters		The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary	Measurement of cholinesterases	Cholinesterases (point of care testing (POCT) measurements) are measured in the routine	The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary	Intraoperative routine data		Time of surgery
Secondary	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
Secondary	Drug administration during inpatient treatment		The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary	Routine preventive measures against delirium		The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary	Intraoperative documented peculiarities in patients with delirium		Time of surgery
Secondary	Anticholinergic drug intake	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.	The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary	Incidence of postoperative delirium	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).	The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary	Electroencephalography (EEG) measurement	Objective non-invasive EEG is measured intraoperatively	The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary	Infections	Infections according to surgical site infections (SSI) and according to the US Centers for Disease Control and Preventions (CDC).	The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary	Quality of life 1	Health related quality of life is measured by EQ-5D-5L	Up to three months
Secondary	Post Intensive Care Syndrome (PICS)	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). The Measurement will be performed, when patients present to the outpatient clinic for follow-up examinations. Optionally, the measurement can also be performed via outpatient structures or during a home visit.	Up to one year
Secondary	Postoperative complications	To evaluate the presence or development of postoperative organ complications during inpatient care	The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary	Pain threshold measurement	Automatic measurement of specific pain is measured by pain tracker	During the operation
Secondary	Analgesia consumption	Concomitant pain medication is recorded	Up to one year
Secondary	Postoperative cognitive impairment	Telephone or Video or questionnaire Follow up is offered to every patient with POD three months and one year after their surgery intervention. The aim of Telephone or Video or questionnaire Follow up is to assess to present Neurocognitive disorder (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 visitvisiting a neuropsychologist/ memory clinic.	Up to three months
Secondary	Depression	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).	Up to one year
Secondary	Anxiety	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.	Up to one year
Secondary	Physical function	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).	Up to one year
Secondary	Intensive care unit length of stay	Intensive care unit length of stay is measured in days	Participants will be followed for the duration of intensive care stay, an expected average of 2 days
Secondary	Hospital length of stay	Hospital length of stay is measured in days	The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary	Pain levels	Pain levels are measured by Numeric Rating Scale - Visualized (NRS-V), which ranges from 0 (no pain) to 10 (extreme pain/ worst pain imaginable).	Up to one year
Secondary	Disability 1	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).	Up to one year
Secondary	Disability 2	Disability 2 is measured by Timed up and go test.	Up to one year
Secondary	Disability 3	Disability 3 is measured by hand grip strength test	Up to one year
Secondary	Anxiety-Score	Faces Anxiety Scale score	Up to one year
Secondary	Sedation	Sedation is measured with the Richmond Agitation and Sedation Scale (RASS)	Up to one year
Secondary	Person's level of consciousness	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.	The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary	Permanent medication	Medication at three months compared to baseline is assessed.	Up to one year
Secondary	Frailty status	Frequency of frailty is measured by modified Fried criteria (category 1 +2 = pre-frail, category 3 -5 = frail)	Up to one year
Secondary	Postoperative oral ingestion	Ingestion is measured by the amount of fluids and solid food.	The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary	Barthelindex	Score of the Barthel Index ranging from 0 to 100 were collected when 0 is the minimum (worst outcome) and 100 is the maximum (best outcome).; Score was reported as mean score of the Barthel Index.	Up to one year
Secondary	Patient-related outcome measures (PROMS)	Different tools and questionnaires are combined to measure Patient-related outcome.	Up to one year
Secondary	Patient-related experience measures (PREMS)	Patient-reported experiences of health care are measured with a questionnaire.	Up to one year
Secondary	Therapy recommendations	Therapy recommendations are documented from patient records.	Up to one year
Secondary	Survival		Up to one year