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

NCT04355195 | Recruiting

• 1 other identifier: QV-POD-2
• Study Type: observational
• Target: 18,100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Delirium in Old Age

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 5 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)

  Up to 3 years

Secondary Outcomes (41)

• 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

Other Outcomes (4)

• Preoperative routine data

  At baseline

• Patient-specific characteristics

  At baseline

• Preoperative risk score for delirium

  At baseline

Study Arms (3)

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 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.

Cohort after documentation of routine data until June 2023

From July 1st, 2023, the documentation of the routine data will go on: 1,700 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.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged ≥70 years, male and female, who are receiving surgery

You may qualify if:

• Age ≥ 70 years
• male and female patients
• Patients who are insured with BARMER, HEK, KKH, DAK, TK or hkk Health insurances
• surgery (elective and not elective)

You may not qualify if:

• Moribund patients
• Not enough language skills

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• BARMER: collaborator

Study Sites (2)

Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

RECRUITING

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK) Berlin, Carité - Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Related Publications (1)

• 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 patients' study protocol: a non-randomised, pre-post, monocentric, prospective trial. BMJ Open. 2023 Mar 6;13(3):e066709. doi: 10.1136/bmjopen-2022-066709.

  PMID: 36878649 DERIVED

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Central Study Contacts

Claudia Spies, MD, Prof.

CONTACT

+49 30 450 55 11 02; claudia.spies@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK/CBF)

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: April 20, 2020
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)