Clinical trial NCT04675905: Patient-Centred Outcomes and Resource Utilisation After Noncardiac Surgery-D(Eutschland) (PACORUS-D)
Official title: Patient-Centred Outcomes and Resource Utilisation After Noncardiac Surgery-D(Eutschland) (PACORUS-D)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Noncardiac Surgery
Keywords: Outcome Assessment, Health Care [Mesh];
Surgical Procedures, Operative, Economics
noncardiac surgery
disability
patient-centred outcome
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: Heinrich-Heine University, Duesseldorf
name: University Hospital, Bonn
name: University Hospital, Aachen
name: University Hospital of Cologne
name: University Hospital, Essen
name: University Hospital Heidelberg
name: Ruhr University of Bochum
name: German Society of Anesthesiology and Intensive Care (DGAI)
First posted: 2020-12-19
Enrollment: 1200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients fulfilling the eligibility criteria

Brief summary: The PACORUS-D project aims at 1) quantifying the 30-days and 1-year disability burden (assessed using the 12-item WHODAS 2 \[WHO Disability Assessment Schedule\] questionnaire) after inhospital noncardiac nonneurosurgical procedures ; 2) quantifying the resource utilization up the 1 year after inhospital noncardiac nonneurosurgical procedures; 3) validating days alive and out of hospital (construct and criterion validity) in Germany. PACORUS-D consists of 2 independent cohort: a clinical multicentre cohort to assess "disability" and "days alive and out of hospital" and an administrative cohort to assess "days alive and out of hospital" and "resource utilization" from statutory health insurance data. PACORUS-D is intended as preparatory project in Germany before international expansion. THIS REGISTRATION REFERS TO THE CLINICAL COHORT ONLY.

Detailed description: Objectives:

1a) to quantify patient-reported disability measured using the 12-item WHO Disability Assessment Schedule (WHODAS) after noncardiac surgery

1. b) to assess the impact of preoperative comorbidities (and frailty in patients aged ≥65 years) and procedural risk, and of postoperative complications on 365-day patient-reported disability after noncardiac surgery;
2. a) to quantify days alive and out of hospital (DAOH), a recently proposed, integrative, easily collected and statistically-efficient outcome after noncardiac surgery;

2b) to validate (construct \[convergent\] validity) DAOH at 30 and 365 days after noncardiac surgery, i.e. to assess impact of preoperative risk factors/procedural risk and postoperative complications on DAOH; 2c) to assess in a subcohort of patients ≥ 65 years, the construct (convergent) validity of DAOH in terms of frailty (Clinical Frailty Scale);

3a) to evaluate the criterion (concurrent) validity of DAOH for patient-reported disability at 30 days and 365 days; 3b) to evaluate the criterion (predictive) validity of DAOH at 30 days for patient-reported disability at 365 days.

In addition to the main study, patients≥ 65 years may opt to participate (separate consent) to a nested cohort study to assess the impact of delirium detected by Confusion Assessment Method (CAM) on 365-day patient-reported disability after noncardiac surgery and on DAOH.

Design:

prospective multicentre cohort with nested subcohort (Delirium)

Eligibility:

Inclusion criteria:

* aged ≥50 years
* non-cardiac, non-neurosurgical surgery (thoracic, vascular, abdominal, urinary tract, or orthopaedic/trauma)
* inhospital procedure

Patients will be excluded if:

* they are unwilling or unable to provide informed consent,
* the procedure is cancelled
* they are submitted to a procedure requiring only local anesthetics or analgosedation,
* they were submitted to ≥1 surgical procedure in the 7 days prior to enrollment
* they are unable to complete the WHODAS questionnaire (e.g. language or literacy barriers);
* they were previously enrolled in PACORUS.

Endpoints:

For objectives1a-b and 3a-b, the main endpoint will be "new onset clinically significant disability" at 365 days, defined as an increase in WHODAS score of at least 5% from baseline to a final WHODAS score of at least 35% (Shulman Anesthesiology 2020).

For objectives2a-c, the main endpoint will be days alive and out of hospital. The time horizon will be 30 days (primary) and 365 days.

Additional endpoints will include "new onset clinically significant disability" at 30 days and "clinical relevant disability" at 30 and at 365 days, defined as 12-item WHODAS exceeding 35% (Shulman Anesthesiology 2020); the continuous WHODAS score at 30 days and 365 days; disability defined at 25%.

Eligibility criteria: Eligibility:

Inclusion criteria:

* aged ≥50 years
* non-cardiac, non-neurosurgical surgery (thoracic, vascular, abdominal, urinary tract, or orthopaedic/trauma)
* inhospital procedure

Patients will be excluded if:

* they are unwilling or unable to provide informed consent,
* the procedure is cancelled
* they are submitted to a procedure requiring only local anesthetics or analgosedation,
* they were submitted to ≥1 surgical procedure in the 7 days prior to enrollment
* they are unable to complete the WHODAS questionnaire (e.g. language or literacy barriers);
* they were previously enrolled in PACORUS.

Primary outcomes:
measure: New onset clinically significant disability
timeFrame: 365 days
measure: Days alive and out of hospital
timeFrame: 30 days
Secondary outcomes:
measure: New onset clinically significant disability at 30 days
timeFrame: 30 days
measure: Days alive and out of hospital
timeFrame: 365 days
Other outcomes:
measure: Clinical relevant disability
timeFrame: 30 days and 365 days
measure: Continuous 12-item WHODAS 2 score
timeFrame: 30 days and 365 days
measure: Disability
timeFrame: 30 days anf 365 days
Locations:
Study officials:
affiliation: Anesthesiology Department, University Hospital Düsseldorf
name: Giovanna AL Lurati Buse, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: