Patient-Centred Outcomes and Resource Utilisation After Noncardiac Surgery-D(Eutschland) (PACORUS-D)

NCT04675905 | Unknown

• 1 other identifier: PACORUS-D
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Noncardiac Surgery

Keywords

Outcome Assessment, Health Care [Mesh];; Surgical Procedures, Operative, Economics; noncardiac surgery; disability; patient-centred outcome

Outcome Measures

Primary Outcomes (2)

• New onset clinically significant disability

  applies to objectives 1a-b and 3a-b; Definition:increase in 12-item WHO Disability Assessment Schedule (WHODAS 2) score of at least 5% from baseline to a final WHODAS score of at least 35% (Shulman Anesthesiology 2020); For calculation of the 12-item WHODAS score percentage, the ordinal categories of Linkert scale for each item will be assigned numerical values (none=0 to extreme=4) for a total maximal score of 48 and transformed into the percentage of maximal disability score (Ustun, Bull World Health Organ, 2010); higher percentage indicates higher disability.

  365 days

• Days alive and out of hospital

  applies to objective 2a-c

  30 days

Secondary Outcomes (2)

• New onset clinically significant disability at 30 days

  30 days

• Days alive and out of hospital

  365 days

Other Outcomes (3)

• Clinical relevant disability

  30 days and 365 days

• Continuous 12-item WHODAS 2 score

  30 days and 365 days

• Disability

  30 days anf 365 days

Study Arms (2)

PACORUS-D Main cohort

Eligibility, Endpoints as described above

Other: no intervention (cohort study)

PACORUS-D Delirium-Subcohort

Eligibility: patients aged \>= 65 years undergoing noncardiac nonneurosurgical procedures (definition see above); Endpoints as described above; additional explanatory variable: postoperative Delirium detected by CAM on postoperative day 1 and 2

Other: no intervention (cohort study)

Interventions

no intervention (cohort study) OTHER

Explanatory variables include preoperative comorbidities, baseline disability, surgical risk, postoperative complications, sex, rural/urban area of residency, Oslo Social Support Scale; Clinical Frailty Scale in patients aged \>= 65 years

PACORUS-D Delirium-Subcohort; PACORUS-D Main cohort

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients fulfilling the eligibility criteria

You may qualify if:

• 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.

Sponsors & Collaborators

• PD Dr. med. MSc Giovanna Lurati Buse: lead
• Heinrich-Heine University, Duesseldorf: collaborator
• University Hospital, Bonn: collaborator
• University Hospital, Aachen: collaborator
• University Hospital of Cologne: collaborator
• University Hospital, Essen: collaborator
• University Hospital Heidelberg: collaborator
• Ruhr University of Bochum: collaborator
• German Society of Anesthesiology and Intensive Care (DGAI): collaborator

MeSH Terms

Interventions

Cohort Studies

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Giovanna AL Lurati Buse, MD, MSc

  Anesthesiology Department, University Hospital Düsseldorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanna AL Lurati Buse, MD, MSc

CONTACT

+49-211-8117828; giovanna.luratibuse@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 19, 2020
• Study Start: February 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share