Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
310 participants
INTERVENTIONAL
2017-11-01
2020-05-14
Brief Summary
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Detailed Description
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Early detection of risk factors and implementation of prophylactic measures is important to reduce postoperative complications and improve clinical outcomes in elderly patients. The aim of our study is to develop and verify a protocol - which allows for a systematic evaluation of risk factors and the implementation of prophylactic or therapeutic measures in order to optimize the postoperative outcome. The feasibility of our protocol will be verified in clinical practice by systematic process evaluations.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
For six months, patients will be recruited for the control arm. In this arm, participants receive usual care without any additional intervention initiated by the study.
After finishing recruitment for the control arm, patients will be recruited for the implementation arm for six months. In this arm, stepwise implementation of the study interventions begins with the possibility of flexibly adapting them to the specific conditions.
After finishing recruitment for the implementation arm, patients will be recruited for the full-scale intervention arm for six months. In this arm, all study interventions will be utilized.
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Control
Usual care with assessment only (no study-related intervention)
No interventions assigned to this group
Implementation
Implementation of intervention measures
Systematic inclusion of family members
Systematic inclusion of family members/ reference person in the perioperative process
Preoperative information
Detailed preoperative information about delirium prevention and procedures
Physical and breathing exercises
Preoperative execution of physical and breathing exercises if necessary
Dietary supplements
Dietary supplements if necessary
Evaluation of long-term medication
Avoidance of unsuitable drugs for elderly if possible
Regional anesthesia
Regional anesthesia whenever possible
Personal aids
Personal orientation aids until anesthesia induction
Temperature management
Perioperative warming
Neurmonitoring
Using Bispectral index (BIS) to measure the depth of anesthesia
Pain catheter
A pain catheter will be used as postoperative pain therapy if possible
Full-scale intervention
Systematic inclusion of family members
Systematic inclusion of family members/ reference person in the perioperative process
Preoperative information
Detailed preoperative information about delirium prevention and procedures
Physical and breathing exercises
Preoperative execution of physical and breathing exercises if necessary
Dietary supplements
Dietary supplements if necessary
Evaluation of long-term medication
Avoidance of unsuitable drugs for elderly if possible
Regional anesthesia
Regional anesthesia whenever possible
Personal aids
Personal orientation aids until anesthesia induction
Temperature management
Perioperative warming
Neurmonitoring
Using Bispectral index (BIS) to measure the depth of anesthesia
Pain catheter
A pain catheter will be used as postoperative pain therapy if possible
Interventions
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Systematic inclusion of family members
Systematic inclusion of family members/ reference person in the perioperative process
Preoperative information
Detailed preoperative information about delirium prevention and procedures
Physical and breathing exercises
Preoperative execution of physical and breathing exercises if necessary
Dietary supplements
Dietary supplements if necessary
Evaluation of long-term medication
Avoidance of unsuitable drugs for elderly if possible
Regional anesthesia
Regional anesthesia whenever possible
Personal aids
Personal orientation aids until anesthesia induction
Temperature management
Perioperative warming
Neurmonitoring
Using Bispectral index (BIS) to measure the depth of anesthesia
Pain catheter
A pain catheter will be used as postoperative pain therapy if possible
Eligibility Criteria
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Inclusion Criteria
* Written informed patients consent
* forthcoming elective surgery
* Time interval from inclusion to appointed surgery at least 5 days
Exclusion Criteria
* Illiteracy
* Poor knowledge ofGerman language
* Mental disability
* Vision handicap (not corrected)
* Hearing handicap (not corrected)
* Benzodiazepine abuse
* Drug/ substance abuse
* Psychosis
* Parkinson disease
* Emergency surgery
* Planned postoperative ICU treatment
* Planned inpatient stay 1 night
* Cerebral surgery
* Ophthalmological surgery
65 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Locations
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Department of Anaesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf (UKE)
Hamburg, , Germany
Countries
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References
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Olotu C, Lebherz L, Mende A, Hempel C, Philipp R, Schroeter J, Plumer L, Koch B, Harter M, Zollner C, Kriston L, Kiefmann R. Feasibility and effectiveness of an evidence-based intervention bundle to improve peri-operative care of older adults: A quality improvement study. Eur J Anaesthesiol Intensive Care. 2024 Jul 4;3(4):e0055. doi: 10.1097/EA9.0000000000000055. eCollection 2024 Aug.
Olotu C, Lebherz L, Harter M, Mende A, Plumer L, Goetz AE, Zollner C, Kriston L, Kiefmann R. Improvement of perioperative care of the elderly patient (PeriAge): protocol of a controlled interventional feasibility study. BMJ Open. 2019 Nov 24;9(11):e031837. doi: 10.1136/bmjopen-2019-031837.
Other Identifiers
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01VSF16057
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PV5596
Identifier Type: -
Identifier Source: org_study_id
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