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| ID | Type | Description | Link |
|---|---|---|---|
| 01VSF16057 | Other Grant/Funding Number | DLR German Aerospace Center |
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The focus of this study is the development of a perioperative treatment concept for elderly patients, based on individual necessities and risk factors, aiming to improve patient outcome. The planned interventions include preoperative screening for malnutrition, frailty and uncalled-for long-term medication, if required followed by early prophylaxis and treatment of these risk factors, prior to or during surgery.
In Germany every second inpatient surgical intervention is performed on patients aged 60 years and above. These patients often offer an extensive set of risk factors such as frailty, malnutrition, poor physical fitness and multi-morbidity that may in turn lead to longer hospitalizations and decline of health and functional status after surgery. An age-related increase in postoperative complications, such as postoperative cognitive dysfunction (POCD) and delirium is associated with a higher rate of postoperative morbidity, mortality and longer hospitalization.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Usual care with assessment only (no study-related intervention) | |
| Implementation | Other | Implementation of intervention measures |
|
| Full-scale intervention | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systematic inclusion of family members | Behavioral | Systematic inclusion of family members/ reference person in the perioperative process |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional abilities | Change in functional abilities from baseline, evaluated by Instrumental Activities of Daily Living (IADL) score | Evaluation preoperatively, 1 month, 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive impairment | DemTect: cognitive screening instrument, sensitive to the early symptoms of dementia | Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery |
| Attention and task switching |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of delivery of the intervention components | Continuous documentation of which intervention components were delivered by the clincal staff with a standardized checklist | 6 months |
| Experience of staff with intervention components |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf (UKE) | Hamburg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41412625 | Derived | Lebherz L, Olotu C, Koch B, Kiefmann R, Harter M, Kriston L. Evaluating the implementation process of a multicomponent perioperative intervention for prevention of postoperative functional decline in geriatric patients: a qualitative study. BMJ Open. 2025 Dec 18;15(12):e104460. doi: 10.1136/bmjopen-2025-104460. | |
| 39917250 | Derived |
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The study has 3 arms with patients allocated to them in a fixed chronological order.
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.
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| Preoperative information | Behavioral | Detailed preoperative information about delirium prevention and procedures |
|
| Physical and breathing exercises | Behavioral | Preoperative execution of physical and breathing exercises if necessary |
|
| Dietary supplements | Dietary Supplement | Dietary supplements if necessary |
|
| Evaluation of long-term medication | Other | Avoidance of unsuitable drugs for elderly if possible |
|
| Regional anesthesia | Procedure | Regional anesthesia whenever possible |
|
| Personal aids | Other | Personal orientation aids until anesthesia induction |
|
| Temperature management | Device | Perioperative warming |
|
| Neurmonitoring | Device | Using Bispectral index (BIS) to measure the depth of anesthesia |
|
| Pain catheter | Procedure | A pain catheter will be used as postoperative pain therapy if possible |
|
The Trail Making Test A&B (TMT A&B): a neuropsychological test of visual attention and task alternation
| Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery |
| Attentional capabilities | TAP Alertness: a computerized, standardized neuropsychological test for attentional performance. | Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery |
| Health related quality of life | Measured by a 12-item short-form (SF-12) Health Survey | Evaluation preoperatively, 1 month, 6 months after surgery |
| Hospital length of stay | Day of admission until day of discharge | 1 month |
| Postoperative complications | Incidence of postoperative complications | Evaluation evaluation of complications at 2-5 days, 1 month, 6 months after surgery |
Qualitative interviews with the clinical staff on acceptability, feasibility, barriers, and facilitators of the intervention
| 6 months |
| Mobility | Timed Up&Go-Test | Evaluation preoperatively, 1 month, 6 months after surgery |
| Physical fitness | Sit-to-stand- Test | Evaluation preoperatively, 1 month, 6 months after surgery |
| Grip strength | Measurement by Vigorimeter | Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery |
| Frailty | LUCAS (Longitudinale Urbane Cohorten Alters - Studie) functional Index | Evaluation preoperatively and 6 months after surgery |
| Mental Health | Geriatric Depression Scale (GDS) by Yesavage: a 15-item self-report assessment used to detect depression in the elderly | Evaluation preoperatively, 1 month, 6 months after surgery |
| 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. |
| 31767591 | Derived | 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. |
| ID | Term |
|---|---|
| D000079690 | Postoperative Cognitive Complications |
| D000073496 | Frailty |
| D003863 | Depression |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| D001945 | Breathing Exercises |
| D019587 | Dietary Supplements |
| D000765 | Anesthesia, Conduction |
| D007036 | Hypothermia, Induced |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D017679 | Cryotherapy |
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