An interventional study of Systematic inclusion of family members and Preoperative information in Perioperative Care, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Health services research
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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.
260 studies on the registry are indexed under Postoperative Cognitive Complications; 55 are open to participants now.
This study's enrollment of 310 is above the median of 107 across 145 interventional studies indexed under Postoperative Cognitive Complications.
Browse Postoperative Cognitive Complications studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Usual care with assessment only (no study-related intervention)
Implementation of intervention measures
Behavioral: Systematic inclusion of family members · Behavioral: Preoperative information · Behavioral: Physical and breathing exercises · Dietary Supplement: Dietary supplements · Other: Evaluation of long-term medication · Procedure: Regional anesthesia · Other: Personal aids · Device: Temperature management · Device: Neurmonitoring · Procedure: Pain catheter
Behavioral: Systematic inclusion of family members · Behavioral: Preoperative information · Behavioral: Physical and breathing exercises · Dietary Supplement: Dietary supplements · Other: Evaluation of long-term medication · Procedure: Regional anesthesia · Other: Personal aids · Device: Temperature management · Device: Neurmonitoring · Procedure: Pain catheter
Systematic inclusion of family members/ reference person in the perioperative process
Detailed preoperative information about delirium prevention and procedures
Preoperative execution of physical and breathing exercises if necessary
Dietary supplements if necessary
Avoidance of unsuitable drugs for elderly if possible
Regional anesthesia whenever possible
Personal orientation aids until anesthesia induction
Perioperative warming
Using Bispectral index (BIS) to measure the depth of anesthesia
A pain catheter will be used as postoperative pain therapy if possible
Functional abilities
Change in functional abilities from baseline, evaluated by Instrumental Activities of Daily Living (IADL) score
Time frame: Evaluation preoperatively, 1 month, 6 months after surgery
Cognitive impairment
DemTect: cognitive screening instrument, sensitive to the early symptoms of dementia
Time frame: Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
Attention and task switching
The Trail Making Test A\&B (TMT A\&B): a neuropsychological test of visual attention and task alternation
Time frame: Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
Attentional capabilities
TAP Alertness: a computerized, standardized neuropsychological test for attentional performance.
Time frame: 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
Time frame: Evaluation preoperatively, 1 month, 6 months after surgery
Hospital length of stay
Day of admission until day of discharge
Time frame: 1 month
Postoperative complications
Incidence of postoperative complications
Time frame: Evaluation evaluation of complications at 2-5 days, 1 month, 6 months after surgery
Quality of delivery of the intervention components
Continuous documentation of which intervention components were delivered by the clincal staff with a standardized checklist
Time frame: 6 months
Experience of staff with intervention components
Qualitative interviews with the clinical staff on acceptability, feasibility, barriers, and facilitators of the intervention
Time frame: 6 months
Mobility
Timed Up\&Go-Test
Time frame: Evaluation preoperatively, 1 month, 6 months after surgery
Physical fitness
Sit-to-stand- Test
Time frame: Evaluation preoperatively, 1 month, 6 months after surgery
Grip strength
Measurement by Vigorimeter
Time frame: Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
Frailty
LUCAS (Longitudinale Urbane Cohorten Alters - Studie) functional Index
Time frame: 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
Time frame: Evaluation preoperatively, 1 month, 6 months after surgery
Ran from Nov 2017 to primary completion in May 2020, 30 months.
Of 63 non-industry interventional studies with no phase under Postoperative Cognitive Complications, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 33. This study's 30 months is above that.
Counting every sponsor, half of 63 studies reached it within 16 months; a quarter within 8 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Postoperative Cognitive Complications →
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