Perioperative Care
Conditions
Keywords
Perioperative geriatric care, Geriatric assessment, Postoperative cognitive dysfunction, POCD, Frailty, Depression, Physical fitness, Geriatric anesthesia, IADL, Postoperative functional status, Quality of life
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSystematic inclusion of family members
Systematic inclusion of family members/ reference person in the perioperative process
BEHAVIORALPreoperative information
Detailed preoperative information about delirium prevention and procedures
BEHAVIORALPhysical and breathing exercises
Preoperative execution of physical and breathing exercises if necessary
DIETARY_SUPPLEMENTDietary supplements
Dietary supplements if necessary
OTHEREvaluation of long-term medication
Avoidance of unsuitable drugs for elderly if possible
PROCEDURERegional anesthesia
Regional anesthesia whenever possible
OTHERPersonal aids
Personal orientation aids until anesthesia induction
DEVICETemperature management
Perioperative warming
DEVICENeurmonitoring
Using Bispectral index (BIS) to measure the depth of anesthesia
PROCEDUREPain catheter
A pain catheter will be used as postoperative pain therapy if possible
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>64 years * Written informed patients consent * forthcoming elective surgery * Time interval from inclusion to appointed surgery at least 5 days
Exclusion criteria
* Refusal of consent * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional abilities | Evaluation preoperatively, 1 month, 6 months after surgery | Change in functional abilities from baseline, evaluated by Instrumental Activities of Daily Living (IADL) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive impairment | Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery | DemTect: cognitive screening instrument, sensitive to the early symptoms of dementia |
| Attention and task switching | Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery | The Trail Making Test A&B (TMT A&B): a neuropsychological test of visual attention and task alternation |
| Attentional capabilities | Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery | TAP Alertness: a computerized, standardized neuropsychological test for attentional performance. |
| Health related quality of life | Evaluation preoperatively, 1 month, 6 months after surgery | Measured by a 12-item short-form (SF-12) Health Survey |
| Hospital length of stay | 1 month | Day of admission until day of discharge |
| Postoperative complications | Evaluation evaluation of complications at 2-5 days, 1 month, 6 months after surgery | Incidence of postoperative complications |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of delivery of the intervention components | 6 months | Continuous documentation of which intervention components were delivered by the clincal staff with a standardized checklist |
| Experience of staff with intervention components | 6 months | Qualitative interviews with the clinical staff on acceptability, feasibility, barriers, and facilitators of the intervention |
| Mobility | Evaluation preoperatively, 1 month, 6 months after surgery | Timed Up&Go-Test |
| Physical fitness | Evaluation preoperatively, 1 month, 6 months after surgery | Sit-to-stand- Test |
| Grip strength | Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery | Measurement by Vigorimeter |
| Frailty | Evaluation preoperatively and 6 months after surgery | LUCAS (Longitudinale Urbane Cohorten Alters - Studie) functional Index |
| Mental Health | Evaluation preoperatively, 1 month, 6 months after surgery | Geriatric Depression Scale (GDS) by Yesavage: a 15-item self-report assessment used to detect depression in the elderly |
Countries
Germany
Outcome results
None listed