Improvement of Perioperative Care of Elderly Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improvement of Perioperative Care of Elderly Patients

Conditions
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Perioperative Care

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care with assessment only (no study-related intervention) | |
| Other: Implementation<br>Implementation of intervention measures | Behavioral: Systematic inclusion of family members<br>* Systematic inclusion of family members/ reference person in the perioperative process<br>Behavioral: Preoperative information<br>* Detailed preoperative information about delirium prevention and procedures<br>Behavioral: Physical and breathing exercises<br>* Preoperative execution of physical and breathing exercises if necessary<br>Dietary Supplement: Dietary supplements<br>* Dietary supplements if necessary<br>Other: Evaluation of long-term medication<br>* Avoidance of unsuitable drugs for elderly if possible<br>Procedure: Regional anesthesia<br>* Regional anesthesia whenever possible<br>Other: Personal aids<br>* Personal orientation aids until anesthesia induction<br>Device: Temperature management<br>* Perioperative warming<br>Device: Neurmonitoring<br>* Using Bispectral index (BIS) to measure the depth of anesthesia<br>Procedure: Pain catheter<br>* A pain catheter will be used as postoperative pain therapy if possible<br>|
| Other: Full-scale intervention<br> | Behavioral: Systematic inclusion of family members<br>* Systematic inclusion of family members/ reference person in the perioperative process<br>Behavioral: Preoperative information<br>* Detailed preoperative information about delirium prevention and procedures<br>Behavioral: Physical and breathing exercises<br>* Preoperative execution of physical and breathing exercises if necessary<br>Dietary Supplement: Dietary supplements<br>* Dietary supplements if necessary<br>Other: Evaluation of long-term medication<br>* Avoidance of unsuitable drugs for elderly if possible<br>Procedure: Regional anesthesia<br>* Regional anesthesia whenever possible<br>Other: Personal aids<br>* Personal orientation aids until anesthesia induction<br>Device: Temperature management<br>* Perioperative warming<br>Device: Neurmonitoring<br>* Using Bispectral index (BIS) to measure the depth of anesthesia<br>Procedure: Pain catheter<br>* A pain catheter will be used as postoperative pain therapy if possible<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perioperative geriatric care, Geriatric assessment, Postoperative cognitive dysfunction, POCD, Frailty, Depression, Physical fitness, Geriatric anesthesia, IADL, Postoperative functional status, Quality of life