Clinical trial NCT03325413: Improvement of Perioperative Care of Elderly Patients
Official title: Improvement of Perioperative Care of Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Care
Keywords: Perioperative geriatric care
Geriatric assessment
Postoperative cognitive dysfunction
POCD
Frailty
Depression
Physical fitness
Geriatric anesthesia
IADL
Postoperative functional status
Quality of life
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 310
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional abilities
timeFrame: Evaluation preoperatively, 1 month, 6 months after surgery
Secondary outcomes:
measure: Cognitive impairment
timeFrame: Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
measure: Attention and task switching
timeFrame: Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
measure: Attentional capabilities
timeFrame: Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
measure: Health related quality of life
timeFrame: Evaluation preoperatively, 1 month, 6 months after surgery
measure: Hospital length of stay
timeFrame: 1 month
measure: Postoperative complications
timeFrame: Evaluation evaluation of complications at 2-5 days, 1 month, 6 months after surgery
Other outcomes:
measure: Quality of delivery of the intervention components
timeFrame: 6 months
measure: Experience of staff with intervention components
timeFrame: 6 months
measure: Mobility
timeFrame: Evaluation preoperatively, 1 month, 6 months after surgery
measure: Physical fitness
timeFrame: Evaluation preoperatively, 1 month, 6 months after surgery
measure: Grip strength
timeFrame: Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
measure: Frailty
timeFrame: Evaluation preoperatively and 6 months after surgery
measure: Mental Health
timeFrame: Evaluation preoperatively, 1 month, 6 months after surgery
Locations:
city: Hamburg
country: Germany
facility: Department of Anaesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf (UKE)
Study officials:
References:
citation: 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.