Improvement of Perioperative Care of Elderly Patients (PeriAge)

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.

Study Overview

• Status: Completed
• Conditions: Perioperative Care
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • Department of Anaesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf (UKE)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): May 14, 2020
• Study Completion (Actual): May 14, 2020

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 15, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Depression; Quality of life; Physical fitness; Postoperative cognitive dysfunction; Frailty; POCD; Geriatric assessment; IADL; Perioperative geriatric care; Geriatric anesthesia; Postoperative functional status
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: PV5596; 01VSF16057 (Other Grant/Funding Number: DLR German Aerospace Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No