Improvement of Perioperative Care of Elderly Patients

NCT03325413 | Completed

• 2 other identifiers: PV559601VSF16057
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Cognitive impairment

  Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery

• Attention and task switching

  Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery

• Attentional capabilities

  Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery

• Health related quality of life

  Evaluation preoperatively, 1 month, 6 months after surgery

• Hospital length of stay

  1 month

Other Outcomes (7)

• Quality of delivery of the intervention components

  6 months

• Experience of staff with intervention components

  6 months

• Mobility

  Evaluation preoperatively, 1 month, 6 months after surgery

Study Arms (3)

Control

NO INTERVENTION

Usual care with assessment only (no study-related intervention)

Implementation

OTHER

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

Full-scale intervention

OTHER

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

Interventions

Systematic inclusion of family members BEHAVIORAL

Systematic inclusion of family members/ reference person in the perioperative process

Full-scale intervention; Implementation

Preoperative information BEHAVIORAL

Detailed preoperative information about delirium prevention and procedures

Full-scale intervention; Implementation

Physical and breathing exercises BEHAVIORAL

Preoperative execution of physical and breathing exercises if necessary

Full-scale intervention; Implementation

Dietary supplements DIETARY_SUPPLEMENT

Dietary supplements if necessary

Full-scale intervention; Implementation

Evaluation of long-term medication OTHER

Avoidance of unsuitable drugs for elderly if possible

Full-scale intervention; Implementation

Regional anesthesia PROCEDURE

Regional anesthesia whenever possible

Full-scale intervention; Implementation

Personal aids OTHER

Personal orientation aids until anesthesia induction

Full-scale intervention; Implementation

Temperature management DEVICE

Perioperative warming

Full-scale intervention; Implementation

Neurmonitoring DEVICE

Using Bispectral index (BIS) to measure the depth of anesthesia

Full-scale intervention; Implementation

Pain catheter PROCEDURE

A pain catheter will be used as postoperative pain therapy if possible

Full-scale intervention; Implementation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \>64 years
• Written informed patients consent
• forthcoming elective surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

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

Hamburg, Germany

Location

Related Publications (3)

• Lebherz L, Olotu C, Koch B, Kiefmann R, Harter M, Kriston L. Evaluating the implementation process of a multicomponent perioperative intervention for prevention of postoperative functional decline in geriatric patients: a qualitative study. BMJ Open. 2025 Dec 18;15(12):e104460. doi: 10.1136/bmjopen-2025-104460.

  PMID: 41412625 DERIVED

• Olotu C, Lebherz L, Mende A, Hempel C, Philipp R, Schroeter J, Plumer L, Koch B, Harter M, Zollner C, Kriston L, Kiefmann R. Feasibility and effectiveness of an evidence-based intervention bundle to improve peri-operative care of older adults: A quality improvement study. Eur J Anaesthesiol Intensive Care. 2024 Jul 4;3(4):e0055. doi: 10.1097/EA9.0000000000000055. eCollection 2024 Aug.

  PMID: 39917250 DERIVED

• 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.

  PMID: 31767591 DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications; Frailty; Depression

Interventions

Restraint, Physical; Breathing Exercises; Dietary Supplements; Anesthesia, Conduction; Hypothermia, Induced

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Anesthesia; Anesthesia and Analgesia; Cryotherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 30, 2017
• Study Start: November 1, 2017
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

DE (1)