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Completed

NCT Number: NCT03325413

Improvement of Perioperative Care of Elderly Patients

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.

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Key information

Conditions

Perioperative Care Behavior Behavioral Symptoms Cognition Disorders Cognitive Dysfunction Depression Frailty Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hamburg, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Systematic inclusion of family members

Behavioral

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

Preoperative information

Behavioral

Detailed preoperative information about delirium prevention and procedures

Physical and breathing exercises

Behavioral

Preoperative execution of physical and breathing exercises if necessary

Dietary supplements

Dietary Supplement

Dietary supplements if necessary

Evaluation of long-term medication

Other

Avoidance of unsuitable drugs for elderly if possible

Regional Anesthesia

Procedure

Regional anesthesia whenever possible

Personal aids

Other

Personal orientation aids until anesthesia induction

Temperature management

Device

Perioperative warming

Neurmonitoring

Device

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

Pain catheter

Procedure

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

Primary outcomes

  1. Functional abilities

    Time frame: Evaluation preoperatively, 1 month, 6 months after surgery

    Change in functional abilities from baseline, evaluated by Instrumental Activities of Daily Living (IADL) score

Secondary outcomes

  1. Cognitive impairment

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

    DemTect: cognitive screening instrument, sensitive to the early symptoms of dementia

  2. Attention and task switching

    Time frame: 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

  3. Attentional capabilities

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

    TAP Alertness: a computerized, standardized neuropsychological test for attentional performance.

  4. Health related quality of life

    Time frame: Evaluation preoperatively, 1 month, 6 months after surgery

    Measured by a 12-item short-form (SF-12) Health Survey

  5. Hospital length of stay

    Time frame: 1 month

    Day of admission until day of discharge

  6. Postoperative complications

    Time frame: Evaluation evaluation of complications at 2-5 days, 1 month, 6 months after surgery

    Incidence of postoperative complications

Other outcomes

  1. Quality of delivery of the intervention components

    Time frame: 6 months

    Continuous documentation of which intervention components were delivered by the clincal staff with a standardized checklist

  2. Experience of staff with intervention components

    Time frame: 6 months

    Qualitative interviews with the clinical staff on acceptability, feasibility, barriers, and facilitators of the intervention

  3. Mobility

    Time frame: Evaluation preoperatively, 1 month, 6 months after surgery

    Timed Up&Go-Test

  4. Physical fitness

    Time frame: Evaluation preoperatively, 1 month, 6 months after surgery

    Sit-to-stand- Test

  5. Grip strength

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

    Measurement by Vigorimeter

  6. Frailty

    Time frame: Evaluation preoperatively and 6 months after surgery

    LUCAS (Longitudinale Urbane Cohorten Alters - Studie) functional Index

  7. Mental Health

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Acronym: PeriAge

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2017
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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