Improvement of Perioperative Care of Elderly Patients (PeriAge)

May 15, 2021 updated by: Universitätsklinikum Hamburg-Eppendorf
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
310

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Evaluation preoperatively, 1 month, 6 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
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
Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
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.
Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
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
Evaluation preoperatively, 1 month, 6 months after surgery
Hospital length of stay
Time Frame: 1 month
Day of admission until day of discharge
1 month
Postoperative complications
Time Frame: Evaluation evaluation of complications at 2-5 days, 1 month, 6 months after surgery
Incidence of postoperative complications
Evaluation evaluation of complications at 2-5 days, 1 month, 6 months after surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months
Mobility
Time Frame: Evaluation preoperatively, 1 month, 6 months after surgery
Timed Up&Go-Test
Evaluation preoperatively, 1 month, 6 months after surgery
Physical fitness
Time Frame: Evaluation preoperatively, 1 month, 6 months after surgery
Sit-to-stand- Test
Evaluation preoperatively, 1 month, 6 months after surgery
Grip strength
Time Frame: Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
Measurement by Vigorimeter
Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
Frailty
Time Frame: Evaluation preoperatively and 6 months after surgery
LUCAS (Longitudinale Urbane Cohorten Alters - Studie) functional Index
Evaluation preoperatively and 6 months after surgery
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
Evaluation preoperatively, 1 month, 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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