Improvement of Perioperative Care of Elderly Patients (PeriAge)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03325413 |
|
Recruitment Status :
Completed
First Posted : October 30, 2017
Last Update Posted : May 18, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Perioperative Care | 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 | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 310 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | Improvement of Perioperative Care of Elderly Patients |
| Actual Study Start Date : | November 1, 2017 |
| Actual Primary Completion Date : | May 14, 2020 |
| Actual Study Completion Date : | May 14, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
No Intervention: Control
Usual care with assessment only (no study-related intervention)
|
|
|
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 |
| 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 |
- 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
- 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
- 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
- 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.
- 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
- Hospital length of stay [ Time Frame: 1 month ]Day of admission until day of discharge
- Postoperative complications [ Time Frame: Evaluation evaluation of complications at 2-5 days, 1 month, 6 months after surgery ]Incidence of postoperative complications
- 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
- 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
- Mobility [ Time Frame: Evaluation preoperatively, 1 month, 6 months after surgery ]Timed Up&Go-Test
- Physical fitness [ Time Frame: Evaluation preoperatively, 1 month, 6 months after surgery ]Sit-to-stand- Test
- Grip strength [ Time Frame: Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery ]Measurement by Vigorimeter
- Frailty [ Time Frame: Evaluation preoperatively and 6 months after surgery ]LUCAS (Longitudinale Urbane Cohorten Alters - Studie) functional Index
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325413
| Germany | |
| Department of Anaesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf (UKE) | |
| Hamburg, Germany | |
| Responsible Party: | Universitätsklinikum Hamburg-Eppendorf |
| ClinicalTrials.gov Identifier: | NCT03325413 |
| Other Study ID Numbers: |
PV5596 01VSF16057 ( Other Grant/Funding Number: DLR German Aerospace Center ) |
| First Posted: | October 30, 2017 Key Record Dates |
| Last Update Posted: | May 18, 2021 |
| Last Verified: | May 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Perioperative geriatric care Geriatric assessment Postoperative cognitive dysfunction POCD Frailty Depression |
Physical fitness Geriatric anesthesia IADL Postoperative functional status Quality of life |
|
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |