The aim of the study is to evaluate the effect of a shared decision-making conference and three-week prehabilitation program on the outcome "care dependency" one year after surgery. The cost-effectiveness of the intervention will also be evaluated in this N = 1400 patient, national multicenter, assessor-blinded, randomized, pragmatic, controlled, parallel-group, clinical trial. The objective of PRÄP-GO is to establish and employ a suitable preoperative case-care management system to improve the short and long-term outcome of elderly surgical patients with signs of a frailty syndrome, improving postoperative quality of life and reducing care dependency by a three-week individualized prehabilitation program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,199
The participants in the intervention group take part in a shared decision-making (SDM) conference to plan the intervention. The therapeutic content of the prehabilitation is defined individually for each patient in the SDM conference. Prehabilitation will be a structured and individually tailored 3-week program.
Herz- und Diabetes Zentrum
Bad Oeynhausen, Germany
Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
Berlin, Germany
Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
Berlin, Germany
Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
Berlin, Germany
Bundeswehrkrankenhaus
Berlin, Germany
CARITAS Klinik Maria Heimsuchung
Berlin, Germany
Dominikus-Krankenhaus
Berlin, Germany
Evangelisches Krankenhaus Hubertus
Berlin, Germany
Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
Berlin, Germany
Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH
Berlin, Germany
...and 13 more locations
Degree of care dependency
Assessment results in a degree of care dependency from personal help according to the German dependency assessment (= "Neues Begutachtungs-Assessment" (NBA)) (Wingenfeld et al., 2008). The results of the assessments ranges between 0 and 100 points, which are transformed into a 0-5 ordinal scale. Higher points in the assessments indicate higher demand of care dependency. Accordingly, higher numbers on the ordinal scale indicate a higher level of care dependency as defined in the German statutory care insurance program.
Time frame: Up to one year
Barthel Index
Level of care dependency after surgery reported as Barthel Index
Time frame: Up to one year
Change in NBA score
Assessment results according to the German dependency assessment (= "Neues Begutachtungs-Assessment" (NBA)) (Wingenfeld et al., 2008) using the results of the assessments on the scale from 0 to 100 points
Time frame: Up to one year
NBA domain change
Change in individual domains of the German dependency assessment (= "Neues Begutachtungs-Assessment" (NBA)).
Time frame: Up to one year
Surrogate for Neurocognitive Disorder (NCD)
Frequency of neurocognitive vulnerability at 3 or 12 months as surrogate for NCD is measured as composite score: 1. Frequency of cognitive impairment/vulnerability is calculated from a change in composite of MiniCog, ANT, TMT-B and MOCA 2. subjective concern (MMQ) and 3. IADL/ADL
Time frame: Up to one year
Screening tool for cognitive vulnerability
Cognitive vulnerability is suspected by limited MiniCog-test result. The MiniCog consists of two items, the word recall test and the clock-drawing test. Performance in these test is rated on a scale ranging from 0 - 5, with \<3 points indicating a cognitive vulnerability.
Time frame: Up to one year
Dementia risk assessed by MOCA
Dementia risk is assessed by Montreal Cognitive Assessment (MOCA-30) deterioration (change) and its absolute value if \< 26.
Time frame: Up to one year
Delirium
Delirium as perioperative complication assessed until hospital discharge using billing data.
Time frame: Up to one year
Frailty
Frailty is operationalized using modified Fried frailty criteria. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) represent robust (0), pre-frail (1-2), and frail (3-5) health status.
Time frame: Up to one year
Perioperative complications by Clavien-Dindo
Perioperative complications assessed using Clavien Dindo till hospital discharge
Time frame: Up to hospital discharge
Every mobility
Level of everyday mobility using Life-Space Assessment (LSA)
Time frame: Up to one year
Autonomy Preference
Extent of patients' autonomy preference concerning medical decisions; Autonomy-Preference-Index, modified German version (API-Dm). The scale consists of a 11-item questionnaire with 4 questions on preferred autonomy in health-related decisions and 7 items on information preference. The total results of the API and both subscales are transformed into a 0 - 100 scale with higher values indicating higher levels on autonomy and information preference, respectively.
Time frame: At the beginning of the observation
Extent of involvement in shared decision-making process
Extent of patients, relatives and health professionals' involvement in shared decision-making process; 9-Item Shared Decision Making Questionnaire (SDM-Q-9/SDM-Q-Doc)
Time frame: At the beginning of the observation
Arm circumference
Arm circumference is measured in a standardized position and documented in centimeter.
Time frame: Up to one year
Calf circumference
Calf circumference is measured in a standardized position and documented in centimeter.
Time frame: Up to one year
Nutritional Status
Changes of nutritional status after elective surgery.
Time frame: Up to one year
Change in body weight
Changes in body weight measured in kg.
Time frame: Up to one year
Instrumental Activities of daily living (IADL)
Instrumental Activities of daily living (IADL) using the questionnaire by Lawton and Brody.
Time frame: Up to one year
Functional endurance
Functional endurance is measured using the 2-Minute-Step-Test (2-MST). The patient steps in place, raising each leg to a marker. The markers height is derived from biometrical measures of the patient. The assessor counts each step of the right leg in which the knee of the patient passes the marker. Higher counts of steps indicates better functional endurance.
Time frame: Up to one year
Function of the respiratory system
The function of the respiratory system is assessed by expiratory peak flow measurement as surrogate parameter.
Time frame: Up to one year
Depression
Depression is measured by frequency of depressive symptoms; Patient Health Questionnaire-8 (PHQ-8)\]
Time frame: Up to one year
Anxiety
Anxiety is measured frequency of anxiety symptoms; Generalized Anxiety Disorder Scale-7 (GAD-7)
Time frame: Up to one year
Health related quality of life
Health related quality of life is measured with EQ-5D-5L questionnaire.
Time frame: Up to one year
Disability by WHODAS 2.0
Patient- or proxy-reported functioning and disability is measured by the WHO Disability Assessment Schedule (WHODAS 2.0, 12-item version.
Time frame: Up to one year
Falls
Incidence of falls
Time frame: Up to one year
Fear of Falling
Activities-Specific Balance Confidence (ABC)-6-Scale. The scale consists of 6 questions who are rated on a 0-100 NRS-scale. The total result of the ABC-6-scale comprises of the average of all 6 items.
Time frame: Up to one year
Satisfaction with the intervention: ZUF-8
The satisfaction of the patient is measured with the questionnaire on patient satisfaction (ZUF-8). The ZUF-8 is a questionnaire on patient satisfaction after treatment. It consists of 8 questions which results in a score between 0 and 24 points, with higher values.indicating higher levels of satisfaction.
Time frame: Up to one year
Mortality
Data from patient records and residents' registration
Time frame: Up to one year
Muscle strength
Muscle strength measured by handgrip strength
Time frame: Up to one year
Functional mobility
Functional mobility is measured with gait speed over 15ft
Time frame: Up to one year
Stair climbing speed
Stair climbing speed test
Time frame: Up to one year
Timed Up & Go Test (TUG
Timed Up \& Go Test (TUG) to test mobility and body balance
Time frame: Up to one year
Postoperative functional mobility
Postoperative complication of mobilization speed measured with CHARMI
Time frame: Up to one year
Length of stay Intensive Care Unit
Intensive care unit length of stay describes every day spent in an ICU bed.
Time frame: Participants are followed up for the duration of rehabilitation, an expected average of 1 day]
Admission Intensive Care Unit (ICU) Admission rate on Intensive Care Unit (ICU)
Admission rate (planned / unplanned) on ICU
Time frame: Participants are followed up for the duration of rehabilitation, an expected average of 1 day]
Duration of hospital stay
Time in hospital
Time frame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
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