Prehabilitation of Elderly Patients With Frailty Syndrome Before Elective Surgery (PRAEP-GO)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prehabilitation Prefrail and frail patients receive prehabilitation (new form of care) |
Behavioral: Prehabilitation- new form of care
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.
|
| No Intervention: Standard of Care Prefrail and frail patients receive no prehabilitation, but receive standard of care |
Outcome Measures
Primary Outcome Measures
- Degree of care dependency [Up to one year]
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.
Secondary Outcome Measures
- Neurocognitive Disorder (NCD) [Up to one year]
New diagnosis of mild/major Neurocognitive Disorder at 3 and 12 months. The diagnosis is made based on DSM-V criteria including a multi-component cognitive test battery comparing with baseline testing and comparison to a non-surgical observational control group.
- Suspected Neurocognitive disorder by MiniCog [Up to one year]
Dementia 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 suspicion of dementia.
- Suspected Dementia by MOCA [Up to one year]
Dementia is suspected by a Montreal Cognitive Assessment (MOCA) according to normative age-adjusted values. The MOCA consists of 13 items which are rated on a scale between 0 and 30 points.
- Suspected postoperative neurocognitive disorder (POCD) [Up to one year]
The non-computerized neuropsychological Trail Making Test are used as indicator screening test for relevant cognitive change after surgery. An increase of >55 seconds in TMT-B test performance at three and/or 12 months after surgery compared to baseline is set as cut off.
- Frailty [Up to one year]
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.
- Polypharmacy [Up to one year]
Measured by number of drug agents
- Alcohol Use [Up to one year]
Measured by number of drug agents
- Tobacco Use [Up to one year]
Measured by Fagerstrom (Fagerstrom & Schneider, 1989)
- Intraoperative Neuromonitoring [During surgery]
Monitoring of electroencephalography during surgery
- Result of surgery [Up to one year]
Incidence of complications (intra- and post-operative)
- Autonomy Preference [At the beginning of the observation]
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.
- Extent of involvement in shared decision-making process [At the beginning of the observation]
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)
- Arm circumference [Up to one year]
Arm circumference is measured in a standardized position and documented in centimeter.
- Calf circumference [Up to one year]
Calf circumference is measured in a standardized position and documented in centimeter.
- Mini Nutritional Assessment-Short [Up to one year]
Nutritional Status is measured using Mini Nutritional Assessment-Short-form (MNA-SF).
- Sarcopenia [Up to one year]
Sarcopenia is evaluated as a composite measure by three criteria that are assessed: 1) low muscle strength (hand grip strength), 2) low muscle quantity (calf circumference) and 3) low physical performance (gait speed).
- Independence of Functional Status [Up to one year]
Assessment of the patient's independence in mobilization, i.e. mobilization in daily living without personnel or device support.
- Functional endurance [Up to one year]
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.
- Function of the respiratory system [Up to one year]
The function of the respiratory system is assessed by expiratory peak flow measurement as surrogate parameter.
- Depression [Up to one year]
Depression is measured by frequency of depressive symptoms; Patient Health Questionnaire-8 (PHQ-8)]
- Anxiety [Up to one year]
Anxiety is measured frequency of anxiety symptoms; Generalized Anxiety Disorder Scale-7 (GAD-7)
- Frequency of depressive and anxiety symptoms [Up to one year]
Frequency of depressive and anxiety symptoms; Patient Health Questionnaire-4 (PHQ-4)]
- Health related quality of life [Up to one year]
Health related quality of life is measured with EQ-5D-5L questionnaire.
- Patient-reported Functioning and Disability (WHO Disability Assessment) Schedule) [Up to one year]
Patient-reported functioning and disability is measured by patient self report of functioning and disability due to health conditions; WHO Disability Assessment Schedule (WHODAS 2.0, 12-item version)
- Proxy-reported Functioning and Disability (WHO Disability Assessment) Schedule) [Up to one year]
Proxy-reported Functioning and Disability is measured by Proxy-rated functioning and disability due to health conditions; WHO Disability Assessment Schedule (WHODAS 2.0, 12-item Version)
- Falls [Up to one year]
Incidence of falls
- Fear of Falling [Up to one year]
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.
- Social situation measurement 1 [Up to one year]
The social situation 1 of the patient is measured by a Questionnaire for Social Situation (SOS, Subscales 1 and 2).
- Social situation measurement 2 [Up to one year]
The social situation 2 of the patient is measured by BSSS, 8-items
- Pain: Numeric rating scale [Up to one year]
Pain is measured with a pain score Numeric rating scale (0-10), a higher score indicates more pain.
- Satisfaction with the prehabilitation and overall process: ZUF-8 [Up to one year]
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.
- Loneliness [Up to one year]
Frequency of sensations of loneliness; 3-item UCLA Loneliness Scale
- Survival [Up to one year]
Data from patient records and residents' registration
Other Outcome Measures
- Length of stay Intensive Care Unit [Participants are followed up for the duration of rehabilitation, an expected average of 1 day]]
Intensive care unit length of stay describes every day spent in an ICU bed.
- Admission Intensive Care Unit (ICU) Admission rate on Intensive Care Unit (ICU) [Participants are followed up for the duration of rehabilitation, an expected average of 1 day]]
Admission rate (planned / unplanned) on ICU
- Duration of hospital stay [Participants are followed up for the duration of rehabilitation, an expected average of 7 days]]
Time in hospital
- Adverse Discharge Disposition [Participants are followed up after hospital discharge for 1 day]
Adverse discharge disposition other than to home and planned rehabilitation facility.
- Necessity for follow-up treatment and rehabilitation [Up to one year]
Assessment if a follow-up treatment or rehabilitation is necessary after the hospital stay.
- Count of new discharge diagnoses [Participants are followed up for the duration of rehabilitation, an expected average of 7 days]]
New medical diagnoses at hospital discharge compared to baseline are assessed.
- Count of new discharge medication [Participants are followed up for the duration of rehabilitation, an expected average of 7 days]]
New medication at hospital discharge compared to baseline is assessed.
- Duration of rehabilitation [Participants are followed up for the duration of rehabilitation, an expected average of 25 days]]
Patient record data, discharge letter
- Health economic benefit [Up to one year]
ScreeningThe health economic benefit of the intervention (prehabilitation) will be compared to standard of care in the German health care system using a health cost analysis framework.
- Adequacy of exercise interventions [Up to one year]
Assessment of the appropriateness of the quantity and quality of the exercise interventions compared to exercise prescription guidelines.
- Evaluation of the nutritional intervention [Up to three weeks]
Questionnaire on operability of the nutritional intervention and dietary records
- Anesthesia duration [During surgery]
Measured form anesthesia induction until stop of anesthesia (Patient records)
- Preoperative Cognitive Impairment [At baseline]
For NCD diagnosis at baseline (Preoperative Cognitive Impairment) the same distinction criteria for mild and major NCD were applied, although here formal neurocognitive test performance at baseline was compared to the corresponding mean baseline value in the non-surgical control group.
- Assistive Devices (Hilfsmittel) [Up to one year]
The need of any aid and device that is designed, made, or adapted to assist a patient perform a particular task.
- Treatment (Heilmittel) [Up to one year]
The need of a substance or method for curing an illness.
Eligibility Criteria
Criteria
Study patients:
Inclusion Criteria:
-
Age ≥ 70 years
-
Consent by Patient or Legal Representative
-
Elective surgery planned
-
Expected anesthesia duration≥ 60 min
-
Statutory health insurance
-
Frailty syndrome (≥1 positive out of 5 standardized parameters according to the Physical Frailty Phenotype according to Fried et. al.)
Exclusion Criteria:
-
Severe cardiac or pulmonary disease (NYHA IV, Gold IV)
-
Intracranial interventions
-
Moribund patients (palliative situation)
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Not enough language skills
-
Participation in another interventional rehabilitation study or other interventional clinical trial that has not been approved by the study management committee (Exception: Participation in adjuvant intervention study)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herz- und Diabetes Zentrum | Bad Oeynhausen | Germany | ||
| 2 | Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin | Berlin | Germany | 12203 | |
| 3 | Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin | Berlin | Germany | 13353 | |
| 4 | Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH | Berlin | Germany | ||
| 5 | Bundeswehrkrankenhaus | Berlin | Germany | ||
| 6 | CARITAS Klinik Maria Heimsuchung | Berlin | Germany | ||
| 7 | Dominikus-Krankenhaus | Berlin | Germany | ||
| 8 | Evangelisches Krankenhaus Hubertus | Berlin | Germany | ||
| 9 | Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH | Berlin | Germany | ||
| 10 | Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH | Berlin | Germany | ||
| 11 | Martin-Luther-Krankenhaus | Berlin | Germany | ||
| 12 | Sankt Joseph Krankenhaus | Berlin | Germany | ||
| 13 | Unfallkrankenhaus Berlin | Berlin | Germany | ||
| 14 | Klinikum Frankfurt Oder GmbH | Frankfurt/Oder | Germany | ||
| 15 | Universitätsmedizin Greifswald | Greifswald | Germany | ||
| 16 | Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany | ||
| 17 | Sana Kliniken Sommerfeld | Kremmen | Germany | ||
| 18 | Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu Lübeck | Lübeck | Germany | ||
| 19 | Klinikum der Universität München, LMU Campus Großhadern | München | Germany | ||
| 20 | Klinikum rechts der Isar - Technische Universität München | München | Germany | ||
| 21 | München Klinik Bogenhausen | München | Germany | ||
| 22 | Havelland Kliniken GmbH - Klinik Nauen | Nauen | Germany | 14641 | |
| 23 | Havelland Kliniken-Klinik Rathenow | Rathenow | Germany | 14712 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
- Ludwig-Maximilians - University of Munich, The Institute for Medical Information Processing, Biometry, and Epidemiology
- Technische Universität Berlin
- BARMER
Investigators
- Study Chair: Claudia Spies, Prof., MD, Charite University, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRAEP-GO
- U1111-1253-4820