Frail Elderly, Frailty
Conditions
Keywords
Prehabilitation, Physiotherapy, Exercise Therapy, Rehabilitation, Nutritional Intervention, Multidisciplinary Intervention, Frailty, Surgery
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.
Interventions
BEHAVIORALPrehabilitation- 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.
Sponsors
Ludwig-Maximilians - University of Munich, The Institute for Medical Information Processing, Biometry, and Epidemiology
Technische Universität Berlin
BARMER
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients with frailty syndrome (≥1 of the standardized parameters (Pre-Frail = 1-2; Frail≥3) according to Fried et al.(2001) are offered randomised participation in the new form of care.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion 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) * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Timed Up & Go Test (TUG | Up to one year | Timed Up & Go Test (TUG) to test mobility and body balance |
| Disability by WHODAS 2.0 | Up to one year | Patient- or proxy-reported functioning and disability is measured by the WHO Disability Assessment Schedule (WHODAS 2.0, 12-item version. |
| 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. |
| Nutritional Status | Up to one year | Changes of nutritional status after elective surgery. |
| Change in body weight | Up to one year | Changes in body weight measured in kg. |
| Instrumental Activities of daily living (IADL) | Up to one year | Instrumental Activities of daily living (IADL) using the questionnaire by Lawton and Brody. |
| 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) |
| Health related quality of life | Up to one year | Health related quality of life is measured with EQ-5D-5L questionnaire. |
| Stair climbing speed | Up to one year | Stair climbing speed test |
| 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. |
| Satisfaction with the intervention: 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. |
| 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 |
| Postoperative functional mobility | Up to one year | Postoperative complication of mobilization speed measured with CHARMI |
| 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. |
| Mortality | Up to one year | Data from patient records and residents' registration |
| Barthel Index | Up to one year | Level of care dependency after surgery reported as Barthel Index |
| Change in NBA score | Up to one year | 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 |
| NBA domain change | Up to one year | Change in individual domains of the German dependency assessment (= Neues Begutachtungs-Assessment (NBA)). |
| Surrogate for Neurocognitive Disorder (NCD) | Up to one year | 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 |
| Screening tool for cognitive vulnerability | Up to one year | 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. |
| Muscle strength | Up to one year | Muscle strength measured by handgrip strength |
| Functional mobility | Up to one year | Functional mobility is measured with gait speed over 15ft |
| Dementia risk assessed by MOCA | Up to one year | Dementia risk is assessed by Montreal Cognitive Assessment (MOCA-30) deterioration (change) and its absolute value if \< 26. |
| Delirium | Up to one year | Delirium as perioperative complication assessed until hospital discharge using billing data. |
| 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. |
| Perioperative complications by Clavien-Dindo | Up to hospital discharge | Perioperative complications assessed using Clavien Dindo till hospital discharge |
| Every mobility | Up to one year | Level of everyday mobility using Life-Space Assessment (LSA) |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Exercise adherence and planned prehabilitation composition | Up to one year | Assessment of the appropriateness of the quantity and quality of the exercise interventions compared to exercise prescription guidelines. |
| Patient support | Up to one year | Patient support by need/prescription of assistive devices (Hilfsmittel) and therapeutic treatment (Heilmittel). |
| Polypharmacy | Up to one year | Measured by number of drug agents |
| Alcohol Use | Up to one year | Measured by Alcohol Use Disorders Identification Test (AUDIT-C) |
| Tobacco Use | Up to one year | Measured by Fagerstrom (Fagerstrom & Schneider, 1989) |
| 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 or TUG). |
| 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. |
| Loneliness | Up to one year | Frequency of sensations of loneliness; 3-item UCLA Loneliness Scale |
| Adverse Discharge Disposition | Participants are followed up after hospital discharge for 1 day | Adverse discharge disposition other than to home and planned rehabilitation facility. |
Countries
Germany
Outcome results
None listed