Clinical trial NCT02793934: The Pilot Project Development Of MEdical Rehabilitation System in Russian Federation
Official title: The Development Of MEdical Rehabilitation inRussia Pilot Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
AMI
Total Hip Replacement
Keywords: Rehabilitation
ICF
Pilot project
Stroke
Acute myocardial infarction
Total hip replacement
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Russian Federation
name: Pirogov Russian National Research Medical University
name: Voino-Yasenetsky Krasnoyarsk State Medical University
name: Vladivostok State Medical University
name: Ural district Institute of Brain
name: Nizhegorodskoye Federal State Unitary Enterprise
First posted: 2016-06-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Programme is focused on adult patients of any gender and age more than 18 y.o., with the next conditions:

Acute cerebrovascular events (ACE, ischemic stroke or intracerebral hemorrhage - specialty neurology) Acute myocardial infarction (AMI, specialty cardiology) Patients after total hip replacement (THR, specialty orthopaedia)

Brief summary: The Programme is focused on adult patients of any gender and age more than 18 y.o., with the next conditions:

1. Acute cerebrovascular events (ACE, ischemic stroke or intracerebral hemorrhage - specialty neurology)
2. Acute myocardial infarction (AMI, specialty cardiology)
3. Patients after total hip replacement (THR, specialty orthopaedia) The program is performed in the in-patient and out-patient rehabilitation departments in 13 regions of the Russian Federation (total 244 departments).

Detailed description: The program is performed in the in-patient and out-patient rehabilitation departments in 13 regions of the Russian Federation (total 244 departments).

The basic goals of the Programme are:

1. To develop the system of organizations for medical rehabilitation providing succession of rehabilitation care in Russia with covering all needs.
2. To improve the accessibility for rehabilitation care by the system of successive 3-stages and 3-level medical rehabilitation
3. To develop the multidisciplinary approaches on medical rehabilitation in each stages and in medical organizations of different levels
4. To improve patient's daily living activity, functioning, enable participation, reduce sick-leaves duration and working absenteeism, increase social role in community, prevent pain recurrence and chronicity, prevent recurrent events and hospitalizations
5. To develop the efficacy criteria for medical rehabilitation on each stages of rehabilitation and establishing the logistic pathways for patients during rehabilitation
6. To implement the educational programmes for personnel on PRM according to the European model.
7. Preparation for introducing the new specialty in Russia - doctor of PRM
8. To establish the financial methods of calculating the costs and tariffs of rehabilitation care for patients with different diseases/conditions in each stage of rehabilitation and in medical organizations of different levels
9. To improve the financial efficacy of medical rehabilitation and substantiation for new tariff prices for rehabilitation care
10. To demonstrate the effectiveness of the "new" model of medical rehabilitation system compared to the traditional model in the multicenter study, in patients with ACE, AMI and THR.
11. To evaluate the clinical efficacy of the "new" model of medical rehabilitation compared to the "old" model in patients with ACE, AMI and THR by following indicators:

    in-hospital and 3-months mortality , the number of complications, length of hospital stay, the degree of recovery of functions, activities and participation. To calculate the economic advantage of the "new" model of medical rehabilitation in patients with ACE, AMI and THR by the calculation of the financial cost of one case of and of the complete course of rehabilitation To study characteristics of disorders of functioning and participation. To develop the methodological framework for the establishment of a register of patients receiving rehabilitation in Russia.
12. To develop basics for establishing a quality assessment system of rehabilitative care in the Russian Federation.

The differences between the new and the old model of rehabilitation are:

1. The doctor-patient relationship In the old model - Patient is passive recipient of the service In the new model - The patient-oriented approach
2. Diagnosis In the old model -According to the International Classification of Diseases (ICD-10) In the new model - ICD -10 and ICF
3. Doctors tasks In the old model - To assign the necessary consultation of experts conducting rehabilitation activities in accordance with the standard of care.

   In the new model - To organize the discussion about the patients problems, to formulate how to achieve the goals of rehabilitation and short-term and long-term outcomes, to evaluate the criteria of rehabilitation treatment, to organize an effective use of time and equipment required for rehabilitation adequately address problems of technology
4. Education In the old model - Education on separated specialties on physiotherapy (kinesiotherapy), acupuncture (RTI), massage therapy, speech therapy, etc.

   In the new model - The unified system of education for all professionals for medical rehabilitation in accordance with the European training program for the doctor of Physical and Rehabilitation Medicine, the modular principle, network form of educational programs
5. Work organization In the old model - Everyone works in accordance with the official duties, each expert is free to decide what treatment should be done for patient (kinesiotherapist, psychologist etc) In the new model - Multidisciplinary approach. Experts in the joint discussion set the goal of rehabilitation, tasks, time solutions, performers, based on the patient's needs.
6. The composition of the rehabilitation team In the old model - Instructor-methodologist and exercise therapy doctor, physiotherapy doctor and nurse, massage nurse, speech therapist, clinical psychologist, nurse In the new model - Clinician on relevant specialty, the instructor-methodologist of physical therapy and a physician, doctor and nurse on physiotherapy, ergotherapist, physiotherapy instructor, massage nurse, a speech therapist, a clinical psychologist , nurse
7. length of stay In the old model -Fixed (14, 21 and 30 days, depends on the stage of rehabilitation) in accordance with the National regulations of care In the new model -Duration of stay in this programme depends on the goals and objectives individually for each patient. When the goals, objectives and the achievement of certain clinical / instrumental parameters are reached patient is transferred to the next stage or discharged
8. The criteria to refer of patient to the next stage of rehabilitation In the old model -completion of the standard course of care In the new model -A single algorithm for completion of rehabilitation at a certain stage (for all project participants) when the goals and objectives are reached
9. Payment case In the old model -Fixed tariff for the completed case Diagnosis related group (DRG) In the new model -According to clinical and statistical group on each of the three stages of rehabilitation - case mix group (CMG)
10. The volume of work done In the old model -According to the regulations and standards of treatment In the new model -Required to achieve the objectives in each case
11. An audit of the rehabilitation measures In the old model -no In the new model -Internal and external Inclusion/exclusion criteria The inclusion and exclusion criteria to the programme are defined by the Russian professional association (ARUR) and more precisely described in the Protocols of Pilot Project (Neurology, Cardiology and Orthopedia Protocols, respectively).

The Programme is focused on adult patients of any gender and age more than 18 y.o., with the next conditions:

1. Acute cerebrovascular events (ACE, ischemic stroke or intracerebral hemorrhage - specialty neurology)
2. Acute myocardial infarction (AMI, specialty cardiology)
3. Patients after total hip replacement (THR, specialty orthopaedia)

Our management of stroke, AMI and THR refers to international guidelines although scientific evidence is still lacking for some physical techniques. Our programme is based on an individual approach of each patient. During different phases of the diseases we put emphasis on adequate drug treatment, increasing of exercise's tolerance, gradual mobilization and verticalization with simultaneous improvement of daily activity, increasing of mobility and self-servicing, improvement of activity and participation.

Safety and patient rights are defined by National regulations, national law and internal rules. Each patient signs an informed consent form. Each patient signs an informed consent. The patient and his/her relatives are invited to participate in multidisciplinary team meetings.

All patient's medical and functional information, assessment and further monitoring data is recorded manually into a standardized medical documentation. It is fulfilled at the entry and on discharge from each level of the treatment. All the Programme documents are stored in the clinical archive and are accessible for periodic internal or external audit and outcomes assessment.

One of the most features of the Pilot Project in Russia is the using of ICF for the assessment of efficacy of medical rehabilitation and for the configuring of activity for individualized rehabilitation processes For each model of patient included to the Pilot Project the set of domains of ICF have been created . Analysis of ICF domains will be done automatically by the soft "ICF-reader". The program "ICF-reader" also can help to generate documentation for the adoption of the patient or the patient's discharge or transfer. The main function of the "ICF-reader" is the accumulation and analysis of all the data.

Each patient is assigned a unique number, which allows to identify him/her at the electronic database of the program "ICF-reader".

Each center is responsible for working with the program "ICF-reader". In the second phase of the Pilot Project, program "ICF-reader" will give an opportunity to establish a rehabilitation diagnosis on the basis of the ICF, and the option for ICF assessment using rating scales.

At the 1st stage of rehabilitation patients to be included to the programme after detailed examination, stabilization of condition and assessment of rehabilitation potential. On the basis of primary examination with the using of ICF tools individualized programme of rehabilitation, goals of rehabilitation and methods and technologies are established.

The transfer of patient from one stage of rehabilitation to another depends on:

achievement of defined goals and functional parameters (data of laboratory, instrumental, functional methods, results of clinical examination by appropriate scales), assessment of activity and participation achievement of requirements of National regulations (number of appropriate diagnostic methods, prespecified treatment, prevention procedures etc) The degree of functional disturbances is assessed by appropriate diagnostic methods: laboratory, instrumental and clinical .

Referral patients: At the 1st stage of rehabilitation (in acute unit) patients should be included to rehabilitation process during the first 48 hours after onset of event or surgery after examination of doctor (trained on PRM) and other members of multidisciplinary team. Each member of multidisciplinary team assesses a patient at the beginning and at the end of each stage of rehabilitation by appropriate pre-defined clinical scales.

At the 2nd stage of rehabilitation patients should be included to rehabilitation process just after admission from the 1st stage (by referral of PRM doctor of the 1st stage) At the 3rd stage of rehabilitation patients should be included to rehabilitation process after admission from the 1st or 2nd stages (by referral of PRM doctor of the 1st or 2nd stages, by referral of general practitioner after assessment of multidisciplinary team).

Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* Ischemic stroke or intracerebral hemorrhage
* Patients with acute myocardial infarction with elevation of segment ST (STMI)
* Total hip replacement caused by degenerative processes

Exclusion Criteria:

* uncorrected metabolic diseases (diabetes mellitus, myxoedema, thyrotoxicosis);
* III hepatic or pancreatic insufficiency
* heavy or repeated hemorrhages of any reason or anaemia Hb\<80g/l;
* parasitoses;
* acute infectious disease;
* active stage of any form of tuberculosis;
* patients with transmissible sexual diseases;
* mental illness with personality desocialisation;
* complicate ventricular rhythm disturbances
* high risk of thromboembolism
* absence of motivation
* decompensation of somatic functions

Primary outcomes:
measure: Mortality
timeFrame: through study completion, an average of 1 month
measure: Recovery of functions, activity and participation
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: Mortality
timeFrame: 90 days after discharge
measure: Recovery of functions, activity and participation
timeFrame: 90 days after discharge
measure: Environmental adaptation
timeFrame: 90 days after discharge
measure: Preventable conditions
timeFrame: 90 days after discharge
measure: Time of start of rehabilitation
timeFrame: through study completion, an average of 1 month
measure: Time of the first, interim and final expert assessment of rehabilitation potential
timeFrame: through study completion, an average of 1 month
measure: Duration of hospitalization
timeFrame: through study completion, an average of 1 month
measure: Duration of rehabilitation process for the achievement the goals for each stage of rehabilitation
timeFrame: through study completion, an average of 1 month
measure: Duration of rehabilitation process from onset of disease to final or to transfer the patient or to establishing the disability
timeFrame: through study completion, an average of 1 month
Other outcomes:
measure: Criteria of rehabilitation potential
timeFrame: up to 6 months
measure: Criteria for the transferring to the next stage or to another hospital
timeFrame: up to 6 months
measure: Case mix groups on basic functional disturbances (by ICF)
timeFrame: up to 6 months
measure: Criteria for the transferring to the palliative or nursing care
timeFrame: up to 6 months
Locations:
city: Saint Petersburg
country: Russian Federation
facility: StPetersburgSPMU
Study officials:
affiliation: St. Petersburg State Pavlov Medical University
name: Shmonin Alexey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pirogov Russian National Medical Research University
name: Shamalov Nikolay, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Pirogov Russian National Medical Research University
name: Suvorov Andrey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rehabilitation Center of Federal State Unitary Enterprise Nizhegorodskoye PROP
name: Buylova Tatiana, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Research Institute of Traumatology and Orthopedics . Priorov Russian Ministry of Health
name: Tsykunov Mikhail, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Vladivostok State Medical University
name: Belyaev Anatoliy, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky
name: Prokopenko Sergei, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Kazan State Medical University Russian Ministry of Health
name: Khasanova Dina, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Kazan State Medical Academy
name: Bodrova Rezeda, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: State Research Center for Preventive Medicine Health Ministry of Russia
name: Aronov David, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: State Research Center for Preventive Medicine Health Ministry of Russia
name: Bubnova Marina, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ural State Medical University Russian Ministry of Health
name: Belkin Anatoliy, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ivanovo State Medical Academy Russian Ministry of Health
name: Mishina Irina, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint-Petersburg City Hospital № 40 of Recreation Area
name: Sarana Andrey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Russian Research Neurosurgical Polenovs Institute
name: Ivanova Natalya, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Samara State Medical University
name: Yashkov Alexander, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Petersburg State Pavlov Medical University
name: Maltseva Mariya, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Petersburg State Pavlov Medical University
name: Soloveva Liudmila, MD
role: PRINCIPAL_INVESTIGATOR
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