Stroke Clinical Trial
Official title:
The Development Of MEdical Rehabilitation inRussia Pilot Project
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).
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).
;
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