StrokeNCT02793934
The Pilot Project Development Of MEdical Rehabilitation System in Russian Federation
An observational study of Stroke and AMI, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, AMI, Total Hip Replacement
- What is being tested?
- Scales, New model of rehabilitation and Old model of rehabilitation
- How many people
- 2,000 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
StPetersburgSPMU
Saint Petersburg, 197022
Elena V. Melnikova, MD, Ph.D, +7117431508, melnikovae2002@gmail.com
Alexey A. Shmonin, Ph.D, +79213568136, langendorff@gmail.com
About this study
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:
- 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) The program is performed in the in-patient and out-patient rehabilitation departments in 13 regions of the Russian Federation (total 244 departments).
Read the 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:
- To develop the system of organizations for medical rehabilitation providing succession of rehabilitation care in Russia with covering all needs.
- To improve the accessibility for rehabilitation care by the system of successive 3-stages and 3-level medical rehabilitation
- To develop the multidisciplinary approaches on medical rehabilitation in each stages and in medical organizations of different levels
- 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
- To develop the efficacy criteria for medical rehabilitation on each stages of rehabilitation and establishing the logistic pathways for patients during rehabilitation
- To implement the educational programmes for personnel on PRM according to the European model.
- Preparation for introducing the new specialty in Russia - doctor of PRM
- 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
- To improve the financial efficacy of medical rehabilitation and substantiation for new tariff prices for rehabilitation care
- 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.
- 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.
- 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:
- The doctor-patient relationship In the old model - Patient is passive recipient of the service In the new model - The patient-oriented approach
- Diagnosis In the old model -According to the International Classification of Diseases (ICD-10) In the new model - ICD -10 and ICF
- 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
- 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
- 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.
- 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
- 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
- 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
- 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)
- 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
- 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:
- 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)
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).
- Conditions
- Stroke, AMI, Total Hip Replacement
- Being tested
- Scales, New model of rehabilitation, Old model of rehabilitation, ICF reader
- Keywords
- Rehabilitation, ICF, Pilot project, Stroke, Acute myocardial infarction, Total hip replacement
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScalesOther
For stroke patients there are used scales:
Modified Rankin Scale, NIH Stroke Scale , Glasgow Coma Scale, Dysphagia Severity, Rating Scale Speech or Language Impairment Severity Rating Scale, Modified Rivermead Mobility Index, Berg Balance Scale, Modified Ashworth Scale, Medical Research Council Scale, Frenchay Arm Test, Montreal Cognitive Assessment Scale, Spielberger Scale, Beck's Depression Inventory, Visual Analogue Scale, Functional Independence Measure For patients after AMI: Rankin scale, GRACE scale, MoCA, VAS, Hospital scale of anxiety and depression, Canadian classification if stenocardia
For patients after THR:
The pain of the operated joint on VAS scores The Harris scale (the total amount), Scale Lequesne (total), Hospital scale of anxiety
New model of rehabilitationOther
Old model of rehabilitationOther
ICF readerOther
| Study group | Role | What they receive |
|---|---|---|
| 1st phase | In the 1st phase of the study the staff of the medical organizations continue to work in the familiar "old" scheme, but using the set of scales. Receives: Other: Scales; Other: Old model of rehabilitation; Other: ICF reader | |
| 2nd phase | In the 2nd phase, medical organizations will start to work on a new model with the implementation of problem-oriented multidisciplinary approach and the use of modern rehabilitation technologies. There is planning to use clearly defined criteria for transfer from stage to stage, developed by the professional community. When doctors will be trained program "ICF-reader" will have an opportunity to establish a rehabilitation diagnosis on the basis of the ICF, and the option for ICF assessment using rating scales. Receives: Other: Scales; Other: New model of rehabilitation; Other: ICF reader |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: through study completion, an average of 1 month
Recovery of functions, activity and participation
modified Renkin scale)
Measured: through study completion, an average of 1 month
Secondary outcomes (9)
Mortality
Measured: 90 days after discharge
Recovery of functions, activity and participation
Measured: 90 days after discharge
Environmental adaptation
Measured: 90 days after discharge
Preventable conditions
Pain Trophic disturbances Muscle tonus disturbances Contractures Cognitive disorders Inadequate tolerance Social disadaptation etc
Measured: 90 days after discharge
Time of start of rehabilitation
Measured: through study completion, an average of 1 month
Time of the first, interim and final expert assessment of rehabilitation potential
Measured: through study completion, an average of 1 month
Duration of hospitalization
Measured: through study completion, an average of 1 month
Duration of rehabilitation process for the achievement the goals for each stage of rehabilitation
Measured: through study completion, an average of 1 month
Duration of rehabilitation process from onset of disease to final or to transfer the patient or to establishing the disability
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Russian Federation, Pirogov Russian National Research Medical University, Voino-Yasenetsky Krasnoyarsk State Medical University, Vladivostok State Medical University, Ural district Institute of Brain, Nizhegorodskoye Federal State Unitary Enterprise
- Responsible party
- Sponsor
- Investigators
- Shmonin Alexey, PhD, Principal investigator, St. Petersburg State Pavlov Medical UniversityShamalov Nikolay, Professor, Principal investigator, Pirogov Russian National Medical Research UniversitySuvorov Andrey, PhD, Principal investigator, Pirogov Russian National Medical Research UniversityBuylova Tatiana, Professor, Principal investigator, Rehabilitation Center of Federal State Unitary Enterprise Nizhegorodskoye PROPTsykunov Mikhail, Professor, Principal investigator, Central Research Institute of Traumatology and Orthopedics . Priorov Russian Ministry of HealthBelyaev Anatoliy, Professor, Principal investigator, Vladivostok State Medical UniversityProkopenko Sergei, Professor, Principal investigator, Krasnoyarsk State Medical University named after Prof. V.F.Voino-YasenetskyKhasanova Dina, Professor, Principal investigator, Kazan State Medical University Russian Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793934
- Sponsor's protocol ID
- DOME
- Status last verified
- Apr 2018
- First submitted
- 15 May 2016
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.
PubMed 27145936Duncan PW, Zorowitz R, Bates B, Choi JY, Glasberg JJ, Graham GD, Katz RC, Lamberty K, Reker D. Management of Adult Stroke Rehabilitation Care: a clinical practice guideline. Stroke. 2005 Sep;36(9):e100-43. doi: 10.1161/01.STR.0000180861.54180.FF. No abstract available.
PubMed 16120836Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.
PubMed 20813995Law M, Polatajko H, Pollock N, McColl MA, Carswell A, Baptiste S. Pilot testing of the Canadian Occupational Performance Measure: clinical and measurement issues. Can J Occup Ther. 1994 Oct;61(4):191-7. doi: 10.1177/000841749406100403.
PubMed 10137673Pollock N, Baptiste S, Law M, McColl MA, Opzoomer A, Polatajko H. Occupational performance measures: a review based on the guidelines for the client-centred practice of occupational therapy. Can J Occup Ther. 1990 Apr;57(2):77-81. doi: 10.1177/000841749005700206.
PubMed 10106647Kube E, Erhardt E. [Drug abuse prevention by police educational measures--Some remarks]. Arch Kriminol. 1991 Jan-Feb;187(2):23-7. No abstract available. German.
PubMed 2036055Robbins CE, Casey D, Bono JV, Murphy SB, Talmo CT, Ward DM. A multidisciplinary total hip arthroplasty protocol with accelerated postoperative rehabilitation: does the patient benefit? Am J Orthop (Belle Mead NJ). 2014 Apr;43(4):178-81.
PubMed 24730003
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development Of MEdical Rehabilitation inRussia Pilot Project
- ClinicalTrials.gov ID
- NCT02793934
- Acronym / sponsor ID
- DOME
- Conditions
- Stroke, AMI, Total Hip Replacement
- Keywords
- Rehabilitation, ICF, Pilot project, Stroke, Acute myocardial infarction, Total hip replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Russian Federation, Pirogov Russian National Research Medical University, Voino-Yasenetsky Krasnoyarsk State Medical University, Vladivostok State Medical University, Ural district Institute of Brain, Nizhegorodskoye Federal State Unitary Enterprise
- Study start
- Sep 2015
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) 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:
- To develop the system of organizations for medical rehabilitation providing succession of rehabilitation care in Russia with covering all needs.
- To improve the accessibility for rehabilitation care by the system of successive 3-stages and 3-level medical rehabilitation
- To develop the multidisciplinary approaches on medical rehabilitation in each stages and in medical organizations of different levels
- 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
- To develop the efficacy criteria for medical rehabilitation on each stages of rehabilitation and establishing the logistic pathways for patients during rehabilitation
- To implement the educational programmes for personnel on PRM according to the European model.
- Preparation for introducing the new specialty in Russia - doctor of PRM
- 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
- To improve the financial efficacy of medical rehabilitation and substantiation for new tariff prices for rehabilitation care
- 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.
- 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.
- 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:
- The doctor-patient relationship In the old model - Patient is passive recipient of the service In the new model - The patient-oriented approach
- Diagnosis In the old model -According to the International Classification of Diseases (ICD-10) In the new model - ICD -10 and ICF
- 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
- 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
- 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.
- 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
- 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
- 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
- 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)
- 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
- 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:
- 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)
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1st phase | – | Other: Scales, Other: Old model of rehabilitation, Other: ICF readerIn the 1st phase of the study the staff of the medical organizations continue to work in the familiar "old" scheme, but using the set of scales. |
| 2nd phase | – | Other: Scales, Other: New model of rehabilitation, Other: ICF readerIn the 2nd phase, medical organizations will start to work on a new model with the implementation of problem-oriented multidisciplinary approach and the use of modern rehabilitation technologies. There is planning to use clearly defined criteria for transfer from stage to stage, developed by the professional community. When doctors will be trained program "ICF-reader" will have an opportunity to establish a rehabilitation diagnosis on the basis of the ICF, and the option for ICF assessment using rating scales. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScalesFor stroke patients there are used scales: Modified Rankin Scale, NIH Stroke Scale , Glasgow Coma Scale, Dysphagia Severity, Rating Scale Speech or Language Impairment Severity Rating Scale, Modified Rivermead Mobility Index, Berg Balance Scale, Modified Ashworth Scale, Medical Research Council Scale, Frenchay Arm Test, Montreal Cognitive Assessment Scale, Spielberger Scale, Beck's Depression Inventory, Visual Analogue Scale, Functional Independence Measure For patients after AMI: Rankin scale, GRACE scale, MoCA, VAS, Hospital scale of anxiety and depression, Canadian classification if stenocardia For patients after THR: The pain of the operated joint on VAS scores The Harris scale (the total amount), Scale Lequesne (total), Hospital scale of anxiety | Other | 1st phase, 2nd phase |
| New model of rehabilitation | Other | 2nd phase |
| Old model of rehabilitation | Other | 1st phase |
| ICF reader | Other | 1st phase, 2nd phase |
Primary outcome
Mortality
Time frame: through study completion, an average of 1 month
Recovery of functions, activity and participation
Time frame: through study completion, an average of 1 month
modified Renkin scale)
9 secondary outcomes
Mortality
Time frame: 90 days after discharge
Recovery of functions, activity and participation
Time frame: 90 days after discharge
Environmental adaptation
Time frame: 90 days after discharge
Preventable conditions
Time frame: 90 days after discharge
Time of start of rehabilitation
Time frame: through study completion, an average of 1 month
Time of the first, interim and final expert assessment of rehabilitation potential
Time frame: through study completion, an average of 1 month
Duration of hospitalization
Time frame: through study completion, an average of 1 month
Duration of rehabilitation process for the achievement the goals for each stage of rehabilitation
Time frame: through study completion, an average of 1 month
Duration of rehabilitation process from onset of disease to final or to transfer the patient or to establishing the disability
Time frame: through study completion, an average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Results publication: PubMed 27145936Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.
- Results publication: PubMed 16120836Duncan PW, Zorowitz R, Bates B, Choi JY, Glasberg JJ, Graham GD, Katz RC, Lamberty K, Reker D. Management of Adult Stroke Rehabilitation Care: a clinical practice guideline. Stroke. 2005 Sep;36(9):e100-43. doi: 10.1161/01.STR.0000180861.54180.FF. No abstract available.
- Results publication: PubMed 20813995Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.
- Results publication: PubMed 10137673Law M, Polatajko H, Pollock N, McColl MA, Carswell A, Baptiste S. Pilot testing of the Canadian Occupational Performance Measure: clinical and measurement issues. Can J Occup Ther. 1994 Oct;61(4):191-7. doi: 10.1177/000841749406100403.
- Results publication: PubMed 10106647Pollock N, Baptiste S, Law M, McColl MA, Opzoomer A, Polatajko H. Occupational performance measures: a review based on the guidelines for the client-centred practice of occupational therapy. Can J Occup Ther. 1990 Apr;57(2):77-81. doi: 10.1177/000841749005700206.
- Results publication: PubMed 2036055Kube E, Erhardt E. [Drug abuse prevention by police educational measures--Some remarks]. Arch Kriminol. 1991 Jan-Feb;187(2):23-7. No abstract available. German.
- Results publication: PubMed 24730003Robbins CE, Casey D, Bono JV, Murphy SB, Talmo CT, Ward DM. A multidisciplinary total hip arthroplasty protocol with accelerated postoperative rehabilitation: does the patient benefit? Am J Orthop (Belle Mead NJ). 2014 Apr;43(4):178-81.
- Guidelines for Client-centered Practice of Occupational Therapy) (DNHW \& CAOT, 1985)Link provided by the sponsor.
- Management of patients with stroke: Rehabilitation, prevention and management of complications, and discharge planning. June 2010. SIGN. A national clinical guideline. Scottish Intercollegiate Guidelines Network.Link provided by the sponsor.
- Stroke rehabilitation guide: supporting London commissioners to commission quality services in 2010/11. NHS. Healthcare for London.Link provided by the sponsor.
- ICFLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shmonin Alexey, PhD principal investigator
St. Petersburg State Pavlov Medical University
Shamalov Nikolay, Professor principal investigator
Pirogov Russian National Medical Research University
Suvorov Andrey, PhD principal investigator
Pirogov Russian National Medical Research University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and AMI, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivanova Galina, Professor (+79161144504, reabiivanova@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: through study completion, an average of 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02793934, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.