HOMECARE Clinical Continuity by Integrated Care Grant Agreement No

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1 HOMECARE Clinical Continuity by Integrated Care Grant Agreement No Home rehabilitation of patients with stroke Description and evaluation of the randomized control trial performed in Portugal Interim report, April 2011 Silvina Santana 1

2 Title: Home rehabilitation of patients with stroke Evaluation of the randomized control trial performed in Portugal Author: Silvina Santana Institute of Electronics Engineering and Telematics of Aveiro Department of Economics, Management and Industrial Engineering Research Unit in Governance, Competitiveness and Public Policies Publisher: University of Aveiro Released: May 2011 Published at University of of Aveiro, Print and Sign 2

3 Table of contents Summary... 4 Motivation and purpose... 4 Project organisation and management in Portugal... 5 Participants... 5 Members of the steering committee of the project in Portugal... 5 Consultants in the Danish procedure... 6 HOMECARE team of professionals providing care at home... 6 Work organisation and control and coordination procedures... 6 Implementation and results... 7 Methods... 7 Preparation of the randomized control trial... 7 Inclusion of patients and randomisation procedure... 7 Outcome measures... 8 Data... 9 Results The therapeutic intervention Evaluation of the RCT Conclusion

4 Summary The post discharge model and setting awaiting patients discharged from stroke unites in Portugal is very complex and demanding. Several types of providers exist, with different costs and level of competencies and performance and the information available for the common citizen is not easy to get, understand and compare. Articulating health care with social care at home is challenging as the patient or her/his family will have to find help from different providers on their own. The situation has improved recently with the launch of the National Network of Integrated Care (RNCCI), but resources within the network are limited and, until last year, very much confined to inpatient based care. Costs with health and social care are increasing, calling for urgent efforts aimed at controlling expenses while keeping the quality of care and the satisfaction of those involved in the processes, being it the patients and their carers or the health professionals. Integrating care might be an important step on this endeavour but efforts must be evaluated and documented in order to be of help for policy makers and serve as guide for further actions. The study here reported represents the first coordinated experience of community-based rehabilitation home care for stroke patients in Portugal, which include a case manager responsible for the continuity of relationship as the patient advance from admission at the acute care ward to returning to the community. In the absence of an integrated information system linking all the entities involved, the case manager also acts at the level of the continuity of information and is involved in patient management. In fact, the HOMECARE case manager is the only person with a complete vision over the patient pathway. The interim results seem to show that it is possible to introduce home rehabilitation in Portugal for stroke patients. The arrangement of activities will have to be adapted to the country conditions, thought. Probably, the most viable possibility is the implementation of health centre based home rehabilitation, as it is already previewed inside the RNCCI. However, in many health centres, Community Care Units and teams have not yet been implemented. Guidelines and training has to be developed and provided to these teams, including evaluation tools and procedures. Scales such as FIM and FAI seem insufficient to clearly assess results of this kind of procedure: reasons, complements and alternatives need to be further investigated. The need to maintain patients in rehabilitation units more time than strictly necessary for social reasons and the difficulty in diagnosing co-morbidities at the admission ward before randomization due to the absence of a national electronic health record might collide with the definition of Poor Outcome, as defined in similar international studies. The envisaged distributed environment will be particularly challenging in terms of information management and this aspect has to be accounted for in the planning phase. Guidelines must address the coordination procedure and channels with all the entities involved in the patient care. Financial and rewarding issues have also to be accounted for, as new arrangements will certainly call for new balances. Fundamental aspect respects to the decision on the right time for discharge and the transition of care. In the project, patients discharged to RNCCI units generally stay there for the all period, which means at least 30 days. National wide implementations of EHSD should work further on this aspect as it seems that there is room for improvement. Motivation and purpose Stroke is the main cause of death in Portugal and the main cause of disability on elderly people. It has been estimated that, each year, 200/ die from stroke in Portugal, corresponding to 2-3 persons/hour; 50% of the survivors will experience limitations with ADL and 20% will become totally dependent (Martins, 2006). The number of stroke episodes per 1000 inhabitants in the North of Portugal was 3.05 in the rural population (IC 95%, 2.65 to 3.44) and 2.69 in the urban population (IC 95%, 2.44 to 2.93), compared to 2.02 and 1.73 in Europe. Moreover, 14.6% of those living in the rural area and 16.9% of those living in the urban area will die before the 28th day after stroke. 4

5 The objective of the research here reported was to implement and evaluate a randomised control trial (RCT) of EHSD (Early Home Supported Discharge) of stroke patients in the District of Aveiro, Portugal. The final aim was to assess the viability of the implementation of a Danish procedure in Portugal, considering the specific setting and conditions, the process and the outcomes, including effectiveness and economic evaluation. This research departs from an early study conducted in Denmark, which resulted in the publication of an HTA of Home Training of patients with apoplexy [Larsen, 2005]. This HTA recommends home training of patients with stroke (ESD) establishing this as a health economic determinant intervention, which improves both the rehabilitation effect and the economic aspect of the care provision. This study was further developed with the funding of the Danish Ministry of Interior and Health. Later, it was upgraded to a RCT, granted by The European Commission as part of FP7-Homecare The RCT that is being conducted in Portugal is part of FP7-Homecare The main objectives of the Homecare WP2 in Portugal are to implement and evaluate an RCT on EHSD in Aveiro with about 140 patients and to report the experience on guidance material for further dissemination. This include to assess the EHSD effect on quality of rehabilitation in terms of health outcome, costs and satisfaction, to identify and validate impacting factors and to develop guides for similar interventions. Due to the delay in the starting of the project, mainly as a consequence of the delay in receiving initial funding from the Commission and the long time it took to sign a protocol with the ARSC (Regional Health Administration for the Centre of Portugal) and to receive permission from the Administration and the Ethics Committee of the Hospital Infante Dom Pedro (HIP) to start the inclusion of patients, this report is based on 100 complete cases, the number of admitted patients that had reached the sixth month by the end of March This corresponds to a bit less than 13 months of field work, meaning the period effectively available for patients admission to the study. The rate of stroke patients arriving to the HIP is out of our control. By the same time, 150 patients had been included in the RCT and are still being treated and followed. The present interim report aims at providing a complete description of the work done so far in Portugal and an evaluation of the implementation process and the results achieved. The basis for this evaluation is a data set with key figures from the medical and the project management record supplemented with cost data from all the involved entities, collected by the University of Aveiro. The database is briefly presented in the section Method. Project organisation and management in Portugal Participants Members of the steering committee of the project in Portugal Silvina Santana, PhD, University of Aveiro, coordinator of the Homecare project in Portugal, responsible for the effectiveness and economic evaluation José Rente, MD, Chief Neurologist of the Hospital Infante Dom Pedro Stroke Unit Conceição Neves, MSc, PhD candidate, University of Aveiro, Chief Nurse of the Hospital Infante Dom Pedro Stroke Unit Sandra Loureiro, PhD, University of Aveiro, consultant in data analysis Nina Szczygiel, MSc Economy, PhD candidate, University of Aveiro, network analysis Raquel Fonseca, PhD, University of Aveiro, consultant in economics and financial aspects Patrícia Redondo, BA in Public Administration, MSc in Management, PhD candidate, joined the steering committee in January

6 Consultants in the Danish procedure Torben Larsen, Chief Consultant, MSc Econ CAST/SDU, Birgitte Jepsen, OT, MR, OUH Ringe HOMECARE team of professionals providing care at home Marta Viana, Gerontologist, MSc in Management, HOMECARE case manager Mariana Ribeiro, Gerontologist, MSc in Management, HOMECARE case manager Joana Freitas, Ocupational therapist Margarida Cerveira, Psychologist, Post-graduation in Neuropsychology Francisco Martins, Physiotherapist, MSc Sílvia Pinto, Occupational therapist Liliana Cardoso, Physiotherapist Work organisation and control and coordination procedures A scheme of coordination and accompanying meetings was settled. General rule is: - UA team meets briefly each Monday, to discuss previous week work and new cases. - Silvina Santana meets with Conceição Neves each 15 days, to discuss previous period work and issues in need of further action. - The teams of therapists (on a patient base) meet whenever necessary is to discus cases and plan further work. - Therapists meet at UA each month, in order to discuss ongoing cases and issues in need of further action. Besides that, a web based coordination tool has been set in order to easy the contacts and the coordination and lower their costs, organize the therapists individual and team s agendas and keep management information. Protocols and more informal contacts have been established with relevant bodies in the health and social care sectors, including public and private bodies. Authorizations have been requested from several entities. Among those we would like to point out, for its relevance for the project and the proper development of field work: - Protocol established between the University of Aveiro and the Administração Regional de Saúde do Centro (ARSC, the Health Regional Administration for the centre region of Portugal), that regulates the conditions for the selection of health professionals providing care at home within HOMECARE and the general lines regulating the provision of this service to the patients admitted to the study by the HOMECARE team; - Authorization from the Administration of the Hospital Infante Dom Pedro (HIP) to visit patients in the Stroke Unit and start the randomisation procedure and the inclusion process there; 6

7 - Protocols and authorizations from the administrations boards of several rehabilitation units, including units working with the RNCCI; - Evaluation and final decision regarding ethical aspects from the Ethics Committee of the Hospital Infante Dom Pedro. The SPSS-Database was created and is being maintained by the University of Aveiro. This database is fed by data coming from different datasets organized by themes and kept apart for security reasons. Anonymity of the patients is assured in all the databases in use. Interviews with patients and relatives regarding their experiences and families costs due to the stroke episode were performed and reported by Patrícia Redondo and Nina Szczygiel. Implementation and results Methods Preparation of the randomized control trial The preparation for the randomized control trial in Portugal started several months before the official start of the project, with Torben Larsen and Gitte Jepsen visits to Portugal. Several meetings with more than twenty professionals were held in the University of Aveiro, the HIP and the Ílhavo Health Center, in order to evaluate the conditions to run the RCT. Preparatory work has proceeded with the translation of the Danish preliminary guidelines and forms from English to Portuguese and their adaptation to the Portuguese context, the design of the Portuguese data system adapted to the country context, the development of information sheets for patients and the informed consent formularies for patients and relatives and the piloting of the guidelines and the data collecting instruments in real setting. Inclusion of patients and randomisation procedure In the Portuguese trial, the home training procedure starts at the Stroke Unit of the HIP, where patients are recruited for the study. Nowadays, it is recommended that all patients admitted to a hospital with a diagnosis of stroke must be directed to a Stoke Unit (Unidade de Acidentes Vasculares Cerebrais UAVC). These units integrate health professionals especially trained for these situations and apply diagnostic and therapeutic procedures according to protocols that follow the most recent international recommendations. The multidisciplinary teams that treat stroke patients execute integrated care and rehabilitation plans based on the individual needs. One of the most relevant practices adopted is physiotherapy care that promotes early mobilization and get up (Neves, Rente and Santana, 2011). The post-discharge model is very complex and diversified. Patients are being rehabilitated at home, at Convalescence, Medium-Term and Long-Term Units, residential homes and second line hospitals, among others. These might be public organizations, private non-profit or for-profit entities or public/private partnerships. Patients admitted to the Stroke Unit (SU) of the HIP that fulfil the inclusion criteria and have signed the informed consent are randomised to either the intervention group (50 patients) or the control group (50 patients). Patients in the intervention group receive home rehabilitation at home, after being discharged from the SU, for those discharged directly home, or after being discharged from the rehabilitation unit, for those discharged to a RNCCI convalescence unit for further inpatient rehabilitation. Patients in the control group receive traditional care. The randomization happens within the first 72 hours, around the 2 nd -3 rd day after admission. By that time, it is sometimes too soon to 7

8 know if the patient will be discharge directly home or referred to a convalescence unit for further rehabilitation. Inclusion criteria are: patients with first time clinic stroke being 30 to 85 years old residing in the District of Aveiro having FIM score at admission 100 Exclusion criteria are: being less than 30 or more than 85 residing outside the District of Aveiro having FIM score > 100 suffering from psychological illness and dementia that influences on participation in the study suffering from massive speech and language disturbances which prevents oral and written instructions in the study to be understood pregnancy suffering from earlier acquired problems in the central nervous system or illness in the motor apparatus that influences participation in the project suffering from other severe co-morbidity which influences participation in the project Furthermore, it will be excluded à posterior those remaining in a long term care unit by the time of follow-up, at the 6 th month. Outcome measures Primary and secondary outcome measures have been established. Primary outcome measures are: degree of independence possibility of discharge to own home length of stay at an inpatient centre readmission to hospital costs with inpatient and outpatient care (acute phase and rehabilitation) quality of life burden over informal caregiver As we cannot impose rehabilitation plans for the patients in the study group, our expectation is that helping the patient and her/his family to make the transition and offering rehabilitation at home will result in less use of other options, with equivalent or even better results at several levels. Secondary outcome measures are: empowerment expectations versus experiences of patients and caregivers quality of service (functional not technical) satisfaction of patients and caregivers qualitative information 8

9 Data Due to the specificity of the situation in Portugal, the Danish forms had to be adapted before the initiation of the Portuguese RCT. As a result, a structure for a database intended to support the data collected during the trial was established. Table 1 provides a description of the variables that may be assembled in a SPSS file on a need base. As a result of the complexity of the post-discharge model in Portugal, it may occur that a patient may use the services of several providers of rehabilitation care. To avoid an unnecessarily long list of variables in the report, the associated variables are reported only once, receiving an n, as they represent the n variables that effectively have been created in the database. Table 1- Variables available and database content baseline Profile Name of the variable ICD Injury 2ndDiagnosis Adm_SU Discharge_Su LoS_SU Adm_RU1 Discharge_RU1 LoS_RU1 Adm_RUn Discharge_RUn LoS_RUn SAD_Bath SAD_Meals SAD_Laudry SAD_Clean CI_BeforeStroke DependencyLevel DischargePlace_SU DischargePlace_RU1 DischargePlace_RU2 DischargePlace_RU3 DischargePlace_RU4 WorkHours_BeforeStroke Residence_LastDischarge Situation_DischargeSU TypeResidenceLastDischarge NumberSteps_Outside NumberSteps_Inside Elevator Household_BeforeStroke Household_AfterStroke RCT_Group Age Description Admission diagnosis/icd Right/left hemisphere injury Secondary diagnosis Date of admission to the SU Date of discharge from the SU Length of stay at the SU Date of admission to the 1stRU Date of discharge from the 1stRU Length of stay at the 1stRU Date of admission to the CUn Date of discharge from the CUn Length of stay at the CUn Pre-stroke dependency level bath Pre-stroke dependency level meals Pre-stroke dependency level laundry Pre-stroke dependency - house clean Informal caregiver before stroke Level of dependency before stroke (to be defined) Place of discharge after SU Place of discharge after RU1 Place of discharge after RU2 Place of discharge after RU3 Place of discharge after RU4 Number of work hours before the stroke episode Residence at last discharge Situation at discharge from SU Type of residence at discharge Number of steps to/from residence at last discharge Number of steps in residence at last discharge Elevator Whom the patient lived before stroke Whom the patient lived after stroke (at last discharge) RCT group Age 9

10 first visit to the patient home based rehabilitation sessions follow up visit 2month visit 1Year visit FIM form Gender CivilStatus CountyOfResidence Race MonthlyIncomeHousehold LevelEducation ProfessionalSituation WorkSituation ExemptionCarePayment HealthCareSystem CasaManager Date1stTeamVisit Participants1stHomeVisit Purpose1stHomeVisit RelevanceHomeCare TimeConsumption1stVisit TypeTransport1stVisit KM1stVisit Cost1stVisit NumberOfSessions_Phisio_EHSD NumberOfSessions_TO_EHSD NumberOfSessions_Psico_EHSD TotalOtherTravelling_KM TotalOtherSessions_Cost DateVisit_n ParticipantsSession_n TimeConsumptionSession_n PatientGoalSession_n TherapeuticReasoningSession_n ContentHCSession_n DateFollowUp Situation_FollowUp ParticipantsFollowUp TypeResidenceAtFollowUp ReadmissionsAtFollowUp Gender Civil status County of residence Race Average monthly income of the household Level of education Professional situation Type of work Exemption of health system Healthcare system/sub-system Case manager Date of first home visit team Participants in the first home visit Purpose of the first home visit/first visit to the patient Relevance of home care rehabilitation to the patient Time consumption (rehabilitation and transport) Means of transport Number of kilometers roundtrip Cost of the first visit Number of physiotherapy sessions from the home team Number of OT sessions from the home team Number of psychotherapy sessions from the home team Total travelling with other sessions Total costs with other sessions Date Participants in home care session_n Time consumption for home care (rehabilitation and transport) session n Patient s goal with home care (qualitative data) session_n Therapeutic reasoning (qualitative data) session_n Content of home care session_n Date of follow up visit Situation at follow up Participants in follow up visit Type of residence the patient lives in at the time of the follow-up visit Readmissions (number) Readmissions_n_DateAdmission Readmissions (dates of readmissions ) Readmissions_n_DateDischarge Readmissions_n_LoS Readmission_n_ICD Date2ndMonth Situation_2ndMonth Date1Year Situation_1Year FIM_Item_n FIM_Score_n Readmissions (date discharge) Readmissions (bed days) Readmissions (diagnosis) Date of the second month visit Situation at the second month visit Date of the first year visit Situation at the first year visit All items at admission/discharge/second month/n/follow-up Total FIM score at admission/discharge/second 10

11 FAI form EQ-5D Other support Costs FAI_ItemAdmission_n FAI_ItemFollowUp_n EQ5D_Mobility EQ5D_SelfCare EQ5D_UsualAct EQ5D_PainDeisconfort EQ5D_AnxietyDepression EQ5D_VisualScoreScale HomeCareAfterDischarge HomeNurseAfterDischarge RehabilitationAfterDischarge EHSDTeam HomeCareSessions HomeNurseSessions PrivateRehabilitation RehabilitationHospitalSessions RehabilitationPrivateSessions RehabilitationHomeSessions AlterationsHome ExpensesHomeFacilities AssistiveFacilities HospitalCostsSystem TaxiVoyages TaxiCostsSystem AmbulanceTrips AmbulanceCostsSystem TripsOwnCar CostsOwnCar PublicTransportTrips PublicTransportCosts ConsultationsHealthCentre ConsultationsHealthCentreCosts HospitalAppointments HospitalAppointmentsCosts PhysioSessions PhysioSessionsCosts PrivateMedicalConsultations month/n/follow-up All 15 activities before admission All 15 activities before at follow-up visit Mobility Self-care Usual activities Pain/discomfort Anxiety/depression Visual score on scale Home care (SAD or other) after discharge (Yes/No) Home nurse (health center or other) after discharge (Yes/No) Rehabilitation training after discharge (Yes/No) EHSD team (Yes/No) Home care (SAD or other) hours/sessions Home nurse hours/sessions Private rehabilitation after discharge (Yes/No) Rehabilitation training at the hospital hours/sessions Rehabilitation training at a private clinic hours/sessions Rehabilitation training at home hours/sessions Alterations in home facilities Expenses for alterations in home facilities Assistive facilities (qualitative data) Acute care hospital costs for the system Number of taxi voyages Taxi costs for the system Number of ambulance trips Ambulance costs for the system Number of trips on own car Costs on own car Number of public transports trips Costs of public transport Number of consultations at the health cente Costs of consultations at the health center Number of hospital appointments Costs for hospital appointments Number of physio sessions Costs of physio sessions for the system Number of private medical consultations PrivateMedicalConsultationsCosts Costs of private medical consultations for the system PhysioSessionsOutpatient_Provider Outpatient physiotherapy sessions - identification of provider PhysioSessionsOutpatient_ProviderType Outpatient physiotherapy sessions - provider type PhysioSessionsOutpatient_Number PhysioSessionsOutpatient_Costs PhysioSessionsRU_Provider PhysioSessionsRU_ProviderType Outpatient physiotherapy sessions - number Costs of outpatient physiotherapy for the system Physiotherapy sessions in Rehabilitation Unit name Physiotherapy sessions in Rehabilitation Unit - provider type 11

12 Informal caregiver PhysioSessionsRU_Number PhysioSessionsCosts OTSessionsOutpatient_Provider OTSessionsOutpatient_ProviderType OTSessionsOutpatient_Number OTSessionsOutpatient_Costs OTSessionsRU_Provider OTSessionsRU_ProviderType OTSessionsRU_Number OTSessionsRU_Costs OutpatientSessionsOther_Provider OutpatientSessionsOther_ProviderType OutpatientSessionsOther_Number OutpatientSessionsOther_Costs RUSessionsOther_Provider RUSessionsOther_ProviderType RUSessionsOther_Number RUSessionsOther_Costs TechnicalAids CostTechnicalAids HouseAdapt CostHouseAdapt InstitutionSAD Receipt NumberMonthsSAD NumbersDaysWeekSAD NumbersHoursDaySAD CostHomeSupporttPatient Drugs AverageCostDrugsMonth TotalCostDiagnosisMeans DaysRUn CostsRUnPatient CostOutOfWork NumberDaysOutWork HourlyPay MonthlySalary InformalCaregiver ICNumberHours ICProfile1 ICProfile2 ICProfile3 Physiotherapy sessions in Rehabilitation Unit - number Costs of physiotherapy in Rehabilitation Unit for the system Outpatient occupational therapy sessions - name Outpatient occupational therapy sessions - provider type Outpatient occupational therapy sessions - number Costs of occupational therapy in outpatient for the system Sessions of occupational therapy at the Rehabilitation Unit - name Sessions of occupational therapy at the Rehabilitation Unit - provider type Sessions of occupational therapy at the Rehabilitation Unit - number Costs of occupational therapy at the Rehabilitation Unit Outpatient other specialty sessions - name Outpatient other specialty sessions - type of provider Outpatient other specialty sessions - number Costs of outpatient other specialty sessions Sessions of other specialty in Rehabilitation Unit - name Sessions of other specialty in Rehabilitation Unit - provider type Sessions of other specialty in Rehabilitation Unit - number Costs of another specialty in Rehabilitation Unit Purchase or rental of technical aids (Yes/No) Costs of purchase or rental of technical aids House adaptation (Yes/No) Costs of house adaptation Name of the institution providing home support Receipt exists (Yes/No) Number of months with support Number of days with home support per week Number of hours per days with home support per week Cost of all home support for the patient Quantity of drugs Average amount paid per month for drugs Total costs of diagnosis and treatment means Number of days of stay in Run Costs of RUn for the patient Costs of absence from work (productivity costs) Number of days of absence from work Hourly pay Monthly salary Informal caregiver (Yes, No) Number of hours of care provided by family, friend, neighbor or other Profile var1 Profile var2 Profile var3 12

13 ICProfilen ICSupportedCosts ICTime ICZaritt Profile varn Costs supported by the informal caregiver Time spent by the informal caregiver Burden as measured by the Zaritt itens By the end of March 2011, 100 patients had reached the sixth month and the process of data validation started. The data available in this phase correspond to those collected during the trial, near the patients and their informal caregivers, the several institutions providing care to the patients and other providers operating in the Portuguese context. Data validation comprised two aspects: verification of correctness of data related to events, such as admissions, discharges and payments; and verification of correctness of data already typed in databases. The first aspect was necessary due to the high level of fragmentation of the care system in the country and was tested through triangulation of data sources. The data has been put through a verification process involving the contact of the different entities in the chain of care of each patient, including care providers, patients, informal caregivers and payers (e.g. the RNCCI). This has allowed us to confirm fundamental parameters to be used in the analysis and to account for situations where some of the providers have refused to provide some of the data (usually about costs) or the patients simply could not remember about some of the figures (e.g. amount paid for transportation to rehabilitation sessions). In the end of the process, two faulty registries for date of discharge from the stroke unit where found. The second aspect involved a two-phase process that has allowed us to certify the quality of the data introduced in the databases. First, the data in all the cells of all the excel files produced so far were visually inspected and compared with the corresponding boxes in the registration sheets. Then, the SPSS file was generated by linking variables from different excel files in an automated manner, based on patients identification numbers (ID). Finally, we conducted a final inspection in the SPSS database, by comparing all data boxes in the file with all data boxes in paper sheets for 20 patients. Results The therapeutic intervention In Portugal, home training is handled by the patient s interdisciplinary training team, which is formed for each specific case, according to its requirements. The professionals that integrate these community-based teams have been selected by the ACES Baixo Vouga II, in the context of a protocol between the University of Aveiro and the ARSC. The team includes a case manager with training in gerontology and management sciences, a physiotherapist, an occupational therapist and a psychologist. The intervention starts in the Stroke Unit of the HIP when a patient with a diagnosis of stroke is admitted. The team coordinator or her trained substitute selects potential patients for the study at ward examination, verifies treatment diagnosis and other significant diseases and fill the FIM form. Final consensus scoring takes place by the second/third day. The responsible at the hospital informs the patient and if possible her/his family about the study, presents the informed consent form and ask for her/his participation. By the same time, she contacts the future case manager, one of the two gerontologists in the team, informing about a possible inclusion and between them they program a visit to the patient, should him/her agree on entering the study. After collecting the informed consent from those patients willing to participate, the responsible at the hospital makes the randomisation, assigning the patient either to the study or the control group. At this point, the coordinator at the hospital and the gerontologist start the collection of data, according to the scheme previously piloted and standardized. The patients belonging to the study group (SG) receives the first visit from the gerontologist whenever possible in the presence of a relative or other 13

14 existing informal caregiver. This first visit has proved to be essential in creating involvement from the patient and trust with regard to the community team. When the planning for the discharge starts, those patients in the study group being discharged directly home are offered a early home visit intend to evaluate the house conditions and assess the need for adaptations and other initiatives that may be started while they are still at the hospital. The patient do not participate in this first visit as the difficulty of the internal process in the hospital and the legal aspects involved in taking the patient home and back to the hospital would make it very complicate to handle. The patients discharged to a RNCCI convalescence unit are contacted again when the plan for the discharge from the unit starts. The feasibility of an early home visit has been also evaluated for these patients and the rehabilitation units were inquired about these aspects. In one case, the Convalescence Unit of Ovar, the unit is already performing a discharge procedure that in some cases include early home visits, a procedure similar to the one implemented in Denmark. For patients of these two subgroups pertaining to the study group, when the planningning for discharge starts, a care plan is developed to be followed by the homecare team. This plan details the number, the content and the sequence of sessions. A diagram has been developed to organize and describe this information, in order to facilitate the coordination and the work of the inpatient and the homecare teams. The same coordination and operation procedures are used with patients in the control group (CG). The only difference is that these patients are not offered home rehabilitations services from the HOMECARE team. They receive the traditional care available in the country and more specifically in the district in terms of intervening entities at local level, as explained. The different teams in the project (hospital, homecare and overall coordinating team) have been provided with detailed guidelines, in line with a similar document used in Denmark but adapted to the Portuguese situation and constrains. The guidelines detail the tasks to be done and their description, the relative date in which they are supposed sed to be performed, the associated documents such as forms to be pre-empted, empted, and the persons responsible for the tasks. Figure 1shows the temporal arrangement of the intervention in the case of the study group. Figure 1 Temporal arrangement of the intervention. A fundamental difference between the Portuguese and the Danish implementation results from the fact that most patients in Portugal are still being discharge directly home, after the acute care phase in a stroke unit, and receive rehabilitation care as outpatients, being it in the hospital or in private providers with protocols with the NHS. Some patients with no indication for further training financed by the NHS choose to pay more rehabilitation sessions from their own pocket. This complex model of postsituation in terms of research and evaluation stroke rehabilitation results in a very demanding effort. 14

15 The home rehabilitation project was first planned to ensure an intensity equivalent to an Early Home Visit no later than 10 work days (2 weeks) after admission followed by 8 home rehabilitation sessions, some of them conducted before the patient discharge and the remaining after the discharge. In Portugal, this arrangement was not possible, due to the reasons previously described. In fact, most of the patients are still being discharged directly to their homes, even if the RNCCI is now offering new possibilities in terms of inpatient rehabilitation for those in need of further training after being discharged from the acute care hospital. On the other hand, some patients stay in inpatient care for a few days only, receiving rehabilitation as outpatients after discharge. Mean length of stay at acute care hospital for all reasons is now around 6.8 days in Portugal. This would make it impossible to perform the EHSD procedure in its primary form in many cases. Therefore, the intervention in Portugal had to be redesigned to account for the country specificities. All patients had the first contact with the case managers during the stay at the Stroke Unit but most patients have received the first visit from the HOMECARE team after being discharged home. The mean value for the first visit to the patient home from the HOMECARE team was 35 days after admission, with a minimum=9 days, a maximum=132 days, a standard deviation=27.3 days and a mode=16 days. The relative long time elapsed before some patients received the first visit at home (mean value) is mainly justified by the fact that 10 of the patients in home rehabilitation have stayed at least 30 days in RNCCI units before being discharged home. Some of them have made more than one transition between units. In the Portuguese trial, there were made on average 10 home sessions per patient, with a minimum=1 session, a maximum=21 sessions, a standard deviation=5.3 sessions and a mode=12 sessions. Table 2 describes the situation in terms of specific sessions made. Table 2 - Sessions, by type and total Physiotherapy Occupational therapy Psychology All types Valid number of patients Mean Minimum Maximum Standard deviation Mode The data suggests that the home rehabilitation was well adjusted to the individual patient s needs, as the number of home rehabilitation sessions vary from 1 to 21 with a standard deviation of 5. The community-based home rehabilitation should be terminated no later than 1 month after patient discharge to home. In fact, only 6 of the home rehabilitation training sequences were terminated within the first month after discharge, but most of them last for 1 month and only a few surpass the deadline for several days. The reasons for surpassing the 1 month after discharge deadline are mostly related with operational aspects, such as convenience of dates for the patient and/or the informal caregiver. Preliminary results of the Portuguese trial have been published in Santana, Redondo et al., Evaluation of the RCT The preliminary assessment is based on the data respecting to the 100 Intended-to-treat that have reached the sixth month by the end of March Basic descriptive shows that the two groups are balanced in terms of age and gender. 15

16 AGE MEAN all = 67.2; MIN all =35; MAX all =84 MEAN EHSD = 67.4; MIN EHSD =40; MAX EHSD =82 MEAN control = 67; MIN control =35; MAX control =84 GENDER Female all = 47; Male all = 53 Female EHSD = 23; Male EHSD = 27 Female control = 24; Male control = 26 In the CG, 8 patients were lost for the trial, either because they dropped out or otherwise the team was unable to contact them at the scheduled moments in time. In the SG, 9 patients were lost for the trial, either because they quit or otherwise the team was unable to contact them at the scheduled moments in time. Some of the patients in the SG quit the study at discharge, because their families decided they were well enough by that time. In three of the cases, FIMs were above 110 at discharge. Poor outcome In the Danish HTA [Larsen, 2005] which is primarily based on international studies, the sum of deceased and patients in care home (Poor Outcome, PO) is the primary outcome. PO in the Portuguese trial is as follows. In the control group Deceased - 2 patients; one more died a few days after making 6 months post stroke. In the study group Deceased - 2 (PS11, PS40) without starting the intervention from the HOMECARE team. These patients died at RNCCI rehabilitation units. - 1 from heart failure two days after the death of his wife. This patient has been discharged home, having only EHSD support from our team. FIM at 2nd month was 126, having increased with home team intervention. - 1 from severe complication from diabetes, after being amputated. This patient was discharged to a RNCCI unit. After being discharged from the RU, he received the first visit from the HOMECARE team and a rehabilitation plan was made for him. He died in the meanwhile without further intervention. At the 2nd month, while still at the RU, FIM was 73 having increased from 44 at discharge from the SU. - 1 from cancer. This patient has been discharged home, having only HOMECARE team support from our team. FIM at the 2nd month was 105, having increased from 88 at discharge with the team intervention. In the SG, 5 patients discharged to RNCCI units have jumped from unit to unit, being still there at the follow-up visit, by the sixth month after discharge. For most of them, if not for all, the reasons were mainly of a social nature (e.g., no or very poor family support). Improvement and effort related results Mean length of stay at the SU is 9.9 days for the study group (N=50) and 9.1 days for the control group (N=50). 16

17 Basic analysis of FIMs for all patients available in the reported periods shows that mean FIMs for the study group and the control group are similar (Table 3). Table 3 Mean FIMs for all patients available in the reported period. admission discharge 2 nd month 6 th month Study group Control group However, the study group seems to have recruited patients in worse condition. In fact, in the study group, 13 out of 50 patients had FIM<50 at admission. In the control group, 7 out of 50 patients had FIM<50 at admission. In the study group, 13 had FIM<65 at discharge from the SU. In the control group, 9 had FIM<65 at discharge from the SU. In both groups, 18 patients had FIM>100 at discharge. In the study group, 17 patients have been discharged to RNCCI convalescence units. From this, 4 jumped from unit to unit and never came out of the network and 3 died. In the control group, 11 patients have been discharged to RNCCI convalescence units. Only 2 patients in each group came out of the RNCCI units with FIM>100. Some patients have been in 2 units, a few in 2 hospitals, first the acute care hospital and then a second line hospital. Many had rehabilitation as outpatients after being discharged home. In Portugal, there has been an historical reliance on the informal caregiver (IC), as the first line of care of dependant people. The situation has been changing in the last years, due to the very high level of women participation in the labor market and the increasing availability of formal solutions, but there is little published evidence and figures available on the subject. Therefore, we have planned for measuring informal caregiver burden and effort, as measure by their perceptions on the burden supported and by the number of hours spent caring for relatives and the opportunity cost of that effort. The Zaritt scale was used to assess IC perceived burden. Results for the aggregated level of burden are described in Table 4 and Table 5. Preliminary results have been published in Santana, Ribeiro et al., Table 4 IC perceived burden on the control group. Percentage of IC at the 2nd month Percentage of IC at the 6th month Little or no burden Mild to moderate burden Moderate to severe burden Severe burden 0 0 Table 5 IC perceived burden on the study group. Percentage of IC at the 2nd month Percentage of IC at the 6th month Little or no burden Mild to moderate burden Moderate to severe burden Severe burden

18 Further analysis is necessary to investigate the effect of all this effort, also by including other issues such as quality of life, in order to explain aspects not fully addressed by FIM and FAI scales. This will be done based on data that has been collected at the several units involved and the patient home at defined moments in time and will include qualitative information collected through face-to-face interviews. Preliminary results on patients expectations and experiences have been published in Szczzygiel and Santana, Economic assessment The economic assessment is based on a calculation of the costs for the 1st year of treatment of the included patients in inpatient units and in community, both in health and social care. The following process components are used: - First days of acute care at the HIP Bed days in acute ward; costs vary widely according to the diagnosis and are still being determined. - Days in second line hospital Bed days in second line hospital for those patients that have been discharged to other ward for several reasons (e.g., to make space for new patients in the SU); the cost of a bed day in this type of facility is still being determined. - Inpatient care in the RNCCI Bed days in a specific unit, according to the amounts established by decree-law, as described in Table 4. Costs are paid by the Ministry of Health (MoH) or the Ministry of Labour and Social Solidarity (MoLSS). In convalescence and rehabilitation units, the cost includes therapy modules during workdays, which are executed according to the unit practice. Convalesce units are free-of-charge for the patient. In the other units the patient is responsible for a co-participation for the component of social care that is indexed to the family monthly income. Exempt patients do not pay. To the per day costs, the costs of Referred user and User with admission criteria must be added for each user. These costs have been estimated at 189 and 358 in Table 6 Financing of RNCCI units in Typology Funding Health care costs Social care costs Medicine costs Convalescence unit (til 30 days) MoH Rehabilitation unit (30 > days <90) MoH+MoLSS Long-term & rehabilitation unit (> 90 days) MoH+MoLSS Outpatient rehabilitation sessions at the HIP Outpatient rehabilitation sessions at the HIP; the cost of the care provided in this type of service is still being determined. 18

19 - Rehabilitation care in private providers Price of a consultation: between 35 and 60, 35 in the clinics that do not have protocols with the NHS (in which case the consultation is paid by the patient only) 50/60 in the clinics that have protocols with the NHS. Price of treatment: it is established by act and may vary from 10 to 22. For patients with a prescription from a NHS doctor: until 65 years old, the patients pay (includes 2 consultations and 15 rehabilitation sessions); those with 65 years old or more pay (includes 2 consultations and 15 rehabilitation sessions). For the exempt patients, the receipt is paid by the respective ARS (Regional Health Administration). - Costs with transportation As the Portuguese model involves a considerable effort in outpatient rehabilitation, this costs has to be included. It has been established by the ARS that fire departments are paid on a kilometre base. The amount is 0.48 per km when the patient is the only user in the vehicle. When there are more users, the first travel is paid at 0.48 per km and the others at 20% (0.098 per km). However, for short voyages, some fire departments seem to be charging a service activation amount (in one of the corporations in Aveiro, this amount is 7.5 when the patient is the only user in the vehicle; this figure is the base for the other calculations), instead of a per km price. When the patient has got a prescription from a NHS doctor, the receipt is paid by the ARS. For exempt users, the receipt is paid by the ARS. - The home rehabilitation sessions of the HOMECARE teams, at the cost of 22 per visit including 1 hour of rehabilitation and transport. This price level was established between the HOMECARE project coordinator and the team members as there was no reliable data on the cost of similar effort in the country. Price of an hour of physiotherapy at home may be around 50/60, but many professionals are being hired by private companies to execute the service and being paid at very low price. Information on actual use of time and transport distance in the project seems to confirm the appropriateness of the established price. However, with the rise in the costs of transport due to ever growing petrol cost and the recent introduction of more tool charges, this amount will have to be renegotiated. - Use of domiciliary support service (SAD) provided by IPSSs at a 2011 cost still to be determined. In 2006, the amount paid by the MoLSS to IPSSs was per month per patient. Patient co-payment must be added to this amount. - Use of informal caregiver support. Putting a price in this effort is very difficult. - Rehabilitation provided by health centres in the patient s own home is free of charge. The cost for visits to family doctor is not estimated as these are presupposed to be quite alike regardless of the patient receiving HOMECARE rehabilitation or not. Detailed analysis is needed on the real significance of PO in Portugal. In fact, almost all deaths were due to unfortunate developments of co-morbidities already present by the time of the randomisation. Further analysis will be conducted after establishing a suitable model for Portugal. Conclusion The initial preparation for the WP2 in Portugal has proved to be exigent in time, dedication and coordination and motivation effort, due to the high level of fragmentation of the health and social care systems, ongoing restructuring in the health care system (namely, in primary care and the RNCCI 19

20 National Network of Integrated Care) but also to the long period that has elapsed between the first contacts with the several actors and the actual start of the field work. No documented evidence exists on a similar experience in the country. For the first time, it was possible to establish a coordinated experience of community-based rehabilitation home care for stroke patients, which include a case manager responsible for the continuity of relationship as the patient advance from admission at the acute care ward to return to the community. In the absence of an integrated information system linking all the entities involved, the case manager also acts at the level of the continuity of information and is involved in patient management. In fact, the HOMECARE case manager is the only person with a complete vision over the patient pathway. The interim results seem to show that it is possible to introduce home rehabilitation in Portugal for stroke patients. The arrangement of activities will have to be adapted to the country conditions, thought. Probably, the most viable possibility is the implementation of health centre based home rehabilitation, as it is already previewed inside the RNCCI. However, in many health centres, Community Care Units and teams have not yet been implemented. Guidelines and training has to be developed and provided to these teams, including evaluation tools and procedures. Such a distributed environment will be particularly challenging in terms of information management and this aspect has to be accounted for in the planning phase. Guidelines must address the coordination procedure and channels with all the entities involved in the patient care. Financial and rewarding issues have also to be accounted for, as new arrangements will certainly call for new balances. Fundamental aspect respects to the decision on the right time for discharge and the transition of care. In the project, patients discharged to RNCCI units generally stay there for the all period, which means at least 30 days. National wide implementations of EHSD should work further on this aspect as it seems that there is room for improvement. With the completion of the cases that are still being treated and followed and the collection of full data about primary and secondary outcomes we expect to be able to successfully complete the RCT in Portugal and deliver a final report in September References Larsen T. Hjemmetræning af patienter med apopleksi. Medicinsk Teknologivurdering puljeprojekter 2005; 5(1). Martins R. A especial importância do AVC para a população Portuguesa. Revista Saúde Pública Neves C., Rente J., Santana S. Current status and developments in the care of stroke patients in Portugal, INIC11 - the 11th International Conference of the International Network of Integrated Care, Odense, Denmark, 31 March-01 April Santana S., Ribeiro M., Redondo P., Viana M., Expectations and experiences of informal caregivers of stroke patients in Portugal, INIC11 - the 11th International Conference of the International Network of Integrated Care, Odense, Denmark, 31 March-01 April Santana S., Redondo P., Neves C., Rente J., Viana M., Ribeiro, M., Szczygiel N. Stroke patients pathways to rehabilitation in Portugal, INIC11 - the 11th International Conference of the International Network of Integrated Care, Odense, Denmark, 31 March-01 April Szczygiel N. Santana S. Patients expectations versus experiences as a premise to assess intersectoral collaborations in health and social care, INIC11 - the 11th International Conference of the International Network of Integrated Care, Odense, Denmark, 31 March-01 April

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