Study design
The design of this study was a two-arm multicenter randomised controlled trial with patients allocated to either the integrated programme or usual care. The study was conducted in eight geriatric rehabilitation units for patients with stroke. More specific information about the methodology of the study can be obtained from protocol article published earlier15. This study adheres to CONSORT guidelines for Randomized Controlled Trials. The protocol of this study was registered with the International Standard Randomised Controlled Trial Register Number (ISRCTN62286281), and The Dutch Trial Register (NTR2412).
Study population
The study population involved stroke patients and their informal caregivers who were admitted to one of the eight participating geriatric rehabilitation stroke units after hospital discharge. The study population was restricted to patients aged 65 or over, living in the community before admission to geriatric rehabilitation, and expected to be able to return home after discharge. Inclusion started directly after admission to the geriatric rehabilitation unit. At admission the rehabilitation team under the responsibility of an elderly care physician, conducted a comprehensive geriatric assessment to determine if the patient was expected to return home after discharge. Based on this assessment (in combination with the other eligibility criteria), patients were included in the study. Patients who did not give informed consent for participation, or were medically unstable and thereby not able to start rehabilitation, were excluded. In addition, the primary informal caregiver of each participating patient was invited to participate in the study. A person is considered to be the primary informal caregiver in case the patient indicates him/her as the person mostly involved in informal care activities for this patient. The multidisciplinary teams of the participating geriatric rehabilitation units received a three hour training which included the important key elements of the intervention protocol. During the study, the participating multidisciplinary teams were responsible for checking which admitted patients fulfilled the inclusion criteria of the study. To calculate the sample size, data from earlier research was used. Based on the Frenchay Activity Index score as primary outcome variable16, the assumed clinically relevant difference in activity level of two stroke populations had to be at least 3.5. Based on a power of 0.8 and an alpha of 0.05, the study would need a sample size of 102 patients in each group. With an expected drop-out during follow-up estimated at approximately 25%, each group should include 128 participants. In total 256 participants were needed for the study.
Randomisation
After inclusion, all patients and their informal caregivers of each participating nursing stroke unit were randomised on patient level by an independent research assistant. The randomisation procedure was conducted by a computerised block randomization schedule using IBM SPSS software version 19.0 (10 patients per block) to allocate the included patients to the intervention or usual care group. Patients allocated to the intervention group received the integrated programme and patients allocated to the usual care group received care as usual. Data were collected by research assistants who were blinded for treatment allocation. Because of study characteristics, blinding of patients, informal caregivers and care professionals involved was not possible.
Integrated multidisciplinary geriatric rehabilitation programme
Organisation of the integrated programme
The integrated programme consisted of three care modules; 1) inpatient neurorehabilitation treatment; 2) home-based self-management training for patient and informal caregiver; and 3) stroke education for patient and informal caregiver. Table 1 presents both the integrated multidisciplinary geriatric programme and usual care.
The treatment progress was evaluated in monthly multidisciplinary team meetings for every individual patient. All communication and information by the care professionals about the patient and informal caregiver was conducted by using a shared electronic patient record, which was specifically developed for this study. To optimise care by facilitating faster discharge and to give support after discharge a stroke care coordinator was introduced in all participating rehabilitation teams. The total programme duration, including all three modules, varied between 2 to 6 months, depending on the care needs of the patient. All care professionals of the participating stroke teams were trained in conducting the programme according to protocol15.
The stroke care coordinator
When the patient was admitted to the geriatric rehabilitation unit, the stroke care coordinator was introduced. The stroke care coordinator facilitated the transition of nursing home rehabilitation care services to community care by supporting the collaboration between the multidisciplinary stroke team of the nursing home and the community health services, namely community nurses, paramedical professionals and the general practitioner. After discharge, the coordinator conducted home visits, supports the general practitioner by organising multidisciplinary stroke team meetings and guided the patient and informal care giver in learning to apply self-management principles.
At the start of geriatric rehabilitation, the coordinator had an introduction meeting with both the patient and informal caregiver. In this meeting, the coordinator provided general information about the rehabilitation programme. Furthermore, during the rehabilitation process the coordinator facilitated the transition of the patient from inpatient geriatric rehabilitation care to home-based care by supporting the collaboration between the multidisciplinary stroke team of the geriatric rehabilitation unit, community health services and general practitioner. After discharge, the coordinator conducted at least two home visits, organised multidisciplinary stroke team meetings in the community and supported the patient and informal caregiver in practicing self-management skills at home.
Module 1: inpatient neurorehabilitation treatment for patients
The first module focused on (re)learning the abilities needed for individual patients to function as independently as possible in their own home environment. At the start of this module, an individual treatment plan was made together with the patient including the development of rehabilitation goals facilitating the transition from in-patient to home-based rehabilitation care and to guide further rehabilitation at the patient’s home.
To make rehabilitation goals more measurable during inpatient rehabilitation, the principles of the Goal Attainment Scaling (GAS) method were used. GAS is a methodology, which is shown to be appropriate for developing rehabilitation goals among older persons16. To facilitate transition to the home environment, during the stay at the geriatric rehabilitation unit, an occupational or physical therapist, depending on the rehabilitation goals, trained with the patients at least twice in their own home environment. These training sessions were done to optimise recovery, to train specific functional skills at home to increase independence, and to check if any home adjustments were needed before discharge. The training programme within this module was conducted by a multidisciplinary stroke team consisting of professionals working at the geriatric rehabilitation unit of the nursing home. The stroke rehabilitation team included an elderly care physician, a physical therapist, an occupational therapist, a speech therapist, a (neuro)psychologist and a stroke coordinator.
Module 2: home-based self-management training for patient and informal caregiver
The second module started directly after discharge to the home environment. Treatment focused on learning to cope with residual cognitive and functional impairments as a result of stroke. The stroke care coordinator trained patients and caregivers to improve their coping strategies and empowerment techniques. This training which included formulating rehabilitation goals for the patients and making action plans, were based on the basic principles of self-management and aimed to increase problem-solving skills and participation13,17. If necessary, patients could still receive ambulatory follow-up rehabilitation treatment by a physical or occupational therapist, with the intention that at least half of the treatment sessions should take place in the patient’s home. If home treatment was not possible, the patient could receive this treatment in a day care facility or private therapy practice. The training in this module was also provided by the professionals of the regional multidisciplinary team consisting of professionals of the geriatric rehabilitation unit and community health care.
Module 3: stroke education for patient and informal caregiver
The third module was a short stroke education course for patients and their involved informal caregivers. The course consisted of four education sessions of two hours each with the focus on respectively the psychological and emotional consequences of stroke, perceived problems during independent living and participation in societal activities, and on the role of the informal caregiver. The course was provided by a (neuro)psychologist, two volunteers of the Dutch Stroke Patient Association and Informal Caregivers Association, and a social worker. The stroke coordinator invited the patients and informal caregivers to participate in the course. In two of the four meetings patients and informal caregivers were divided in two separate groups, to provide them the opportunity to express their problems and concerns more freely and share experiences with other patients/caregivers.
Usual care
In the Netherlands, usual care for older people with a stroke that need inpatient-rehabilitation consists of multidisciplinary neurorehabilitation on a geriatric rehabilitation unit. After discharge, there is in general no coordinated multidisciplinary aftercare for patient and informal caregiver. Most care programs vary in content and are in general more focused on the recovery of the patient and limited on the needs of the informal caregiver. After discharge, the follow-up care is usually provided by monodisciplinary community services, with no multidisciplinary approach. In general, there is no additional involvement anymore of the stroke rehabilitation team of the