Gothenburg Very Early Supported Discharge study (GOTVED): a randomised controlled trial investigating anxiety and overall disability in the first year after stroke
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Background and purpose
Early supported discharge (ESD) has been shown to be efficient and safe as part of the stroke care pathway. The best results have been seen with a multidisciplinary team and after mild to moderate stroke. However, how very early supported discharge (VESD) works has not been studied.
The aim of this study was to investigate whether VESD for stroke patients in need of ongoing individualized rehabilitation affects the level of anxiety and overall disability for the patient compared with ordinary discharge routine.
A randomized controlled trial was performed with intention to treat analyses comparing VESD and ordinary discharge from hospital. All patients admitted at the stroke care unit at Sahlgrenska University Hospital of Gothenburg between August 2011 and April 2016 were screened. Inclusion occurred on day 4 using a block randomization of 20 and with a blinded assessor. Assessments were made 5 days post-stroke and 3 and 12 months post-stroke. Patients in the VESD group underwent continued rehabilitation in their homes with a multidisciplinary team from the stroke care unit for a maximum of 1 month. The patients in the control group had support as usual after discharge when needed such as home care service and outpatient rehabilitation.
The primary outcome was anxiety as assessed by the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A). The secondary outcome was the patients’ degree of overall disability, measured by the modified Rankin Scale (mRS).
No significant differences were found between the groups regarding anxiety at three or 12 months post-stroke (p = 0.811). The overall disability was significantly lower in the VESD group 3 months post-stroke (p = 0.004), compared to the control group. However, there was no significant difference between the groups 1 year post-stroke.
The VESD does not affects the level of anxiety compared to ordinary rehabilitation. The VESD leads to a faster improvement of overall disability compared to ordinary rehabilitation. We suggest considering coordinated VESD for patients with mild to moderate stroke in addition to ordinary rehabilitation as part of the service from a stroke unit.
Clinical Trials.gov: NCT01622205. Registered 19 June 2012 (retrospectively registered).
KeywordsStroke Very early supported discharge Anxiety Rehabilitation
Activity of Daily Life
Early Supported Discharge
Gothenburg Very Early Supported Discharge
Hospital Anxiety and Depression Scale
Montreal Cognetive Assessment
modified Ranking Scale
National Institute of Health Stroke Scale
Very Early Supported Discharge
Physical impairments are often present after a stroke, as are a variety of psychological consequences, for instance mood disorders, which can compromise the rehabilitation process and influence long-term recovery . Globally the most common mental health problems post-stroke are anxiety disorders , generally reported by 3.8–25% of patients post-stroke . Anxiety disorders refer to a group of mental disorders characterized by feelings of anxiety and fear including generalised anxiety disorder, panic disorder, phobias and social anxiety disorder . As with depression, symptoms can range from mild to severe. Anxiety is a common symptom after stroke onset, both in the acute phase and in the chronic phase [5, 6, 7]. Approximately 29% suffer from anxiety during the first year after stroke . A review from 2012 concluded that anxiety after stroke receives significantly less attention compared to other psychological problems after stroke .
Early supported discharge (ESD) with continued rehabilitation in the home from a multidisciplinary stroke team has been shown to be beneficial . This form of rehabilitation can accelerate the discharge from the hospital [11, 12]. The activity in daily life (ADL) ability was found to be the same after this form of rehabilitation as after inpatient rehabilitation [13, 14]. This type of care can reduce activity impairment and increase independent living and patient satisfaction compared to conventional care . A permanent team including a nurse, a physiotherapist and an occupational therapist is necessary for efficacy . At the time of this study ESD was not implemented in Sweden as a standard rehabilitation option. Despite the fact that today ESD is recommended in national stroke guidelines, it is still not fully implemented and it is unclear how many hospitals in Sweden today offer this form of rehabilitation.
Today, many patients in Sweden are being discharged home very early after stroke. According to the Swedish stroke quality register, the average hospital stay in Sweden after acute stroke is 13 days (median 7 days) . This is much shorter than in the referred studies investigating ESD [10, 18]. We are using the term very early supported discharge (VESD) in the current study due to the shortened hospital stay in Sweden the last years.
There are no apparent differences seen in mood scores such as anxiety between ESD groups and groups receiving ordinary rehabilitation , but it is unknown whether VESD influences the level of anxiety during the first year after stroke. The assumption is that some anxiety is normal when being discharged very early after stroke [5, 6, 7], but with the supported discharge intervention, one can perhaps reduce the risk of anxiety during the first year after stroke.
The primary aim of the present study was to investigate whether VESD with continued rehabilitation from a multi-professional stroke team from the stroke unit affects the level of anxiety compared to ordinary discharge routine. A secondary aim was to evaluate whether VESD is useful regarding overall disability for stroke patients in need of ongoing individualised rehabilitation at home due to motor and/or cognitive impairment.
The Gothenburg Very Early Supported Discharge study (GOTVED) is a randomised controlled trial with blinded assessors. This trial is registered on clinicaltrials.gov (identifier: NCT01622205). Participants were enrolled in the trial from September 2011 to April 2016.
Inclusion criteria were confirmed stroke according to World Health Organization criteria [19, 20], age > 18 years, residence within 30 min by car of the stroke unit, a National Institute of Health Stroke Scale (NIHSS)  score of 0–16 points, which corresponds to mild to moderate stroke , a Barthel Index (BI)  score of > 50 points on day two , and a Montreal Cognitive Assessment (MoCA)  index of < 26 if BI = 100. Thus, exclusion criteria were a NIHSS score of > 16 and a BI score < 50. Patients with a life expectancy of < 1 year (e.g. with severe malignancy) or who were unable to speak or communicate in Swedish prior to stroke were also excluded.
Intervention in the very early supported discharge group
Prior to discharge of the patients in the VESD group, as a part of the person-centred intervention, a goal-setting meeting was held at which the patient was asked to formulate his or her goals based on the Canadian Occupational Performance Measure . These goals guided the focus of the rehabilitation. Examples of goals were to be able to go to the local store to buy milk, to be able to hang the laundry, or to be able to travel on the tram to a daughter, or to manage the bills. The intervention had a person-centred approach based on the person, her or his context, history, next of kin, individual strengths and weaknesses and expressed personal goals .
A rehabilitation team made up of physiotherapists, occupational therapists, and a stroke nurse from the stroke care unit continued the rehabilitation in the patient’s home. At discharge, the intervention group received an individual schedule for the first week of home rehabilitation. The intervention comprised 2–4 visits per week by the physiotherapist and/or occupational therapist and 1–2 visits by the stroke nurse. The intervention could include varied activities or methods to think about different ways of adapting in difficult situations. For some patients, the intervention was to try the intended activities with safe support so that they could feel secure in their performance. The patient and the VESD team together decided when the support from the team should end; the maximum length was 4 weeks after discharge. In connection with the discharge from the VESD, if necessary, the patients were referred to outpatient rehabilitation that would carry on the rehabilitation afterwards. Information and support to next of kin and the home care service on how to best support the patient to reach the decided goals was also of importance .
Patients in the control group were discharged according to the department’s usual routine. They had no goal-setting meeting and were not followed up by a multidisciplinary team from the stroke unit. However when needed, they were referred to continued rehabilitation or/and support (e.g. outpatient rehabilitation with a physiotherapist and/or an occupational therapist, home care service).
A power calculation was performed based on the level of anxiety (assessed with the HADS) . With a power of 80% and a p-value of 0.05 (2-sided test), a sample size of 44 patients per group were needed to detect a 4 point difference [34, 35]. As deaths may occur or consent be withdrawn, we aimed at 55 patients per group. During the inclusion process, more participants than expected dropped out. Therefore, after 2 years of screening, we decided to include a total of 140 patients. Intention to treat analyses were performed, and for missing observations, the “last value carried forward” was used meaning that everyone who started the study was included in the analysis, even though they did not complete the treatment. This meant that dropouts were also included in the analysis. The HADS outcome is presented both as a continuous variable and as a trichotomized. Shifts in the proportions of anxiety disorders were analysed for the intervention group and control group at admittance and after three and 12 months and reported using bar graphs. For this analysis the HADS-A scores at baseline and after three and 12 months were trichotomized according to the subscale scores proposed in the assessment tool: “no annoying anxiety” (0–7) = 1, “mild to moderate anxiety” [8, 9, 10]=2, and “occurrence of anxiety disorders” (> 10) = 3 . This was also performed with the mRS: 0 = no symptom at all, 1 = no significant disability despite symptoms, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability. For each outcome, the common odds ratio and 95% confidence intervals were reported for the shift in the direction of a better outcome in both groups. The chi-square test and Mann-Whitney U-test were used to test for group differences in descriptive data, and to evaluate whether there was any statistically significant difference in outcome between those who were included in the study and those who were not. Descriptive statistics are expressed in percentages, mean ± SD or median and interquartile range (IQR), as appropriate. The Wilcoxon signed rank test was used to assess the change in proportions between admittance, 3 months and 12 months after onset with the HADS-A and the mRS. The effect size was reported according to Cohen . A two-sided value of p ≤ 0.05 was considered statistically significant. Statistical analyses were performed using IBM SPSS statistics for Windows, version 24.0 (IBM Corp., Armonk, NY, USA).
Baseline demographics and clinical characteristics
(n = 140)
(n = 69)
(n = 71)
Length of hospital stay (days)
Stroke subtype, n (%)
Ischemic infarct/ Intracerebral haemorrhage
130 (92.8)/ 10 (7.1)
66 (95.6)/ 3 (4.3)
64 (90.1)/ 7 (9.9)
Treatment, n (%)
15 (10.7)/6 (4.3)
6 (8.7/4 (4.3))
9 (12.7)/3 (4.2)
NIHSSa, Median (IQR)
2 (0–4), n = 139
3 (1–5.25), n = 70
BIa, Median (IQR)
80 (65–90), n = 139
82.5 (65–90), n = 68
MoCAa, Median (IQR)
22 (19–26), n = 105
23 (20–26), n = 57
22 (18–25.7), n = 48
HADS-A Median (IQR)
4 (1–8), n = 134
4 (1–8), n = 63
HADS-D Median (IQR)
3 (1–7), n = 134
3 (1–6), n = 63
mRS Median (IQR)
2 (2–3), n = 134
2 (2–3), n = 63
The patients in the VESD group received a median of 11 (IQR 7–14) visits from the team over 4 weeks, and each visit lasted an average of about 1 h. The most common rehabilitation treatment in the VESD group was to improve ADL, in order to be able to manage daily activities in one’s home, to be able to walk in a more secure way indoors and outside and to be able to travel by public transportation. After discharge from the VESD team 58 % received continued rehabilitation during the first year after stroke onset. In average the intervention group received nine visits during the first 3 month after onset and six visits during the first year.
Seventy-six percent (54) of the patients in the control group were referred to some sort of continued rehabilitation after discharge from the stroke unit, such as a rehabilitation unit, primary care, or community care. Of those, six continued inpatient rehabilitation and stayed there for an average of 31 days (IQR 10–56). After discharge 50 patients in the control group received continued outpatient rehabilitation during the first year after stroke onset such as physiotherapy, occupational therapy and/or speech and language therapy. In average, they received seven visits per patient during the first 3 months after onset, and 13 visits during the first year post stroke.
Comparison of outcome variables across groups
All (n = 140)
VESD group (n = 69)
Control group (n = 71)
p m 12
BI, Median (IQR)
3 (0–7), n = 134
3 (0–7), n = 134
2 (0–6), n = 63
3 (0–7), n = 63
% ≥ 8 ⃰ ⃰
1 (1–1) n = 134
1 (1–1) n = 134
1 (1–1) n = 63
1 (1–1) n = 63
% ≥ 8
mRS, Median (IQR)
2 (1–2), n = 63
2 (1–3), n = 63
MoCA, Median (IQR)
24 (20–26), n = 66
24 (20–26), n = 66
24 (19–26), n = 63
24 (21–26), n = 64
Our aim was to assess the presence and severity of any anxiety in patients after stroke, depending on what sort of rehabilitation they received. We did not have the intention to diagnose anxiety. We could not show any difference in anxiety related to group allocation. The presence of anxiety in our study agreed well with earlier studies, in which approximately 24% of stroke patients were reported to experience anxiety of varying degrees between 3 and 12 months post-stroke [8, 37].
Another finding was that VESD can accelerate the recovery of mild to moderate stroke survivors, as measured by the degree of overall disability using the mRS. It may be possible to reduce disability, at least for a specific group of patients with stroke. These results are in line with previous results for early supported discharge . A possible explanation for this is the dosage. Not all (46%) in the control group received continued outpatient rehabilitation. The control group had an average of three visits compared with five visits in the VESD group during the first 3 months after stroke onset. This can have an impact on the mRS and this may be an explanation for the fact that the VESD group had a lower mRS value during the three-month follow-up.
For this study, we screened > 2700 patients to be able to include 140 patients in the study. This was due to having very low numbers that matched the inclusion criteria (5%) compared to previous reviews . This may be due to some of our inclusion criteria. One of the inclusion criteria was NIHSS ≤16 on day two, which corresponds to mild to moderate stroke . The participants had a median value of NIHSS = 2 on the second day, but at discharge from the hospital, the NIHSS score was often zero, indicating normal neurological function. The median BI value on day two in the VESD group was 82.5. Kay et al. concluded that BI ≤80 is the optimal cut-off for self-reported dependency . A score of 75–90 is reported as mild dependency and 50–74 as moderate dependency . We wanted to include patients with mild to moderate stroke, but we mainly captured those with mild stroke. With a somewhat higher NIHSS score and lower BI values as inclusion criteria, we perhaps would have captured not only patients with mild stroke but also more patients with moderate stroke, and the exclusion rate would have been lower.
Our intention was to give support and make it possible to discharge patients very early compared to early, as in other studies on ESD. Therefore, we made our inclusion decisions based on values from day two, whereas some of the previous studies made them based on values from day 4. Perhaps screening on day four instead of day two would have captured more patients with mild to moderate stroke. The problems with the inclusion criteria for ESD have also been noted in other studies . Further studies are needed to investigate both the optimal inclusion criteria and the best day for screening in order to be able to offer this form of rehabilitation to as many patients as possible who are post-stroke and in need of continued rehabilitation.
Our results show that, although the VESD group was discharged 2 days earlier than the control group, there was no significant difference between the groups regarding length of hospital stay. We had an average length of stay at the stroke unit of 12 days in the VESD group and 14 days in the control group. The finding that there was a difference of only 2 days, compared to earlier studies, could be explained by the overall reduction in the length of hospital stay of all stroke patients in the last few years, as shown in a Cochrane review from 2017 . Therefore, a reduction in the length of hospital stay at very early discharge is probably overly optimistic.
Strengths of the current study are that power was calculated before the start of the study, the randomization was concealed and the assessor was blinded. It is also a strength that the intervention was given by a multidisciplinary team coordinated from the stroke unit, as shown in previous research . Another strength is that the intervention did not aim to influence the procedures at the stroke unit, only to provide the possibility for early supported discharge. That the decision, however, was with physicians not involved in the study. It is also a strength that both groups were similar at baseline.
A limitation with this study is that the set level for NIHSS and BI scores could have an impact on enrolment and that the screening was performed mainly on weekdays. Although the stroke unit was aware of the intervention group receiving very early supported discharge, this did not seem to influence the discharge very much, which resulted in rather long hospital stays in the intervention group, as well. A third limitation was that the choice of inclusion window may have impacted the fact that we mainly captured patients with mild stroke due to our intention to capture patients with mild to moderate stroke. A limitation is that the study cannot distinguish pre-existing psychiatric symptoms from problems caused by the current cerebrovascular accident, as the premorbid emotional status is unknown.
Our study did not find any significant difference in anxiety after stroke depending on when and how the patient was discharged. Therefore, one should not be doubtful from a mood perspective in discharging patients with stroke very early. A previous study found that the change and disruption of life becomes more clear for the patient once at home . This method can make the patient more aware of and more motivated for rehabilitation. This may be one explanation for the significantly lower mRS score in the VESD group compared to the control group 3 months post-stroke. The impact of stroke severity on anxiety is unknown and could have impacted the results in this study.
Very early supported discharge after stroke does not affect the level of anxiety at any point compared to ordinary rehabilitation.
Very early supported discharge leads to a faster recovery of independence after discharge.
We suggest that coordinated very early supported discharge could be considered for patients with mild to moderate stroke, in addition to ordinary rehabilitation, as a part of the service from a stroke unit.
The authors wish to express gratitude to the following persons who were committed to carrying out the testing and inclusion during the project period: Tamar Abzhandadze, Birgitta Eriksson, Elin Barra Gustafsson, Ellen Hansson, Kerstin Kåmark, Lena Nilsson, Barbro Petersson, Ulla Sandberg, and Katarina Sjöberg (all occupational therapists and main testers of the BI and MoCA); Mare Teinlum Kruse (nurse in the VESD team); and Karin Fröjd (physician and head of the stroke unit at the start of the project), all working at the stroke unit at Sahlgrenska University Hospital of Gothenburg during the project. We also thank Cathrine Peterson for the help with the inclusion and Åsa Axelsson (part of the project group).
LR, KSS, and AD contributed to the study design and the concept, in analysis and interpretation of results. LR was responsible for the primary data analysis. LR, KSS, AD, AB, MEHL, ÅLN and ÅN contributed to the writing and review. All authors read and approved the final manuscript.
This study was funded in part by grants from the Swedish Science Council (VR2012–3523) and from the Health & Medical Care Committee of the Regional Executive Board of the Region Västra Götaland, King Gustaf V’s and Queen Victoria’s Freemasons´ Foundation, the Swedish National Stroke Association, the Local Research and Development Board for Gothenburg and Södra Bohuslän, Agneta Prytz-Folke’s Gösta Folke’s Foundation, the Wilhelm & Martina Lundgrens Foundation, Felix Neubergh’s Foundation, Hjalmar Svensson’s Research Foundation, Renée Enander’s Foundation, Rune and Ulla Amlöv’s Foundation and John and Berit Wennerström’s Foundation. Founding bodies did not play a role in the collection, analysis or interpretation of data. Funding bodies did not contribute to the writing of this manuscript.
Ethics approval and consent to participate
Ethical approval for the trial was granted by the Regional Ethical Review Board in Gothenburg (reference number: 042–11), and the Helsinki declaration was followed. The patients were informed by a research coordinator about the study and asked if they wanted to participate. Written informed consent was obtained from the participants or from their closest relative.
Consent for publication
The authors declare that they have no competing interests.
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