Gothenburg very early supported discharge study (GOTVED) NCT01622205: a block randomized trial with superiority design of very early supported discharge for patients with stroke

Abstract

BackgroundStroke is the disease with the highest costs for hospital care and also after discharge. Early supported discharge (ESD) has shown to be efficient and safe and the best results with well-organised discharge teams and patients with less severe strokes.The aim is to investigate if very early supported discharge (VESD) for stroke patients in need for on-going individualised rehabilitation at home is useful for the patient and cost effective.Methods/designA randomized controlled trial comparing VESD with ordinary discharge. Inclusion criteria: confirmed stroke, >18 years of age, living within 30 min from the stroke unit, on day 2 0–16 points on the National institute of health stroke scale (NIHSS) and 50–100 points on the Barthel Index (BI), with BI 100 then the patient can be included if the Montreal Cognitive Assessment is < 26. Exclusion criteria are: NIHSS >16, BI < 50, life expectancy < 1 year, inability to speak or to communicate in Swedish. The inclusion occurs on day 4 and in block randomization of 20 and with blinded assessor.Primary outcome: levels of anxiety and depression. Secondary outcomes: independence, security, level of function, quality of health, needs of support in activities of daily living and caregiver burden.Power calculation is based on the level of anxiety and with a power of 80%, p-value 0.05 (2 sided test) 44 persons per group are needed. Data is gathered on co-morbidity, re-entry to hospital, mortality and a health economic analysis. Interviews will be accomplished with a strategic sample of 15 patients in the intervention group before discharge, within two weeks after homecoming and 3 months later. Interviews are also planned with 15 relatives in the intervention group 3 months after discharge.DiscussionThe ESD studies in the Cochrane review present hospital stays of a length that no longer exist in Sweden. There is not yet, to our knowledge, any study of early supported discharge with present length of hospital stay. Thus it is not clear if home rehabilitation nowadays without risks, is cost effective, or with the same patient usefulness as earlier studies.Trial registrationClinicalTrials.gov NCT01622205

Stroke Unit at Home: A Prospective Observational Implementation Study for Early Supported Discharge from the Hospital

“…In our study, there was no end date for the ESD intervention. It is interesting that the number of visits is in our study is consistent with the preliminary results from the on-going GOTVED RCT [24] that test ESD in the setting with short in-hospital stay and up-to-date acute interventions.…”

“…With this routine, the stroke patients were discharged from the hospital much earlier (mean 8.6 days) than has previously reported (mean 31 days, range 10 to 42 days) [4]. This very early supported discharge needs to be further studiedin RCT [24].…”

“…Therefore it is considered important to adapt activities based on local conditions [8]. In addition, criticism has been raised that most of the randomized controlled trials on ESD services were published more than 10 years ago and that the efficacy and safety of ESD has not been tested in the today's stroke care with shorter hospital stay and access to hyper-acute therapies [4,24]. Our study demonstrates that it is possible to develop and implement an ESD service based on evidence-based principles, national stroke guidelines [25] and local conditions in a setting with a mean of 8,6 days, i.e., a short hospital stay at the in-hosiptal stroke unit and also with use of hyper-acute and acute interventions such as intravenous thrombolysis, mechanical thrombectomy and carotid end arterectomy within the first week in case of symptomatic carotid stenosis.…”

Experiential Virtual Scenarios With Real-Time Monitoring (Interreality) for the Management of Psychological Stress: A Block Randomized Controlled Trial

“…Compared to a completely randomized design, this design reduces variability within treatment conditions and potential confounding (the variability within blocks is less than the variability between blocks), producing a better estimate of treatment effects [44]. …”

Stroke Rehabilitation at Home

“…When linked to cost, the home-care group was more advantageous, ≈£30 950 per quality-adjusted life years gained not surprising as a large proportion of stroke unit and team care is for hospital resources. A new generation of ESD trials are being designed in the context of early discharge 19,20 with the inclusion of a utility measure 19 to permit this type of cost-effectiveness analysis.…”