BackgroundFluid therapy is a common intervention in critically ill patients. It is increasingly recognised that deresuscitation is an essential part of fluid therapy and delayed deresuscitation is associated with longer invasive ventilation and length of intensive care unit (ICU) stay. However, optimal timing and rate of deresuscitation remain unclear. Lung ultrasound (LUS) may be used to identify fluid overload. We hypothesise that daily LUS-guided deresuscitation is superior to deresuscitation without LUS in critically ill patients expected to undergo invasive ventilation for more than 24 h in terms of ventilator free-days and being alive at day 28.MethodsThe “effect of lung ultrasound-guided fluid deresuscitation on duration of ventilation in intensive care unit patients” (CONFIDENCE) is a national, multicentre, open-label, randomised controlled trial (RCT) in adult critically ill patients that are expected to be invasively ventilated for at least 24 h. Patients with conditions that preclude a negative fluid balance or LUS examination are excluded. CONFIDENCE will operate in 10 ICUs in the Netherlands and enrol 1000 patients. After hemodynamic stabilisation, patients assigned to the intervention will receive daily LUS with fluid balance recommendations. Subjects in the control arm are deresuscitated at the physician’s discretion without the use of LUS. The primary endpoint is the number of ventilator-free days and being alive at day 28. Secondary endpoints include the duration of invasive ventilation; 28-day mortality; 90-day mortality; ICU, in hospital and total length of stay; cumulative fluid balance on days 1–7 after randomisation and on days 1–7 after start of LUS examination; mean serum lactate on days 1–7; the incidence of reintubations, chest drain placement, atrial fibrillation, kidney injury (KDIGO stadium ≥ 2) and hypernatremia; the use of invasive hemodynamic monitoring, and chest-X-ray; and quality of life at day 28.DiscussionThe CONFIDENCE trial is the first RCT comparing the effect of LUS-guided deresuscitation to routine care in invasively ventilated ICU patients. If proven effective, LUS-guided deresuscitation could improve outcomes in some of the most vulnerable and resource-intensive patients in a manner that is non-invasive, easy to perform, and well-implementable.Trial registrationClinicalTrials.gov NCT05188092. Registered since January 12, 2022
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BACKGROUND: The performance of activities of daily living (ADL) at home is important for the recovery of older individuals after hip fracture. However, 20-90% of these individuals lose ADL function and never fully recover. It is currently unknown to what extent occupational therapy (OT) with coaching based on cognitive behavioral treatment (CBT) improves recovery. The same holds for sensor monitoring-based coaching in addition to OT. Here, we describe the design of a study investigating the effect of sensor monitoring embedded in an OT rehabilitation program on the recovery of ADL among older individuals after hip fracture.METHODS/ DESIGN: Six nursing homes will be randomized in a three-arm stepped wedge cluster randomized trial. All nursing homes will initially provide standard care. At designated time points, nursing homes, successively and in random order, will cross over to the provision of OT and at the next time point, to sensor monitoring-enhanced OT. A total of 288 older individuals, previously living alone in the community, who after a hip fracture were admitted to a geriatric rehabilitation ward for a short-term rehabilitation, will be enrolled. Individuals in the first intervention group (OTc) will participate in an OT rehabilitation program with coaching based on cognitive behavioral therapy (CBT) principles. In the sensor monitoring group, sensor monitoring is added to the OT intervention (OTcsm). Participants will receive a sensor monitoring system consisting of (i) an activity monitor during nursing home stay, (ii) a sensor monitoring system at home and a (iii) a web-based feedback application. These components will be embedded in the OT. The OT consists of a weekly session with an occupational therapist during the nursing home stay followed by four home visits and four telephone consultations. The primary outcome is patient-perceived daily functioning at 6 months, assessed using the Canadian Occupational Performance Measure (COPM).DISCUSSION: As far as we know, this study is the first large-scale stepped wedge trial, studying the effect of sensor monitoring embedded in an OT coaching program. The study will provide new knowledge on the combined intervention of sensor monitoring and coaching in OT as a part of a rehabilitation program to enable older individuals to perform everyday activities and to remain living independently after hip fracture.TRIAL REGISTRATION NUMBER: Netherlands National Trial Register, NTR 5716 Date registered: April 1 2016.
Backgroundafter hospitalisation for cardiac disease, older patients are at high risk of readmission and death.Objectivethe cardiac care bridge (CCB) transitional care programme evaluated the impact of combining case management, disease management and home-based cardiac rehabilitation (CR) on hospital readmission and mortality.Designsingle-blind, randomised clinical trial.Settingthe trial was conducted in six hospitals in the Netherlands between June 2017 and March 2020. Community-based nurses and physical therapists continued care post-discharge.Subjectscardiac patients ≥ 70 years were eligible if they were at high risk of functional loss or if they had had an unplanned hospital admission in the previous 6 months.Methodsthe intervention group received a comprehensive geriatric assessment-based integrated care plan, a face-to-face handover with the community nurse before discharge and follow-up home visits. The community nurse collaborated with a pharmacist and participants received home-based CR from a physical therapist. The primary composite outcome was first all-cause unplanned readmission or mortality at 6 months.Resultsin total, 306 participants were included. Mean age was 82.4 (standard deviation 6.3), 58% had heart failure and 92% were acutely hospitalised. 67% of the intervention key-elements were delivered. The composite outcome incidence was 54.2% (83/153) in the intervention group and 47.7% (73/153) in the control group (risk differences 6.5% [95% confidence intervals, CI −4.7 to 18%], risk ratios 1.14 [95% CI 0.91–1.42], P = 0.253). The study was discontinued prematurely due to implementation activities in usual care.Conclusionin high-risk older cardiac patients, the CCB programme did not reduce hospital readmission or mortality within 6 months.Trial registrationNetherlands Trial Register 6,316, https://www.trialregister.nl/trial/6169
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De mondgezondheid van te veel jonge kinderen in Nederland is slecht: tandbederf (cariës) komt vaak voor. Een deel van de kinderen bezoekt de mondzorgprofessional te laat. Om de mondgezondheid van deze kinderen te verbeteren is de interventie Gezonde Peutermonden ontwikkeld. Op consultatiebureaus zorgt een mondzorgcoach (mondzorgprofessional) voor coaching en begeleiding van ouders van jonge kinderen bij het aanleren van gezonde eet-/ en mondzorg gedrag. Het effect hiervan wordt momenteel in een 'clinical trial' getest. De tussentijdse resultaten zijn veelbelovend en de interventie heeft enthousiaste reacties opgeleverd. Terwijl een definitieve trialuitkomst op zich laat wachten, nemen mondzorgpraktijken het initiatief tot samenwerking met Jeugdgezondheidszorg. In de regio Heerlen en Tilburg is vanwege een hoog percentage van kinderen met tandbederf, grote belangstelling en bereidheid van mondzorgprofessionals, gemeente, GGD en zorgverzekeraar om het initiatief te nemen. Zij vragen ons om hulp en ondersteuning bij interventie implementatie in hun regio. Naar aanleiding hiervan willen wij in samenwerking met deze partijen in beide regio’s de implementatie van Gezonde Peutermonden onderzoeken. Het doel daarbij is het krijgen van inzicht in de belemmerende en bevorderende factoren bij de implementatie van Gezonde Peutermonden. Zodoende wordt beoogd de ‘beste’ implementatiestrategieën te kunnen achterhalen. Door het verzamelen van kwantitatieve en kwalitatieve gegevens middels ‘mixed methods’ wordt de context in kaart gebracht, gericht op factoren binnen en buiten de organisatie, kenmerken van de doelgroep en de zorgverleners. Scholing, een ‘toolkit’ en voorlichtingsmateriaal worden ontwikkeld en beschikbaar gesteld aan mondzorgprofessionals. Proces-en effectuitkomsten worden gemeten, waartoe gegevens worden verzameld voor, tijdens en na de implementatie van de interventie. Deze aanvraag beschrijft de extra inspanning om de interventie Gezonde Peutermonden om te zetten naar een blended vorm, combinatie van fysieke en video/telefonische consulten, en de ontwikkeling van een protocol voor de gecombineerde consulten voor kinderen tussen 0-4 jaar ten gevolge van de Covid-19 maatregelen.
