Background: A pragmatic, stepped wedge trial design can be an appealing design to evaluate complex interventions in real-life settings. However, there are certain pitfalls that need to be considered. This paper reports on the experiences and lessons learned from the conduct of a cluster randomized, stepped wedge trial evaluating the effect of the Hospital Elder Life Program (HELP) in a Dutch hospital setting to prevent older patients from developing delirium. Methods: We evaluated our trial which was conducted in eight departments in two hospitals in hospitalized patients aged 70 years or older who were at risk for delirium by reflecting on the assumptions that we had and on what we intended to accomplish when we started, as compared to what we actually realized in the different phases of our study. Lessons learned on the design, the timeline, the enrollment of eligible patients and the use of routinely collected data are provided accompanied by recommendations to address challenges. Results: The start of the trial was delayed which caused subsequent time schedule problems. The requirement for individual informed consent for a quality improvement project made the inclusion more prone to selection bias. Most units experienced major difficulties in including patients, leading to excluding two of the eight units from participation. This resulted in failing to include a similar number of patients in the control condition versus the intervention condition. Data on outcomes routinely collected in the electronic patient records were not accessible during the study, and appeared to be often missing during analyses. Conclusions: The stepped wedge, cluster randomized trial poses specific risks in the design and execution of research in real-life settings of which researchers should be aware to prevent negative consequences impacting the validity of their results. Valid conclusions on the effectiveness of the HELP in the Dutch hospital setting are hampered by the limited quantity and quality of routine clinical data in our pragmatic trial. Executing a stepped wedge design in a daily practice setting using routinely collected data requires specific attention to ethical review, flexibility, a spacious time schedule, the availability of substantial capacity in the research team and early checks on the data availability and quality.
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Severe mental illness (SMI) imposes a significant burden on individuals, resulting in long-lasting symptoms, lower social functioning and impaired physical health. Physical activity (PA) interventions can improve both mental and physical health and care workers can serve as healthy role models. Yet, individuals with SMI face barriers to PA participation. This study evaluated the effects of Muva, and assessed if mental health worker’s (MHW) characteristics were associated with clients’ change in social functioning. Muva, an intervention package primarily created to increase PA of people with SMI, places a special focus on MHWs as they might play a key role in overcoming barriers. Other PA barrier-decreasing elements of Muva were a serious game app, lifestyle education, and optimization of the medication regime. Method: This study is a pragmatic stepped wedge cluster controlled trial. Controls received care as usual. Mixedeffects linear regressions were performed to assess changes in the primary outcome social functioning, and secondary outcomes quality of life, psychiatric symptoms, PA, body mass index, waist circumference, and blood pressure. Results: 84 people with SMI were included in three intervention clusters, and 38 people with SMI in the control cluster. Compared to the control condition, there was significant clinical improvement of social functioning in interpersonal communication (p=<0.01) and independent competence (p=<0.01) in people receiving Muva. These outcomes were not associated with MHW’s characteristics. There were no changes in the other outcome measures. Conclusions: Muva improved social functioning in people with SMI compared to care as usual.
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OBJECTIVES: to test the effects of an intervention involving sensor monitoring-informed occupational therapy on top of a cognitive behavioural treatment (CBT)-based coaching therapy on daily functioning in older patients after hip fracture.DESIGN, SETTING AND PATIENTS: three-armed randomised stepped wedge trial in six skilled nursing facilities, with assessments at baseline (during admission) and after 1, 4 and 6 months (at home). Eligible participants were hip fracture patients ≥ 65 years old.INTERVENTIONS: patients received care as usual, CBT-based occupational therapy or CBT-based occupational therapy with sensor monitoring. Interventions comprised a weekly session during institutionalisation, followed by four home visits and four telephone consultations over three months.MAIN OUTCOMES AND MEASURES: the primary outcome was patient-reported daily functioning at 6 months, assessed with the Canadian Occupational Performance Measure.RESULTS: a total of 240 patients (mean[SD] age, 83.8[6.9] years were enrolled. At baseline, the mean Canadian Occupational Performance Measure scores (range 1-10) were 2.92 (SE 0.20) and 3.09 (SE 0.21) for the care as usual and CBT-based occupational therapy with sensor monitoring groups, respectively. At six months, these values were 6.42 (SE 0.47) and 7.59 (SE 0.50). The mean patient-reported daily functioning in the CBT-based occupational therapy with sensor monitoring group was larger than that in the care as usual group (difference 1.17 [95% CI (0.47-1.87) P = 0.001]. We found no significant differences in daily functioning between CBT-based occupational therapy and care as usual.CONCLUSIONS AND RELEVANCE: among older patients recovering from hip fracture, a rehabilitation programme of sensor monitoring-informed occupational therapy was more effective in improving patient-reported daily functioning at six months than to care as usual.TRIAL REGISTRATION: Dutch National Trial Register, NTR 5716.
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Background During acute hospital admission, patients often experience loss of functional status. A low level of physical activity is associated with higher levels of loss of functional status. Stimulating physical activity to maintain functional status is considered essential nursing care. Function Focused Care is a promising approach stimulating physical activity. In a previous study, Function Focused Care in Hospital was deemed feasible. Objective To determine the effectiveness of Function Focused Care in Hospital compared with usual care on the functional status of hospitalized stroke and geriatric patients. Design A multicenter stepped wedge cluster trial. Methods A neurological and a geriatric ward of an academic hospital and a general hospital in the Netherlands participated in this study; each was considered a cluster in the trial. The primary outcome was patients' functional status over time, measured with the Barthel Index and Elderly Mobility Scale. Secondary outcomes were the patients' length of stay, fear of falling, self-efficacy, motivation, resilience, and outcome expectations for functional and exercise activities. Data was collected at hospital admission (baseline), day of discharge, and three and six months after discharge via patient files and questionnaires and analyzed with generalized linear mixed models. Results In total, we included 892 patients, of which 427 received Function Focused Care in Hospital and 465 received usual care. Although we did not find significant differences in the Barthel Index and Elderly Mobility Scale at discharge or follow-up, we found a significant decrease in the mean length of stay (− 3.3 days, 95 % CI − 5.3 to − 1.1) in favor of the Function Focused Care in Hospital group. In addition, in the Function Focused Care in Hospital group, a larger proportion of patients were discharged to home compared to the control group (38.2 % vs. 29.0 %, p = 0.017), who were discharged more often to a care facility. Conclusion The length of hospital stay was substantially decreased, and discharge to home was more common in the group receiving Function Focused Care in Hospital with equal levels of independence in Activities of Daily Living and mobility in both groups upon discharge. Although significant differences in the Barthel Index and Elderly Mobility Scale were not found, we observed that neurological and geriatric patients were discharged significantly earlier compared to the control group.
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Abstract Background: People with severe mental illness (SMI) often suffer from long-lasting symptoms that negatively influence their social functioning, their ability to live a meaningful life, and participation in society. Interventions aimed at increasing physical activity can improve social functioning, but people with SMI experience multiple barriers to becoming physically active. Besides, the implementation of physical activity interventions in day-to-day practice is difficult. In this study, we aim to evaluate the effectiveness and implementation of a physical activity intervention to improve social functioning, mental and physical health. Methods: In this pragmatic stepped wedge cluster randomized controlled trial we aim to include 100 people with SMI and their mental health workers from a supported housing organization. The intervention focuses on increasing physical activity by implementing group sports activities, active guidance meetings, and a serious game to set physical activity goals. We aim to decrease barriers to physical activity through active involvement of the mental health workers, lifestyle courses, and a medication review. Participating locations will be divided into four clusters and randomization will decide the start of the intervention. The primary outcome is social functioning. Secondary outcomes are quality of life, symptom severity, physical activity, cardiometabolic risk factors, cardiorespiratory fitness, and movement disturbances with specific attention to postural adjustment and movement sequencing in gait. In addition, we will assess the implementation by conducting semi-structured interviews with location managers and mental health workers and analyze them by direct content analysis. Discussion: This trial is innovative since it aims to improve social functioning in people with SMI through a physical activity intervention which aims to lower barriers to becoming physically active in a real-life setting. The strength of this trial is that we will also evaluate the implementation of the intervention. Limitations of this study are the risk of poor implementation of the intervention, and bias due to the inclusion of a medication review in the intervention that might impact outcomes. Trial registration: This trial was registered prospectively in The Netherlands Trial Register (NTR) as NTR NL9163 on December 20, 2020. As the The Netherlands Trial Register is no longer available, the trial can now be found in the International Clinical Trial Registry Platform via: https:// trial search. who. int/ Trial2. aspx? Trial ID= NL9163.
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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.
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Abstract: Teledentistry offers possibilities for improving efficiency and quality of care and supporting cost-effective healthcare systems. This umbrella review aims to synthesize existing systematic reviews on teledentistry and provide a summary of evidence of its clinical- and cost-effectiveness. A comprehensive search strategy involving various teledentistry-related terms, across seven databases, was conducted. Articles published until 24 April 2023 were considered. Two researchers independently reviewed titles, abstracts and full-text articles. The quality of the included reviews was critically appraised with the AMSTAR-2 checklist. Out of 749 studies identified, 10 were included in this umbrella review. Two reviews focusing on oral-health outcomes revealed that, despite positive findings, there is not yet enough evidence for the long-term clinical effectiveness of teledentistry. Ten reviews reported on economic evaluations or costs, indicating that teledentistry is cost-saving. However, these conclusions were based on assumptions due to insufficient evidence on cost-effectiveness. The main limitation of our umbrella review was the critically low quality of the included reviews according to AMSTAR-2 criteria, with many of these reviews basing their conclusions on low-quality studies. This highlights the need for high-quality experimental studies (e.g., RCTs, factorial designs, stepped-wedge designs, SMARTs and MRTs) to assess teledentistry’s clinical- and cost-effectiveness.
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The Hospital Elder Life Program (HELP) has been shown to be highly efficient and (cost-)effective in reducing delirium incidence in the USA. HELP provides multicomponent protocols targeted at specific risk factors for delirium and introduces a different view on care organization, with trained volunteers playing a pivotal role. The primary aim of this study is the quantification of the (cost-)effectiveness of HELP in the Dutch health care system. The second aim is to investigate the experiences of patients, families, professionals and trained volunteers participating in HELP.
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Objective To evaluate the effectiveness of a comprehensive workers’ health surveillance (WHS) program on aspects of sustainable employability and cost-benefit. Methods A cluster randomized stepped wedge trial was performed in a Dutch meat processing company from february 2012 until march 2015. In total 305 workers participated in the trial. Outcomes were retrieved during a WHS program, by multiple questionnaires, and from company registries. Primary outcomes were sickness absence, work ability, and productivity. Secondary outcomes were health, vitality, and psychosocial workload. Data were analyzed with linear and logistic multilevel models. Cost-benefit analyses from the employer’s perspective were performed as well. Results Primary outcomes sickness absence (OR = 1.40), work ability (B = −0.63) and productivity (OR = 0.71) were better in the control condition. Secondary outcomes did not or minimally differ between conditions. Of the 12 secondary outcomes, the only outcome that scored better in the experimental condition was meaning of work (B = 0.18). Controlling for confounders did not or minimally change the results. However, our stepped wedge design did not enable adjustment for confounding in the last two periods of the trial. The WHS program resulted in higher costs for the employer on the short and middle term. Conclusions Primary outcomes did not improve after program implementation and secondary outcomes remained equal after implementation. The program was not cost-beneficial after 1–3 year follow-up. Main limitation that may have contributed to absence of positive effects may be program failure, because interventions were not deployed as intended.
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In het rapport ‘Artificiële Intelligentie en passende zorg’ van het Zorginstituut Nederland worden kansen en uitdagingen van AI binnen de zorg belicht. Artificiële Intelligentie (AI) biedt ook talrijke mogelijkheden voor de medisch specialistische revalidatiezorg (MSR). Aan de hand van dit rapport beschouwen we de kansen en uitdagingen van AI voor de MSR. Samenwerking binnen de revalidatiesector is daarbij essentieel om AI-toepassingen effectief en verantwoord te integreren in de revalidatiezorg.
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