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.
DOCUMENT
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.
DOCUMENT
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.
LINK
