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Effect of sensor monitoring in an occupational therapy rehabilitation program for older individuals after hip fracture: the SO-HIP trial A three-arm stepped wedge cluster randomized trial

De SO-HIP study: study protocol of a three arm stepped wedge cluster randomized trial

The effectiveness of Function Focused Care among patients acutely admitted to hospital

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.

Effectiveness of sensor monitoring in a rehabilitation programme for older patients after hip fracture

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.

Effectiveness of sensor monitoring in an occupational therapy rehabilitation program for older individuals after hip fracture, the SO-HIP trial

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.

HELP! Problems in executing a pragmatic, randomized, stepped wedge trial on the Hospital Elder Life Program to prevent delirium in older patients

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.