Smart continence care for people with profound intellectual and multiple disabilities:Protocol for a cluster randomized trial and trial-based economic evaluation

Background: People with profound intellectual and multiple disabilities (PIMD) cannot communicate the need to change their incontinence products. The smart continence care (SCC) product Abena Nova signals caregivers when change is needed. This provides the opportunity for more person-centered care, increased quality of life, and a decreased number of leakages. However, there is a need for evidence of the effectiveness and cost-effectiveness of such technology compared with regular continence care (RCC) for people with PIMD. Objective: This paper presents the research protocol for an effectiveness and cost-effectiveness study with people with PIMD living in long-term care facilities in the Netherlands. Methods: A cluster randomized trial will be conducted in 3 consecutive waves across 6 long-term care providers for people with disabilities and 160 participants with PIMD. Long-term care providers are randomized at a 1:1 ratio, resulting in an intervention group and a group continuing RCC. The intervention group will receive implementation guidance and use SCC for 3 months; the other group will continue their RCC as usual and then switch to SCC. This study consists of three components: effectiveness study, economic evaluation, and process evaluation. The primary outcome will be a change in the number of leakages. The secondary outcomes are quality of life, the difference in the number of changes, the work perception of caregivers, cost-effectiveness, and cost utility. Data collection will occur at T0 (baseline), T1 (6 weeks), T2 (12 weeks), and T3 (9-month follow-up) for the first 2 intervention groups. An intention-to-treat analysis will be performed. The economic evaluation will be conducted alongside the trial from the societal and long-term care provider perspectives. Qualitative data collection through interviews and field notes will complement these quantitative results and provide input for the process evaluation. Results: This research was funded in December 2019 by ZonMw, the Netherlands Organization for Health Research and Development. As of June 2022, we enrolled 118 of the 160 participants. The enrollment of participants will continue in the third and fourth quarters of 2022. Conclusions: This study will provide insights into the effectiveness and cost-effectiveness of SCC for people with PIMD, allowing long-term care providers to make informed decisions about implementing such a technology. This is the first time that such a large-scale study is being conducted for people with PIMD

The Mental Vitality @ Work study: design of a randomized controlled trial on the effect of a workers' health surveillance mental module for nurses and allied health professionals

Employees in health care service are at high risk for developing mental health complaints. The effects of mental health complaints on work can have serious consequences for the quality of care provided by these workers. To help health service workers remain healthy and productive, preventive actions are necessary. A Workers' Health Surveillance (WHS) mental module may be an effective strategy to monitor and promote good (mental) health and work performance. The objective of this paper is to describe the design of a three arm cluster randomized controlled trial on the effectiveness of a WHS mental module for nurses and allied health professionals. Two strategies for this WHS mental module will be compared along with data from a control group. Additionally, the cost effectiveness of the approaches will be evaluated from a societal perspective. The study is designed as a cluster randomized controlled trial consisting of three arms (two intervention groups, 1 control group) with randomization at ward level. The study population consists of 86 departments in one Dutch academic medical center with a total of 1731 nurses and allied health professionals. At baseline, after three months and after six months of follow-up, outcomes will be assessed by online questionnaires. In both intervention arms, participants will complete a screening to detect problems in mental health and work functioning and receive feedback on their screening results. In cases of impairments in mental health or work functioning in the first intervention arm, a consultation with an occupational physician will be offered. The second intervention arm offers a choice of self-help e-mental health interventions, which will be tailored based on each individual's mental health state and work functioning. The primary outcomes will be help-seeking behavior and work functioning. Secondary outcomes will be mental health and wellbeing. Furthermore, cost-effectiveness in both intervention arms will be assessed, and a process evaluation will be performed. When it is proven effective compared to a control group, a WHS mental module for nurses and allied health professionals could be implemented and used on a regular basis by occupational health services in hospitals to improve employees' mental health and work functioning. NTR278

Improving Work Functioning and Mental Health of Health Care Employees Using an E-Mental Health Approach to Workers' Health Surveillance: Pretest–Posttest Study

Background: Mental health complaints are quite common in health care employees and can have adverse effects on work functioning. The aim of this study was to evaluate an e-mental health (EMH) approach to workers' health surveillance (WHS) for nurses and allied health professionals. Using the waiting-list group of a previous randomized controlled trial with high dropout and low compliance to the intervention, we studied the pre- and posteffects of the EMH approach in a larger group of participants. Methods: We applied a pretest–posttest study design. The WHS consisted of online screening on impaired work functioning and mental health followed by online automatically generated personalized feedback, online tailored advice, and access to self-help EMH interventions. The effects on work functioning, stress, and work-related fatigue after 3 months were analyzed using paired t tests and effect sizes. Results: One hundred and twenty-eight nurses and allied health professionals participated at pretest as well as posttest. Significant improvements were found on work functioning (p = 0.01) and work-related fatigue (p < 0.01). Work functioning had relevantly improved in 30% of participants. A small meaningful effect on stress was found (Cohen d = .23) in the participants who had logged onto an EMH intervention (20%, n = 26). Conclusion: The EMH approach to WHS improves the work functioning and mental health of nurses and allied health professionals. However, because we found small effects and participation in the offered EMH interventions was low, there is ample room for improvement

Mental Vitality @ Work: The effectiveness of a mental module for workers' health surveillance for nurses and allied health professionals, comparing two approaches in a cluster-randomised controlled trial

The aim of this study was to compare two approaches for a worker's health surveillance (WHS) mental module on work functioning and work-related mental health. Nurses and allied health professionals from one organisation were cluster-randomised at ward level to e-mental health care (EMH) (N = 579) or occupational physician care (OP) (N = 591). Both groups received screening and personalised feedback on impaired work functioning and mental health. Positively screened participants received an invitation to follow a self-help EMH intervention, or for a consultation with an OP. The primary outcome was impaired work functioning. Follow-up was performed after 3 and 6 months. Linear mixed models were applied to determine differences. Non-inferiority of the EMH-care approach was demonstrated if the mean absolute improvement on work functioning in the OP-care group was ≤10 points higher than the EMH-care group. Analyses were performed on the positively screened participants (almost 80 %) (EMH N = 75; OP N = 108) and all participants (EMH N = 98; OP N = 142). Both groups improved over time regarding impaired work functioning. A considerable percentage of participants had improved relevantly at follow-up regarding work functioning (3 months: EMH 30 %, OP 46 %; 6 months: EMH 36 %, OP 41 %) compared to baseline. No statistically significant differences were found between the groups, and the difference did not exceed the pre-defined criterion for non-inferiority. The OP-care approach for a WHS mental module trended towards better performance in targeting work functioning, but our findings indicate that the EMH-care approach was non-inferior. However, the high dropout rate and low compliance to EMH interventions should be taken into accoun

Mental Vitality @ Work--a workers' health surveillance mental module for nurses and allied health care professionals: process evaluation of a randomized controlled trial

To evaluate the process of workers' health surveillance (WHS) targeting work functioning and mental health of health care professionals, alongside a randomized controlled trial comparing two strategies. Nurses and allied health care professionals working in one hospital were invited. Process indicators were assessed using methods such as questionnaires and track-and-trace data. All participants (32%; N = 369) received screening and personalized feedback. In group 1, 41% went to a preventive consultation with their occupational physician. Protocol adherence of participating occupational physicians (n = 5) was high. They regarded the WHS mental module to be meaningful. In group 2, 16% logged into an e-mental health intervention. Most participants would appreciate a future offer of the WHS. The WHS mental module was well received and fitted in the occupational health service activities. Nevertheless, response and compliance should be improve

Workplace mental health promotion online to enhance well-being of nurses and allied health professionals: A cluster-randomized controlled trial

Objective Well-being is an important prerequisite for the mental health and work functioning of nurses and allied health professionals. The objective of this study was to examine the effectiveness of a workers' health surveillance (WHS) module that offers screening, tailored feedback and online interventions targeting positive mental health and mental health complaints. WHS is a strategy at the workplace to implement preventive action by identifying and treating health complaints. Methods All wards of one hospital were randomized, and all nurses and allied health professionals working in these wards (N = 1140) were invited to participate in either the Online Intervention group (OI) or the Waitlisted control group (WL). Primary outcome was positive mental health (Mental Health Continuum — Short Form, MHC-SF); secondary outcomes were work engagement (Utrecht Work Engagement Scale, UWES), a specific well-being measure (WHO-5 Well-being Index) and mental health symptoms (Brief Symptom Inventory, BSI). Online self-report measurements were conducted at baseline, and after three and six months. Results Participation rate for the intervention at baseline was 32% (NOI = 178; NWL = 188). The intervention significantly enhanced positive mental health, in comparison to the control group (F = 3.46, p = 0.03). Cohen's d was 0.37 at post-test and 0.28 at follow-up, which can be considered as a moderate effect and a small effect respectively. In particular, psychological well-being (a subscale on the MHC-SF) was enhanced (Cohen's d 0.43 at post-test and 0.50 at follow-up). No significant or relevant differences between groups on secondary outcomes were found. The uptake and compliance of the online interventions was very low (28/178, 16% logged in; 9/178, 5% started with one or more modules within an intervention). Conclusion We can conclude that the intervention was capable of enhancing positive mental health. However, due to a high attrition rate, especially in the intervention group, this result should be considered with caution. Improvement of the screening instrument, more use of persuasive technology within the interventions and individual guidance to support engagement and compliance may be recommende

Effect of an E-mental health approach to workers' health surveillance versus control group on work functioning of hospital employees: a cluster-RCT.

To evaluate an e-mental health (EMH) approach to workers' health surveillance (WHS) targeting work functioning (WF) and mental health (MH) of healthcare professionals in a randomised controlled trial.Nurses and allied health professionals (N = 1140) were cluster-randomised at ward level to the intervention (IG) or control group (CG). The intervention consisted of two parts: (a) online screening and personalised feedback on impaired WF and MH, followed by (b) a tailored offer of self-help EMH interventions. CG received none of these parts. Primary outcome was impaired WF (Nurses Work Functioning Questionnaire), assessed at baseline and after three and six months. Analyses were performed in the positively screened subgroup (i) and in all participants (ii).Participation rate at baseline was 32% (NIG = 178; NCG = 188). Eighty-two percent screened positive for at least mild impairments in WF and/or MH (NIG = 139; NCG = 161). All IG-participants (N = 178) received part (a) of the intervention, nine participants (all positively screened, 6%) followed an EMH intervention to at least some extent. Regarding the subgroup of positively screened participants (i), both IG and CG improved over time regarding WF (non-significant between-group difference). After six months, 36% of positively screened IG-participants (18/50) had a relevant WF improvement compared to baseline, versus 28% (32/115) of positively screened CG-participants (non-significant difference). In the complete sample (ii), IG and CG improved over time but IG further improved between three and six months while CG did not (significant interaction effect).In our study with a full compliance rate of 6% and substantial drop-out leading to a small and underpowered sample, we could not demonstrate that an EMH-approach to WHS is more effective to improve WF and MH than a control group. The effect found in the complete sample of participants is not easily interpreted. Reported results may be useful for future meta-analytic work.Dutch Trial Register NTR2786

Implementing complaint-directed mini-interventions for depressive complaints in primary care to increase participation among patients with a lower socioeconomic status: Design of a cluster randomised controlled trial

Background Depression is a major public health concern. E-health interventions for preventing and reducing depressive complaints have proven to be effective, and have the potential to make (mental) health care more accessible and efficient. However, the reach of these interventions needs to be improved, especially among people with a lower socioeconomic status (SES). Stimulating and supporting implementation of e-health in primary care, and offering guidance from general practice nurses (GP nurses) may be important strategies to achieve this. Methods/design The online ‘Complaint Directed Mini-Interventions’ (CDMIs) for stress, sleep and worry complaints, which were found to be (cost-)effective in a self-guided format, will be implemented in the primary care setting using a blended care format (i.e. combining e-health with face-to-face sessions) with minimal guidance provided by the GP nurse. The main aim is to evaluate whether a SES-sensitive implementation strategy improves the participation rate (i.e. reach) of lower-SES patients in the blended online CDMIs as compared to a regular implementation strategy in a cluster randomised controlled trial. Randomisation will occur at the level of the GP nurse, and 228 patients will be included in the study. The primary outcome is the participation rate (completing at least one face-to-face session and two online exercises) of the lower-SES target group. It is hypothesised that this percentage will be higher in the SES-sensitive group as compared to the regular group. Secondary objectives are to evaluate the implementation process, to monitor and evaluate psychological complaints (depression, sleep, stress, worry and anxiety) and well-being over time. Patient assessments will take place at baseline, 3 and 12 months post baseline. Discussion This study should contribute to our knowledge of reaching the lower-SES groups with a brief and complaint-specific blended approach for depressive complaints in primary care. It should also further our knowledge on successful strategies to implement depression prevention in primary care. Trial registration Netherlands Trial Register, ID: NL6595. Registered on 12 November 2017

Comparing a ses-sensitive and an all-ses implementation strategy to improve participation rates of patients with a lower socioeconomic background in a web-based intervention for depressive complaints: a cluster randomised trial in primary care

Background: Depression is a major public health concern, which is most pronounced in population segments with a lower social-economic status (SES). E-health interventions for depressive complaints are proven to be effective, but their reach needs to be improved, especially among people with a lower socioeconomic status (SES). Implementing e-health interventions in the primary care setting with SES-sensitive guidance from General Practice nurses (GP nurses) may be a useful strategy to increase the reach of e-health in lower SES groups. We implemented an evidence-based online intervention that targets depressive complaints in primary care. Methods: A pragmatic cluster-randomised trial was conducted in two parallel groups where a SES sensitive (SES-sens) implementation strategy with additional face-to-face guidance by GP nurses was compared to an all-SES implementation strategy. The primary outcome was the percentage of lower SES participants in either condition. Participation was defined as completing at least 1 face-to-face session and 2 online exercises. Participation rates were evaluated using logistic mixed modelling. Results: In both conditions, the participation rates of lower SES participants were quite high, but were notably lower in the SES-sens implementation condition (44%) than in the all-SES implementation condition (58%). This unexpected outcome remained statistically significant even after adjusting for potential confounders between the conditions (Odds Ratio 0.43, 95%-CI 0.22 to 0.81). Less guidance was provided by the GP nurses in the SES-sens group, contrary to the implementation instructions. Conclusions: From a public health point of view, it is good news that a substantial number of primary care patients with a lower SES level used the implemented e-health intervention. It is also positive that an all-SES implementation strategy performed well, and even outperformed a SES-sensitive strategy. However, this was an unexpected finding, warranting further research into tailoring implementation strategies of e-health interventions towards specific target groups in the primary care setting. Trial registration: Netherlands Trial Register, identifier: NL6595, registered on 12 November 2017

Descriptives and analysis results on primary and secondary outcomes of the positively screened sample at baseline, 3 and 6 months follow-up.

*<p>Note: NWFQ total scores were calculated without the subscale <i>impaired decision-making</i>.</p>**<p>Number analysed in EMH-approach group: N = 75 (impaired work functioning), N = 74 (distress and work-related fatigue), N = 73 (posttraumatic stress and work ability); numbers analysed in Control group: N = 131 (all outcomes).</p><p>b, baseline; 3 mn, follow-up after 3 months; 6 mn, follow-up after 6 months.</p