Debby L. Gerritsen

Stepped wedge designs could reduce the required sample size in cluster randomized trials

OBJECTIVE The stepped wedge design is increasingly being used in cluster randomized trials (CRTs). However, there is not much information available about the design and analysis strategies for these kinds of trials. Approaches to sample size and power calculations have been provided, but a simple sample size formula is lacking. Therefore, our aim is to provide a sample size formula for cluster randomized stepped wedge designs. STUDY DESIGN AND SETTING We derived a design effect (sample size correction factor) that can be used to estimate the required sample size for stepped wedge designs. Furthermore, we compared the required sample size for the stepped wedge design with a parallel group and analysis of covariance (ANCOVA) design. RESULTS Our formula corrects for clustering as well as for the design. Apart from the cluster size and intracluster correlation, the design effect depends on choices of the number of steps, the number of baseline measurements, and the number of measurements between steps. The stepped wedge design requires a substantial smaller sample size than a parallel group and ANCOVA design. CONCLUSION For CRTs, the stepped wedge design is far more efficient than the parallel group and ANCOVA design in terms of sample size.

Nurses in distress? An explorative study into the relation between distress and individual neuropsychiatric symptoms of people with dementia in nursing homes

To optimize care and interventions to improve care, and to reduce staff burden, it is important to have knowledge of the relation between individual neuropsychiatric symptoms and distress of care staff. We therefore explored the relation between frequency and severity of individual neuropsychiatric symptoms and distress of care staff.

A revised index for social engagement for long-term care

The objective of this study was to improve validity and reliability estimates of the Index for Social Engagement (ISE) for long-term care. After exploring content validity and internal consistency in Dutch and Canadian data, two ISE items were dropped, and two new items were added. Reliability of this Revised ISE (RISE) was tested in 189 nursing home residents. It appeared that the RISE has enhanced reliability estimates, especially in residents with cognitive impairment. The RISE for long-term care improves the existing index by including additional dimensions of social engagement and by increasing the reliability of results for residents with cognitive impairment.

The relationship between organizational culture of nursing staff and quality of care for residents with dementia: Questionnaire surveys and systematic observations in nursing homes

BACKGROUND Since the 1990s, several studies have shown that organizational culture is an important characteristic in long-term care. However, at the moment little is known about organizational culture and its relationship with quality of care. OBJECTIVES In this study, the relationship between organizational culture and quality of care in long-term care was investigated using the competing values framework. Thereto, two independent measurements of quality of care were applied: the perceived quality of care by nursing staff of dementia units and the observed quality of care on the units by researchers. DESIGN The study used a cross-sectional design. SETTINGS Data were collected on 11 dementia units in 11 Dutch nursing homes. PARTICIPANTS All nursing staff on the units were asked to complete a questionnaire, of whom 248 staff members responded. The average response rate on the 11 units was 63%. METHODS Data were collected during two days of field-work on each unit. Systematic observations were performed, and questionnaires were distributed among nursing staff. Data were analyzed using multilevel analyses. RESULTS Organizational culture was related to both perceived and observed quality of care on the units. Units that are characterized by a clan culture provide better quality of care, both in the eyes of the nursing staff as in the eyes of outsiders. Market culture, compared to clan culture, is negatively related to quality of care in this sample. CONCLUSIONS The results indicate that organizational culture in long-term dementia care is important for organizational performance.

Coming to Grips With Challenging Behavior: A Cluster Randomized Controlled Trial on the Effects of a Multidisciplinary Care Program for Challenging Behavior in Dementia

OBJECTIVES The Grip on Challenging Behavior care program was developed using the current guidelines and models on managing challenging behavior in dementia in nursing homes. It was hypothesized that the use of the care program would lead to a decrease in challenging behavior and in the prescription of psychoactive drugs without increase in use of restraints. DESIGN A randomized controlled trial was undertaken using a stepped-wedge design to implement the care program and to evaluate the effects. An assessment of challenging behavior and psychoactive medication was undertaken every 4 months on all participating units followed by the introduction of the care program in a group of 3 to 4 units. A total of 6 time assessments took place over 20 months. SETTING Seventeen dementia special care units of different nursing homes. PARTICIPANTS A total of 659 residents of dementia special care units. All residents with dementia on the unit were included. Units were assigned by random allocation software to 1 of 5 groups with different starting points for the implementation of the care program. INTERVENTION A care program consisting of various assessment procedures and tools, which ensure a multidisciplinary approach and which structure the process of managing challenging behavior in dementia. MEASUREMENTS Challenging behavior was measured using the Cohen-Mansfield Agitation Inventory (CMAI) and the Neuropsychiatric Inventory. Research assistants (blinded for intervention status of the unit) interviewed nurses on the units about challenging behavior. Data on psychoactive drugs and restraints were retrieved from resident charts. RESULTS A total of 2292 assessments took place involving 659 residents (1126 control measurements, 1166 intervention measurements). The group of residents who remained in the intervention condition compared with the group in the control condition differed significantly in the CMAI change scores between successive assessments [-2.4 CMAI points, 95% confidence interval (CI) -4.3 to -0.6]. No significant effects were found for the control-to-intervention group compared with the group who remained in the control group (0.0 CMAI points, 95% CI -2.3 to 2.4). Significant effects were found on 5 of the 12 Neuropsychiatric Inventory items and on the use of antipsychotics (odds ratio 0.54, 95% CI 0.37- 0.80) and antidepressants (odds ratio 0.65, 95% CI 0.44-0.94). No effect on use of restraints was observed. CONCLUSIONS The Grip on Challenging behavior program was able to diminish some forms of challenging behavior and the use of psychoactive drugs.

A structural multidisciplinary approach to depression management in nursing-home residents: a multicentre, stepped-wedge cluster-randomised trial

BACKGROUND Depression in nursing-home residents is often under-recognised. We aimed to establish the effectiveness of a structural approach to its management. METHODS Between May 15, 2009, and April 30, 2011, we undertook a multicentre, stepped-wedge cluster-randomised trial in four provinces of the Netherlands. A network of nursing homes was invited to enrol one dementia and one somatic unit per nursing home. In enrolled units, nursing-home staff recruited residents, who were eligible as long as we had received written informed consent. Units were randomly allocated to one of five groups with computer-generated random numbers. A multidisciplinary care programme, Act in Case of Depression (AiD), was implemented at different timepoints in each group: at baseline, no groups were implenting the programme (usual care); the first group implemented it shortly after baseline; and other groups sequentially began implementation after assessments at intervals of roughly 4 months. Residents did not know when the intervention was being implemented or what the programme elements were; research staff were masked to intervention implementation, depression treatment, and results of previous assessments; and data analysts were masked to intervention implementation. The primary endpoint was depression prevalence in units, which was the proportion of residents per unit with a score of more than seven on the proxy-based Cornell scale for depression in dementia. Analyses were by intention to treat. This trial is registered with the Netherlands National Trial Register, number NTR1477. FINDINGS 16 dementia units (403 residents) and 17 somatic units (390 residents) were enrolled in the course of the study. In somatic units, AiD reduced prevalence of depression (adjusted effect size -7·3%, 95% CI -13·7 to -0·9). The effect was not significant in dementia units (0·6, -5·6 to 6·8) and differed significantly from that in somatic units (p=0·031). Adherence to depression assessment procedures was lower in dementia units (69% [SD 19%]) than in somatic units (82% [15%]; p=0·045). Adherence to treatment pathways did not differ between dementia units (43% [SD 33%]) and somatic units (38% [40%]; p=0·745). INTERPRETATION A structural approach to management of depression in nursing homes that includes assessment procedures can reduce depression prevalence in somatic units. Improvements are needed in depression screening in dementia units and in implementation of nursing-home treatment protocols generally. FUNDING The Netherlands Organization for Health Research and Development.

Act In case of Depression: The evaluation of a care program to improve the detection and treatment of depression in nursing homes. Study Protocol

BackgroundThe aim of this study is evaluating the (cost-) effectiveness of a multidisciplinary, evidence based care program to improve the management of depression in nursing home residents of somatic and dementia special care units. The care program is an evidence based standardization of the management of depression, including standardized use of measurement instruments and diagnostical methods, and protocolized psychosocial, psychological and pharmacological treatment.Methods/DesignIn a 19-month longitudinal controlled study using a stepped wedge design, 14 somatic and 14 dementia special care units will implement the care program. All residents who give informed consent on the participating units will be included. Primary outcomes are the frequency of depression on the units and quality of life of residents on the units. The effect of the care program will be estimated using multilevel regression analysis. Secondary outcomes include accuracy of depression-detection in usual care, prevalence of depression-diagnosis in the intervention group, and response to treatment of depressed residents. An economic evaluation from a health care perspective will also be carried out.DiscussionThe care program is expected to be effective in reducing the frequency of depression and in increasing the quality of life of residents. The study will further provide insight in the cost-effectiveness of the care program.Trial registrationNetherlands Trial Register (NTR): NTR1477

Grip on challenging behaviour: a multidisciplinary care programme for managing behavioural problems in nursing home residents with dementia. Study protocol

BackgroundBehavioural problems are common in nursing home residents with dementia and they often are burdensome for both residents and nursing staff. In this study, the effectiveness and cost-effectiveness of a new care programme for managing behavioural problems will be evaluated.Methods/DesignThe care programme is based on Dutch national guidelines. It will consist of four steps: detection, analysis, treatment and evaluation. A stepped wedge design will be used. A total of 14 dementia special care units will implement the care programme. The primary outcome is behavioural problems. Secondary outcomes will include quality of life, prescription rate of antipsychotics, use of physical restraints and workload and job satisfaction of nursing staff. The effect of the care programme will be estimated using multilevel linear regression analysis. An economic evaluation from a societal perspective will also be carried out.DiscussionThe care programme is expected to be cost-effective and effective in decreasing behavioural problems, workload of nursing staff and in increasing quality of life of residents.Trial registrationThe Netherlands National Trial Register (NTR). Trial number: NTR%202141

Quality of life in dementia: do professional caregivers focus on the significant domains?

The domains of quality of life that are considered important by people with dementia and professional caregivers are not in agreement. This explorative study addresses the question, “To what degree do professional caregivers, in their daily working routine, focus on the quality-of-life domains that people with dementia consider essential?” Study participants were nursing assistants who work in 24-hour nursing home care and professionals who offer daytime activities. Three hundred and seventy-four caregivers working on 29 units and 3 day care facilities of 13 nursing homes and in 12 meeting centers filled out a questionnaire. The caregivers reported to focus at least to some degree on most domains considered important by people with dementia. However, relatively little attention was paid to “financial situation” and “being useful/giving meaning to life.” Professionals who offer daytime activities focused more than 24-hour care staff on “attachment,” “enjoyment of activities,” “sense of aesthetics,” and “being useful/giving meaning to life.”

Comprehensive assessment of depression and behavioral problems in long-term care.

BACKGROUND The IPA Taskforce on Mental Health Issues in Long-Term Care Homes seeks to improve mental health care in long-term care (LTC) homes. The aim of this paper is to provide recommendations on comprehensive assessment of depression and behavioral problems in order to further stimulate countries and professionals to enhance their quality of care. METHODS Existing guidelines on comprehensive assessment of depression or behavioral problems in nursing home (NH) patients or patients residing in LTC homes were collected and a literature review was carried out to search for recent evidence. RESULTS Five guidelines from several countries all over the world and two additional papers were included in this paper as a starting point for the recommendations. Comprehensive assessment of depression in LTC homes consists of a two-step screening procedure: an investigation to identify factors that influence the symptoms, followed by a formal diagnosis of depression according to DSM-IV-TR or the Provisional Diagnostic Criteria for Depression in Alzheimer Disease in cases of dementia. Comprehensive assessment of behavioral problems encompasses three steps: description and clarification of the behavior, additional investigation, and assessment of probable causes of the behavior. The procedure starts in the case of moderate behavioral problems. CONCLUSION The recommendations given in this paper provide a useful guide to professional workers in the LTC sector, but clinical judgment and the consideration of the unique aspects of individual residents and their situations is necessary for an optimal assessment of depression and behavioral problems. The recommendations should not be rigidly applied and implementation will differ from country to country.