The unrecognized role of fidelity in effectiveness-implementation hybrid trials: simulation study and guidance for implementation researchers.

BACKGROUND: Effectiveness-implementation hybrid designs are a relatively new approach to evaluate efficacious interventions in real-world settings while concurrently gathering information on the implementation. Intervention fidelity can significantly influence the effectiveness of an intervention during implementation. However little guidance exists for applied researchers conducting effectiveness-implementation hybrid trials regarding the impact of fidelity on intervention effects and power. METHODS: We conducted a simulation study based on parameters from a clinical example study. For the simulation, we explored parallel and stepped-wedge cluster randomized trials (CRTs) and hypothetical patterns of fidelity increase during implementation: slow, linear, and fast. Based on fixed design parameters, i.e., the number of clusters (C = 6), time points (T = 7), and patients per cluster (n = 10) we used linear mixed models to estimate the intervention effect and calculated the power for different fidelity patterns. Further, we conducted a sensitivity analysis to compare outcomes based on different assumptions for the intracluster-correlation coefficient and the cluster size. RESULTS: Ensuring high fidelity from the beginning is central to achieve accurate intervention effect estimates in stepped-wedge and parallel CRTs. The importance of high fidelity in the earlier stages is more emphasized in stepped-wedge designs than in parallel CRTs. In contrast, if the increase of fidelity is too slow despite relatively high starting levels, the study will likely be underpowered and the intervention effect estimates will also be biased. This effect is more accentuated in parallel CRTs, here reaching 100% fidelity within the next measurement points is crucial. CONCLUSIONS: This study discusses the importance of intervention fidelity for the study`s power and highlights different recommendations to deal with low fidelity in parallel and stepped-wedge CRTs from a design perspective. Applied researchers should consider the detrimental effect of low fidelity in their evaluation design. Overall, there are fewer options to adjust the trial design after the fact in parallel CRT as compared to stepped-wedge CRTs. Particular emphasis should be placed on the selection of contextually relevant implementation strategies.

Process evaluation of the response of nursing homes to the implementation of the dementia-specific case conference concept WELCOME-IdA: A qualitative study.

BACKGROUND: The implementation of clearly structured dementia-specific case conferences could be an important tool to enable nursing staff to properly analyse and manage challenging behaviour in nursing home residents with dementia. A process evaluation of the responses of nursing homes to the implementation of WELCOME-IdA (Wittener model of case conferences for people with dementia - the Innovative dementia-oriented Assessment tool) was carried out to gain insight into which key elements of the intervention were adopted by the nursing homes and which elements were adapted. METHODS: This study was part of a larger process evaluation using a qualitative design. Thirty-four semi-structured telephone interviews and 15 focus group interviews were conducted in four nursing homes. The interviews were analysed using deductive content analysis, although inductive categories have been developed. RESULTS: Nursing home staff adopted the roles of moderator, case reporter, keeper of the minutes and reflection partner in WELCOME-IdA, but the selection of the staff members who filled these roles differed across nursing homes. The recommended group size of 5-8 participants per case conference was sometimes adopted. The key element of having core nursing teams who participated continuously in all case conferences was not adopted at all. Instead, there was a high level of rotation among staff members. The pre-defined process structure of WELCOME-IdA was adapted in such a way that the assessment of the residents' behaviour and the selection of the relevant domain for the behaviour analysis were conducted in advance of the case conference. The evaluation of the interventions was also organized differently. CONCLUSION: The scope of the response implies that WELCOME-IdA requires further adaptation to the requirements of nursing processes in nursing homes. The results provide important information on the selection of role keepers and offer insights into a) how knowledge of the structured training was circulated and transformed into self-organized case conferences and b) how knowledge was circulated throughout the entire processing of one case. Thus, these results can be used to optimize intervention and implementation. Overall, the intervention should allow more possibilities for tailored adaptation than it currently does.

Interne Konsistenz und Konstruktvalidität des demenzspezifischen Lebensqualitätsinstruments QUALIDEM - Eine Sekundärdatenanalyse einer Querschnittserhebung.

Internal consistency and construct validity of the Quality of Life measurement in dementia QUALIDEM - a secondary data analysis of cross-sectional data Abstract. Background: Maintaining and improving the Quality of Life (QoL) of people with dementia is the principal aim of nursing and medical care. The QUALIDEM is a theory-based, dementia-specific QoL instrument in the German language. Until now, however, there are hardly any findings on the construct validity. OBJECTIVE: Evaluation of the item difficulty, internal consistency, discriminant and convergent validity of the German QUALIDEM. METHOD: The evaluation of the construct validity is based on a Multi-Trait-One-Method approach, using a sample of 167 people with mild to severe dementia and 71 people with very severe dementia. RESULTS: The correlation between the QUALIDEM subscales and the comparative constructs agitation, depression, anxiety, aberrant motoric behavior, apathy, pain and QoL, measured with the Alzheimer's Disease Related Quality of Life instrument, was confirmed in the expected direction in 82 % of the predefined hypotheses. The correlation coefficients range between 0.04 and -0.60 (discriminant validity) and -0.21 and 0.71 (convergent validity). For the majority of QUALIDEM subscales a good internal consistency could be demonstrated. CONCLUSION: The results indicate first indications for the construct validity of the QUALIDEM subscales and for the further development of the instrument. In future studies, the validity of the German QUALIDEM should be further investigated.

Construct validity and internal consistency of the neuropsychiatric inventory - nursing home (NPI-NH) in German nursing homes.

BACKGROUND: The Neuropsychiatric Inventory (NPI) is one of the most popular and frequently used instruments for assessing so-called challenging behavior in individuals with dementia in research practice. However, no information is available regarding the factor structure of the German version of the Neuropsychiatric Inventory - Nursing Home (NPI-NH). The aim of this study was to evaluate the factor structure (an aspect of construct validity) and internal consistency of the NPI-NH for two different stages of dementia severity in a large German nursing home population. METHODS: A total of 784 residents with dementia from 40 nursing homes in three studies was included in a secondary data analysis. Principal component analysis (PCA) using an orthogonal rotational procedure (with varimax rotation) was used to evaluate the factor structure of the NPI. Cronbach's α was used to assess the stability of the scale. RESULTS: The factors agitation & restless behavior, psychosis, and mood were identified (with factor loading > 0.4 explaining 50% of the variance). The factors showed a moderate internal consistency of 0.55 and 0.68 (Cronbach's α). CONCLUSIONS: The results show the acceptable factor structure of the NPI for a German population in nursing homes and confirm the results of studies from other countries. The three identified factors appear to be robust over the various stages of dementia severity. The results also support the hypothesis that the NPI-NH can be subdivided into multiple domains.

People with dementia in nursing home research: a methodological review of the definition and identification of the study population.

BACKGROUND: There are various definitions and diagnostic criteria for dementia, leading to discrepancies in case ascertainment in both clinical practice and research. We reviewed the different definitions, approaches and measurements used to operationalize dementia in health care studies in German nursing homes with the aim of discussing the implications of different approaches. METHODS: We conducted a systematic search of the MEDLINE and CINAHL databases to identify pre-2016 studies conducted in German nursing homes that focused on residents with dementia or cognitive impairment. In- or exclusion of studies were consented by all authors; data extraction was independently carried out by 2 authors (RP, SJ). The studies' sampling methods were compared with respect to their inclusion criteria, assessment tools and methods used to identify the study population. RESULTS: We summarized case ascertainment methods from 64 studies. Study participants were identified based on a diagnosis that was evaluated during the study, or a recorded medical dementia diagnosis, or a recorded medical diagnosis either with additional cognitive screenings or using screening tests exclusively. The descriptions of the diagnostics that were applied to assess a diagnosis of dementia were not fully transparent in most of the studies with respect to either a clear reference definition of dementia or applied diagnostic criteria. If reported, various neuropsychological tests were used, mostly without a clear rationale for their selection. CONCLUSION: Pragmatic considerations often determine the sampling strategy; they also may explain the variances we detected in the different studies. Variations in sampling methods impede the comparability of study results. There is a need to consent case ascertainment strategies in dementia studies in health service research in nursing homes. These strategies should consider resource constraints and ethical issues that are related to the vulnerable population of nursing home residents. Additionally, reporting about dementia studies in nursing homes need to be improved. If a diagnosis cannot be evaluated based on either ICD or DSM criteria, the study population may not be reported as having dementia. If a diagnosis is evaluated based on ICD or DSM criteria within the study, there is a need for more transparency of the diagnostic process.

Case conferences as interventions dealing with the challenging behavior of people with dementia in nursing homes: a systematic review.

BACKGROUND: Challenging behaviors such as aggression, screaming, and apathy are often encountered when caring for people with dementia in nursing homes. In this context, a case conference is often recommended for healthcare professionals as an effective instrument to improve the quality of care. However, the subject case conference has not had great consideration in scientific literature. The aim of this review is to describe the effects of case conferences on people with dementia and challenging behavior and the staff in nursing homes. METHODS: A search of intervention studies in nursing homes in the German or English language was performed in the following databases: Medline, Cinahl, PsycINFO, Cochrane library, Embase, and Google Scholar. The selection and the methodological quality of the studies were assessed independently by two authors. The results were summarized and compared based on categories such as study quality or outcomes. RESULTS: Seven of 432 studies were included in the review. A total of four of seven studies showed a reduction in the challenging behavior of people with dementia, and five showed an influence on the competence, attitudes, and job satisfaction of the staff. However, due to the middle-range quality of several studies, the methodological heterogeneity and differences in the interventions, the results must be interpreted with caution. CONCLUSIONS: In summary, little evidence exists for the positive effects of case conferences in the care of people with dementia. This review highlights the need for methodologically well-designed intervention studies to provide conclusive evidence of the effects of case conferences.

Organizational Capacity Building in Nursing Facilities to Promote Resident Mobility: A Systematic Review.

OBJECTIVES: The objective of the present systematic review was to investigate the effects of organizational capacity building interventions on the environment, nursing staff capacity, and mobility of residents in nursing facilities. DESIGN: Systematic review. SETTING AND PARTICIPANTS: Nursing facilities, staff, and residents. METHODS: We conducted a systematic review according to the methods of the Cochrane Collaboration. The systematic review was prospectively registered in the PROSPERO database of systematic reviews (registration number CRD42020202996). We searched for studies in MEDLINE (via PubMed), CINAHL (via EBSCO), the Physiotherapy Evidence Database (PEDro), and the Cochrane Library (07/20). A narrative synthesis was conducted because of the high heterogeneity of the included studies. RESULTS: We identified 6747 records and included 14 studies in our review. We clustered the 14 interventions into 3 different categories (environmental modification, nursing staff capacity, and multifactorial interventions). Three studies assessed outcomes at the nursing staff level, and all studies reported outcomes at the resident level. We found highly heterogeneous and inconsistent effects of organizational capacity building on increasing nursing staff capacity and/or resident mobility. CONCLUSIONS AND IMPLICATIONS: The findings emphasize the need for further research focusing on an international understanding and definition of organizational capacity building. Additionally, research and intervention development for organizational capacity building interventions to promote resident mobility are needed while applying the framework of the Medical Research Council. Furthermore, studies should assess outcomes regarding the environment and nursing staff to better understand if and how environmental structures and nursing staff capacity effect resident mobility.

Dealing with the behaviour of residents with dementia that challenges: A stepped-wedge cluster randomized trial of two types of dementia-specific case conferences in nursing homes (FallDem).

BACKGROUND: The negative effects of behavioural changes among dementia residents and the consequences for caregivers are a major problem in the care of people with dementia. Case conferences (CC) are recommended as a useful method to understand the underlying causes of the behaviour and to plan tailored interventions OBJECTIVES: The aim of this article is to describe the effects of two dementia-specific CC models on the prevalence of behaviour that challenges and other secondary outcomes. DESIGN: Stepped-wedge cluster randomized trial. SETTING: Nursing homes: The inclusion criterion was the participation of at least two units with a minimum of 30 residents who were mainly cared for in the study units. PARTICIPANTS: A total of 224 residents and 189 staff from six nursing homes in the IdA (Innovative dementia-orientated Assessment system) cohort and 241 residents and 284 staff from six nursing homes in the Neo (Narrative Approach) cohort were included in the study. The inclusion criteria were the following: medical diagnosis of dementia from nursing charts, FAST (Functional Assessment Staging) score > 1, living at least 15 days in the unit, and informed consent. METHODS: The nursing homes were randomized to the type of intervention and time point of intervention delivery. The two interventions in the form of the case conference models (Welcome-IdA and -Neo) differed in the type of behaviour analysis method. The intervention duration was seven months. The primary outcome was the change in the prevalence of behaviour that challenges. Secondary outcomes were residents' quality of life, prescription of psychotropic medications, formal caregiver burnout, dementia-related stress, and vocational action competence. The outcomes were measured on seven data points every three months. Linear mixed-effects models were used to analyze intervention effects between the control, intervention and follow-up periods. RESULTS: No differences were found concerning the primary outcome between the control and intervention cohorts for both CC models. Further exploratory data analyses showed a reduction in behaviours such as apathy (18%) and eating disturbances (29%) for the IdA cohort and hallucination (27%) and delusion (28%) in the NEO cohort. Only staff in the IdA cohort demonstrated a reduction in work-related burnout from the control phase to the intervention phase. CONCLUSION: Specific CC for behaviour that challenges do not decrease the overall prevalence of residents showing changes in behaviour. However, there are indications that the case conferences influence some types of behaviour and reduce the risk factors for work-related burnout.

[Risk for dysphagia screening tools - a review of the international literature]. / Screening-Verfahren zur Identifikation einer Dysphagie bei älteren Menschen - Ein systematischer Literaturüberblick.

Elderly people have an increased risk to suffer from dysphagia due to age-related physiological alterations and neurological disorders. The consequences of untreated dysphagia are malnutrition and dehydration and the aspiration of solid and liquid food into the respiratory tract, which can lead to life-threatening pneumonia. On this background the care of the elderly people in nursing homes is a challenge for nurses. The aim of this literature review is to identify suitable screening tools and to evaluate their practicability for nurses' everyday work. The database search was conducted in CINAHL, Ovid Medline and EMBASE. Ten screening tools fitted the selection criteria. Most of them are developed by speech and language therapists and physicians, only two tools are designed by nursing scientists. A swallowing test is part of all screening tools; the target population are stroke patients in their acute phase. Other relevant criteria besides the swallowing test are, e. g. the patients' health status, taking of psychotropic drugs, and posture. All instruments are described as simple to use. They are tested for validity, and sometimes for reliability, but the tools are mostly not appropriate for the use in institutional geriatric care settings. The two instruments developed by nurse scientists are only of limited use in nursing homes, because both instruments were not tested in nursing homes and only one of these tools shows acceptable values of interrater reliability and criterion-related validity. As a result, a screening tool for the target group and a training programme for nurses should be developed.

Process evaluation of the context, reach and recruitment of participants and delivery of dementia-specific case conferences (WELCOME-IdA) in nursing homes (FallDem): a mixed-methods study.

BACKGROUND: A system of dementia-specific case conferences (WELCOME-IdA) was evaluated using a stepped-wedge design in six nursing homes (NHs) to enable nursing staff to analyse properly the behavioural and psychological symptoms (BPSD) of residents with dementia. A process evaluation of the context, the recruitment and target populations reached (residents and nursing staff) and the delivery of the intervention and implementation strategy was carried out to explore the lack of effectiveness of WELCOME-IdA on the residents' prevalence of BPSD. METHODS: This study was part of a larger process evaluation using a mixed-methods design. Standardised questionnaires, semi-structured interviews, attendance lists, standardised protocols and written self-reports were used to collect the data. The quantitative data were analysed by calculating descriptive statistics. The qualitative interviews were analysed using deductive content analysis and the self-reports were analysed using a documentary analysis. RESULTS: None of the NHs had prior experience with dementia-specific case conferences on a specific concept related to BPSD. The number of residents for whom a dementia-specific case conference was held was lower than expected. The number of nursing staff reached was high, although as defined in the study protocol, core nursing teams continuously participating in all components of the intervention were not established throughout the study. An analysis of the delivery of the intervention showed a reduction in the frequency of dementia-specific case conferences and deviations in the process structure and role structure of WELCOME-IdA. The strategy used to facilitate the implementation of WELCOME-IdA was mostly followed. An analysis of the recruitment of residents indicated that the variation in which residents were included in the study sample was high and that the intended sample size required to achieve a power >80% was not reached. CONCLUSION: An analysis of the process evaluation data indicated that there were inaccuracies in the implementation of WELCOME-IdA and there were methodological limitations within the design of the effectiveness trial, both of which could explain the lack of effectiveness of WELCOME-IdA. To optimise the process structure of WELCOME-IdA, an assessment of BPSD and a pre-selection of possible domains for the behavioural analysis could be conducted prior to a dementia-specific case conference. TRIAL REGISTRATION: ISRCTN20203855 . Registered on 10 July 2013.

Care arrangements for community-dwelling people with dementia in Germany as perceived by informal carers - a cross-sectional pilot survey in a provincial-rural setting.

The majority of people with dementia live at home, and informal carers assume the role of key care providers, often supported by formal services. The purpose of this pilot study was to assess home-based care arrangements, to illustrate utilisation of formal services over time and to identify factors associated with perceived stability of the care situation from the informal carer's perspective. A self-administered questionnaire (D-IVA 'Instrument for Assessing Home-Based Care Arrangements for People with Dementia') was developed and distributed in a provincial-rural setting in Germany as a cross-sectional survey. Data analysis used descriptive statistics, unbiased conditional inference trees and thematic analysis for open-ended questions. In total, 84 care arrangements were assessed. The majority of participants were direct relatives of the care-dependent person [mostly adult children (48.8%) or spouses (27.4%)]. Formal services were already sought in the first year after onset of memory problems. The most frequently used formal services were home care nursing services (53.0%), day care (49.4%) and respite care (29.6%), whereas 15.5% did not use any type of formal support. Companion home visit, home care nursing service and day care were used over the longest periods of time. The recruitment strategy used in this study may have recruited persons who were relatively more dependent on their informal carers. In this small sample, carers' perceived stability of the care situation was high, and this was associated with the country of origin and sex of the person with dementia (P = 0.004 and 0.023 respectively). Most care arrangements consisted of a mix of informal and formal services. However, informal carers assumed prime responsibility. The questionnaire D-IVA proved to be suitable. It remains a challenge to further examine factors associated with perceived stability and to explain the phenomenon in its whole complexity. Further research using the D-IVA should consider applying complementing quantitative measures as well as qualitative methods.

Effect evaluation of two types of dementia-specific case conferences in German nursing homes (FallDem) using a stepped-wedge design: study protocol for a randomized controlled trial.

BACKGROUND: Case conferences for people with dementia and challenging behaviors (e.g., apathy) are recommended as useful tools that enable staff in nursing homes to understand the behavior of people with this type of disease. Understanding peoples' behaviors is the basis for the initiation of targeted interventions to improve the quality of care for people with dementia. Furthermore, case conferences demonstrate positive effects on burnout, dementia-specific burden, and vocational action competence of the staff. The two likely approaches for conducting case conferences include the following: A) using a structured assessment instrument, which guides the staff in understanding the residents' behaviors and B) using a narrative approach in which the staff must identify the reasons for the residents' behaviors in an unstructured manner. Case conferences are a complex intervention, and evaluating their multiple effects is challenging. The aim of this study protocol was to describe a likely solution for evaluating this type of complex intervention using a special cluster randomized trial. METHODS: In this stepped-wedged cluster randomized trial, the two interventions will be sequentially implemented every three months in a group of 12 nursing homes (clusters) with a minimum of 360 residents over 19 months (7 months of intervention for each cluster and follow-up). The primary outcome is the reduction of challenging behavior (measured with the neuropsychiatric inventory-nursing home version [NPI-NH]). Secondary outcomes are residents' quality of life, prescription of psychotropic medications, staff burnout, dementia-related stress, and vocational action competence. The effectiveness of the study will be accompanied by a process evaluation. The primary data will be analyzed using a Bayesian mixed effect model; the secondary data will be analyzed using descriptive statistics and mixed effects models. DISCUSSION: The implementation and effect measurement of complex interventions such as case conferences within a cluster randomized trial are challenging (e.g., complex and intensive training, delayed treatment effect). In this study protocol, the methodological advantages and disadvantages of using the stepped wedge design to answer the research questions are discussed. TRIAL REGISTRATION: http://www.controlled-trials.com/ISRCTN20203855; registered 10 July 2013.

Process evaluation of the implementation of dementia-specific case conferences in nursing homes (FallDem): study protocol for a randomized controlled trial.

BACKGROUND: Challenging behaviors exhibited by individuals with dementia might result from an unmet need that they cannot communicate directly due to cognitive restrictions. A dementia-specific case conference represents a promising means of analyzing and exploring these unmet needs. The ongoing FallDem study is a stepped-wedged, cluster-randomized trial evaluating the effects of two different types of dementia-specific case conferences on the challenging behaviors of nursing home residents. This study protocol describes the process evaluation that is conducted, along with the FallDem study.The goal of the process evaluation is to explain potential discrepancies between expected and observed outcomes, and to provide insights into implementation processes and recruitment strategies, as well as the contexts and contextual factors that promote or inhibit the implementation of dementia-specific case conferences. METHODS/DESIGN: The process evaluation will use a mixed-method design comprising longitudinal elements, in which quantitative and qualitative data will be gathered. Qualitative data will be analyzed using content analysis, documentary analysis and a documentary method. Quantitative data (standardized questionnaires) will be analyzed using descriptive statistics. Both types of data will complement one another and provide a more comprehensive picture of the different objects under investigation. DISCUSSION: The process evaluation will allow for a comprehensive understanding of the changing processes and mechanisms underlying the 'black box' of the complex intervention of the FallDem study. These findings will provide practical knowledge regarding issues related to the implementation of dementia-specific case conferences in nursing homes. TRIAL REGISTRATION: Current Controlled Trials identifier: ISRCTN20203855, registered on 10th July 2013.