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1.  Improvement of care for ICU patients with delirium by early screening and treatment: study protocol of iDECePTIvE study 
Background
Delirium in critically ill patients has a strong adverse impact on prognosis. In spite of its recognized importance, however, delirium screening and treatment procedures are often not in accordance with current guidelines. This implementation study is designed to assess barriers and facilitators for guideline adherence and next to develop a multifaceted tailored implementation strategy. Effects of this strategy on guideline adherence as well as important clinical outcomes will be described.
Methods
Current practices and guideline deviations will be assessed in a prospective baseline measurement. Barriers and facilitators will be identified from a survey among intensive care health care professionals (intensivists and nurses) and focus group interviews with selected health care professionals (n = 60). Findings will serve as a foundation for a tailored guideline implementation strategy. Adherence to the guideline and effects of the implementation strategies on relevant clinical outcomes will be piloted in a before-after study in six intensive care units (ICUs) in the southwest Netherlands. The primary outcomes are adherence to screening and treatment in line with the Dutch ICU delirium guideline. Secondary outcomes are process measures (e.g. attendance to training and knowledge) and clinical outcomes (e.g. incidence of delirium, hospital-mortality changes, and length of stay). Primary and secondary outcome data will be collected at four time points including at least 924 patients. Furthermore, a process evaluation will be done, including an economical evaluation.
Discussion
Little is known on effective implementation of delirium management in the critically ill. The proposed multifaceted implementation strategy is expected to improve process measures such as screening adherence in line with the guideline and may improve clinical outcomes, such as mortality and length of stay. This ICU Delirium in Clinical Practice Implementation Evaluation study (iDECePTIvE-study) will generate important knowledge for ICU health care providers on how to improve their clinical practice to establish optimum care for delirious patients.
Trials registration
Clinical Trials NCT01952899
doi:10.1186/s13012-014-0143-7
PMCID: PMC4192432  PMID: 25273854
Intensive care; Critical care; Delirium; Screening; Delirium management; Implementation; Guideline
2.  Everyday life consequences of substance use in adult patients with a substance use disorder (SUD) and co-occurring attention deficit/hyperactivity disorder (ADHD) or autism spectrum disorder (ASD): a patient’s perspective 
BMC Psychiatry  2014;14(1):264.
Background
Although the prevalence of substance use disorder (SUD) with co-occurring attention deficit/hyperactivity disorder (ADHD) or autism spectrum disorder (ASD) is relatively high in adult patients, there is hardly any knowledge about these dual diagnoses. A recent study reported met- and unmet needs for several life domains regarding these patient groups. To improve treatment, it is necessary to identify the everyday life consequences of SUD and co-occurring ADHD or ASD in adult patients.
Methods
Qualitative study using in-depth interviews. 11 SUD + ADHD and 12 SUD + ASD patients participated in the study. The interview transcripts were coded and analysed according to the seven steps for descriptive phenomenology by Colaizzi.
Results
Both patients with ADHD and patients with ASD can get caught in a jumble of thoughts and emotions which can often lead to agitation and impulsivity in the case of ADHD or passivity and melancholia in the case of ASD with co-occurring SUD in both cases. Initially substance use ameliorates the symptoms and related problems, but both patient groups can later experience even greater problems: difficulties with the structuring of daily life due to a lack of planning (SUD + ADHD) or due to a lack of initiative (SUD + ASD). Both groups indicate that structure helps them function better. They also recognize that substance use disorganizes their lives and that an absence of structure contributes to substance use in what becomes a vicious circle which needs to be broken for effective treatment and care.
Conclusions
This study provides insight into the daily life consequences of SUD with a co-occurring ADHD or ASD. Substance use is reported to solve some ADHD- or ASD-related problems in the short run but have negative consequences in the long run (i.e., contribute to already impaired cognitive functioning). Insight is provided into what clinicians can do to break this vicious circle and thus help ADHD patients to refrain from action and ASD patients to take action.
doi:10.1186/s12888-014-0264-1
PMCID: PMC4173065  PMID: 25234344
Substance use disorders; Attention deficit hyperactivity disorder; Autism spectrum disorder; Everyday life consequences; Adults
3.  Patient Safety Policy in Long-Term Care: A Research Protocol to Assess Executive WalkRounds to Improve Management of Early Warning Signs for Patient Safety 
JMIR Research Protocols  2014;3(3):e36.
Background
At many hospitals and long-term care organizations (such as nursing homes), executive board members have a responsibility to manage patient safety. Executive WalkRounds offer an opportunity for boards to build a trusting relationship with professionals and seem useful as a leadership tool to pick up on soft signals, which are indirect signals or early warnings that something is wrong. Because the majority of the research on WalkRounds has been performed in hospitals, it is unknown how board members of long-term care organizations develop their patient safety policy. Also, it is not clear if these board members use soft signals as a leadership tool and, if so, how this influences their patient safety policies.
Objective
The objective of this study is to explore the added value and the feasibility of WalkRounds for patient safety management in long-term care. This study also aims to identify how executive board members of long-term care organizations manage patient safety and to describe the characteristics of boards.
Methods
An explorative before-and-after study was conducted between April 2012 and February 2014 in 13 long-term care organizations in the Netherlands. After implementing the intervention in 6 organizations, data from 72 WalkRounds were gathered by observation and a reporting form. Before and after the intervention period, data collection included interviews, questionnaires, and studying reports of the executive boards. A mixed-method analysis is performed using descriptive statistics, t tests, and content analysis.
Results
Results are expected to be ready in mid 2014.
Conclusions
It is a challenge to keep track of ongoing development and implementation of patient safety management tools in long-term care. By performing this study in cooperation with the participating long-term care organizations, insight into the potential added value and the feasibility of this method will increase.
doi:10.2196/resprot.3256
PMCID: PMC4129115  PMID: 25048598
governance, long-term care, executive board, patient safety, WalkRounds, soft signals
4.  Prevalence of interpersonal trauma exposure and trauma-related disorders in severe mental illness 
European Journal of Psychotraumatology  2013;4:10.3402/ejpt.v4i0.19985.
Background
Interpersonal trauma exposure and trauma-related disorders in people with severe mental illness (SMI) are often not recognized in clinical practice.
Objective
To substantiate the prevalence of interpersonal trauma exposure and trauma-related disorders in people with SMI.
Methods
We conducted a systematic review of four databases (1980–2010) and then described and analysed 33 studies in terms of primary diagnosis and instruments used to measure trauma exposure and trauma-related disorders.
Results
Population-weighted mean prevalence rates in SMI were physical abuse 47% (range 25–72%), sexual abuse 37% (range 24–49%), and posttraumatic stress disorder (PTSD) 30% (range 20–47%). Compared to men, women showed a higher prevalence of sexual abuse in schizophrenia spectrum disorder, bipolar disorder, and mixed diagnosis groups labelled as having SMI.
Conclusions
Prevalence rates of interpersonal trauma and trauma-related disorders were significantly higher in SMI than in the general population. Emotional abuse and neglect, physical neglect, complex PTSD, and dissociative disorders have been scarcely examined in SMI.
doi:10.3402/ejpt.v4i0.19985
PMCID: PMC3621904  PMID: 23577228
Childhood trauma; sexual abuse; physical abuse; emotional abuse; neglect; posttraumatic stress disorder; complex posttraumatic stress disorder; dissociative disorder; severe mental illness
5.  Adherence to guidelines and protocols in the prehospital and emergency care setting: a systematic review 
A gap between guidelines or protocols and clinical practice often exists, which may result in patients not receiving appropriate care. Therefore, the objectives of this systematic review were (1) to give an overview of professionals’ adherence to (inter)national guidelines and protocols in the emergency medical dispatch, prehospital and emergency department (ED) settings, and (2) to explore which factors influencing adherence were described in studies reporting on adherence. PubMed (including MEDLINE), CINAHL, EMBASE and the Cochrane database for systematic reviews were systematically searched. Reference lists of included studies were also searched for eligible studies. Identified articles were screened on title, abstract and year of publication (≥1990) and were included when reporting on adherence in the eligible settings. Following the initial selection, articles were screened full text and included if they concerned adherence to a (inter)national guideline or protocol, and if the time interval between data collection and publication date was <10 years. Finally, articles were assessed on reporting quality. Each step was undertaken by two independent researchers. Thirty-five articles met the criteria, none of these addressed the emergency medical dispatch setting or protocols. Median adherence ranged from 7.8-95% in the prehospital setting, and from 0-98% in the ED setting. In the prehospital setting, recommendations on monitoring came with higher median adherence percentages than treatment recommendations. For both settings, cardiology treatment recommendations came with relatively low median adherence percentages. Eight studies identified patient and organisational factors influencing adherence. The results showed that professionals’ adherence to (inter)national prehospital and emergency department guidelines shows a wide variation, while adherence in the emergency medical dispatch setting is not reported. As insight in influencing factors for adherence in the emergency care settings is minimal, future research should identify such factors to allow the development of strategies to improve adherence and thus improve quality of care.
doi:10.1186/1757-7241-21-9
PMCID: PMC3599067  PMID: 23422062
Emergency medical technicians [MeSH]; Emergency medical services [MeSH]; Emergency medicine [MeSH]; Emergency nursing [MeSH]; Guideline adherence [MeSH]
6.  Barriers, facilitators and attitudes influencing health promotion activities in general practice: an explorative pilot study 
BMC Family Practice  2013;14:20.
Background
The number of chronically ill patients increases every year. This is partly due to an unhealthy lifestyle. However, the frequency and quality of (evidence-based) health promotion activities conducted by Dutch general practitioners (GPs) and practice nurses (PNs) are limited. The aim of this pilot study was to explore which lifestyle interventions Dutch GPs and PNs carry out in primary care, which barriers and facilitators can be identified and what main topics are with respect to attitudes towards health promoting activities. These topic areas will be identified for a future, larger scale study.
Method
This qualitative study consisted of 25 semi-structured interviews with sixteen GPs and nine PNs. ATLAS.ti was used to analyse the transcripts of the interviews.
Results
All GPs and PNs said they discuss lifestyle with their patients. Next to this, GPs and PNs counsel patients, and/or refer them to other disciplines. Only few said they refer patients to specific lifestyle programs or interventions in their own practice or in the neighbourhood. Several barriers and facilitators were identified. The main topics as barriers are: a lack of patients’ motivation to make lifestyle changes, insufficient reimbursement, a lack of proven effectiveness of interventions and a lack of overview of health promoting programs in their neighbourhood. The most cited facilitators are availability of a PN, collaboration with other disciplines and availability of interventions in their own practice. With respect to attitudes, six different types of GPs were identified reflecting the main topics that relate to attitudes, varying from ‘ignorer’ to ‘nurturer’. The topics relating to PNs attitudes towards health promotion activities, were almost unanimously positive.
Conclusion
GPs and PNs all say they discuss lifestyle issues with their patients, but the health promotion activities that are organized in their practice vary. Main topics that hinder or facilitate implementation are identified, including those that relate to attitudes of GPs and PNs.
doi:10.1186/1471-2296-14-20
PMCID: PMC3575260  PMID: 23394162
Life styles; Family practice; Family nursing; Implementation; Qualitative study; Attitude
7.  Haloperidol prophylaxis in critically ill patients with a high risk for delirium 
Critical Care  2013;17(1):R9.
Introduction
Delirium is associated with increased morbidity and mortality. We implemented a delirium prevention policy in intensive care unit (ICU) patients with a high risk of developing delirium, and evaluated if our policy resulted in quality improvement of relevant delirium outcome measures.
Methods
This study was a before/after evaluation of a delirium prevention project using prophylactic treatment with haloperidol. Patients with a predicted risk for delirium of ≥ 50%, or with a history of alcohol abuse or dementia, were identified. According to the prevention protocol these patients received haloperidol 1 mg/8 h. Evaluation was primarily focused on delirium incidence, delirium free days without coma and 28-day mortality. Results of prophylactic treatment were compared with a historical control group and a contemporary group that did not receive haloperidol prophylaxis mainly due to non-compliance to the protocol mostly during the implementation phase.
Results
In 12 months, 177 patients received haloperidol prophylaxis. Except for sepsis, patient characteristics were comparable between the prevention and the historical (n = 299) groups. Predicted chance to develop delirium was 75 ± 19% and 73 ± 22%, respectively. Haloperidol prophylaxis resulted in a lower delirium incidence (65% vs. 75%, P = 0.01), and more delirium-free-days (median 20 days (IQR 8 to 27) vs. median 13 days (3 to 27), P = 0.003) in the intervention group compared to the control group. Cox-regression analysis adjusted for sepsis showed a hazard rate of 0.80 (95% confidence interval 0.66 to 0.98) for 28-day mortality. Beneficial effects of haloperidol appeared most pronounced in the patients with the highest risk for delirium. Furthermore, haloperidol prophylaxis resulted in less ICU re-admissions (11% vs. 18%, P = 0.03) and unplanned removal of tubes/lines (12% vs. 19%, P = 0.02). Haloperidol was stopped in 12 patients because of QTc-time prolongation (n = 9), renal failure (n = 1) or suspected neurological side-effects (n = 2). No other side-effects were reported. Patients who were not treated during the intervention period (n = 59) showed similar results compared to the untreated historical control group.
Conclusions
Our evaluation study suggests that prophylactic treatment with low dose haloperidol in critically ill patients with a high risk for delirium probably has beneficial effects. These results warrant confirmation in a randomized controlled trial.
Trial registration
clinicaltrial.gov Identifier: NCT01187667.
doi:10.1186/cc11933
PMCID: PMC4056261  PMID: 23327295
8.  The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly 
BMC Family Practice  2012;13:115.
Background
With increasing age and longevity, the rising number of frail elders with complex and numerous health-related needs demands a coordinated health care delivery system integrating cure, care and welfare. Studies on the effectiveness of such comprehensive chronic care models targeting frail elders show inconclusive results. The CareWell-primary care program is a complex intervention targeting community-dwelling frail elderly people, that aims to prevent functional decline, improve quality of life, and reduce or postpone hospital and nursing home admissions of community dwelling frail elderly.
Methods/design
The CareWell-primary care study includes a (cost-) effectiveness study and a comprehensive process evaluation. In a one-year pragmatic, cluster controlled trial, six general practices are non-randomly recruited to adopt the CareWell-primary care program and six control practices will deliver ‘care as usual’. Each practice includes a random sample of fifty frail elders aged 70 years or above in the cost-effectiveness study. A sample of patients and informal caregivers and all health care professionals participating in the CareWell-primary care program are included in the process evaluation. In the cost-effectiveness study, the primary outcome is the level of functional abilities as measured with the Katz-15 index. Hierarchical mixed-effects regression models / multilevel modeling approach will be used, since the study participants are nested within the general practices. Furthermore, incremental cost-effectiveness ratios will be calculated as costs per QALY gained and as costs weighed against functional abilities. In the process evaluation, mixed methods will be used to provide insight in the implementation degree of the program, patients’ and professionals’ approval of the program, and the barriers and facilitators to implementation.
Discussion
The CareWell-primary care study will provide new insights into the (cost-) effectiveness, feasibility, and barriers and facilitators for implementation of this complex intervention in primary care.
Trial registration
The CareWell-primary care study is registered in the ClinicalTrials.gov Protocol Registration System: NCT01499797
doi:10.1186/1471-2296-13-115
PMCID: PMC3527269  PMID: 23216685
Frail elderly; Complex intervention; Integrated care; Functional status; Cost-effectiveness; Implementation; Process evaluation; Primary care
9.  Factors influencing the implementation of a lifestyle counseling program in patients with venous leg ulcers: a multiple case study 
Background
Implementation of lifestyle interventions in patient care is a major challenge. Understanding factors that influence implementation is a first step in programs to enhance uptake of these interventions. A lifestyle-counseling intervention, Lively Legs, delivered by trained nurses, can effectively improve the lifestyle in patients with venous leg ulcers. The aim of this study was to identify factors that hindered or facilitated implementation of this intervention in outpatient dermatology clinics and in home care.
Methods
A mixed-methods multiple case study in five purposefully selected healthcare settings in the Netherlands was conducted. Measurements to identify influencing factors before and after implementation of Lively Legs included interviews, focus groups, questionnaires, and nurses’ registration. Analyses focused on qualitative data as the main data source. All data were compared across multiple cases to draw conclusions from the study as a whole.
Results
A total of 53 patients enrolled in the Lively Legs program, which was delivered by 12 trained nurses. Barriers for implementation were mainly organizational. It was difficult to effectively organize reaching and recruiting patients for the program, especially in home care. Main barriers were a lack of a standardized healthcare delivery process, insufficient nursing time, and a lack of motivated nurses to deliver the program. Facilitating factors were nurse-driven coordination of care and a standardized care process to tie Lively Legs into, as this resulted in better patient recruitment and better program implementation.
Conclusions
This study identified a range of factors influencing the implementation of a lifestyle-counseling program, mainly related to the organization of healthcare. Using a case study method proved valuable in obtaining insight into influencing factors for implementation. This study also shed light on a more general issue, which is that leg ulcer care is often fragmented, indicating that quality improvement is needed.
doi:10.1186/1748-5908-7-104
PMCID: PMC3520793  PMID: 23101504
Lifestyle; Varicose ulcer; Venous leg ulcers; Implementation; Case study
10.  Filling the Gaps in a Fragmented Health Care System: Development of the Health and Welfare Information Portal (ZWIP) 
JMIR Research Protocols  2012;1(2):e10.
Background
Current health care systems are not optimally designed to meet the needs of our aging populations. First, the fragmentation of care often results in discontinuity of care that can undermine the quality of care provided. Second, patient involvement in care decisions is not sufficiently facilitated.
Objective
To describe the development and the content of a program aimed at: (1) facilitating self-management and shared decision making by frail older people and informal caregivers, and (2) reducing fragmentation of care by improving collaboration among professionals involved in the care of frail older people through a combined multidisciplinary electronic health record (EHR) and personal health record (PHR).
Methods
We used intervention mapping to systematically develop our program in six consecutive steps. Throughout this development, the target populations (ie, professionals, frail older people, and informal caregivers) were involved extensively through their participation in semi-structured interviews and working groups.
Results
We developed the Health and Welfare Information Portal (ZWIP), a personal, Internet-based conference table for multidisciplinary communication and information exchange for frail older people, their informal caregivers, and professionals. Further, we selected and developed methods for implementation of the program, which included an interdisciplinary educational course for professionals involved in the care of frail older people, and planned the evaluation of the program.
Conclusions
This paper describes the successful development and the content of the ZWIP as well as the strategies developed for its implementation. Throughout the development, representatives of future users were involved extensively. Future studies will establish the effects of the ZWIP on self-management and shared decision making by frail older people as well as on collaboration among the professionals involved.
doi:10.2196/resprot.1945
PMCID: PMC3626145  PMID: 23611877
Self-care; cooperative behavior; interdisciplinary communication; electronic health records; frail elderly
11.  A systematic review of hand hygiene improvement strategies: a behavioural approach 
Background
Many strategies have been designed and evaluated to address the problem of low hand hygiene (HH) compliance. Which of these strategies are most effective and how they work is still unclear. Here we describe frequently used improvement strategies and related determinants of behaviour change that prompt good HH behaviour to provide a better overview of the choice and content of such strategies.
Methods
Systematic searches of experimental and quasi-experimental research on HH improvement strategies were conducted in Medline, Embase, CINAHL, and Cochrane databases from January 2000 to November 2009. First, we extracted the study characteristics using the EPOC Data Collection Checklist, including study objectives, setting, study design, target population, outcome measures, description of the intervention, analysis, and results. Second, we used the Taxonomy of Behavioural Change Techniques to identify targeted determinants.
Results
We reviewed 41 studies. The most frequently addressed determinants were knowledge, awareness, action control, and facilitation of behaviour. Fewer studies addressed social influence, attitude, self-efficacy, and intention. Thirteen studies used a controlled design to measure the effects of HH improvement strategies on HH behaviour. The effectiveness of the strategies varied substantially, but most controlled studies showed positive results. The median effect size of these strategies increased from 17.6 (relative difference) addressing one determinant to 49.5 for the studies that addressed five determinants.
Conclusions
By focussing on determinants of behaviour change, we found hidden and valuable components in HH improvement strategies. Addressing only determinants such as knowledge, awareness, action control, and facilitation is not enough to change HH behaviour. Addressing combinations of different determinants showed better results. This indicates that we should be more creative in the application of alternative improvement activities addressing determinants such as social influence, attitude, self-efficacy, or intention.
doi:10.1186/1748-5908-7-92
PMCID: PMC3517511  PMID: 22978722
Hospital-acquired infection; Behaviour; Quality improvement; Handwashing; Program evaluation; Review
12.  Implementation of an innovative web-based conference table for community-dwelling frail older people, their informal caregivers and professionals: a process evaluation 
Background
Due to fragmentation of care, continuity of care is often limited in the care provided to frail older people. Further, frail older people are not always enabled to become involved in their own care. Therefore, we developed the Health and Welfare Information Portal (ZWIP), a shared Electronic Health Record combined with a communication tool for community-dwelling frail older people and primary care professionals. This article describes the process evaluation of its implementation, and aims to establish (1) the outcomes of the implementation process, (2) which implementation strategies and barriers and facilitators contributed to these outcomes, and (3) how its future implementation could be improved.
Methods
Mixed methods study, consisting of (1) a survey among professionals (n = 118) and monitoring the use of the ZWIP by frail older people and professionals, followed by (2) semi-structured interviews with purposively selected professionals (n = 12).
Results
290 frail older people and 169 professionals participated in the ZWIP. At the end of the implementation period, 55% of frail older people and informal caregivers, and 84% of professionals had logged on to their ZWIP at least once. For professionals, the exposure to the implementation strategies was generally as planned, they considered the interprofessional educational program and the helpdesk very important strategies. However, frail older people’s exposure to the implementation strategies was less than intended. Facilitators for the ZWIP were the perceived need to enhance interprofessional collaboration and the ZWIP application being user-friendly. Barriers included the low computer-literacy of frail older people, a preference for personal communication and limited use of the ZWIP by other professionals and frail older people. Interviewees recommended using the ZWIP for other target populations as well and adding further strategies that may help frail older people to feel more comfortable with computers and the ZWIP.
Conclusions
This study describes the implementation process of an innovative e-health intervention for community-dwelling frail older people, informal caregivers and primary care professionals. As e-health is an important medium for overcoming fragmentation of healthcare and facilitating patient involvement, but its adoption in everyday practice remains a challenge, the positive results of this implementation are promising.
doi:10.1186/1472-6963-12-251
PMCID: PMC3470954  PMID: 22894654
E-health; Implementation; Process evaluation; Frail older people; Primary care
13.  Problems of Adults with a Mitochondrial Disease – The Patients’ Perspective: Focus on Loss 
JIMD Reports  2012;6:85-94.
Objective: This study aimed to identify problems as experienced by adults with a mitochondrial disease. We chose to describe these problems from the patients’ perspective as we thought this would give optimal input for care improvement.
Design: A qualitative design using the grounded theory approach, involving single individual open interviews with 16 adults with a mitochondrial disease.
Results: This study revealed “loss” as the main concept, where one loss often preceded other losses. Respondents mentioned loss of energy as the most basic loss in having a mitochondrial disease, leading to multiple varied losses in all areas of daily life. Looking back, they mentioned psychosocial-spiritual problems and dealing with actual and expected future losses as most prominent and difficult. In our study, we determined seven comprehensive themes: “loss of energy”, “loss of independence and autonomy”, “loss of social participation”, “loss of personal identity”, “loss of dreams and future” as well as “lack of health care” and “coping and adjustment”.
Conclusions: In this first study on this theme, we developed a theory about patient’s losses related to mitochondrial disease. They experience a variety of problems in the physical, psychological, social and spiritual human domain. Patients experience a lack of health care and professional support as well. They use various strategies to manage their multiple losses and experience circumstances in which it is difficult to manage them effectively. The results can be used as a guide for improving health care, education and research and might result in an improved quality of life.
doi:10.1007/8904_2011_121
PMCID: PMC3565683  PMID: 23430944
14.  A prospective study of bowel preparation for colonoscopy with polyethylene glycol-electrolyte solution versus sodium phosphate in Lynch syndrome: a randomized trial 
Familial Cancer  2012;11(3):337-341.
Lynch gene carriers undergo regular surveillance colonoscopies. Polyethylene glycol-electrolyte solution (PEG) is routinely prescribed for bowel cleansing, but often poorly tolerated by patients. Sodium phosphate (NaP) may be an alternative. Prospective and random comparison of bowel preparation with PEG and NaP on colon cleansing and patients’ acceptance. Patients, who previously underwent a colonoscopy, were invited to participate and randomly assigned to either PEG or NaP. They were asked to fill in a questionnaire about preparation tolerability and future preferences. The endoscopist filled out a report about the quality of colon cleansing. 125 Patients were included in the study. Nine (7%) were excluded because of missing data. The remaining 116 patients (53 PEG and 63 NaP) were included in the analysis. Baseline characteristics did not differ between groups. Before colonoscopy 20 (38%) patients using PEG experienced the preparation almost intolerable, in contrast to 7(11%) of those using NaP (P = 0.001). Eleven patients in the PEG group and 48 in the NaP group would prefer NaP in the future. The colonoscopy was poorly tolerated in 17% of the individuals in both groups (P = 0.963). The endoscopist observed a more than 75% clean colon in 83% of patients on PEG and in 71% of patients on NaP (P = 0.076), however the coecum (P = 0.025) and ascending colon was cleaner after PEG. Lynch patients tolerated NaP better and preferred this formula for future bowel preparation. Colon cleansing was suboptimal with both treatments with a tendency towards a cleaner proximal colon with PEG.
doi:10.1007/s10689-012-9517-7
PMCID: PMC3496479  PMID: 22359099
Lynch syndrome; Colonoscopy; Polyethylene glycol; Sodium phosphate
15.  Biomarkers associated with delirium in critically ill patients and their relation with long-term subjective cognitive dysfunction; indications for different pathways governing delirium in inflamed and noninflamed patients 
Critical Care  2011;15(6):R297.
Introduction
Delirium occurs frequently in critically ill patients and is associated with disease severity and infection. Although several pathways for delirium have been described, biomarkers associated with delirium in intensive care unit (ICU) patients is not well studied. We examined plasma biomarkers in delirious and nondelirious patients and the role of these biomarkers on long-term cognitive function.
Methods
In an exploratory observational study, we included 100 ICU patients with or without delirium and with ("inflamed") and without ("noninflamed") infection/systemic inflammatory response syndrome (SIRS). Delirium was diagnosed by using the confusion-assessment method-ICU (CAM-ICU). Within 24 hours after the onset of delirium, blood was obtained for biomarker analysis. No differences in patient characteristics were found between delirious and nondelirious patients. To determine associations between biomarkers and delirium, univariate and multivariate logistic regression analyses were performed. Eighteen months after ICU discharge, a cognitive-failure questionnaire was distributed to the ICU survivors.
Results
In total, 50 delirious and 50 nondelirious patients were included. We found that IL-8, MCP-1, procalcitonin (PCT), cortisol, and S100-β were significantly associated with delirium in inflamed patients (n = 46). In the noninflamed group of patients (n = 54), IL-8, IL-1ra, IL-10 ratio Aβ1-42/40, and ratio AβN-42/40 were significantly associated with delirium. In multivariate regression analysis, IL-8 was independently associated (odds ratio, 9.0; 95% confidence interval (CI), 1.8 to 44.0) with delirium in inflamed patients and IL-10 (OR 2.6; 95% CI 1.1 to 5.9), and Aβ1-42/40 (OR, 0.03; 95% CI, 0.002 to 0.50) with delirium in noninflamed patients. Furthermore, levels of several amyloid-β forms, but not human Tau or S100-β, were significantly correlated with self-reported cognitive impairment 18 months after ICU discharge, whereas inflammatory markers were not correlated to impaired long-term cognitive function.
Conclusions
In inflamed patients, the proinflammatory cytokine IL-8 was associated with delirium, whereas in noninflamed patients, antiinflammatory cytokine IL-10 and Aβ1-42/40 were associated with delirium. This suggests that the underlying mechanism governing the development of delirium in inflamed patients differs from that in noninflamed patients. Finally, elevated levels of amyloid-β correlated with long-term subjective cognitive-impairment delirium may represent the first sign of a (subclinical) dementia process. Future studies must confirm these results.
The study was registered in the Clinical Trial Register (NCT00604773).
doi:10.1186/cc10598
PMCID: PMC3388649  PMID: 22206727
16.  Sample size considerations for GEE analyses of three-level cluster randomized trials 
Biometrics  2010;66(4):1230-1237.
SUMMARY
Cluster randomized trials in health care may involve three instead of two levels, for instance, in trials where different interventions to improve quality of care are compared. In such trials, the intervention is implemented in health care units (“clusters”) and aims at changing the behavior of health care professionals working in this unit (“subjects”), while the effects are measured at the patient level (“evaluations”). Within the generalized estimating equations (GEE) approach, we derive a sample size formula that accounts for two levels of clustering: that of subjects within clusters and that of evaluations within subjects. The formula reveals that sample size is inflated, relative to a design with completely independent evaluations, by a multiplicative term that can be expressed as a product of two variance inflation factors, one that quantifies the impact of within-subject correlation of evaluations on the variance of subject-level means and the other that quantifies the impact of the correlation between subject level means on the variance of the cluster means. Power levels as predicted by the sample size formula agreed well with the simulated power for more than 10 clusters in total, when data was analyzed using bias-corrected estimating equations for the correlation parameters in combination with the model-based covariance estimator or the sandwich estimator with a finite sample correction.
doi:10.1111/j.1541-0420.2009.01374.x
PMCID: PMC2896994  PMID: 20070297
Cluster randomization; Generalized Estimating Equations (GEE); Sample size; Sandwich estimator; Small sample correction; Three-level data; Power
17.  Helping hands: A cluster randomised trial to evaluate the effectiveness of two different strategies for promoting hand hygiene in hospital nurses 
Background
Hand hygiene prescriptions are the most important measure in the prevention of hospital-acquired infections. Yet, compliance rates are generally below 50% of all opportunities for hand hygiene. This study aims at evaluating the short- and long-term effects of two different strategies for promoting hand hygiene in hospital nurses.
Methods/design
This study is a cluster randomised controlled trial with inpatient wards as the unit of randomisation. Guidelines for hand hygiene will be implemented in this study. Two strategies will be used to improve the adherence to guidelines for hand hygiene. The state-of-the-art strategy is derived from the literature and includes education, reminders, feedback, and targeting adequate products and facilities. The extended strategy also contains activities aimed at influencing social influence in groups and enhancing leadership. The unique contribution of the extended strategy is built upon relevant behavioural science theories. The extended strategy includes all elements of the state-of-the-art strategy supplemented with gaining active commitment and initiative of ward management, modelling by informal leaders at the ward, and setting norms and targets within the team. Data will be collected at four points in time, with six-month intervals. An average of 3,000 opportunities for hand hygiene in approximately 900 nurses will be observed at each time point.
Discussion
Performing and evaluating an implementation strategy that also targets the social context of teams may considerably add to the general body of knowledge in this field. Results from our study will allow us to draw conclusions on the effects of different strategies for the implementation of hand hygiene guidelines, and based on these results we will be able to define a preferred implementation strategy for hospital based nursing.
Trial registration
The study is registered as a Clinical Trial in ClinicalTrials.gov, dossier number: NCT00548015.
doi:10.1186/1748-5908-6-101
PMCID: PMC3177889  PMID: 21888660
18.  Development of the Nurses' Observation Scale for Cognitive Abilities (NOSCA) 
ISRN Nursing  2011;2011:895082.
Background. To assess a patient's cognitive functioning is an important issue because nurses tailor their nursing interventions to the patient's cognitive abilities. Although some observation scales exist concerning one or more cognitive domains, so far, no scale has been available which assesses cognitive functioning in a comprehensive way. Objectives. To develop an observation scale with an accepted level of content validity and which assesses elderly patients' cognitive functioning in a comprehensive way. Methods. Delphi technique, a multidisciplinary panel developed the scale by consensus through four Delphi rounds (>70% agreement). The International Classification of Functioning/ICF was used as theoretical framework. Results. After the first two Delphi rounds, the panel reached consensus about 8 cognitive domains and 17 sub domains. After two other rounds, 39 items were selected, divided over 8 domains and 17 sub domains. Discussion. The Nurses' Observation Scale Cognitive Abilities (NOSCA) was successfully designed. The content validity of the scale is high because the scale sufficiently represents the concept of cognitive functioning: the experts reached a consensus of 70% or higher on all domains and items included; and no domains or items were lacking. As a next step, the psychometric qualities of the NOSCA will have to be tested.
doi:10.5402/2011/895082
PMCID: PMC3168942  PMID: 22007329
19.  Predicting Fatigue in Patients Using Home Parenteral Nutrition: A Longitudinal Study 
Background
Home parenteral nutrition (HPN) is a life-saving therapy for patients with diseases that preclude adequate oral or enteral food intake. HPN has a large impact on daily life. Many patients suffer from fatigue and depression, and they experience limits in social activities. This all contributes to a lower quality of life.
Purpose
Fatigue is the most frequently mentioned problem in Dutch HPN patients. Therefore, we studied the prevalence, course and predictors of fatigue in these patients.
Methods
Patients completed questionnaires at baseline and follow-up (12 months later). Measurements included fatigue, depression, functional impairment, social support, self-efficacy, coping, anxiety and acceptance. Laboratory measures, including total bilirubin, creatinine, albumin and haemoglobin levels, were obtained from the medical records. Descriptive statistics, correlations and linear regression analysis were performed.
Results
The response rate was 71% (n = 75). Sixty-five per cent of the patients were severely fatigued (n = 49). Eighty-nine per cent experienced persistent fatigue. Baseline fatigue predicted 57% of the variance of fatigue at follow-up, and avoidance was responsible for 3% of the variance. No significant correlations between fatigue and laboratory measures were found. A cross-sectional analysis showed that 46% of the variance of fatigue was explained by functional impairment, self-efficacy and depression.
Conclusion
Severe fatigue is a persistent problem for HPN patients. Baseline fatigue was the strongest predictor of fatigue at follow-up. Functional impairment, self-efficacy and depression are strongly related to fatigue. Early recognition and treatment of fatigue are important.
doi:10.1007/s12529-010-9116-7
PMCID: PMC3145911  PMID: 20862618
Home parenteral nutrition; Fatigue; Functional impairment; Self-efficacy; Depression
20.  How to promote healthy behaviours in patients? An overview of evidence for behaviour change techniques 
Health Promotion International  2010;26(2):148-162.
To identify the evidence for the effectiveness of behaviour change techniques, when used by health-care professionals, in accomplishing health-promoting behaviours in patients. Reviews were used to extract data at a study level. A taxonomy was used to classify behaviour change techniques. We included 23 systematic reviews: 14 on smoking cessation, 6 on physical exercise, and 2 on healthy diets and 1 on both exercise and diets. None of the behaviour change techniques demonstrated clear effects in a convincing majority of the studies in which they were evaluated. Techniques targeting knowledge (n = 210 studies) and facilitation of behaviour (n = 172) were evaluated most frequently. However, self-monitoring of behaviour (positive effects in 56% of the studies), risk communication (52%) and use of social support (50%) were most often identified as effective. Insufficient insight into appropriateness of technique choice and quality of technique delivery hinder precise conclusions. Relatively, however, self-monitoring of behaviour, risk communication and use of social support are most effective. Health professionals should avoid thinking that providing knowledge, materials and professional support will be sufficient for patients to accomplish change and consider alternative strategies which may be more effective.
doi:10.1093/heapro/daq050
PMCID: PMC3090154  PMID: 20739325
health behaviour; health promotion; patient care; review
21.  Implementation of a delirium assessment tool in the ICU can influence haloperidol use 
Critical Care  2009;13(4):R131.
Introduction
In critically ill patients, delirium is a serious and frequent disorder that is associated with a prolonged intensive care and hospital stay and an increased morbidity and mortality. Without the use of a delirium screening instrument, delirium is often missed by ICU nurses and physicians. The effects of implementation of a screening method on haloperidol use is not known. The purpose of this study was to evaluate the implementation of the confusion assessment method-ICU (CAM-ICU) and the effect of its use on frequency and duration of haloperidol use.
Methods
We used a tailored implementation strategy focused on potential barriers. We measured CAM-ICU compliance, interrater reliability, and delirium knowledge, and compared the haloperidol use, as a proxy for delirium incidence, before and after the implementation of the CAM-ICU.
Results
Compliance and delirium knowledge increased from 77% to 92% and from 6.2 to 7.4, respectively (both, P < 0.0001). The interrater reliability increased from 0.78 to 0.89. More patients were treated with haloperidol (9.9% to 14.8%, P < 0.001), however with a lower dose (18 to 6 mg, P = 0.01) and for a shorter time period (5 [IQR:2–9] to 3 [IQR:1–5] days, P = 0.02).
Conclusions
With a tailored implementation strategy, a delirium assessment tool was successfully introduced in the ICU with the main goals achieved within four months. Early detection of delirium in critically ill patients increases the number of patients that receive treatment with haloperidol, however with a lower dose and for a shorter time period.
doi:10.1186/cc7991
PMCID: PMC2750188  PMID: 19664260
22.  The design of the SAFE or SORRY? study: a cluster randomised trial on the development and testing of an evidence based inpatient safety program for the prevention of adverse events 
Background
Patients in hospitals and nursing homes are at risk of the development of, often preventable, adverse events (AEs), which threaten patient safety. Guidelines for prevention of many types of AEs are available, however, compliance with these guidelines appears to be lacking. Besides general barriers that inhibit implementation, this non-compliance is associated with the large number of guidelines competing for attention. As implementation of a guideline is time-consuming, it is difficult for organisations to implement all available guidelines. Another problem is lack of feedback about performance using quality indicators of guideline based care and lack of a recognisable, unambiguous system for implementation. A program that allows organisations to implement multiple guidelines simultaneously may facilitate guideline use and thus improve patient safety.
The aim of this study is to develop and test such an integral patient safety program that addresses several AEs simultaneously in hospitals and nursing homes. This paper reports the design of this study.
Methods and design
The patient safety program addresses three AEs: pressure ulcers, falls and urinary tract infections. It consists of bundles and outcome and process indicators based on the existing evidence based guidelines. In addition it includes a multifaceted tailored implementation strategy: education, patient involvement, and a computerized registration and feedback system. The patient safety program was tested in a cluster randomised trial on ten hospital wards and ten nursing home wards. The baseline period was three months followed by the implementation of the patient safety program for fourteen months. Subsequently the follow-up period was nine months. Primary outcome measure was the incidence of AEs on every ward. Secondary outcome measures were the utilization of preventive interventions and the knowledge of nurses regarding the three topics. Randomisation took place on ward level. The results will be analysed separately for hospitals and nursing homes.
Discussion
Major challenges were the development of the patient safety program including a digital registration and feedback system and the implementation of the patient safety program.
Trial registration
Trial registration: ClinicalTrials.gov ID [NCT00365430]
doi:10.1186/1472-6963-9-58
PMCID: PMC2675519  PMID: 19338655
23.  The design of the Dutch EASYcare study: a randomised controlled trial on the effectiveness of a problem-based community intervention model for frail elderly people [NCT00105378] 
Background
Because of their complex clinical presentations and needs frail elderly people require another approach than people who age without many complications. Several inpatient geriatric health services have proven effectiveness in frail persons. However, the wish to live independently and policies that promote independent living as an answer to population aging call for community intervention models for frail elderly people. Maybe models such as preventive home visits, comprehensive geriatric assessment, and intermediate care qualify, but their efficacy is controversial, especially in frail elderly persons living in the community. With the Dutch EASYcare Study Geriatric Intervention Programme (DGIP) we developed a model to study effectiveness of problem based community intervention models in frail elderly people.
Methods/Design
DGIP is a community intervention model for frail elderly persons where the GP refers elderly patients with a problem in cognition, mood, behaviour, mobility, and nutrition. A geriatric specialist nurse applies a guideline-based intervention with a limited number of follow up visits. The intervention starts with the application of the EASYcare instrument for geriatric screening. The EASYcare instrument assesses (instrumental) activities of daily life, cognition, mood, and includes a goal setting item. During the intervention the nurse regularly consults the referring GP and a geriatrician. Effects on functional performance (Groningen Activity Restriction Scale), health related quality of life (MOS-20), and carer burden (Zarit Burden Interview) are studied in an observer blinded randomised controlled trial. 151 participants were randomised over two treatment arms – DGIP and regular care – using pseudo cluster randomisation. We are currently performing the follow up visits. These visits are planned three and six months after inclusion. Process measures and cost measures will be recorded. Intention to treat analyses will focus on post intervention differences between treatment groups.
Discussion
The design of a trial evaluating the effects of a community intervention model for frail elderly people was presented. The problem-based participant selection procedure satisfied; few patients that the GP referred did not meet our eligibility criteria. The use of standard terminology makes detailed insight into the contents of our intervention possible using terminology others can understand well.
doi:10.1186/1472-6963-5-65
PMCID: PMC1298295  PMID: 16207382

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