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1.  Research funders’ roles and perceived responsibilities in relation to the implementation of clinical research results: a multiple case study of Swedish research funders 
Implementation of clinical research results is challenging, yet the responsibility for implementation is seldom addressed. The process from research to the use of clinical research results in health care can be facilitated by research funders. In this paper, we report the roles of ten Swedish research funders in relation to implementation and their views on responsibilities in implementation.
Ten cases were studied and compared using semi-structured interviews. In addition, websites and key documents were reviewed. Eight facilitative roles for research funders in relation to the implementation of clinical research results were identified. Three of them were common for several funders: “Advocacy work,” “Monitoring implementation outcomes,” and “Dissemination of knowledge.” Moreover, the research funders identified six different actors responsible for implementation, five of which belonged to the healthcare setting. Collective and organizational responsibilities were the most common forms of responsibilities among the identified actors responsible for implementation.
The roles commonly identified by the Swedish funders, “Advocacy work,” “Monitoring implementation outcomes,” and “Dissemination of knowledge,” seem feasible facilitative roles in relation to the implementation of clinical research results. However, many actors identified as responsible for implementation together with the fact that collective and organizational responsibilities were the most common forms of responsibilities entail a risk of implementation becoming no one’s responsibility.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-015-0290-5) contains supplementary material, which is available to authorized users.
PMCID: PMC4506440  PMID: 26183210
Quality improvement; Implementation responsibility; Support of research; Research funder roles
2.  Coping styles in substance use disorder (SUD) patients with and without co-occurring attention deficit/hyperactivity disorder (ADHD) or autism spectrum disorder (ASD) 
BMC Psychiatry  2015;15:159.
Patients with a substance use disorder (SUD) and co-occurring attention deficit hyperactivity disorder (ADHD) or autism spectrum disorder (ASD) often start using substances in an attempt to cope with the stress related to their ADHD or ASD. To improve treatment for these patient groups, it is important to identify and compare the various coping styles between SUD patients with and without ADHD or ASD and with subjects from a general population sample.
Cross-sectional study using the Utrecht Coping List (UCL) in 50 SUD patients, 41 SUD + ADHD patients, 31 SUD + ASD patients and 1,200 railway employees.
Compared with the reference group, all three SUD groups showed a significant higher mean on the Palliative reaction, Avoidance, and Passive reaction subscales of the UCL. The scores for all UCL subscales of the SUD and the SUD + ADHD groups were very similar. However, the SUD + ASD group scored higher on Passive reaction and lower on Reassuring thoughts than the SUD and the SUD + ADHD groups and lower on Expression of emotions subscale in comparison with the SUD + ADHD group.
Regardless of the presence of a co-occurring disorder, SUD patients reported more palliative, avoidant and passive coping when confronted than people in the general population. In addition, SUD patients with co-occurring ASD were different from other SUD patients in their coping and professionals should take this into account when working on more adaptive coping strategies with these patients.
PMCID: PMC4501102  PMID: 26169586
Coping styles; Substance Use Disorder; Attention Deficit/Hyperactivity Disorder; Autism Spectrum Disorder
3.  Nurse staffing and education and hospital mortality in nine European countries: a retrospective observational study 
Lancet  2014;383(9931):1824-1830.
Austerity measures and health-system redesign to minimise hospital expenditures risk adversely affecting patient outcomes. The RN4CAST study was designed to inform decision making about nursing, one of the largest components of hospital operating expenses. We aimed to assess whether differences in patient to nurse ratios and nurses’ educational qualifications in nine of the 12 RN4CAST countries with similar patient discharge data were associated with variation in hospital mortality after common surgical procedures.
For this observational study, we obtained discharge data for 422 730 patients aged 50 years or older who underwent common surgeries in 300 hospitals in nine European countries. Administrative data were coded with a standard protocol (variants of the ninth or tenth versions of the International Classification of Diseases) to estimate 30 day in-hospital mortality by use of risk adjustment measures including age, sex, admission type, 43 dummy variables suggesting surgery type, and 17 dummy variables suggesting comorbidities present at admission. Surveys of 26 516 nurses practising in study hospitals were used to measure nurse staffing and nurse education. We used generalised estimating equations to assess the effects of nursing factors on the likelihood of surgical patients dying within 30 days of admission, before and after adjusting for other hospital and patient characteristics.
An increase in a nurses’ workload by one patient increased the likelihood of an inpatient dying within 30 days of admission by 7% (odds ratio 1·068, 95% CI 1·031–1·106), and every 10% increase in bachelor’s degree nurses was associated with a decrease in this likelihood by 7% (0·929, 0·886–0·973). These associations imply that patients in hospitals in which 60% of nurses had bachelor’s degrees and nurses cared for an average of six patients would have almost 30% lower mortality than patients in hospitals in which only 30% of nurses had bachelor’s degrees and nurses cared for an average of eight patients.
Nurse staffing cuts to save money might adversely affect patient outcomes. An increased emphasis on bachelor’s education for nurses could reduce preventable hospital deaths.
European Union’s Seventh Framework Programme, National Institute of Nursing Research, National Institutes of Health, the Norwegian Nurses Organisation and the Norwegian Knowledge Centre for the Health Services, Swedish Association of Health Professionals, the regional agreement on medical training and clinical research between Stockholm County Council and Karolinska Institutet, Committee for Health and Caring Sciences and Strategic Research Program in Care Sciences at Karolinska Institutet, Spanish Ministry of Science and Innovation.
PMCID: PMC4035380  PMID: 24581683
4.  Nurses’ worry or concern and early recognition of deteriorating patients on general wards in acute care hospitals: a systematic review 
Critical Care  2015;19(1):230.
Nurses often recognize deterioration in patients through intuition rather than through routine measurement of vital signs. Adding the ‘worry or concern’ sign to the Rapid Response System provides opportunities for nurses to act upon their intuitive feelings. Identifying what triggers nurses to be worried or concerned might help to put intuition into words, and potentially empower nurses to act upon their intuitive feelings and obtain medical assistance in an early stage of deterioration. The aim of this systematic review is to identify the signs and symptoms that trigger nurses’ worry or concern about a patient’s condition.
We searched the databases PubMed, CINAHL, Psychinfo and Cochrane Library (Clinical Trials) using synonyms related to the three concepts: ‘nurses’, ‘worry/concern’ and ‘deterioration’. We included studies concerning adult patients on general wards in acute care hospitals. The search was performed from the start of the databases until 14 February 2014.
The search resulted in 4,006 records, and 18 studies (five quantitative, nine qualitative and four mixed-methods designs) were included in the review. A total of 37 signs and symptoms reflecting the nature of the criterion worry or concern emerged from the data and were summarized in 10 general indicators. The results showed that worry or concern can be present with or without change in vital signs.
The signs and symptoms we found in the literature reflect the nature of nurses’ worry or concern, and nurses may incorporate these signs in their assessment of the patient and their decision to call for assistance. The fact that it is present before changes in vital signs suggests potential for improving care in an early stage of deterioration.
Electronic supplementary material
The online version of this article (doi:10.1186/s13054-015-0950-5) contains supplementary material, which is available to authorized users.
PMCID: PMC4461986  PMID: 25990249
5.  Cost effectiveness of interpersonal community psychiatric treatment for people with long-term severe non-psychotic mental disorders: protocol of a multi-centre randomized controlled trial 
BMC Psychiatry  2015;15:100.
This study aims for health gain and cost reduction in the care for people with long-term non-psychotic psychiatric disorders. Present care for this population has a limited evidence base, is often open ended, little effective, and expensive. Recent epidemiological data shows that 43.5% of the Dutch are affected by mental illness during their life. About 80% of all patients receiving mental health services (MHS) have one or more non-psychotic disorders. Particularly for this group, long-term treatment and care is poorly developed. Care As Usual (CAU) currently is a form of low-structured treatment/care. Interpersonal Community Psychiatric Treatment (ICPT) is a structured treatment for people with long-term, non-psychotic disorders, developed together with patients, professionals, and experts. ICPT uses a number of evidence-based techniques and was positively evaluated in a controlled pilot study.
Multi-centre cluster-randomized clinical trial: 36 professionals will be randomly allocated to either ICPT or CAU for an intervention period of 12 months, and a follow-up of 6 months. 180 Patients between 18–65 years of age will be included, who have been diagnosed with a non-psychotic psychiatric disorder (depressive, anxiety, personality or substance abuse disorder), have long-term (>2 years) or high care use (>1 outpatient contact per week or >2 crisis contacts per year or >1 inpatient admission per year), and who receive treatment in a specialized mental health care setting. The primary outcome variable is quality of life; secondary outcomes are costs, recovery, general mental health, therapeutic alliance, professional-perceived difficulty of patient, care needs and social contacts.
No RCT, nor cost-effectiveness study, has been conducted on ICPT so far. The empirical base for current CAU is weak, if not absent. This study will fill this void, and generate data needed to improve daily mental health care.
Trial registration
Netherlands Trial Register (NTR): 3988. Registered 13th of May 2013.
PMCID: PMC4422542  PMID: 25934175
Severe mental illness; Community mental health care; Long-term care; Cluster randomized controlled trial; Cost-effectiveness
6.  Factors influencing ambulance nurses’ adherence to a national protocol ambulance care: an implementation study in the Netherlands 
Adherence to prehospital guidelines and protocols is suboptimal. Insight into influencing factors is necessary to improve adherence. The aim of this study was to identify factors that influence ambulance nurses’ adherence to a National Protocol Ambulance Care (NPAC).
A questionnaire was developed using the literature, a questionnaire and expert opinion. Ambulance nurses (n=452) from four geographically spread emergency medical services (EMSs) in the Netherlands were invited to fill out the questionnaire. The questionnaire included questions on influencing factors and self-reported adherence.
Questionnaires were returned by 248 (55%) of the ambulance nurses. These ambulance nurses’ adherence to the NPAC was 83.4% (95% confidence interval 81.9–85.0). Bivariate correlations showed 23 influencing factors that could be related to the individual professional, organization, protocol characteristics and social context. Multilevel regression analysis showed that 21% of the variation in adherence (R2=0.208) was explained by protocol characteristics and social influences.
Ambulance nurses’ self-reported adherence to the NPAC seems high. To improve adherence, protocol characteristics (complexity, the degree of support for diagnosis and treatment, the relationship of the protocol with patient outcomes) and social influences (expectance of colleagues to work with the national protocol) should be addressed.
PMCID: PMC4410961  PMID: 24595355
clinical protocols; emergency medical services; emergency medical technicians; guideline adherence
7.  Improvement of care for ICU patients with delirium by early screening and treatment: study protocol of iDECePTIvE study 
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.
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.
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
PMCID: PMC4192432  PMID: 25273854
Intensive care; Critical care; Delirium; Screening; Delirium management; Implementation; Guideline
8.  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;14:264.
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.
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.
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.
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.
PMCID: PMC4173065  PMID: 25234344
Substance use disorders; Attention deficit hyperactivity disorder; Autism spectrum disorder; Everyday life consequences; Adults
9.  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.
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.
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.
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 are expected to be ready in mid 2014.
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.
PMCID: PMC4129115  PMID: 25048598
governance, long-term care, executive board, patient safety, WalkRounds, soft signals
10.  Prevalence of interpersonal trauma exposure and trauma-related disorders in severe mental illness 
European Journal of Psychotraumatology  2013;4:10.3402/ejpt.v4i0.19985.
Interpersonal trauma exposure and trauma-related disorders in people with severe mental illness (SMI) are often not recognized in clinical practice.
To substantiate the prevalence of interpersonal trauma exposure and trauma-related disorders in people with SMI.
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.
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.
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.
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
11.  Explaining the effects of two different strategies for promoting hand hygiene in hospital nurses: a process evaluation alongside a cluster randomised controlled trial 
There is only limited understanding of why hand hygiene improvement strategies are successful or fail. It is therefore important to look inside the ‘black box’ of such strategies, to ascertain which components of a strategy work well or less well. This study examined which components of two hand hygiene improvement strategies were associated with increased nurses’ hand hygiene compliance.
A process evaluation of a cluster randomised controlled trial was conducted in which part of the nursing wards of three hospitals in the Netherlands received a state-of-the-art strategy, including education, reminders, feedback, and optimising materials and facilities; another part received a team and leaders-directed strategy that included all elements of the state-of-the-art strategy, supplemented with activities aimed at the social and enhancing leadership. This process evaluation used four sets of measures: effects on nurses’ hand hygiene compliance, adherence to the improvement strategies, contextual factors, and nurses’ experiences with strategy components. Analyses of variance and multiple regression analyses were used to explore changes in nurses’ hand hygiene compliance and thereby better understand trial effects.
Both strategies were performed with good adherence to protocol. Two contextual factors were associated with changes in hand hygiene compliance: a hospital effect in long term (p < 0.05), and high hand hygiene baseline scores were associated with smaller effects (p < 0.01). In short term, changes in nurses’ hand hygiene compliance were positively correlated with experienced feedback about their hand hygiene performance (p < 0.05). In the long run, several items of the components ‘social influence’ (i.e., addressing each other on undesirable hand hygiene behaviour p < 0.01), and ‘leadership’ (i.e., ward manager holds team members accountable for hand hygiene performance p < 0.01) correlated positively with changes in nurses’ hand hygiene compliance.
This study illustrates the use of a process evaluation to uncover mechanisms underlying change in hand hygiene improvement strategies. Our study results demonstrate the added value of specific aspects of social influence and leadership in hand hygiene improvement strategies, thus offering an interpretation of the trial effects.
Trial registration
The study is registered in, dossier number: NCT00548015.
PMCID: PMC3646709  PMID: 23566429
Process evaluation; Quality improvement; Implementation; Handwashing; Infection control; Randomised controlled trial; Leadership
12.  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.
PMCID: PMC3599067  PMID: 23422062
Emergency medical technicians [MeSH]; Emergency medical services [MeSH]; Emergency medicine [MeSH]; Emergency nursing [MeSH]; Guideline adherence [MeSH]
13.  Barriers, facilitators and attitudes influencing health promotion activities in general practice: an explorative pilot study 
BMC Family Practice  2013;14:20.
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.
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.
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.
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.
PMCID: PMC3575260  PMID: 23394162
Life styles; Family practice; Family nursing; Implementation; Qualitative study; Attitude
14.  Haloperidol prophylaxis in critically ill patients with a high risk for delirium 
Critical Care  2013;17(1):R9.
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.
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.
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.
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 Identifier: NCT01187667.
PMCID: PMC4056261  PMID: 23327295
15.  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.
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.
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.
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 Protocol Registration System: NCT01499797
PMCID: PMC3527269  PMID: 23216685
Frail elderly; Complex intervention; Integrated care; Functional status; Cost-effectiveness; Implementation; Process evaluation; Primary care
16.  Factors influencing the implementation of a lifestyle counseling program in patients with venous leg ulcers: a multiple case study 
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.
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.
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.
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.
PMCID: PMC3520793  PMID: 23101504
Lifestyle; Varicose ulcer; Venous leg ulcers; Implementation; Case study
17.  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.
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.
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).
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.
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.
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.
PMCID: PMC3626145  PMID: 23611877
Self-care; cooperative behavior; interdisciplinary communication; electronic health records; frail elderly
18.  A systematic review of hand hygiene improvement strategies: a behavioural approach 
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.
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.
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.
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.
PMCID: PMC3517511  PMID: 22978722
Hospital-acquired infection; Behaviour; Quality improvement; Handwashing; Program evaluation; Review
19.  Implementation of an innovative web-based conference table for community-dwelling frail older people, their informal caregivers and professionals: a process evaluation 
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.
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).
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.
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.
PMCID: PMC3470954  PMID: 22894654
E-health; Implementation; Process evaluation; Frail older people; Primary care
20.  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.
PMCID: PMC3496479  PMID: 22359099
Lynch syndrome; Colonoscopy; Polyethylene glycol; Sodium phosphate
21.  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.
PMCID: PMC3565683  PMID: 23430944
22.  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.
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.
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.
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.
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).
PMCID: PMC3388649  PMID: 22206727
23.  Sample size considerations for GEE analyses of three-level cluster randomized trials 
Biometrics  2010;66(4):1230-1237.
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.
PMCID: PMC2896994  PMID: 20070297
Cluster randomization; Generalized Estimating Equations (GEE); Sample size; Sandwich estimator; Small sample correction; Three-level data; Power
24.  Helping hands: A cluster randomised trial to evaluate the effectiveness of two different strategies for promoting hand hygiene in hospital nurses 
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.
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.
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, dossier number: NCT00548015.
PMCID: PMC3177889  PMID: 21888660
25.  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.
PMCID: PMC3168942  PMID: 22007329

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