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author:("wollheim, Hub")
1.  Effects of auditing patient safety in hospital care: design of a mixed-method evaluation 
Background
Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little is known about their effects on the behaviour of healthcare professionals and patient safety outcomes. This study was initiated to evaluate the effects of patient safety auditing in hospital care and to explore the processes and mechanisms underlying these effects.
Methods and design
Our study aims to evaluate an audit system to monitor and improve patient safety in a hospital setting. We are using a mixed-method evaluation with a before-and-after study design in eight departments of one university hospital in the period October 2011–July 2014. We measure several outcomes 3 months before the audit and 15 months after the audit. The primary outcomes are adverse events and complications. The secondary outcomes are experiences of patients, the standardised mortality ratio, prolonged hospital stay, patient safety culture, and team climate. We use medical record reviews, questionnaires, hospital administrative data, and observations to assess the outcomes. A process evaluation will be used to find out which components of internal auditing determine the effects.
Discussion
We report a study protocol of an effect and process evaluation to determine whether auditing improves patient safety in hospital care. Because auditing is a complex intervention targeted on several levels, we are using a combination of methods to collect qualitative and quantitative data about patient safety at the patient, professional, and department levels. This study is relevant for hospitals that want to early detect unsafe care and improve patient safety continuously.
Trial registration
Netherlands Trial Register (NTR): NTR3343
doi:10.1186/1472-6963-13-226
PMCID: PMC3708817  PMID: 23800253
Hospital; Patient safety; Safety management; Risk management; Complications; Management system audit; Clinical governance; Professional practice; Adverse events; Auditing
2.  A strategy to enhance the safety and efficiency of handovers of ICU patients: study protocol of the pICUp study 
Background
To use intensive care unit (ICU) facilities efficiently and ensure high quality of care, an optimal patient flow is necessary. Discharging patients relieves the pressure on ICU beds but the risk of premature discharge must be managed carefully. Suboptimal patient discharge may result in ICU readmissions and in patients’ death.
The aim of this study is to obtain insight into the safety and efficiency of current ICU discharge practices and into barriers and facilitators to the implementation of effective ICU discharge interventions, and to develop an implementation strategy tailored to the barriers and facilitators identified.
Methods/design
This study exists of five phases. Phase A: analysis of routinely registered data on variation in ICU readmissions and hospital mortality after ICU discharge of all ICUs participating in the Dutch National Intensive Care Evaluation registry (n = 83). Phase B: systematic review of effective interventions aiming to improve the efficiency and safety of the ICU discharge process. Phase C: assessing the intervention adherence with a questionnaire survey among all Dutch ICUs (n = 90). Phase D: assessing barriers and facilitators to the implementation of effective ICU discharge interventions with a questionnaire survey among all Dutch intensivists (n = 700). The questionnaire will be based on barriers and facilitators identified by focus groups (n = 4) and individual interviews with professionals of ICUs and general wards and adult discharged ICU patients (n = 25 to 30). Phase E: systematic development of an implementation strategy based on the sampled data in phase A to D, and effective implementation strategies from the literature using the intervention mapping method.
Discussion
Using theory and empirical data, an implementation strategy will be developed to improve the safety and efficiency of the ICU discharge process. The developed strategy will be evaluated in a subsequent study. The knowledge obtained in this study should be used for further implementation of ICU discharge interventions, and can be used for implementation of handover interventions in other healthcare transition settings.
doi:10.1186/1748-5908-8-67
PMCID: PMC3697992  PMID: 23767696
Intensive care; Critical care; Patient safety; Quality of healthcare; Patient handoff; Patient readmission; Hospital mortality; Guideline adherence; Implementation
3.  Medication reconciliation at hospital admission and discharge: insufficient knowledge, unclear task reallocation and lack of collaboration as major barriers to medication safety 
Background
Medication errors are a leading cause of patient harm. Many of these errors result from an incomplete overview of medication either at a patient’s referral to or at discharge from the hospital. One solution is medication reconciliation, a formal process in which health care professionals partner with patients to ensure an accurate and complete transfer of medication information at interfaces of care. In 2007, the Dutch government compelled hospitals to implement a bundle concerning medication reconciliation at hospital admission and discharge. But to date many hospitals have failed to implement this bundle fully. The aim of this study was to gain insight into the barriers and drivers of the implementation process.
Methods
We performed face to face, semi-structured interviews with twenty health care professionals and managers from several departments at a 953 bed university hospital in the Netherlands and also from the surrounding community health services. The interviews were analysed using a combined theoretical framework of Grol and Cabana to classify the drivers and barriers identified.
Results
There is lack of awareness and insufficient knowledge of health care professionals about the health care problem and the bundle medication reconciliation. These result in a lack of support for implementing the bundle. In addition clinicians are reluctant to reallocate tasks to nurses or pharmacy technicians. Another major barrier is a lack of communication, understanding and collaboration between hospital and community caregivers. The introduction of more competitive market forces has made matters worse. Major drivers are a good implementation plan, patient awareness, and obligation by the government.
Conclusions
We identified a wide range of barriers and drivers which health care professionals believe influence the implementation of medication reconciliation. This reflects the complexity of implementation. Implementation can be improved if these factors are adequately addressed. The feasibility and effectiveness of these strategies should be tested in controlled trails.
doi:10.1186/1472-6963-12-170
PMCID: PMC3416693  PMID: 22721361
Adverse events; Safety; Quality; Medication reconciliation; Medication error; Implementation; Implementation barriers
4.  Evaluation of physicians' professional performance: An iterative development and validation study of multisource feedback instruments 
Background
There is a global need to assess physicians' professional performance in actual clinical practice. Valid and reliable instruments are necessary to support these efforts. This study focuses on the reliability and validity, the influences of some sociodemographic biasing factors, associations between self and other evaluations, and the number of evaluations needed for reliable assessment of a physician based on the three instruments used for the multisource assessment of physicians' professional performance in the Netherlands.
Methods
This observational validation study of three instruments underlying multisource feedback (MSF) was set in 26 non-academic hospitals in the Netherlands. In total, 146 hospital-based physicians took part in the study. Each physician's professional performance was assessed by peers (physician colleagues), co-workers (including nurses, secretary assistants and other healthcare professionals) and patients. Physicians also completed a self-evaluation. Ratings of 864 peers, 894 co-workers and 1960 patients on MSF were available. We used principal components analysis and methods of classical test theory to evaluate the factor structure, reliability and validity of instruments. We used Pearson's correlation coefficient and linear mixed models to address other objectives.
Results
The peer, co-worker and patient instruments respectively had six factors, three factors and one factor with high internal consistencies (Cronbach's alpha 0.95 - 0.96). It appeared that only 2 percent of variance in the mean ratings could be attributed to biasing factors. Self-ratings were not correlated with peer, co-worker or patient ratings. However, ratings of peers, co-workers and patients were correlated. Five peer evaluations, five co-worker evaluations and 11 patient evaluations are required to achieve reliable results (reliability coefficient ≥ 0.70).
Conclusions
The study demonstrated that the three MSF instruments produced reliable and valid data for evaluating physicians' professional performance in the Netherlands. Scores from peers, co-workers and patients were not correlated with self-evaluations. Future research should examine improvement of performance when using MSF.
doi:10.1186/1472-6963-12-80
PMCID: PMC3349515  PMID: 22448816
5.  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
6.  Development of indicators for patient-centred cancer care 
Supportive Care in Cancer  2009;18(1):121-130.
Purpose
Assessment of current practice with a valid set of indicators is the key to successfully improving the quality of patient-centred care. For improvement purposes, we developed indicators of patient-centred cancer care and tested them on a population of patients with non-small cell lung cancer (NSCLC).
Methods
Recommendations for patient-centred care were extracted from clinical guidelines, and patients were interviewed to develop indicators for assessing the patient-centredness of cancer care. These indicators were tested with regard to psychometric characteristics (room for improvement, applicability, discriminating capacity and reliability) on 132 patients with NSCLC treated in six hospitals in the east Netherlands. Data were collected from patients by means of questionnaires.
Results
Eight domains of patient-centred cancer care were extracted from 61 oncology guidelines and 37 patient interviews and were translated into 56 indicators. The practice test amongst patients with NSCLC showed the most room for improvement within the domains ‘emotional and psychosocial support’, ‘physical support’ and ‘information supply’. Overall, 26 of the 56 indicators had good psychometric characteristics.
Conclusions
Developing a valid set of patient-centred indicators is a first step towards improving the patient centredness of cancer care. Indicators can be based on recommendations from guidelines, but adding patient opinions leads to a more complete picture of patient centredness. The practice test on patients with NSCLC showed that the patient centredness of cancer care can be improved. Our set of indicators may also be useful for future quality assessments for other patients with cancers or chronic diseases.
doi:10.1007/s00520-009-0638-y
PMCID: PMC2778774  PMID: 19387693
Cancer; Oncology; Quality indicators; Health care; Patient-centred care; Quality of health care
7.  Systematic care for caregivers of people with dementia in the ambulatory mental health service: designing a multicentre, cluster, randomized, controlled trial 
BMC Geriatrics  2009;9:21.
Background
Care for people with dementia and their informal caregivers is a challenging aim in healthcare. There is an urgent need for cost-effective support programs that prevent informal caregivers of people with dementia from becoming overburdened, which might result in a delay or decrease of patient institutionalization. For this reason, we have developed the Systematic Care Program for Dementia (SCPD). The SCPD consists of an assessment of caregiver's sense of competence and suggestions on how to deal with competence deficiencies. The efficiency of the SCPD will be evaluated in our study.
Methods and design
In our ongoing, cluster, randomized, single-blind, controlled trial, the participants in six mental health services in four regions of the Netherlands have been randomized per service. Professionals of the ambulatory mental health services (psychologists and social psychiatric nurses) have been randomly allocated to either the intervention group or the control group. The study population consists of community-dwelling people with dementia and their informal caregivers (patient-caregiver dyads) coming into the health service. The dyads have been clustered to the professionals. The primary outcome measure is the patient's admission to a nursing home or home for the elderly at 12 months of follow-up. This measure is the most important variable for estimating cost differences between the intervention group and the control group. The secondary outcome measure is the quality of the patient's and caregiver's lives.
Discussion
A novelty in the SCPD is the pro-active and systematic approach. The focus on the caregiver's sense of competence is relevant to economical healthcare, since this sense of competence is an important determinant of delay of institutionalization of people with dementia. The SCPD might be able to facilitate this with a relatively small cost investment for caregivers' support, which could result in a major decrease in costs in the management of dementia. Implementation on a national level will be started if the SCPD proves to be efficient.
Trial Registration
NCT00147693
doi:10.1186/1471-2318-9-21
PMCID: PMC2703638  PMID: 19500421
8.  A retrospective cohort study on lifestyle habits of cardiovascular patients: how informative are medical records? 
Background
To evaluate the vigilance of medical specialists as to the lifestyle of their cardiovascular outpatients by comparing lifestyle screening as registered in medical records versus a lifestyle questionnaire (LSQ), a study was carried out at the cardiovascular outpatient clinic of the university hospital of Nijmegen, The Netherlands, between June 2004 and June 2005.
Methods
For 209 patients information from medical records on lifestyle habits, physician feedback, and interventions in the past year was compared to data gathered in the last month by a self-report LSQ.
Results
Doctors register smoking habits most consistently (90.4%), followed by alcohol use (81.8%), physical activity (50.2%), and eating habits (27.3%). Compared to the LSQ, smoking, unhealthy alcohol use, physical activity, and unhealthy eating habits are underreported in medical records by 31, 83, 54 and 97%, respectively. Feedback, advice or referral was documented in 8% for smoking, 3% for alcohol use, 12% for physical activity, and 26% for eating habits.
Conclusion
Lifestyle is insufficiently registered or recognized by doctors providing routine care in a cardiovascular outpatient setting. Of the unhealthy lifestyle habits that are registered, few are accompanied by notes on advice or intervention. A lifestyle questionnaire facilitates screening and interventions in target patients and should therefore be incorporated in the cardiovascular setting as a routine patient intake procedure.
doi:10.1186/1472-6963-9-59
PMCID: PMC2670825  PMID: 19338656
9.  Organizational interventions to implement improvements in patient care: a structured review of reviews 
Background
Changing the organization of patient care should contribute to improved patient outcomes as functioning of clinical teams and organizational structures are important enablers for improvement.
Objective
To provide an overview of the research evidence on effects of organizational strategies to implement improvements in patient care.
Design
Structured review of published reviews of rigorous evaluations.
Data sources
Published reviews of studies on organizational interventions.
Review methods
Searches were conducted in two data-bases (Pubmed, Cochrane Library) and in selected journals. Reviews were included, if these were based on a systematic search, focused on rigorous evaluations of organizational changes, and were published between 1995 and 2003.
Two investigators independently extracted information from the reviews regarding their clinical focus, methodological quality and main quantitative findings.
Results
A total of 36 reviews were included, but not all were high-quality reviews. The reviews were too heterogeneous for quantitative synthesis. None of the strategies produced consistent effects. Professional performance was generally improved by revision of professional roles and computer systems for knowledge management. Patient outcomes was generally improved by multidisciplinary teams, integrated care services, and computer systems. Cost savings were reported from integrated care services. The benefits of quality management remained uncertain.
Conclusion
There is a growing evidence base of rigorous evaluations of organizational strategies, but the evidence underlying some strategies is limited and for no strategy can the effects be predicted with high certainty.
doi:10.1186/1748-5908-1-2
PMCID: PMC1436010  PMID: 16722567
10.  Effectiveness of opportunistic brief interventions for problem drinking in a general hospital setting: systematic review 
BMJ : British Medical Journal  2004;328(7435):318.
Objective To determine the effectiveness of opportunistic brief interventions for problem drinking in a general hospital setting.
Design Systematic review.
Data sources Medline, PsychInfo, Cochrane Library, reference lists from identified studies and review articles, and contact with experts.
Main outcome measure Change in alcohol consumption.
Results Eight studies were retrieved. Most had methodological weaknesses. Only one study, with a relatively intensive intervention and a short follow up period, showed a significantly large reduction in alcohol consumption in the intervention group.
Conclusions Evidence for the effectiveness of opportunistic brief interventions in a general hospital setting for problem drinkers is still inconclusive.
doi:10.1136/bmj.37956.562130.EE
PMCID: PMC338095  PMID: 14729657
11.  The key actor: a qualitative study of patient participation in the handover process in Europe 
BMJ quality & safety  2012;21(Suppl_1):i89-i96.
Background
Patient safety experts have postulated that increasing patient participation in communications during patient handovers will improve the quality of patient transitions, and that this may reduce hospital readmissions. Choosing strategies that enhance patient safety through improved handovers requires better understanding of patient experiences and preferences for participation.
Objective
The aim of this paper is to explore the patients’ experiences and perspectives related to the handovers between their primary care providers and the inpatient hospital.
Methods
A qualitative secondary analysis was performed, based on individual and focus group patient interviews with 90 patients in five European countries.
Results
The analysis revealed three themes: patient positioning in the handover process; prerequisites for patient participation and patient preferences for the handover process. Patients’ participation ranged from being the key actor, to sharing the responsibility with healthcare professional(s), to being passive participants. For active participation patients required both personal and social resources as well as prerequisites such as information and respect. Some patients preferred to be the key actor in charge; others preferred their healthcare professionals to be the key actors in the handover.
Conclusions
Patients’ participation is related to the healthcare system, the activity of healthcare professionals’ and patients’ capacity for participation. Patients prefer a handover process where the responsibility is clear and unambiguous. Healthcare organisations need a clear and well-considered system of responsibility for handover processes, that takes into account the individual patient's need of clarity, and support in relation to his/hers own recourses.
doi:10.1136/bmjqs-2012-001171
PMCID: PMC3551200  PMID: 23112290
Patient-centred care; Transitions in care; Qualitative research

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