Increased adherence to perioperative safety guidelines associated with improved patient safety outcomes: a stepped-wedge, cluster-randomised multicentre trial.

BACKGROUND: National Dutch guidelines have been introduced to improve suboptimal perioperative care. A multifaceted implementation programme (IMPlementatie Richtlijnen Operatieve VEiligheid [IMPROVE]) has been developed to support hospitals in applying these guidelines. This study evaluated the effectiveness of IMPROVE on guideline adherence and the association between guideline adherence and patient safety. METHODS: Nine hospitals participated in this unblinded, superiority, stepped-wedge, cluster RCT in patients with major noncardiac surgery (mortality risk ≥1%). IMPROVE consisted of educational activities, audit and feedback, reminders, organisational, team-directed, and patient-mediated activities. The primary outcome of the study was guideline adherence measured by nine patient safety indicators on the process (stop moments from the composite STOP bundle, and timely administration of antibiotics) and on the structure of perioperative care. Secondary safety outcomes included in-hospital complications, postoperative wound infections, mortality, length of hospital stay, and unplanned care. RESULTS: Data were analysed for 1934 patients. The IMPROVE programme improved one stop moment: 'discharge from recovery room' (+16%; 95% confidence interval [CI], 9-23%). This stop moment was related to decreased mortality (-3%; 95% CI, -4% to -1%), fewer complications (-8%; 95% CI, -13% to -3%), and fewer unscheduled transfers to the ICU (-6%; 95% CI, -9% to -3%). IMPROVE negatively affected one other stop moment - 'discharge from the hospital' - possibly because of the limited resources of hospitals to improve all stop moments together. CONCLUSIONS: Mixed implementation effects of IMPROVE were found. We found some positive associations between guideline adherence and patient safety (i.e. mortality, complications, and unscheduled transfers to the ICU) except for the timely administration of antibiotics. CLINICAL TRIAL REGISTRATION: NTR3568 (Dutch Trial Registry).

Complexity and involvement as implementation challenges: results from a process analysis.

BACKGROUND: The study objective was to analyse the implementation challenges experienced in carrying out the IMPROVE programme. This programme was designed to implement checklist-related improvement initiatives based on the national perioperative guidelines using a stepped-wedge trial design. A process analysis was carried out to investigate the involvement in the implementation activities. METHODS: An involvement rating measure was developed to express the extent to which the implementation programme was carried out in the hospitals. This measure reflects the number of IMPROVE-implementation activities executed and the estimated participation in these activities in all nine participating hospitals. These data were compared with prospectively collected field notes. RESULTS: Considerable variation between the hospitals was found with involvement ratings ranging from 0 to 6 (mean per measurement = 1.83 on a scale of 0-11). Major implementation challenges were respectively the study design (fixed design, time planning, long duration, repeated measurements, and data availability); the selection process of hospitals, departments and key contact person(s) (inadequately covering the entire perioperative team and stand-alone surgeons); the implementation programme (programme size and scope, tailoring, multicentre, lack of mandate, co-interventions by the Inspectorate, local intervention initiatives, intervention fatigue); and competitive events such as hospital mergers or the introduction of new IT systems, all reducing involvement. CONCLUSIONS: The process analysis approach helped to explain the limited and delayed execution of the IMPROVE-implementation programme. This turned out to be very heterogeneous between hospitals, with variation in the number and content of implementation activities carried out. The identified implementation challenges reflect a high complexity with regard to the implementation programme, study design and setting. The involvement of the target professionals was put under pressure by many factors. We mostly encountered challenges, but at the same time we provide solutions for addressing them. A less complex implementation programme, a less fixed study design, a better thought-out selection of contact persons, as well as more commitment of the hospital management and surgeons would likely have contributed to better implementation results. TRIAL REGISTRATION: Dutch Trial Registry: NTR3568 , retrospectively registered on 2 August 2012.

Development of a tool for identifying and addressing prioritised determinants of quality improvement initiatives led by healthcare professionals: a mixed-methods study.

BACKGROUND: Several frameworks have been developed to identify essential determinants for healthcare improvement. These frameworks aim to be comprehensive, leading to the creation of long lists of determinants that are not prioritised based on being experienced as most important. Furthermore, most existing frameworks do not describe the methods or actions used to identify and address the determinants, limiting their practical value. The aim of this study is to describe the development of a tool with prioritised facilitators and barriers supplemented with methods to identify and address each determinant. The tool can be used by those performing quality improvement initiatives in healthcare practice. METHODS: A mixed-methods study design was used to develop the tool. First, an online survey was used to ask healthcare professionals about the determinants they experienced as most facilitating and most hindering during the performance of their quality improvement initiative. A priority score was calculated for every named determinant, and those with a priority score ≥ 20 were incorporated into the tool. Semi-structured interviews with implementation experts were performed to gain insight on how to analyse and address the determinants in our tool. RESULTS: The 25 healthcare professionals in this study experienced 64 facilitators and 66 barriers when performing their improvement initiatives. Of these, 12 facilitators and nine barriers were incorporated into the tool. Sufficient support from management of the department was identified as the most important facilitator, while having limited time to perform the initiative was considered the most important barrier. The interviews with 16 experts in implementation science led to various inputs for identifying and addressing each determinant. Important themes included maintaining adequate communication with stakeholders, keeping the initiative at a manageable size, learning by doing and being able to influence determinants. CONCLUSIONS: This paper describes the development of a tool with prioritised determinants for performing quality improvement initiatives with suggestions for analysing and addressing these determinants. The tool is developed for those engaged in quality improvement initiatives in practice, so in this way it helps in bridging the research to practice gap of determinants frameworks. More research is needed to validate and develop the tool further.

Reducing work pressure and IT problems and facilitating IT integration and audit & feedback help adherence to perioperative safety guidelines: a survey among 95 perioperative professionals.

BACKGROUND: To improve perioperative patient safety, guidelines for the preoperative, peroperative, and postoperative phase were introduced in the Netherlands between 2010 and 2013. To help the implementation of these guidelines, we aimed to get a better understanding of the barriers and drivers of perioperative guideline adherence and to explore what can be learned for future implementation projects in complex organizations. METHODS: We developed a questionnaire survey based on the theoretical framework of Van Sluisveld et al. for classifying barriers and facilitators. The questionnaire contained 57 statements derived from (a) an instrument for measuring determinants of innovations by the Dutch Organization for Applied Scientific Research, (b) interviews with quality and safety policy officers and perioperative professionals, and (c) a publication of Cabana et al. The target group consisted of 232 perioperative professionals in nine hospitals. In addition to rating the statements on a five-point Likert scale (which were classified into the seven categories of the framework: factors relating to the intervention, society, implementation, organization, professional, patients, and social factors), respondents were invited to rank their three most important barriers in a separate, extra open-ended question. RESULTS: Ninety-five professionals (41%) completed the questionnaire. Fifteen statements (26%) were considered to be barriers, relating to social factors (N = 5), the organization (N = 4), the professional (N = 4), the patient (N = 1), and the intervention (N = 1). An integrated information system was considered an important facilitator (70.4%) as well as audit and feedback (41.8%). The Barriers Top-3 question resulted in 75 different barriers in nearly all categories. The most frequently reported barriers were as follows: time pressure (16% of the total number of barriers), emergency patients (8%), inefficient IT structure (4%), and workload (3%). CONCLUSIONS: We identified a wide range of barriers that are believed to hinder the use of the perioperative safety guidelines, while an integrated information system and local data collection and feedback will also be necessary to engage perioperative teams. These barriers need to be locally prioritized and addressed by tailored implementation strategies. These results may also be of relevance for guideline implementation in general in complex organizations. TRIAL REGISTRATION: Dutch Trial Registry: NTR3568.

Does a Long-Term Quality and Safety Curriculum for Health Care Professionals Improve Clinical Practice? An Evaluation of Quality Improvement Projects.

INTRODUCTION: Little is known about the effects on clinical practice of continuing education quality and safety curricula. The aim of this study is to gain insight into learning outcomes on the fourth level of the Kirkpatrick evaluation model for systematically deployed quality improvement projects performed by health care professionals during a Masters in Healthcare Quality and Safety in the Netherlands. METHODS: The researchers reviewed 35 projects led by health care professionals in 16 different hospitals to determine their scopes and effects. Afterward, professionals took an online survey to determine the extent of their project's sustainability and spread. RESULTS: Improving health care safety was the most prevalent quality dimension (n = 11, 31%). A positive change was measured by professionals for 64% (n = 35) of the primary outcomes. Statistical significance was measured in 19 (35%) of the outcomes, of which nine (47%) were found to have a statistically significant effect. A minority of professionals (17%) judged their project as sustained by the department, while some stated that the intervention (37%) or the results of the project (11%) had spread. DISCUSSION: Although most projects indicated an improvement in their primary outcomes, only a few resulted in statistically significant changes. Teaching professionals in using evaluation methods that take into account the complex context where these projects are performed and teaching them leadership skills is needed to reduce the likelihood of unmeasured outcomes. Analyzing learning experiences of professionals in performing the project is important to see what they learned from performing quality improvement projects, providing experiences that may lead to sustainable effects in future projects.

Case-mix adjustment for diabetes indicators: a systematic review.

OBJECTIVES: Case-mix adjustment is generally considered indispensable for fair comparison of healthcare performance. Inaccurate results are also unfair to patients as they are ineffective for improving quality. However, little is known about what factors should be adjusted for. We reviewed case-mix factors included in adjustment models for key diabetes indicators, the rationale for their inclusion, and their impact on performance. STUDY DESIGN: Systematic review. METHODS: This systematic review included studies published up to June 2013 addressing case-mix factors for 6 key diabetes indicators: 2 outcomes and 2 process indicators for glycated hemoglobin (A1C), low-density lipoprotein cholesterol, and blood pressure. Factors were categorized as demographic, diabetes-related, comorbidity, generic health, geographic, or care-seeking, and were evaluated on the rationale for inclusion in the adjustment models, as well as their impact on indicator scores and ranking. RESULTS: Thirteen studies were included, mainly addressing A1C value and measurement. Twenty-three different case-mix factors, mostly demographic and diabetes-related, were identified, and varied from 1 to 14 per adjustment model. Six studies provided selection motives for the inclusion of case-mix factors. Marital status and body mass index showed a significant impact on A1C value. For the other factors, either no or conflicting associations were reported, or too few studies (n ≤ 2) investigated this association. CONCLUSIONS: Scientific knowledge about the relative importance of case-mix factors for diabetes indicators is emerging, especially for demographic and diabetes-related factors and indicators on A1C, but is still limited. Because arbitrary adjustment potentially results in inaccurate quality information, meaningful stratification that demonstrates inequity in care might be a better guide, as it can be a driver for quality improvement.

Improving the implementation of perioperative safety guidelines using a multifaceted intervention approach: protocol of the IMPROVE study, a stepped wedge cluster randomized trial.

BACKGROUND: This study is initiated to evaluate the effects, costs, and feasibility at the hospital and patient level of an evidence-based strategy to improve the use of Dutch perioperative safety guidelines. Based on current knowledge, expert opinions and expertise of the project team, a multifaceted implementation strategy has been developed. METHODS/DESIGN: This is a stepped wedge cluster randomized trial including nine representative hospitals across The Netherlands. Hospitals are stratified into three groups according to hospital type and geographical location and randomized in terms of the period for receipt of the intervention. All adult surgical patients meeting the inclusion criteria are assessed for patient outcomes. The implementation strategy includes education, audit and feedback, organizational interventions (e.g., local embedding of the guidelines), team-directed interventions (e.g., multi-professional team training), reminders, as well as patient-mediated interventions (e.g., patient safety cards). To tailor the implementation activities, we developed a questionnaire to identify barriers for effective guideline adherence, based on (a) a theoretical framework for classifying barriers and facilitators, (b) an instrument for measuring determinants of innovations, and (c) 19 semi-structured interviews with perioperative key professionals. Primary outcome is guideline adherence measured at the hospital (i.e., cluster) and patient levels by a set of perioperative Patient Safety Indicators (PSIs), which was developed parallel to the perioperative guidelines. Secondary outcomes at the patient level are in-hospital complications, postoperative wound infections and mortality, length of hospital stay, and unscheduled transfer to the intensive care unit, non-elective readmission to the hospital and unplanned reoperation, all within 30 days after the initial surgery. Also, patient safety culture and team climate will be studied as potential determinants. Finally, a process evaluation is conducted to identify the compliance with the implementation strategy, as well as an economic evaluation to assess the costs. Data sources are registered clinical data and surveys. There is no form of blinding. DISCUSSION: The perioperative setting is an unexplored area with respect to implementation issues. This study is expected to yield important new evidence about the effects of a multifaceted approach on guideline adherence in the perioperative care setting. TRIAL REGISTRATION: Dutch trial registry: NTR3568.

The impact of a standardized incident reporting system in the perioperative setting: a single center experience on 2,563 'near-misses' and adverse events.

BACKGROUND: The reduction of perioperative harm is a major priority of in-hospital health care and the reporting of incidents and their causes is an important source of information to improve perioperative patient safety. We explored the number, nature and causes of voluntarily reported perioperative incidents in order to highlight the areas where further efforts are required to improve patient safety. METHODS: Data from the Hospital Incident Management System (HIMS), entered in the period from July 2009 to July 2012, were analyzed in a Dutch university hospital. Employees in the perioperatve field filled out a semi-structured digital form of the reporting system. The risk classification of the reported adverse events and 'near misses' was based on the estimated patient consequences and the risk of recurrence, according to national guidelines. Predefined reported incident causes were categorized as human, organizational, technical and patient related. RESULTS: In total, 2,563 incidents (1,300 adverse events and 1,263 'near-miss' events) were reported during 67,360 operations. Reporters were anesthesia, operating room and recovery nurses (37%), ward nurses (31%), physicians (17%), administrative personnel (5%), others (6%) and unmentioned (3%). A total of 414 (16%) adverse events had patient consequences (which affected 0,6% of all surgery patients), estimated as catastrophic in 2, very serious in 34, serious in 105, and marginally serious in 273 cases. Shortcomings in communication was the most frequent reported type of incidents. Non-compliance with Standard Operating Procedures (SOPs: instructions, regulations, protocols and guidelines) was reported with 877 (34%) of incident reports. In total, 1,194 (27%) voluntarily reported causes were SOP-related, mainly human-based (79%) and partially organization-based (21%). SOP-related incidents were not associated with more patient consequences than other voluntarily reported incidents. Furthermore 'mistake or forgotten' (15%) and 'communication problems' (11%) were frequently reported causes of incidents. CONCLUSIONS: The analysis of voluntarily reported perioperative incidents identified an association between perioperative patient safety problems and human failure, such as SOP non-compliance, mistakes, forgetting, and shortcomings in communication. The data suggest that professionals themselves indicate that SOP compliance in combination with other human failures provide room for improvement.

Performance measurements in diabetes care: the complex task of selecting quality indicators.

PURPOSE: To review the literature on the content and development of the sets of quality indicators used in studies on the quality of diabetes care in primary care settings. DATA SOURCES: The MEDLINE (Ovid), PubMed, PsychINFO, Embase and CINAHL databases were searched for relevant articles published up to January 2011. STUDY SELECTION: and data extraction We included studies on the quality of adult diabetes care, using quality indicators. We excluded studies focusing on the hospital setting, patient subgroups, specific components of diabetes care and specific outcomes. In total, 102 studies (including 102 sets and 1494 indicators) were analyzed by two independent reviewers, using the criteria of the National Quality Measures Clearinghouse and international guidelines to document the content and selection of the identified indicators. RESULTS OF DATA SYNTHESIS: Sets varied greatly in number, content and definitions of quality indicators. Most of the indicators concerned HbA1C, lipids, blood pressure, eye and foot examination and urinalysis. Few sets included indicators on lifestyle counseling, patient experiences, healthcare structure or access to healthcare providers. Seventy sets did not specify explicit selection criteria, and 19 of these did not report the sources of the indicators. CONCLUSIONS: Sets of quality indicators are diverse in number, content and definitions. This diversity reflects a lack of uniformity in the concept of diabetes care quality and hinders the interpretation of and comparison between quality assessments. Methodology regarding defining constructs such as the quality of diabetes care and indicator selection procedures is available and should be used more rigorously.

Stakeholders' perspectives on quality indicators for diabetes care: a qualitative study.

BACKGROUND: Transparency in diabetes care requires quality indicators that are of interest to stakeholders in order to optimise their usage. Indicator development is often focused on consensus, and little is known about stakeholders' preferences for information on quality. AIM: To explore the preferences of consumers, providers, purchasers and policy makers for different quality domains and indicators in relation to the intended use of quality indicators. METHODS: Between June and December 2009, 14 semi-structured interviews were held with stakeholders who have a decisive vote in the selection of the national indicator set for diabetes care in the Netherlands. The following subjects were explored: (1) the aims of using information on quality; (2) the interpretation of and preferences for the quality domains of safety, timeliness, effectiveness and patient-centredness in relation to the user aims; and (3) the preferences for structure, process or outcome indicators. Content analysis was used to analyse qualitative data. RESULTS: Stakeholders had similar and different aims according to their roles. The interpretations of quality domains varied greatly between the stakeholders. Besides differences in interpretation, their preferences were similar. Most stakeholders prioritised patient-centredness above the other domains of quality, ranked in order of priority as safety, effectiveness and timeliness, whereas purchasers also prioritised efficiency. All stakeholders preferred to use process indicators or a mix of process and outcome indicators. CONCLUSIONS: The preferences of the stakeholders for quality indicators seem to be neither well-refined nor congruent. The implementation of an indicator set can probably be improved if the stakeholders' definitions and preferences for quality domains become more explicit during the selection process for indicators.

Knowledge and attitudes towards genetic testing: a two year follow-up study in patients with asthma, diabetes mellitus and cardiovascular disease.

Adequate knowledge and personal attitudes towards DNA-testing are major determinants of optimal utilization of genetic testing. This study aims to (1) assess the genetic knowledge and attitude towards genetic testing of patients with asthma, diabetes mellitus type II and cardiovascular diseases, (2) determine whether their knowledge or attitude changed since 2002, and (3) investigate the predictive role of knowledge on attitude. Data were collected within the Panel of Patients with Chronic Diseases in 2002 and 2004, resulting in 398 data-pairs. Results show that factual knowledge mainly relates to associations between genes and diseases, less is known on associations between genes, chromosomes, cells and body. The perceived knowledge on DNA-testing has not increased since 2002. The attitude towards genetic testing also appeared to be rather consistent. Less perceived medical genetic knowledge and more perceived social genetic knowledge were found predictive for a more reserved attitude towards genetic testing. In conclusion, advanced developments in the field of genetics are not accompanied by increased knowledge of patients with common multi-factorial diseases. The finding that more perceived social genetic knowledge results in more reluctance can be considered an indicator for the necessity of social debates on genetic testing.

School and leisure activities in adolescents and young adults with chronic digestive disorders: impact of burden of disease.

First, we compared the nature of burden of disease (i.e., manifestations of the disease in daily life) in adolescents and young adults with various chronic digestive disorders with controls. After that, we investigated whether burden of disease is associated with difficulties in school and leisure activities of adolescents and young adults with various digestive disorders. For this purpose, we performed a multicenter study in 5 diagnostic groups (total N = 758; ages 12 to 25 years) including inflammatory bowel diseases (IBD), chronic liver diseases, congenital disorders, celiac disease, and food allergy and a population based control group (N = 306) using a self-report questionnaire. Especially adolescents and young adults with a chronic liver disease, IBD, and food allergy were found to experience daily manifestations of their disease. Several disease burden characteristics, of which especially depression, could be identified as important contributors to difficulties in school performance and leisure activities.

Disease characteristics as determinants of the labour market position of adolescents and young adults with chronic digestive disorders.

BACKGROUND: Job prospects can be problematic for young patients with chronic digestive disorders. OBJECTIVES: To compare the employment status and disease burden in young adult patients with several chronic digestive disorders with healthy controls, and to determine whether labour participation depends on disease characteristics, such as type of diagnosis and burden of disease. PARTICIPANTS: In total 622 patients categorized into five diagnostic groups--inflammatory bowel disease (IBD) (n=274), chronic liver diseases (n=78), congenital digestive disorders (n=104), food allergy (n=77), celiac disease (n=89)--and a population-based control group (n=248), age 15-24 years. METHODS: Labour participation and burden of disease (i.e. consequences of the disease in daily life) were assessed by a postal questionnaire. Multivariate statistics were computed to investigate the relationship between disease characteristics and labour participation. RESULTS: Patients with IBD or chronic liver diseases were found to have limited job prospects. Patients with chronic liver diseases, IBD and food allergy reported more disease burden regarding several indicators compared with controls. Logistic regression analyses including background characteristics revealed socio-economic status (educational level of parents) and nocturnal toilet use as important determinants of employment. In addition, gender and medication intake were found to be most determinative for a full-time position. CONCLUSIONS: The possible impact of IBD and chronic liver diseases on the labour participation of young adults should be recognized and deserves extra attention from gastroenterologists so that young patients can be supported to increase their job opportunities.

Social position of adolescents with chronic digestive disorders.

OBJECTIVE: To investigate the consequences of having a chronic digestive disorder on the social position of adolescents. METHODS: Five diagnostic groups, including inflammatory bowel disease (IBD), chronic liver diseases, congenital digestive disorders, coeliac disease and food allergy (total n = 758, ages 12-25 years), were each compared with a population-based control group in a multicentre study using a cross-sectional design. Social position was assessed by a mailed questionnaire measuring 24 aspects, categorized as education, leisure activities, friendship, labour participation, financial situation, partnership and sexuality. RESULTS: Eight aspects of social position were found to be affected negatively by one or more chronic digestive diseases: absence from school due to illness, going out, having a paid job, needing re-education in order to get a job, getting benefits as main income source, encountering bottlenecks in establishing financial commitments, having self-confidence in making a pass at someone, and restrictions in making love. Adolescents with chronic liver disease and IBD were found to experience more restrictions in social position. Adolescents with food allergy and congenital digestive disorders appear to experience some restrictions, but to a lesser degree, and adolescents with coeliac disease do not appear to have any problems regarding social position compared with controls. CONCLUSION: The social position of adolescents is affected negatively by having a chronic digestive disease, in particular chronic liver disease and IBD. Negative consequences occur in education, leisure activities, labour participation, financial situation, partnership and sexuality.