A case vignette study to refine the target group of an intermediate care model: the Acute Geriatric Community Hospital.

PURPOSE: To refine the admission criteria of the Acute Geriatric Community Hospital (AGCH) by defining its target group boundaries with (geriatric) hospital care and other bed-based intermediate care models in the Netherlands. METHODS: A qualitative study consisting of a three-phase refinement procedure with case vignettes. Physicians, medical specialists, nurse practitioners, and physician assistants in hospitals (n = 10) or intermediate care facilities (n = 10) in the Netherlands participated. They collected case vignettes from clinical practice (phase one). The referral considerations and decisions for each case were then documented through surveys (phase two) and two focus groups (phase 3). For thematic data analysis, inductive and deductive approaches were used. RESULTS: The combination of medical specialist care (MSC) and medical generalist care (MGC), is unique for the AGCH compared to other intermediate care models in the Netherlands. Compared to (geriatric) hospital care, the AGCH offers a more limited scope of MSC. Based on these findings, 13 refined admission criteria were developed such as 'The required diagnostic tests to monitor the effectiveness of treatment are available at the AGCH'. Besides admission criteria, additional clinical and organizational considerations played a role in referral decision-making; 10 themes were identified. CONCLUSION: This case vignette study defined the target group boundaries between the AGCH and other care models, allowing us to refine the AGCH admission criteria. Our findings may help to determine the required competencies of the interdisciplinary AGCH team and to develop triage instruments. The identified consideration themes can be used as conceptual framework in further research. The findings may also be of interests for healthcare systems outside the Netherlands who aspire to design integrated care for older people closer to home.

The effect of structured medication review followed by face-to-face feedback to prescribers on adverse drug events recognition and prevention in older inpatients - a multicenter interrupted time series study.

BACKGROUND: The effectiveness of interventions to improve medication safety in older inpatients is unclear, given a paucity of properly designed intervention studies applying clinically relevant endpoints such as hospital-acquired preventable Adverse Drug Events (pADEs) and unrecognized Adverse Drug Events (uADEs). Therefore, we conducted a quality improvement study and used hospital-acquired pADEs and uADEs as main outcomes to assess the effect of an intervention aimed to improve medication safety in older inpatients. METHOD: The study followed an interrupted time series design and consisted of three equally spaced sampling points during baseline and during intervention measurements. Each sampling point included between 80 to 90 patients. A total of 500 inpatients ≥65 years and admitted to internal medicine wards of three Dutch hospitals were included. An expert team retrospectively identified and assessed ADEs via a structured patient chart review. The findings from baseline measurement and meetings with the internal medicine and hospital pharmacy staff were used to design the intervention. The intervention consisted of a structured medication review by hospital pharmacists, followed by face-to-face feedback to prescribers, on average 3 days per week. RESULTS: The rate of hospital-acquired pADEs per 100 hospitalizations was reduced by 50.6% (difference 16.8, 95% confidence interval (CI): 9.0 to 24.6, P <  0.001), serious hospital-acquired pADEs by 62.7% (difference 12.8, 95% CI: 6.4 to 19.2, P <  0.001), and uADEs by 51.8% (difference 11.2, 95% CI: 4.4 to 18.0, P <  0.001). Additional analyses confirmed the robustness of the intervention effect, but residual bias cannot be excluded. CONCLUSIONS: The intervention significantly decreased the overall and serious hospital-acquired pADE occurrence in older inpatients, and significantly improved overall ADE recognition by prescribers. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number Register, trial registration number: ISRCTN64974377 , registration date (date assigned): 07/02/2011.

A qualitative study of patient-centered goal-setting in geriatric rehabilitation: patient and professional perspectives.

OBJECTIVE:: To characterize how rehabilitation goals of older patients change over time and to explore professionals' attitudes toward patient-centered goal-setting and their perspectives on rehabilitation goals. DESIGN:: Qualitative interview study. SETTING:: Three geriatric rehabilitation centers. SUBJECTS:: Ten patients (aged ⩾ 80), who had recently received inpatient geriatric rehabilitation, and seven professionals were purposively recruited. METHODS:: Semi-structured interviews. Patients were interviewed in the third or fourth week after discharge from inpatient rehabilitation, to reflect on their inpatient goals and to investigate long-term goals now that they were at home. A thematic analysis was performed. RESULTS:: During inpatient rehabilitation, participants' main goals were regaining independence in self-care activities and going home. Post-discharge, patients were not at their baseline functioning level. Rehabilitation goals appeared to shift over time, and once at home, patients formulated more ambitious rehabilitation goals that were related to regaining full independence and being able to perform activities. Although professionals thought goal-setting together with the patient is important, they also stated that older individuals often are either unable to formulate goals or they set unrealistic ones. In addition, professionals indicated that goals have to be related to discharge criteria, such as performing basic self-care activities, and rehabilitation revolves around getting patients ready for discharge. CONCLUSION:: During inpatient rehabilitation, patient goals are related to going home. After discharge, patients have ambitious goals, related to their premorbid functioning level. Rehabilitation services should distinguish between goals that are important while patients are inpatient and goals that are important after discharge.

Outcomes Associated With the Nationwide Introduction of Rapid Response Systems in The Netherlands.

OBJECTIVE: To describe the effect of implementation of a rapid response system on the composite endpoint of cardiopulmonary arrest, unplanned ICU admission, or death. DESIGN: Pragmatic prospective Dutch multicenter before-after trial, Cost and Outcomes analysis of Medical Emergency Teams trial. SETTING: Twelve hospitals participated, each including two surgical and two nonsurgical wards between April 2009 and November 2011. The Modified Early Warning Score and Situation-Background-Assessment-Recommendation instruments were implemented over 7 months. The rapid response team was then implemented during the following 17 months. The effects of implementing the rapid response team were measured in the last 5 months of this period. PATIENTS: All patients 18 years old and older admitted to the study wards were included. MEASUREMENTS AND MAIN RESULTS: In total, 166,569 patients were included in the study representing 1,031,172 hospital admission days. No differences were observed in patient demographics between periods. The composite endpoint of cardiopulmonary arrest, unplanned ICU admission, or death per 1,000 admissions was significantly reduced in the rapid response team versus the before phase (adjusted odds ratio, 0.847; 95% CI, 0.725-0.989; p = 0.036). Cardiopulmonary arrests and in-hospital mortality were also significantly reduced (odds ratio, 0.607; 95% CI, 0.393-0.937; p = 0.018 and odds ratio, 0.802; 95% CI, 0.644-1.0; p = 0.05, respectively). Unplanned ICU admissions showed a declining trend (odds ratio, 0.878; 95% CI, 0.755-1.021; p = 0.092), whereas severity of illness at the moment of ICU admission was not different between periods. CONCLUSIONS: In this study, introduction of nationwide implementation of rapid response systems was associated with a decrease in the composite endpoint of cardiopulmonary arrests, unplanned ICU admissions, and mortality in patients in general hospital wards. These findings support the implementation of rapid response systems in hospitals to reduce severe adverse events.

Adverse drug events in older hospitalized patients: results and reliability of a comprehensive and structured identification strategy.

BACKGROUND: Older patients are at high risk for experiencing Adverse Drug Events (ADEs) during hospitalization. To be able to reduce ADEs in these vulnerable patients, hospitals first need to measure the occurrence of ADEs, especially those that are preventable. However, data on preventable ADEs (pADEs) occurring during hospitalization in older patients are scarce, and no 'gold standard' for the identification of ADEs exists. METHODOLOGY: The study was conducted in three hospitals in the Netherlands in 2007. ADEs were retrospectively identified by a team of experts using a comprehensive and structured patient chart review (PCR) combined with a trigger-tool as an aid. This ADE identification strategy was applied to a cohort of 250 older hospitalized patients. To estimate the intra- and inter-rater reliabilities, Cohen's kappa values were calculated. PRINCIPAL FINDINGS: In total, 118 ADEs were detected which occurred in 62 patients. This ADE yield was 1.1 to 2.7 times higher in comparison to other ADE studies in older hospitalized patients. Of the 118 ADEs, 83 (70.3%) were pADEs; 51 pADEs (43.2% of all ADEs identified) caused serious patient harm. Patient harm caused by ADEs resulted in various events. The overall intra-rater agreement of the developed strategy was substantial (κ = 0.74); the overall inter-rater agreement was only fair (κ = 0.24). CONCLUSIONS/SIGNIFICANCE: The ADE identification strategy provided a detailed insight into the scope of ADEs occurring in older hospitalized patients, and showed that the majority of (serious) ADEs can be prevented. Several strategy related aspects, as well as setting/study specific aspects, may have contributed to the results gained. These aspects should be considered whenever ADE measurements need to be conducted. The results regarding pADEs can be used to design tailored interventions to effectively reduce harm caused by medication errors. Improvement of the inter-rater reliability of a PCR remains challenging.

A checklist to improve patient safety in interventional radiology.

PURPOSE: To develop a specific RADiological Patient Safety System (RADPASS) checklist for interventional radiology and to assess the effect of this checklist on health care processes of radiological interventions. MATERIALS AND METHODS: On the basis of available literature and expert opinion, a prototype checklist was developed. The checklist was adapted on the basis of observation of daily practice in a tertiary referral centre and evaluation by users. To assess the effect of RADPASS, in a series of radiological interventions, all deviations from optimal care were registered before and after implementation of the checklist. In addition, the checklist and its use were evaluated by interviewing all users. RESULTS: The RADPASS checklist has two parts: A (Planning and Preparation) and B (Procedure). The latter part comprises checks just before starting a procedure (B1) and checks concerning the postprocedural care immediately after completion of the procedure (B2). Two cohorts of, respectively, 94 and 101 radiological interventions were observed; the mean percentage of deviations of the optimal process per intervention decreased from 24 % before implementation to 5 % after implementation (p < 0.001). Postponements and cancellations of interventions decreased from 10 % before implementation to 0 % after implementation. Most users agreed that the checklist was user-friendly and increased patient safety awareness and efficiency. CONCLUSION: The first validated patient safety checklist for interventional radiology was developed. The use of the RADPASS checklist reduced deviations from the optimal process by three quarters and was associated with less procedure postponements.

Recognition of adverse drug events in older hospitalized medical patients.

OBJECTIVE: To assess medical teams' ability to recognize adverse drug events (ADEs) in older inpatients. METHODS: The study cohort comprised 250 patients aged 65 years or older consecutively admitted to Internal Medicine wards of three hospitals in the Netherlands between April and November 2007. An independent expert team identified ADEs present upon admission or occurring during hospitalization by a structured retrospective patient chart review. For all ADEs identified, the expert team assessed causality, severity, preventability, and recognition by medical teams. RESULTS: The medical teams did not recognize 19.9 % of all ADEs present upon admission {60.4 ADEs [95 % confidence interval (CI) 51.5-70.8] per 100 hospitalizations} and 20.3 % of all ADEs occurring during the hospital stay [47.2 ADEs (95 % CI 39.4-56.5) per 100 hospitalizations]. Unrecognized ADEs were significantly more often ADEs with possible causality (p=0.014, df=1), ADEs caused by medication errors (p<0.001, df=1), and ADEs not manifesting as new symptoms (p<0.001, df=1). The medical teams did not recognize 23.2 % of mild to moderately severe ADEs and 16.5 % of severe, life-threatening, or fatal ADEs. The recognition of ADEs varied with event type. CONCLUSIONS: The recognition of ADEs by medical teams was substantial for those ADEs with evident causality and with clinically apparent and severe consequences. ADEs mimicking underlying pathologies with a lower severity went unrecognized much more often, as did those resulting only in abnormal laboratory values. Tools to improve the recognition of ADEs by medical teams should, therefore, focus on those ADEs that are more challenging to detect.

How nurses and physicians judge their own quality of care for deteriorating patients on medical wards: self-assessment of quality of care is suboptimal*.

OBJECTIVE: To describe how nurses and physicians judge their own quality of care for deteriorating patients on medical wards compared with the judgment of independent experts. DESIGN: Cross-sectional study using interviews of care-providers regarding their perceived quality of care for clinically deteriorating patients compared with retrospective judgment by independent experts. SETTING: Academic Medical Center of Amsterdam, the Netherlands. PATIENTS: Between April and July 2009, all patients with cardiopulmonary arrests and unplanned intensive care unit admissions from six medical nursing wards were included. The care-providers (nurses and physicians) taking care of these patients in the previous 12 hrs were included. MEASUREMENTS AND MAIN RESULTS: Forty-seven events and 198 interviews were analyzed. Skill and knowledge level regarding the recognition of a deteriorating patient were rated on a scale of 1-10 with means (SD) of 7.9 (0.8) and 7.7 (0.9), respectively. Nurses and residents attributed coordination of care largely to themselves (74% and 76%, respectively). Communication, cooperation, and coordination were graded in a positive manner (medians between 7.3 and 8), whereas the medical staff graded these factors higher compared to the grading by nurses and residents. Negative predictive values regarding the presence of a delay compared with an expert panel was 37% for nurses and 38% for residents and specialists. CONCLUSIONS: Care-providers mostly rate their care provided to patients in the hours preceding a life-threatening adverse event as good. In contrast, independent experts had a more critical appraisal of the provided care in regards to timely recognition. These findings may partly explain the reluctance of care-providers to implement patient safety initiatives.

Association between acute geriatric syndromes and medication-related hospital admissions.

BACKGROUND: Elderly patients are at a 4-fold higher risk of adverse drug events (ADEs) and drug-related hospitalization. Hospitalization of an elderly patient is often preceded by geriatric syndromes, like falls or delirium. OBJECTIVES: The primary aim of this study was to investigate whether geriatric syndromes were associated with ADEs in acutely admitted elderly patients. METHODS: Consecutive medical patients, aged 65 years or more, who were acutely admitted, were enrolled. An initial multidisciplinary evaluation was completed and baseline characteristics were collected. A fall before admission was retrieved from medical charts. Delirium was determined by the Confusion Assessment Method. RESULTS: A total of 641 patients were included. Over 25% had an ADE present at admission, 26% presented with delirium and 12% with a fall. Delirium was associated with the use of antidepressants, antipsychotics and antiepileptics. In all ADEs (n = 167), ADEs were associated with a fall, with non-steroidal anti-inflammatory drugs or diuretics, but not with pre-existing functioning, delirium or older age. For ADEs involving psychoactive medication (n = 35), an association was found between delirium, falls, opioids and antipsychotics in bivariate analyses. A fall just before hospitalization (odds ratio [OR] 3.69 [95% CI 1.41, 9.67]), antipsychotics (OR 3.70 [95% CI 1.19, 11.60]) and opioids (OR 14.57 [95% CI 2.02, 105.30]) remained independently associated with an ADE involving psychoactive medication. CONCLUSION: This prospective study demonstrated that, in a cohort of elderly hospital patients, a fall before admission and prevalent delirium are associated with several pharmacological groups and/or with ADE-related hospital admission.

Nature and timing of incidents intercepted by the SURPASS checklist in surgical patients.

INTRODUCTION: More than half of in-hospital adverse events can be attributed to a surgical discipline. Checklists can effectively decrease errors and adverse events. However, the mechanisms by which checklists lead to increased safety are unclear. This study aimed to assess the number, nature and timing of incidents intercepted by use of the Surgical Patient Safety System (SURPASS) checklist, a patient-specific multidisciplinary checklist that covers the entire surgical patient pathway. METHODS: The checklist was implemented in two academic hospitals and four teaching hospitals in the Netherlands. Users of the checklist had three options for each item that was checked: 'not applicable', 'yes' and 'intercepted by checklist'. In each hospital, the first 1000 completed checklists were entered into an online central database. RESULTS: In six participating hospitals, 6313 checklists were collected. One or more incidents were intercepted in 2562 checklists (40.6%). In total, 6312 incidents were intercepted. After correction for the number of items and the extent of adherence in each part of the checklist, the number of intercepted incidents was highest in the preoperative and postoperative stages. CONCLUSIONS: The checklist intercepts many potentially harmful incidents across all stages of the surgical patient pathway. The majority of incidents were intercepted in the preoperative and postoperative stages of the pathway. The degree to which these incidents would have been intercepted by a single checklist in the operating room only, compared with a checklist for the entire surgical pathway, remains a subject for future study.

Identification of deteriorating patients on general wards; measurement of vital parameters and potential effectiveness of the Modified Early Warning Score.

BACKGROUND AND PURPOSE: Clear and detectable signs of deterioration have been shown to be present in many patients multiple hours before undergoing a serious life-threatening event. To date, few studies are available describing normal practice and the possible effectiveness of structured tools regarding recognition of deteriorating patients. The aim of this study was to describe the current practice in measurement and documentation of vital signs and the possible usefulness of the Modified Early Warning Score (MEWS) to identify deteriorating patients on hospital wards. METHODS: A retrospective observational study of medical and surgical patients from 2007 with a severe adverse event including cardiopulmonary arrest, unplanned intensive care unit admission, emergency surgery, or unexpected death was performed. We studied all vital parameters that were collected and documented in the 48 hours before these events, and the MEWS was retrospectively calculated. RESULTS: Two hundred four patients were included. In the 48 hours before the event, a total of 2688 measurements of one or more vital signs were taken. Overall, 81% of the patients had an MEWS value of 3 or more at least once during the 48 hours before their event. Recordings of vital signs were mostly incomplete. Even when the MEWS was 3 or more, respiratory rate, diuresis, and oxygen saturation were documented in only 30% to 66% of assessments.

The effect of an active on-ward participation of hospital pharmacists in Internal Medicine teams on preventable Adverse Drug Events in elderly inpatients: protocol of the WINGS study (Ward-oriented pharmacy in newly admitted geriatric seniors).

BACKGROUND: The potential of clinical interventions, aiming at reduction of preventable Adverse Drug Events (preventable ADEs) during hospital stay, have been studied extensively. Clinical Pharmacy is a well-established and effective service, usually consisting of full-time on-ward participation of clinical pharmacists in medical teams. Within the current Hospital Pharmacy organisation in the Netherlands, such on-ward service is less feasible and therefore not yet established. However, given the substantial incidence of preventable ADEs in Dutch hospitals found in recent studies, appears warranted. Therefore, "Ward-Oriented Pharmacy", an on-ward service tailored to the Dutch hospital setting, will be developed. This service will consist of multifaceted interventions implemented in the Internal Medicine wards by hospital pharmacists. The effect of this service on preventable ADEs in elderly inpatients will be measured. Elderly patients are at high risk for ADEs due to multi-morbidity, concomitant disabilities and polypharmacy. Most studies on the incidence and preventability of ADEs in elderly patients have been conducted in the outpatient setting or on admission to a hospital, and fewer in the inpatient setting. Moreover, recognition of ADEs by the treating physicians is challenging in elderly patients because their disease presentation is often atypical and complex. Detailed information about the performance of the treating physicians in ADE recognition is scarce. METHODS/DESIGN: The design is a multi-centre, interrupted time series study. Patients of 65 years or older, consecutively admitted to Internal Medicine wards will be included. After a pre-measurement, a Ward-Oriented Pharmacy service will be introduced and the effect of this service will be assessed during a post-measurement. The primary outcome measures are the ADE prevalence on admission and ADE incidence during hospital stay. These outcomes will be assessed using structured retrospective chart review by an independent expert panel. This assessment will include determination of causality, severity and preventability of ADEs. In addition, the extent to which ADEs are recognised and managed by the treating physicians will be considered. DISCUSSION: The primary goal of the WINGS study is to assess whether a significant reduction in preventable ADEs in elderly inpatients can be achieved by a Ward-Oriented Pharmacy service offered. A comprehensive ADE detection method will be used based on expert opinion and retrospective, trigger-tool enhanced, chart review.

Quality indicators for in-hospital pharmaceutical care of Dutch elderly patients: development and validation of an ACOVE-based quality indicator set.

BACKGROUND: In 2001, the ACOVE (Assessing Care Of Vulnerable Elders) quality indicators (QIs) were developed in the US to measure the quality of care of vulnerable elderly patients. However, the ACOVE QI set was developed mainly to assess the overall quality of care of community-dwelling vulnerable elders (as opposed to hospitalized elderly). Therefore, they need to be adapted when used in a non-US hospital setting. In addition, the ACOVE QIs depend on patient and caretaker interviews to assess the quality of care. OBJECTIVE: The aim of this study was to develop and validate a set of explicitly phrased QIs to measure (without the need for interviews) the quality of pharmaceutical care of elderly hospitalized patients in the Netherlands. STUDY DESIGN: The QI set was developed based on the ACOVE QIs, Dutch national guidelines, evidence from the literature and expert opinion. The QI set focused on in-hospital pharmaceutical care and was evaluated in terms of whether the QIs were able to assess the quality of care using medical records and a hospital information system. In three review rounds, the QI set was adapted and judged on face and content validity. The feasibility of implementation of the QI set and inter-rater reliability were determined. SETTING: The study was conducted between September 2007 and August 2008 in a tertiary 1002-bed university hospital. RESEARCH TEAM: Two pharmacists were responsible for the selection and adaptation of QIs. An internist-geriatrician, a physician with experience in quality assurance and internal medicine and a senior hospital pharmacist formed the expert panel responsible for reviewing the QIs. MEASUREMENTS: Fleiss' κ values and the intraclass correlation coefficient were calculated for inter-rater reliability. RESULTS: An 87-item QI set was accepted by the expert panel. Of this set, 49 QIs were based on ACOVE QIs and 38 QIs were newly added. The QI set demonstrated excellent inter-rater reliability and good feasibility. CONCLUSIONS: We developed a valid and reliable set of QIs to efficiently assess the quality of the in-hospital pharmaceutical care provided to elderly Dutch patients.

Prevention of surgical malpractice claims by use of a surgical safety checklist.

OBJECTIVE: To assess what proportion of surgical malpractice claims might be prevented by the use of a surgical safety checklist. BACKGROUND: Surgical disciplines are overrepresented in the distribution of adverse events. The recently described multidisciplinary SURgical PAtient Safety System (SURPASS) checklist covers the entire surgical pathway from admission to discharge and is being validated in various ways. Malpractice claims constitute an important source of information on adverse events. In this study, surgical malpractice claims were evaluated in detail to assess the proportion and nature of claims that might have been prevented if the SURPASS checklist had been used. METHODS: A retrospective claim record review was performed using the database of the largest Dutch insurance company for medical liability. All accepted or settled closed surgical malpractice claims filed as a consequence of an incident that occurred between January 1, 2004 and December 31, 2005 were included. Data on the type and outcome of the incident and contributing factors were extracted. All contributing factors were compared to the SURPASS checklist to assess which incidents the checklist might have prevented. RESULTS: We included 294 claims. Failure in diagnosis and peroperative damage were the most common types of incident; cognitive contributing factors were present in two-thirds of claims. Of a total of 412 contributing factors, 29% might have been intercepted by the SURPASS checklist. The checklist might have prevented 40% of deaths and 29% of incidents leading to permanent damage. CONCLUSION: Nearly one-third of all contributing factors in accepted surgical malpractice claims of patients that had undergone surgery might have been intercepted by using a comprehensive surgical safety checklist. A considerable amount of damage, both physical and financial, is likely to be prevented by using the SURPASS checklist.

Effect of a comprehensive surgical safety system on patient outcomes.

BACKGROUND: Adverse events in patients who have undergone surgery constitute a large proportion of iatrogenic illnesses. Most surgical safety interventions have focused on the operating room. Since more than half of all surgical errors occur outside the operating room, it is likely that a more substantial improvement in outcomes can be achieved by targeting the entire surgical pathway. METHODS: We examined the effects on patient outcomes of a comprehensive, multidisciplinary surgical safety checklist, including items such as medication, marking of the operative side, and use of postoperative instructions. The checklist was implemented in six hospitals with high standards of care. All complications occurring during admission were documented prospectively. We compared the rate of complications during a baseline period of 3 months with the rate during a 3-month period after implementation of the checklist, while accounting for potential confounders. Similar data were collected from a control group of five hospitals. RESULTS: In a comparison of 3760 patients observed before implementation of the checklist with 3820 patients observed after implementation, the total number of complications per 100 patients decreased from 27.3 (95% confidence interval [CI], 25.9 to 28.7) to 16.7 (95% CI, 15.6 to 17.9), for an absolute risk reduction of 10.6 (95% CI, 8.7 to 12.4). The proportion of patients with one or more complications decreased from 15.4% to 10.6% (P<0.001). In-hospital mortality decreased from 1.5% (95% CI, 1.2 to 2.0) to 0.8% (95% CI, 0.6 to 1.1), for an absolute risk reduction of 0.7 percentage points (95% CI, 0.2 to 1.2). Outcomes did not change in the control hospitals. CONCLUSIONS: Implementation of this comprehensive checklist was associated with a reduction in surgical complications and mortality in hospitals with a high standard of care. (Netherlands Trial Register number, NTR1943.).

On-ward participation of a hospital pharmacist in a Dutch intensive care unit reduces prescribing errors and related patient harm: an intervention study.

INTRODUCTION: Patients admitted to an intensive care unit (ICU) are at high risk for prescribing errors and related adverse drug events (ADEs). An effective intervention to decrease this risk, based on studies conducted mainly in North America, is on-ward participation of a clinical pharmacist in an ICU team. As the Dutch Healthcare System is organized differently and the on-ward role of hospital pharmacists in Dutch ICU teams is not well established, we conducted an intervention study to investigate whether participation of a hospital pharmacist can also be an effective approach in reducing prescribing errors and related patient harm (preventable ADEs) in this specific setting. METHODS: A prospective study compared a baseline period with an intervention period. During the intervention period, an ICU hospital pharmacist reviewed medication orders for patients admitted to the ICU, noted issues related to prescribing, formulated recommendations and discussed those during patient review meetings with the attending ICU physicians. Prescribing issues were scored as prescribing errors when consensus was reached between the ICU hospital pharmacist and ICU physicians. RESULTS: During the 8.5-month study period, medication orders for 1,173 patients were reviewed. The ICU hospital pharmacist made a total of 659 recommendations. During the intervention period, the rate of consensus between the ICU hospital pharmacist and ICU physicians was 74%. The incidence of prescribing errors during the intervention period was significantly lower than during the baseline period: 62.5 per 1,000 monitored patient-days versus 190.5 per 1,000 monitored patient-days, respectively (P < 0.001). Preventable ADEs (patient harm, National Coordinating Council for Medication Error Reporting and Prevention severity categories E and F) were reduced from 4.0 per 1,000 monitored patient-days during the baseline period to 1.0 per 1,000 monitored patient-days during the intervention period (P = 0.25). Per monitored patient-day, the intervention itself cost €3, but might have saved €26 to €40 by preventing ADEs. CONCLUSIONS: On-ward participation of a hospital pharmacist in a Dutch ICU was associated with significant reductions in prescribing errors and related patient harm (preventable ADEs) at acceptable costs per monitored patient-day. TRIAL REGISTRATION NUMBER: ISRCTN92487665.

The SURgical PAtient Safety System (SURPASS) checklist optimizes timing of antibiotic prophylaxis.

BACKGROUND: Surgical site infection (SSI) is an adverse event in which a close relation between process of care and outcome has been demonstrated: administration of antibiotic prophylaxis decreases the risk of SSI. In our tertiary referral centre, a SURgical PAtient Safety System (SURPASS) checklist was developed and implemented. This multidisciplinary checklist covers the entire surgical pathway and includes, among other items, administration of antibiotic prophylaxis before induction of anaesthesia. The aim of this study was to determine the effect of SURPASS implementation on timing of antibiotic prophylaxis. METHODS: A retrospective analysis was performed on two cohorts of patients: one cohort of surgical patients that underwent surgery before implementation of the checklist and a comparable cohort after implementation. The interval between administration of antibiotic prophylaxis and incision was compared between the two cohorts. RESULTS: A total of 772 surgical procedures were included. More than half of procedures were gastro-intestinal; others were vascular, trauma and hernia repair procedures. After implementation, the checklist was used in 81.4% of procedures. The interval between administration of antibiotic prophylaxis and incision increased from 23.9 minutes before implementation of SURPASS to 29.9 minutes after implementation (p = 0.047). In procedures where the checklist was used, the interval increased to 32.9 minutes (p = 0.004). The proportion of patients that did not receive antibiotics until after the incision decreased significantly. CONCLUSION: The use of the SURPASS checklist leads to better compliance with regard to the timing of antibiotic prophylaxis administration.

Application of the Bow-Tie model in medication safety risk analysis: consecutive experience in two hospitals in the Netherlands.

BACKGROUND: To improve medication safety effectively, one should systematically analyse and assess the risks for medication errors and determine the possible causes. So far, no risk-analysis instrument exists in healthcare that can be used to analyse and visualize risks, causes and consequences of potential adverse events in a prospective manner. In high-risk industries such as petrochemistry and aviation, the Bow-Tie model is frequently used. This model combines causes, errors, preventive and recovery measures, and consequences in one model and gives insight into the magnitude and causes of existing safety risks. The aim of our project was to study the usefulness of the Bow-Tie model in the hospital setting for prospective analysis of risks in the medication process in order to develop a practicable method. METHODS: The model was first adapted to the clinical setting. Thereafter, the risk-analysis model was applied in a large tertiary teaching hospital in multidisciplinary sessions. The sessions and risk-analysis method were evaluated on the following aspects: applicability, comprehensibility, creation of awareness in and motivation of participants, and the capability of the 'system approach' (the approach taken by the Bow-Tie model, which focuses on the conditions under which individuals work and tries to build defences to avert errors or mitigate their effects, in contrast to a 'person approach', which focuses on errors of individuals, blaming them for forgetfulness, inattention etc.). Based on this evaluation, the risk analysis method was adjusted and consecutively applied in a general teaching hospital. After evaluation of the sessions in the second hospital a recommended method for risk analysis with the Bow-Tie model was defined. RESULTS: The risk-analysis method with the Bow-Tie model in the first hospital gave insight into many medication safety-related risks. However, the method was insufficient on comprehensibility and on the creation of awareness and motivation owing to a great number of determined risks which made thorough analysis, drawing of Bow-Ties and prioritizing difficult. The adjusted method in the second hospital focused more on the in-depth analysis of a small number of important safety issues of a department with specific attention for underlying causes. This approach was considered better in applicability, comprehensibility and the creation of awareness. Furthermore, by analyzing underlying causes, more attention could be paid to latent conditions (which can translate into error-provoking conditions) within the system. CONCLUSION: We found the Bow-Tie to be an appropriate model for prospective risk analysis of medication safety in a hospital. By applying the model in two hospitals consecutively we developed a feasible method for risk-analysis sessions. Key factors of this recommended method are a focus on the prioritized selection of safety issues and specific attention to latent conditions within the system by analysing these safety issues in depth to the root causes with the help of the Bow-Tie model.

The effect of low molecular weight heparin on survival in patients with advanced malignancy.

PURPOSE: Studies in cancer patients with venous thromboembolism suggested that low molecular weight heparin may prolong survival. In a double-blind study, we evaluated the effect of low molecular weight heparin on survival in patients with advanced malignancy without venous thromboembolism. METHODS: Patients with metastasized or locally advanced solid tumors were randomly assigned to receive a 6-week course of subcutaneous nadroparin or placebo. The primary efficacy analysis was based on time from random assignment to death. The primary safety outcome was major bleeding. RESULTS: In total, 148 patients were allocated to nadroparin and 154 patients were allocated to placebo. Mean follow-up was 1 year. In the intention-to-treat analysis the overall hazard ratio of mortality was 0.75 (95% CI, 0.59 to 0.96) with a median survival of 8.0 months in the nadroparin recipients versus 6.6 months in the placebo group. After adjustment for potential confounders, the treatment effect remained statistically significant. Major bleeding occurred in five (3%) of nadroparin-treated patients and in one (1%) of the placebo recipients (P = .12). In the a priori specified subgroup of patients with a life expectancy of 6 months or more at enrollment, the hazard ratio was 0.64 (95% CI, 0.45 to 0.90) with a median survival of 15.4 and 9.4 months, respectively. For patients with a shorter life expectancy, the hazard ratio was 0.88 (95% CI, 0.62 to 1.25). CONCLUSION: A brief course of subcutaneous low molecular weight heparin favorably influences the survival in patients with advanced malignancy and deserves additional clinical evaluation.