Joke Mintjes

Fewer adverse events as a result of the SAFE or SORRY? programme in hospitals and nursing homes. part i: primary outcome of a cluster randomised trial.

BACKGROUND Patient care guidelines are usually implemented one at a time, yet patients are at risk for multiple, often preventable, adverse events simultaneously. OBJECTIVE This study aimed to test the effect of the SAFE or SORRY? programme on the incidence of three adverse events (pressure ulcers, urinary tract infections and falls). This paper describes Part I of the study: the effect on the incidence of adverse events. DESIGN A cluster randomised trial was conducted between September 2006 and November 2008. After a three-month baseline period the intervention was implemented followed by a nine-month follow-up period. SETTINGS Ten wards from four hospitals and ten wards from six nursing homes were stratified for institute and ward type and then randomised to intervention or usual care group. PARTICIPANTS During baseline and follow-up, patients (≥18 years) with an expected length of stay of at least five days, were asked to participate. METHODS The SAFE or SORRY? programme consisted of the essential recommendations of guidelines for the three adverse events. A multifaceted implementation strategy was used for the implementation: education, patient involvement and feedback on process and outcome indicators. The usual care group continued care as usual. Data were collected on the incidence of adverse events and a Poisson regression model was used to estimate the rate ratio of the adverse events between the intervention and the usual care group at follow-up. RESULTS At follow-up, 2201 hospital patients with 3358 patient weeks and 392 nursing home patients with 5799 patient weeks were observed. Poisson regression analyses showed a rate ratio for the development of an adverse event in favour of the intervention group of 0.57 (95% CI: 0.34-0.95) and 0.67 (95% CI: 0.48-0.99) for hospital patients and nursing home patients respectively. CONCLUSION This study showed that implementing multiple guidelines simultaneously is possible, which is promising. Patients in the intervention groups developed 43% and 33% fewer adverse events compared to the usual care groups in hospitals and nursing homes respectively. Even so, more research is necessary to underline these results. TRIAL REGISTRATION clinicaltrials.gov, number NCT00365430.

The SAFE or SORRY? programme. Part II: effect on preventive care

BACKGROUND Patient care guidelines are usually implemented one at a time, yet patients are at risk for multiple, often preventable, adverse events simultaneously. OBJECTIVE The SAFE or SORRY? programme targeted three adverse events (pressure ulcers, urinary tract infections and falls) and was successful in reducing the incidence of these events. This article explores the process of change and describes the effect on the preventive care given. DESIGN Separate data on preventive care were collected along the cluster randomised trial, which was conducted between September 2006 and November 2008. SETTINGS Ten hospital wards and ten nursing home wards. PARTICIPANTS We monitored nursing care given to adult patients with an expected length of stay of at least five days. METHODS The SAFE or SORRY? programme consisted of the essential recommendations of guidelines for pressure ulcers, urinary tract infections and falls. A multifaceted implementation strategy was used to implement this multiple guidelines programme. Data on preventive care given to patients were collected in line with these guidelines and the difference between the intervention and the usual care group at follow-up was analysed. RESULTS The study showed no overall difference in preventive pressure ulcer measures between the intervention and the usual care group in hospitals (estimate=6%, CI: -7-19) and nursing homes (estimate=4%, CI: -5-13). For urinary tract infections, even statistically significantly fewer hospital patients at risk received preventive care (estimate=19%, CI: 17-21). For falls in hospitals and nursing homes, no more patients at risk received preventive care. CONCLUSION Though the SAFE OR SORRY? programme effectively reduced the number of adverse events, an increase in preventive care given to patients at risk was not demonstrated. These results seem to emphasise the difficulties in measuring the compliance to guidelines. More research is needed to explore the possibilities for measuring the implementation of multiple guidelines using process indicators.

Incidence of cardiac arrests and unexpected deaths in surgical patients before and after implementation of a rapid response system

BackgroundRapid response systems (RRSs) are considered an important tool for improving patient safety. We studied the effect of an RRS on the incidence of cardiac arrests and unexpected deaths.MethodsRetrospective before- after study in a university medical centre. We included 1376 surgical patients before (period 1) and 2410 patients after introduction of the RRS (period 2). Outcome measures were corrected for the baseline covariates age, gender and ASA.ResultsThe number of patients who experienced a cardiac arrest and/or who died unexpectedly decreased non significantly from 0.50% (7/1376) in period 1 to 0.25% (6/2410) in period 2 (odds ratio (OR) 0.43, CI 0.14-1.30). The individual number of cardiac arrests decreased non-significantly from 0.29% (4/1367) to 0.12% (3/2410) (OR 0.38, CI 0.09-1.73) and the number of unexpected deaths decreased non-significantly from 0.36% (5/1376) to 0.17% (4/2410) (OR 0.42, CI 0.11-1.59). In contrast, the number of unplanned ICU admissions increased from 2.47% (34/1376) in period 1 to 4.15% (100/2400) in period 2 (OR 1.66, CI 1.07-2.55). Median APACHE ll score at unplanned ICU admissions was 16 in period 1 versus 16 in period 2 (NS). Adherence to RRS procedures. Observed abnormal early warning scores ≤72 h preceding a cardiac arrest, unexpected death or an unplanned ICU admission increased from 65% (24/37 events) in period 1 to 91% (91/101 events) in period 2 (p < 0.001). Related ward physician interventions increased from 38% (9/24 events) to 89% (81/91 events) (p < 0.001). In period 2, ward physicians activated the medical emergency team in 65% of the events (59/91), although in 16% (15/91 events) activation was delayed for one or two days. The overall medical emergency team dose was 56/1000 admissions.ConclusionsIntroduction of an RRS resulted in a 50% reduction in cardiac arrest rates and/or unexpected death. However, this decrease was not statistically significant partly due to the low base-line incidence. Moreover, delayed activation due to the two-tiered medical emergency team activation procedure and suboptimal adherence of the ward staff to the RRS procedures may have further abated the positive results.

The design of the SAFE or SORRY? study: a cluster randomised trial on the development and testing of an evidence based inpatient safety program for the prevention of adverse events.

BackgroundPatients in hospitals and nursing homes are at risk of the development of, often preventable, adverse events (AEs), which threaten patient safety. Guidelines for prevention of many types of AEs are available, however, compliance with these guidelines appears to be lacking. Besides general barriers that inhibit implementation, this non-compliance is associated with the large number of guidelines competing for attention. As implementation of a guideline is time-consuming, it is difficult for organisations to implement all available guidelines. Another problem is lack of feedback about performance using quality indicators of guideline based care and lack of a recognisable, unambiguous system for implementation. A program that allows organisations to implement multiple guidelines simultaneously may facilitate guideline use and thus improve patient safety.The aim of this study is to develop and test such an integral patient safety program that addresses several AEs simultaneously in hospitals and nursing homes. This paper reports the design of this study.Methods and designThe patient safety program addresses three AEs: pressure ulcers, falls and urinary tract infections. It consists of bundles and outcome and process indicators based on the existing evidence based guidelines. In addition it includes a multifaceted tailored implementation strategy: education, patient involvement, and a computerized registration and feedback system. The patient safety program was tested in a cluster randomised trial on ten hospital wards and ten nursing home wards. The baseline period was three months followed by the implementation of the patient safety program for fourteen months. Subsequently the follow-up period was nine months. Primary outcome measure was the incidence of AEs on every ward. Secondary outcome measures were the utilization of preventive interventions and the knowledge of nurses regarding the three topics. Randomisation took place on ward level. The results will be analysed separately for hospitals and nursing homes.DiscussionMajor challenges were the development of the patient safety program including a digital registration and feedback system and the implementation of the patient safety program.Trial registrationTrial registration: ClinicalTrials.gov ID [NCT00365430]

The effectiveness of Nurse Practitioners working at a GP cooperative: a study protocol

BackgroundIn many countries out-of-hours care faces serious challenges, including shortage of general practitioners, a high workload, reduced motivation to work out of hours, and increased demand for out-of-hours care. One response to these challenges is the introduction of nurse practitioner as doctor substitutes, in order to maintain the (high) accessibility and safety of out of hours care. Although nurse practitioners have proven to provide equally safe and efficient care during daytime primary care, it is unclear whether substitution is effective and efficient in the more complex out of hours primary care. This study aims to assess the effects of substitution of care from general practitioners to nurse practitioners in an out of hours primary care setting.DesignA quasi experimental study is undertaken at one “general practitioner cooperative” to offer out-of-hours care for 304.000 people in the South East of the Netherlands. In the experimental condition patient care is provided by a team of one nurse practitioner and four general practitioners; where the nurse practitioner replaces one general practitioner during one day of the weekend from 10 am to 5 pm. In the control condition patient care is provided by a team of five general practitioners during the other day of the weekend, also from 10 am to 5 pm. The study period last 15 months, from April 2011 till July 2012.MethodsData will be collected on number of different outcomes using a range of methods. Our primary outcome is substitution of care. This is calculated using the number and characteristics of patients that have a consultation at the GP cooperative. We compare the number of patients seen by both professionals, type of complaints, resource utilization (e.g. prescription, tests, investigations, referrals) and waiting times in the experimental condition and control condition. This data is derived from patient electronic medical records. Secondary outcomes are: patient satisfaction; general practitioners workload; quality and safety of care and barriers and facilitators.DiscussionThe study will provide evidence whether substitution of care in out-of-hours setting is safe and efficient and give insight into barriers and facilitators related to the introduction of nurse practitioners in out-of-hours setting.Trial registrationClinicalTrials.gov ID NCT01388374

Effects of a rapid response system on quality of life: a prospective cohort study in surgical patients before and after implementing a rapid response system

BackgroundThe aim of a rapid response system (RRS) is to improve the timely recognition and treatment of ward patients with deteriorating vital signs The system is based on a set of clinical criteria that are used to assess patient’s vital signs on a general ward. Once a patient is evaluated as critical, a medical emergency team is activated to more thoroughly assess the patient’s physical condition and to initiate treatment. The medical emergency team included a critical care physician and a critical care nurse.AimTo assess the effect of an RRS on health-related quality of life (HRQOL).MethodsProspective cohort study in surgical patients before and after implementing an RRS. HRQOL was measured using the EuroQol-5 dimensions (EQ-5D) and the EQ visual analogue scale (VAS) at pre surgery and at 3 and 6 months following surgery.ResultsNo statistical significant effects of RRS implementation on the EQ-5D index and EQ-VAS were found. This was also true for the subpopulation of patients with an unplanned intensive care unit admission. Regarding the EQ-5D dimensions, deterioration in the ‘mobility’ and ‘usual activities’ dimensions in the post-implementation group was significantly less compared to the pre-implementation group with a respective mean difference of 0.08 (p = 0.03) and 0.09 (p = 0.04) on a three-point scale at 6 months. Lower pre-surgery EQ-5D index and higher American Society of Anesthesiologists physical status (ASA-PS) scores were significantly associated with lower EQ-5D index scores at 3 and 6 months following surgery.ConclusionsImplementation of an RRS did not convincingly affect HRQOL following major surgery. We question if HRQOL is an adequate measure to assess the influence of an RRS. Pre-surgery HRQOL- and ASA-PS scores were strongly associated with HRQOL outcomes and may have abated the influence of the RRS implementation.