The effect of the SAFE or SORRY? programme on patient safety knowledge of nurses in hospitals and nursing homes: a cluster randomised trial

Background: patients in hospitals and nursing homes are at risk for the development of often preventable adverse events. Guidelines for the prevention of many types of adverse events are available, however compliance with these guidelines appears to be lacking. As a result many patients do not receive appropriate care. We developed a patient safety program that allows organisations to implement multiple guidelines simultaneously and therefore facilitates guideline use to improve patient safety. This program was developed for three frequently occurring nursing care related adverse events: pressure ulcers, urinary tract infections and falls. For the implementation of this program we developed educational activities for nurses as a main implementation strategy.Objectives: the aim of this study is to describe the effect of interactive and tailored education on the knowledge levels of nurses.Design: a cluster randomised trial was conducted between September 2006 and July 2008.Settings: ten hospital wards and ten nursing home wards participated in this study. Prior to baseline, randomisation of the wards to an intervention or control group was stratified for centre and type of ward.Participants: all nurses from participating wards.Methods: a knowledge test measured nurses’ knowledge on the prevention of pressure ulcers, urinary tract infections and falls, during baseline en follow-up. The results were analysed for hospitals and nursing homes separately.Results: after correction for baseline, the mean difference between the intervention and the control group on hospital nurses’ knowledge on the prevention of the three adverse events was 0.19 points on a zero to ten scale (95% CI: ?0.03 to 0.42), in favour of the intervention group. There was a statistically significant effect on knowledge of pressure ulcers, with an improved mean mark of 0.45 points (95% CI: 0.10–0.81). For the other two topics there was no statistically significant effect. Nursing home nurses’ knowledge did neither improve (0 points, CI: ?0.35 to 0.35) overall, nor for the separate subjects.Conclusion: the educational intervention improved hospital nurses’ knowledge on the prevention of pressure ulcers only. More research on long term improvement of knowledge is neede

Treating patients with severe mental illness with narrative exposure therapy for comorbid post-traumatic stress disorder

Background Interpersonal trauma and post-traumatic stress disorder (PTSD) in patients with severe mental illness (SMI) negatively affect illness course. Narrative exposure therapy (NET) is effective in vulnerable patient groups, but its efficacy and applicability has not been studied in out-patients with SMI. Aims We aimed to evaluate the efficacy and applicability of NET in SMI on changes in PTSD, dissociation, SMI symptoms, care needs, quality of life, global functioning and care consumption. Method The study had a single-group, pre-test-post-test, repeated-measures design and was registered in The Netherlands National Trial Register (identifier TR571). Primary outcomes were assessed at pre-treatment (T0), 1 month post-treatment (T1) and 7 months' follow-up (T2), with a structured interview for PTSD and dissociation screening. Secondary outcomes followed routinely SMI measurements and medical data. Mixed models were used for data analysis. Results The majority of the 23 participants was female (82%). Mean age was 49.9 years (s.d. 9.8) and mean PTSD duration was 24.1 years (s.d. 14.5). Mean PTSD severity decreased from 37.9 at T0 to 31.9 at T1 (-6.0 difference, 95%CI -10.0 to -2.0), and decreased further to 24.5 at T2 (-13.4 difference, 95%CI -17.4 to -9.4). Dissociation, SMI symptoms, duration of contacts, and medication decreased; global functioning increased; and quality of life and perceived needs did not change. Eleven participants were in remission for PTSD at T2, of which five were also in remission for major depression. Conclusions NET appeared efficacious and applicable to out-patients with SMI and PTSD, and was well tolerated

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

Background: Patients 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 design: The 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.Discussion: Major challenges were the development of the patient safety program including a digital registration and feedback system and the implementation of the patient safety program

Online support program for parents of children with a chronic kidney disease using intervention mapping: a development and evaluation protocol

Background: The care for children with a chronic kidney disease (CKD) is complex. Parents of these children may experience high levels of stress in managing their child’s disease, potentially leading to negative effects on their child’s health outcomes. Although the experienced problems are well known, adequate (online) support for these parents is lacking.Objective: The objective of the study is to describe the systematic development of an online support program for parents of children with CKD, and how this program will be evaluated.Methods: Intervention Mapping (IM) was used for the development of the program. After conducting a needs assessment, defining program objectives, searching for theories, and selecting practical applications, the online program e-Powered Parents was developed. e-Powered Parents consist of three parts: (1) an informative part with information about CKD and treatments, (2) an interactive part where parents can communicate with other parents and health care professionals by chat, private messages, and a forum, and (3) a training platform consisting of four modules: Managing stress, Setting limits, Communication, and Coping with emotions. In a feasibility study, the potential effectiveness and effect size of e-Powered Parents will be evaluated using an explorative randomized controlled trial with parents of 120 families. The outcomes will be the child’s quality of life, parental stress and fatigue, self-efficacy in the communication with health care professionals, and family management. A process evaluation will provide insight in parents’ experiences, including their experienced level of support.Results: Study results are expected to be published in the summer of 2016.Conclusions: Although the development of e-Powered Parents using IM was time-consuming, IM has been a useful protocol. IM provided us with a systematic framework for structuring the development process. The participatory planning group was valuable as well; knowledge, experiences, and visions were shared, ensuring us that parents and health care professionals support the program.Trial Registration: Dutch Trial Registration: NTR4808; www.trialregister.nl (Archived by WebCite at http://www.webcitation.org/6cfAYHcYb

Completeness of assisted bathing in nursing homes related to dementia and bathing method: results from a secondary analysis of cluster-randomised trial data

BACKGROUND: Bathing assistance is a core element of essential care in nursing homes, yet little is known for quality of assisted bathing or its determinants.AIM:To explore differences in completeness of assisted bathing in relation to bathing method and resident characteristics.METHODS: Secondary analysis of a cluster randomised trial including 500 nursing home residents designed to compare traditional bathing methods for skin effects and cost-consequences; GlinicalTrials.gov ID [NCT01187732]. Logistic mixed modelling was used to relate resident characteristics and bathing method to bathing completeness.RESULTS: Bathing completeness was highly variable over wards. Apart from a large effect for ward, logistic mixed modelling indicated bathing was more often complete in case of washing without water (using disposable skin cleaning and caring materials; estimate 2.55, SE 0.17, P < 0.0001) and less often complete in residents with dementia (estimate -0.22, SE 0.08, P = 0.0040).CONCLUSIONS: Introduction of washing without water is likely to lead to more bathing completeness in nursing homes. However, inequity in care was also identified with a view to highly variable bathing completeness over wards and more incomplete bathing by care staff in residents with dementia.IMPLICATIONS FOR PRACTICE: Monitoring the performance of assisted bathing in nursing homes is indicated for the identification of undesirable variation in essential care and poorly performing teams. The introduction of washing without water could serve the promotion of bathing completeness in nursing homes overall, but will not solve inequity issues for residents

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 indicator

Concurrent incidence of adverse events in hospitals and nursing homes

Purpose: To describe the concurrent incidence of pressure ulcers, urinary tract infections, and falls in hospitals and nursing homes, and the preventive care given. Additionally, the correlation between the occurrence of these adverse events and preventive care was explored.Design and Settings: A prospective, 3-month, cohort study at 10 hospitals and 10 nursing homes in the Netherlands.Participants: 687 hospital patients and 241 nursing home patients.Main Outcome Measures: The incidence of three adverse events and preventive care given to patients at risk. During weekly visits, the patients and their files were assessed. Additionally, observations were performed.Results: Seventy-seven hospital patients (11%) and 111 nursing home patients (46%) developed one or more adverse events. The incidence rate for both types of patients, and for the three adverse events combined, was 9% adverse events per patient week.In hospitals, 34% of the patients received adequate pressure ulcer preventive care, while 47% of the patients received adequate urinary tract infection preventive care, and none of the patients received adequate falls preventive care. In nursing homes, 18% of the patients received adequate pressure ulcer preventive care, 42% of the patients received adequate urinary tract infection preventive care, and less than 1% of the patients received adequate falls prevention care.Negative or no correlations were found between the incidence rates for the three adverse events. In nursing homes the incidence of pressure ulcers and preventive care were positively correlated.Conclusions: There is a high incidence of adverse events in hospitals and nursing homes. Many patients at risk do not receive adequate preventive care

The "best balance" allocation led to optimal balance in cluster-controlled trials.

Item does not contain fulltextOBJECTIVE: Balance of prognostic factors between treatment groups is desirable because it improves the accuracy, precision, and credibility of the results. In cluster-controlled trials, imbalance can easily occur by chance when the number of cluster is small. If all clusters are known at the start of the study, the "best balance" allocation method (BB) can be used to obtain optimal balance. This method will be compared with other allocation methods. STUDY DESIGN AND SETTING: We carried out a simulation study to compare the balance obtained with BB, minimization, unrestricted randomization, and matching for four to 20 clusters and one to five categorical prognostic factors at cluster level. RESULTS: BB resulted in a better balance than randomization in 13-100% of the situations, in 0-61% for minimization, and in 0-88% for matching. The superior performance of BB increased as the number of clusters and/or the number of factors increased. CONCLUSION: BB results in a better balance of prognostic factors than randomization, minimization, stratification, and matching in most situations. Furthermore, BB cannot result in a worse balance of prognostic factors than the other methods.1 februari 201