Betsie G.I. van Gaal

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.

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 CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly

BackgroundWith increasing age and longevity, the rising number of frail elders with complex and numerous health-related needs demands a coordinated health care delivery system integrating cure, care and welfare. Studies on the effectiveness of such comprehensive chronic care models targeting frail elders show inconclusive results. The CareWell-primary care program is a complex intervention targeting community-dwelling frail elderly people, that aims to prevent functional decline, improve quality of life, and reduce or postpone hospital and nursing home admissions of community dwelling frail elderly.Methods/designThe CareWell-primary care study includes a (cost-) effectiveness study and a comprehensive process evaluation. In a one-year pragmatic, cluster controlled trial, six general practices are non-randomly recruited to adopt the CareWell-primary care program and six control practices will deliver ‘care as usual’. Each practice includes a random sample of fifty frail elders aged 70 years or above in the cost-effectiveness study. A sample of patients and informal caregivers and all health care professionals participating in the CareWell-primary care program are included in the process evaluation. In the cost-effectiveness study, the primary outcome is the level of functional abilities as measured with the Katz-15 index. Hierarchical mixed-effects regression models / multilevel modeling approach will be used, since the study participants are nested within the general practices. Furthermore, incremental cost-effectiveness ratios will be calculated as costs per QALY gained and as costs weighed against functional abilities. In the process evaluation, mixed methods will be used to provide insight in the implementation degree of the program, patients’ and professionals’ approval of the program, and the barriers and facilitators to implementation.DiscussionThe CareWell-primary care study will provide new insights into the (cost-) effectiveness, feasibility, and barriers and facilitators for implementation of this complex intervention in primary care.Trial registrationThe CareWell-primary care study is registered in the ClinicalTrials.gov Protocol Registration System: NCT01499797

Patients' experience with intermittent catheterisation in everyday life

AIMS AND OBJECTIVES This study reports about the experiences of 11 patients in the Netherlands who use intermittent self-catheterisation to manage their symptoms. The aim of the study was to get insight in underlying barriers and facilitators for patients dealing with intermittent catheterisation in everyday life. BACKGROUND Studies show that intermittent catheterisation has an impact on everyday life. A positive effect does not guarantee that patients maintain catheterisation over a longer period of time. After the implementation of a guideline, a quantitative study was performed to determine successful intermittent catheterisation. The patients of this study had previously taken part in this quantitative study. DESIGN This is a qualitative multicentre study using semistructured in-depth interviews with 11 patients between March-May 2013. METHODS Inclusion criteria included patients of a quantitative study (n = 124) with a variety of diagnoses referred to the outpatient clinic. Those who received instruction from the researcher and who at start of the study performed catheterisation ≤3 months were excluded. Of the total number that met the inclusion criteria, every fourth patient was invited to participate in an interview. Patients were asked about the introducing of intermittent catheterisation, the incorporation into everyday life, the progress after the instruction and guidance perceived, the cause of the bladder problem and the motivation to start intermittent catheterisation. RESULTS Eleven interviews were performed (six males/five females). All patients described the instruction and follow-up care as positive. Barriers were the preparation before the handling, which is more difficult than the catheterisation itself, and the fact that patients felt constrained by the need to plan convenient times to catheterise themselves. CONCLUSION This study shows that patients who perform catheterisation are satisfied about the instruction and follow-up care. Important barriers in everyday life are the preparation and the need to plan convenient times. RELEVANCE TO CLINICAL PRACTICE Interviewing patients gave important additional information about dealing with intermittent catheterisation in everyday life. Prescribers and teachers of intermittent catheterisation must realise that they often have to high expectations of patients when it comes to being flexible in frequency of catheterisation. It is important to realise that patients experience barriers of which healthcare workers are not always aware of, such as the preparation before the handling and feeling constrained by the need to plan convenient times to catheterise. The outcome of this study can be used to improve the content of patient information brochures and guidelines for intermittent catheterisation.

Development of an e-supported illness management and recovery programme for consumers with severe mental illness using intervention mapping, and design of an early cluster randomized controlled trial.

BackgroundE-mental health is a promising medium to keep mental health affordable and accessible. For consumers with severe mental illness the evidence of the effectiveness of e-health is limited. A number of difficulties and barriers have to be addressed concerning e-health for consumers with severe mental illness. One possible solution might be to blend e-health with face-to-face delivery of a recovery-oriented treatment, like the Illness Management & Recovery (IMR) programme. This paper describes the development of an e-health application for the IMR programme and the design of an early clustered randomized controlled trial.Method/DesignWe developed the e-IMR intervention according to the six-step protocol of Intervention Mapping. Consumers joined the development group to address important and relevant issues for the target group. Decisions during the six-step development process were based on qualitative evaluations of the Illness Management & Recovery programme, structured interviews, discussion in the development group, and literature reviews on qualitative papers concerning consumers with severe mental illness, theoretical models, behavioural change techniques, and telemedicine for consumers with severe mental illness. The aim of the e-IMR intervention is to help consumers with severe mental illness to involve others, manage achieving goals, and prevent relapse. The e-IMR intervention consists of face-to-face delivery of the Illness Management & Recovery programme and an e-health application containing peer-testimonials on videos, follow up on goals and coping strategies, monitoring symptoms, solving problems, and communication opportunities.We designed an early cluster randomized controlled trial that will evaluate the e-IMR intervention. In the control condition the Illness Management & Recovery programme is provided. The main effect-study parameters are: illness management, recovery, psychiatric symptoms severity, self-management, quality of life, and general health. The process of the IMR program will be evaluated on fidelity and feasibility in semi-structured interviews with participants and trainers.DiscussionIntervention Mapping provided a systematic procedure for the development of this e-health intervention for consumers with severe mental illness and the preparation of an early randomized controlled trial.Trial RegistrationThe trial is registered in the Dutch Trial Register: NTR4772 .

The association between implementation and outcome of a complex care program for frail elderly people

Background Over the last 20 years, the effectiveness of complex care programs aiming to prevent adverse outcomes in frail elderly people has been disappointing. Recently, we found no effectiveness of the CareWell primary care program. It is largely unknown to what extent incomplete implementation of these complex interventions influences their outcomes. Objective To examine the association between the degree of implementation of the CareWell program and the prevention of functional decline in frail elderly people. Methods Quantitative process evaluation conducted alongside a cluster-controlled trial. Two hundred and four frail elderly participants from six general practitioner practices in the Netherlands received care according to the CareWell program, consisting of four key components: multidisciplinary team meetings, proactive care planning, case management and medication reviews. We measured time registrations of team meetings, case management and medication reviews and care plan data as stored in a digital information portal. These data were aggregated into a total implementation score (TIS) representing the programs overall implementation. We measured functional decline with the Katz-15 change score (follow-up score at 12 months minus the baseline score). The association between TIS and functional decline was analyzed with linear mixed model analyses. Results We found no statistically significant differences in functional decline between TIS groups (F = 1.350, P = 0.245). In the groups with the highest TISs, we found more functional decline. Conclusion A higher degree of implementation of the CareWell program did not lead to the prevention of functional decline in frail elderly people.

What we know about the purpose, theoretical foundation, scope and dimensionality of existing self-management measurement tools: A scoping review

OBJECTIVES To identify self-report, self-management measures for adults with chronic conditions, and describe their purpose, theoretical foundation, dimensionality (multi versus uni), and scope (generic versus condition specific). METHODS A search of four databases (8479 articles) resulted in a scoping review of 28 self-management measures. RESULTS Although authors identified tools as measures of self-management, wide variation in constructs measured, purpose, and theoretical foundations existed. Subscales on 13 multidimensional tools collectively measure domains of self-management relevant to clients, however no one tools subscales cover all domains. CONCLUSIONS Viewing self-management as a complex, multidimensional whole, demonstrated that existing measures assess different, related aspects of self-management. Activities and social roles, though important to patients, are rarely measured. Measures with capacity to quantify and distinguish aspects of self-management may promote tailored patient care. PRACTICE IMPLICATIONS In selecting tools for research or assessment, the reason for development, definitions, and theories underpinning the measure should be scrutinized. Our ability to measure self-management must be rigorously mapped to provide comprehensive and system-wide care for clients with chronic conditions. Viewing self-management as a complex whole will help practitioners to understand the patient perspective and their contribution in supporting each individual patient.

How the Illness Management and Recovery Program Enhanced Recovery of Persons With Schizophrenia and Other Psychotic Disorders: A Qualitative Study.

This study aims to describe how the Illness Management and Recovery program enhanced recovery of persons with schizophrenia and other psychotic disorders from their own perspective. Participants valued learning how to divide huge goals into attainable steps, how to recognize and prevent a relapse by managing symptoms, practicing skills, and talking openly about illness related experience. They learned from the exchange with peers and from the information in the IMR textbook. Nurses should have continuous attention and reinforcement for progress on goals, skills practice and exchange of peer information. A peer-support specialist can contribute to keep this focus.

Access to effective healthcare: effective self-management support intervention for patients with a chronic condition and a low social economic status: a systematic review

Background: access to effective healthcare is in particular challenging for vulnerable and socially disadvantaged patients. Patients with chronic conditions are over-represented in these lower socioeconomic (LSES) groups. No generic review integrating the evidence on Self-Management support interventions in LSES patients with different chronic conditions exists.