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OBJECTIVES: To explore how individuals with spinal cord injury self-manage the prevention and treatment of pressure ulcers and to provide insight into experiences with self-management support. DESIGN: Qualitative study using semi-structured interview and a deductive thematic analysis. SETTING: Community. PARTICIPANTS: Twelve of the 14 participating adults with a spinal cord injury had experience with pressure ulcers, and eight of these had a current pressure ulcer. RESULTS: Respondents suggested to tailor treatment of pressure ulcers to patients' individual wishes and capabilities of patients. Patients and caregivers need to be aware of the importance of determining the cause of pressure ulcers to prevent deterioration. Patients often depend on informal caregivers for follow-up and prevention, and healthcare professionals in non-SCI specialties often lack the knowledge needed to manage pressure ulcers in this specific patient group. Tailored education and peer support are important for patients to set boundaries, be assertive, and cultivate a positive attitude when dealing with pressure ulcers. It is difficult to combine treatment of severe pressure ulcers and preventive measures with work roles. Managing the social impact of pressure ulcers requires more coordination with caregivers. CONCLUSIONS: To support self-management of pressure ulcers in patients with a spinal cord injury, they must find out which preventive measures and treatments suit them best. Healthcare professionals play an important role in the self-management of pressure ulcers and can help patients deal with the emotional and social impact of pressure ulcers. To know patient's needs and tailor their education, healthcare professionals of non SCI organizations need to have knowledge of pressure ulcers management of this specific patient group.

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BACKGROUND: Challenging behavior is prevalent in people with dementia residing in nursing homes and places a high burden on the nursing staff of dementia special care units. This study evaluates an educational program for nursing staff for managing challenging behavior: The Educating Nursing Staff Effectively (TENSE) program. This program can be tailored to care organizations' wishes and needs and combines various learning styles. OBJECTIVE: The aim of this cluster-randomized controlled trial was to examine the short-term (3 months) and long-term (9 months) effects of the TENSE training program on experienced stress, work contentment, and stress reactions at work in nursing staff working in dementia special care units. DESIGN: Cluster-randomized controlled trial. METHODS: Nursing staff members of 18 dementia special care units within nine nursing homes from different Netherlands regions were randomized into an intervention (n = 168) or control (n = 129) group. The TENSE program consisted of a three-day training course and two follow-up sessions after three and six months, respectively. The primary outcome was stress experienced by nursing staff measured with the Utrecht Burnout Scale - C. Secondary outcomes were work contentment and stress reactions at work. Furthermore, process evaluation data on the reach of and compliance with the program and the program's feasibility and relevance were collected. Data were collected between November 2012 and November 2014. RESULTS: In general, the participants appreciated the quality and relevance of the TENSE training and evaluated the content of the training as beneficial. The TENSE training had no effect on the components of experienced stress, i.e., emotional exhaustion (p = 0.751), depersonalization (p = 0.701), and personal accomplishment (p = 0.182). Furthermore, no statistically significant effects of the intervention on work contentment and stress reactions at work were found. CONCLUSIONS: The TENSE training program did not have an effect on experienced stress, work contentment, nor stress reactions at work of nursing staff working in dementia special care units. In future studies, more focus on practicing new skills seems needed. TRIAL REGISTRATION: NTR (Dutch Trial Registration) number NTR3620.

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PURPOSE: Complementary interventions for persons with severe mental illness (SMI) focus on both personal recovery and illness self-management. This paper aimed to identify the patient-reported outcome measures (PROMs) associated with the most relevant and meaningful change in persons with SMI who attended the Illness Management and Recovery Programme (IMR). METHODS: The effect of the IMR was measured with PROMs concerning recovery, illness self-management, burden of symptoms and quality of life (QoL). From the QoL measures, an anchor was chosen based on the most statistically significant correlations with the PROMs. Then, we estimated the minimal important difference (MID) for all PROMs using an anchor-based method supported by distribution-based methods. The PROM with the highest outcome for effect score divided by MID (the effect/MID index) was considered to be a measure of the most relevant and meaningful change. RESULTS: All PROMs showed significant pre-post-effects. The QoL measure 'General Health Perception (Rand-GHP)' was identified as the anchor. Based on the anchor method, the Mental Health Recovery Measure (MHRM) showed the highest effect/MID index, which was supported by the distribution-based methods. Because of the modifying gender covariate, we stratified the MID calculations. In most MIDs, the MHRM showed the highest effect/MID indexes. CONCLUSION: Taking into account the low sample size and the gender covariate, we conclude that the MHRM was capable of showing the most relevant and meaningful change as a result of the IMR in persons with SMI.

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BACKGROUND: We conducted a trial to test the electronic Illness Management and Recovery (e-IMR) intervention to provide conclusions on the potential efficacy of eHealth for people with severe mental illness (SMI). In the e-IMR intervention, we used the standard IMR program content and methodology and combined face-to-face sessions with internet-based strategies on the constructed e-IMR internet platform. During the trial, the e-IMR platform was sparsely used. OBJECTIVE: This study aimed to evaluate the added value of the e-IMR intervention and the barriers and facilitators that can explain the low use of the e-IMR platform. METHODS: This process evaluation was designed alongside a multicenter, cluster randomized controlled trial. In this study, we included all available participants and trainers from the intervention arm of the trial. Baseline characteristics were used to compare users with nonusers. Qualitative data were gathered at the end of the semistructured interviews. Using theoretical thematic analyses, the data were analyzed deductively using a pre-existing coding frame. RESULTS: Out of 41 eligible participants and 14 trainers, 27 participants and 11 trainers were interviewed. Of the 27 participants, 10 were identified as users. eHealth components that had added value were the persuasive nature of the goal-tracking sheets, monitoring, and the peer testimonials, which had the potential to enhance group discussions and disclosure by participants. The low use of the e-IMR platform was influenced by the inflexibility of the platform, the lack of information technology (IT) resources, the group context, participants' low computer skills and disabilities, and the hesitant eHealth attitude of the trainers. CONCLUSIONS: The extent of eHealth readiness and correlations with vulnerabilities in persons with SMI need further investigation. This study shows that flexible options were needed for the use of e-IMR components and that options should be provided only in response to a participant's need. Use of the e-IMR intervention in the future is preconditioned by checking the available IT resources (such as tablets for participants) providing computer or internet guidance to participants outside the group sessions, evaluating the eHealth attitude and skills of trainers, and tailoring eHealth training to increase the skills of future e-IMR trainers. TRIAL REGISTRATION: Netherlands Trial Register NTR4772; https://www.trialregister.nl/trial/4621. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12913-016-1267-z.

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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.

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OBJECTIVE: This observational study explores advanced practice nurses' (APN) performance in secondary prevention and self-management support in patients with cardiovascular disease. METHODS: Real-life consultations in three outpatient clinics were recorded on audio and analysed. First, discussed (sub)categories were determined using five categories of self-management: symptom management, treatment, biomedical cardiovascular risk factors, psychosocial consequences, and lifestyle changes. Second, the extent in which motivational interviewing aspects were applied was determined using the Behaviour Change Counselling Index (BECCI). RESULTS: In total, 49 consultations performed by five female APNs were analysed. Physical topics were discussed in 98% and psychological subthemes in 41% of the consultations. Although not all components of motivational interviewing were applied, talking about current behaviour and behaviours that should change were discussed, and information was provided. Especially setting targets and exchanging ideas on how to reach behavioural goals were applied to a small extent. CONCLUSION: Well-trained APNs in the current study do not carry out motivational interviewing in a structural and complete manner according to BECCI and do not discuss all self-management categories. PRACTICE IMPLICATIONS: Psychological topics should be more integrated in providing self-management support by APNs and the application of motivational interviewing should be enhanced by regularly and repeated training.

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BACKGROUND: The development of de-hospitalization policies in mental health has resulted in a growing emphasis on self-management. In the chronic care model, self-management support is an essential element. Because of the episodic nature of severe mental illness (SMI) and its high relapse rates, we assume that the extent of self-management support needs of individuals with an SMI is considerable. However, a clear overview of the nature of the self-management support needs of persons with SMI is missing. AIMS: This study aimed to identify self-management support needs from the perspective of individuals with SMI. METHOD: A systematic review was conducted using the method of thematic synthesis of qualitative studies. After searching the databases MEDLINE, PsycINFO, CINAHL, and EMBASE, we screened the papers for the eligibility criteria: individuals with an SMI, adequately representing the voice of persons with SMI and describing their self-management support needs. Thirty-one papers were included. RESULTS: The main findings showed that participants in the studies described the need for informational support, emotional support, acknowledgment, encouragement, and guidance to make sense of their illness experiences, ease suffering, obtain validation and recognition, execute self-management tasks, and be led through unfamiliar territory. CONCLUSION: The perspectives of persons with SMI can provide a road map for constructing a self-management support intervention for persons with SMI. Important others have an essential role in fulfilling support needs. Independently managing an SMI is difficult. Therefore, it is preferable to let important others participate in self-management interventions and to introduce peer support.

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BACKGROUND: E-mental health holds promise for people with severe mental illness, but has a limited evidence base. This study explored the effect of e-health added to face-to-face delivery of the Illness Management and Recovery Programme (e-IMR). METHOD: In this multi-centre exploratory cluster randomized controlled trial, seven clusters (n = 60; 41 in intervention group and 19 in control group) were randomly assigned to e-IMR + IMR or IMR only. Outcomes of illness management, self-management, recovery, symptoms, quality of life, and general health were measured at baseline (T0), halfway (T1), and at twelve months (T2). The data were analysed using mixed model for repeated measurements in four models: in 1) we included fixed main effects for time trend and group, in 2) we controlled for confounding effects, in 3) we controlled for interaction effects, and in 4) we performed sub-group analyses within the intervention group. RESULTS: Notwithstanding low activity on e-IMR, significant effects were present in model 1 analyses for self-management (p = .01) and recovery (p = .02) at T1, and for general health perception (p = .02) at T2, all in favour of the intervention group. In model 2, the confounding covariate gender explained the effects at T1 and T2, except for self-management. In model 3, the interacting covariate non-completer explained the effects for self-management (p = .03) at T1. In model 4, the sub-group analyses of e-IMR-users versus non-users showed no differences in effect. CONCLUSION: Because of confounding and interaction modifications, effectiveness of e-IMR cannot be concluded. Low use of e-health precludes definite conclusions on its potential efficacy. Low use of e-IMR calls for a thorough process evaluation of the intervention. TRIAL REGISTRATION: The Dutch Trial Register ( NTR4772 ).

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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 tool's 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.

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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 program's 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.

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AIM: To assess the quality of evidence and determine the effect of patient-related and economic outcomes of self-management support interventions in chronically ill patients with a low socio-economic status. BACKGROUND: Integrated evidence on self-management support interventions in chronically ill people with low socio-economic status is lacking. DESIGN: Systematic literature review. DATA SOURCES: Cochrane database of trials, PubMed, CINAHL, Web of Science, PsycINFO and Joanna Briggs Institute Library were searched (2000-2013). Randomized controlled trials addressing self-management support interventions for patients with cardiovascular disease, stroke, cancer, diabetes and/or chronic respiratory disease were included. REVIEW METHODS: Data extraction and quality assessment were performed by independent researchers using a data extraction form. RESULTS: Studies (n = 27) focused mainly on diabetes. Fourteen studies cited an underlying theoretical basis. Most frequently used self-management support components were lifestyle advice, information provision and symptom management. Problem-solving and goal-setting strategies were frequently integrated. Eleven studies adapted interventions to the needs of patients with a low socio-economic status. No differences were found for interventions developed based on health behaviour theoretical models. CONCLUSION: Limited evidence was found for self-management support interventions in chronically ill patients with low socio-economic status. Essential characteristics and component(s) of effective self-management support interventions for these patients could not be detected. Rigorous reporting on development and underlying theories in the intervention is recommended.

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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.

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BACKGROUND: In the Netherlands, most patients with severe mental illness (SMI) receive flexible assertive community treatment (FACT) provided by multidisciplinary community mental health teams. SMI patients with comorbid posttraumatic stress disorder (PTSD) are sometimes offered evidence-based trauma-focused treatment like eye movement desensitization reprocessing or prolonged exposure. There is a large amount of evidence for the effectiveness of narrative exposure therapy (NET) within various vulnerable patient groups with repeated interpersonal trauma. Some FACT-teams provide NET for patients with comorbid PTSD, which is promising, but has not been specifically studied in SMI patients. OBJECTIVES: The primary aim is to evaluate NET in SMI patients with comorbid PTSD associated with repeated interpersonal trauma to get insight into whether (1) PTSD and dissociative symptoms changes and (2) changes occur in the present SMI symptoms, care needs, quality of life, global functioning, and care consumption. The second aim is to gain insight into patients' experiences with NET and to identify influencing factors on treatment results. METHODS: This study will have a mixed methods convergent design consisting of quantitative repeated measures and qualitative semi-structured in-depth interviews based on Grounded Theory. The study population will include adult SMI outpatients (n=25) with comorbid PTSD and receiving NET. The quantitative study parameters will be existence and severity of PTSD, dissociative, and SMI symptoms; care needs; quality of life; global functioning; and care consumption. In a longitudinal analysis, outcomes will be analyzed using mixed models to estimate the difference in means between baseline and repeated measurements. The qualitative study parameters will be experiences with NET and perceived factors for success or failure. Integration of quantitative and qualitative results will be focused on interpreting how qualitative results enhance the understanding of quantitative outcomes. DISCUSSION: The results of this study will provide more insight into influencing factors for clinical changes in this population.

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BACKGROUND: E-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/DESIGN: We 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. DISCUSSION: Intervention 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 REGISTRATION: The trial is registered in the Dutch Trial Register: NTR4772 .

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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.

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BACKGROUND: No-rinse disposable wash gloves are increasingly implemented in health care to replace traditional soap and water bed baths without proper evaluation of (cost) effectiveness. OBJECTIVES: To compare bed baths for effects on skin integrity and resistance against bathing and costs. DESIGN: Cluster randomized trial. SETTING: Fifty six nursing home wards in the Netherlands. Participants: Five hundred adult care-dependent residents and 275 nurses from nursing home wards. METHODS: The experimental condition 'washing without water' consists of a bed bath with disposable wash gloves made of non-woven waffled fibers, saturated with a no-rinse, quickly vaporizing skin cleaning and caring lotion. The control condition is a traditional bed bath using soap, water, washcloths and towels. Both conditions were continued for 6 weeks. Outcome measures were prevalence of skin damage distinguished in two levels of severity: any skin abnormality/lesion and significant skin lesions. Additional outcomes: resistance during bed baths, costs. RESULTS: Any skin abnormalities/lesions over time decreased slightly in the experimental group, and increased slightly in the control group, resulting in 72.7% vs 77.6% of residents having any skin abnormalities/lesions after 6 weeks, respectively (p=0.04). There were no differences in significant skin lesions or resistance after 6 weeks. Mean costs for bed baths during 6 weeks per resident were estimated at €218.30 (95%CI 150.52-286.08) in the experimental group and €232.20 (95%CI: 203.80-260.60) in the control group (difference €13.90 (95%CI: -25.61-53.42). CONCLUSION: Washing without water mildly protects from skin abnormalities/lesions, costs for preparing and performing bed baths do not differ from costs for traditional bed bathing. Thus, washing without water can be considered the more efficient alternative.

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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.

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BACKGROUND: With 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/DESIGN: The 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. DISCUSSION: The 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 REGISTRATION: The CareWell-primary care study is registered in the ClinicalTrials.gov Protocol Registration System: NCT01499797.

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OBJECTIVE: 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.

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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.

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