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

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

A blended electronic illness management and recovery program for people with severe mental illness : qualitative process evaluation alongside a randomized controlled trial

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

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

Effects on staff outcomes and process evaluation of the educating nursing staff effectively (TENSE) program for managing challenging behavior in nursing home residents with dementia: A cluster-randomized controlled trial

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

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

The Influencing Contexts and Potential Mechanisms Behind the Use of Web-Based Self-management Support Interventions: Realistic Evaluation

Background: Self-management can increase self-efficacy and quality of life and improve disease outcomes. Effective self-management may also help reduce the pressure on health care systems. However, patients need support in dealing with their disease and in developing skills to manage the consequences and changes associated with their condition. Web-based self-management support programs have helped patients with cardiovascular disease (CVD) and rheumatoid arthritis (RA), but program use has been low.   Objective: This study aimed to identify the patient, disease, and program characteristics that determine whether patients use web-based self-management support programs or not.   Methods: A realistic evaluation methodology was used to provide a comprehensive overview of context (patient and disease characteristics), mechanism (program characteristics), and outcome (program use). Secondary data of adult patients with CVD (n=101) and those with RA (n=77) were included in the study. The relationship between context (sex, age, education, employment status, living situation, self-management [measured using Patient Activation Measure-13], quality of life [measured using RAND 36-item health survey], interaction efficacy [measured using the 5-item perceived efficacy in patient-physician interactions], diagnosis, physical comorbidity, and time since diagnosis) and outcome (program use) was analyzed using logistic regression analyses. The relationship between mechanism (program design, implementation strategies, and behavior change techniques [BCTs]) and outcome was analyzed through a qualitative interview study.   Results: This study included 68 nonusers and 111 users of web-based self-management support programs, of which 56.4% (101/179) were diagnosed with CVD and 43.6% (78/179) with RA. Younger age and a lower level of education were associated with program use. An interaction effect was found between program use and diagnosis and 4 quality of life subscales (social functioning, physical role limitations, vitality, and bodily pain). Patients with CVD with higher self-management and quality of life scores were less likely to use the program, whereas patients with RA with higher self-management and quality of life scores were more likely to use the program. Interviews with 10 nonusers, 10 low users, and 18 high users were analyzed to provide insight into the relationship between mechanisms and outcome. Program use was encouraged by an easy-to-use, clear, and transparent design and by recommendations from professionals and email reminders. A total of 5 BCTs were identified as potential mechanisms to promote program use: tailored information, self-reporting behavior, delayed feedback, providing information on peer behavior, and modeling.   Conclusions: This realistic evaluation showed that certain patient, disease, and program characteristics (age, education, diagnosis, program design, type of reminder, and BCTs) are associated with the use of web-based self-management support programs. These results represent the first step in improving the tailoring of web-based self-management support programs. Future research on the interaction between patient and program characteristics should be conducted to improve the tailoring of participants to program components.This study was funded by ZonMw, the Netherlands Organization for Health Research and Development (grant 520001001). The authors would like to thank all the patients with cardiovascular disease (CVD) and rheumatoid arthritis (RA) who contributed to this study. </p

Self-management support needs from the perspectives of persons with severe mental illness : a systematic review and thematic synthesis of qualitative research

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

Self-Management Support Needs From the Perspectives of Persons With Severe Mental Illness: A Systematic Review and Thematic Synthesis of Qualitative Research

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.status: publishe

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