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Background: Learning of burn patient assessment is very important, but heart-breaking for nursing students. This study aimed to compare the effects of feedback lecture method with a serious game (BAM Game) on nursing students' knowledge and skills in the assessment of burn patients. Method: In this randomized controlled clinical trial, 42 nursing students in their 5th semester at Mashhad University of Medical Sciences School of Nursing and Midwifery, were randomly assigned to intervention (BAM game, available for two weeks) and control (feedback lecture method presented in two 90-minute sessions) groups. Two weeks after the intervention, all students were evaluated for their knowledge (using knowledge assessment test) and skills (using an Objective Structured Clinical Examination). Statistical analysis involved independent t-test, Fisher's exact test, analysis of covariance (ANCOVA), and univariable and multivariable ordinal logistic regression models. Results: Following the intervention, the skill scores were 16.4 (SD 2.2) for the intervention group and 11.8 (SD 3.8) for the control group. Similarly, the knowledge scores were 17.4 (SD 2.2) for the intervention group and 14.7 (SD 2.6) for the control group. Both differences were statistically significant (P <.001). These differences remained significant even after adjusting for various factors such as age, gender, marital status, residence, university entrance exam rank, and annual GPA (P <.05). Furthermore, the BAM game group showed significantly higher skills rank than the feedback lecture group across most stations (eight of ten) (P <.05) in the univariable analysis. Multivariable analysis also revealed a significantly higher skills score across most stations even after adjusting for the mentioned factors (P <.05). These results suggest that the BAM game group had higher skills scores over a range of 1.5 to 3.9 compared to the feedback lecture group. Conclusions: This study demonstrated that nursing students who participated in the BAM game group exhibited superior performance in knowledge acquisition and skill development, compared to those in the control group. These results underscore a significant enhancement in educational outcomes for students involved with the BAM game, confirming its utility as a potent and effective pedagogical instrument within the realm of nursing education. Trial registration: Iranian Registry of Clinical Trials: IRCT20220410054483N1, Registration date: 18/04/2022. [ABSTRACT FROM AUTHOR]

Background: IMPACT-AF is a prospective, randomized, cluster design trial comparing atrial fibrillation (AF) management with a computerized decision support system (CDS) to usual care (control) in the primary care setting of Nova Scotia, Canada. The objective of this analysis was to compare the resource use and costs between CDS and usual care groups. Methods: Case costing data, 12-month self-administered questionnaires, and monthly diaries from IMPACT-AF were used in this analysis. Descriptive statistics were used to compare costs and resource use between groups. All costs are presented in 2021 Canadian dollars and cover the 12-month period of participation in the study. Results: A total of 1,145 patients enrolled in the trial. Case costing data were available for 466 participants (41.1%), 12-month self-administered questionnaire data for 635 participants (56.0%) and monthly diary data for 223 participants (19.7%). Emergency department visits and hospitalizations comprised the most expensive component of AF care. Across all three datasets, there were no statistically significant differences in costs or resource use between CDS and usual care groups. Conclusions: Although there were no significant differences in resource use or costs among CDS and usual care groups in the IMPACT-AF trial, this study provides insight into the methodology and practical challenges of collecting economic data alongside a trial. Registration: Clinicaltrials.gov (registration number: NCT01927367, date of registration: 2013-08-20). [ABSTRACT FROM AUTHOR]

Background: Short messages service (SMS) provides a practical medium for delivering content to address patients to adherence to self-management. The aim of study was to design some patient-centered health education messages, evaluate the feasibility of messages, and explore the effect of this model.Methods: The messages were designed by a panel of experts, and SMS Quality Evaluation Questionnaire was used to evaluate their quality. A two-arm randomized controlled trial was conducted to evaluate the effectiveness of this management model. Participants were randomly divided into an intervention group (IG) who received evaluated messages and a control group (CG) who received regular education. The primary outcomes were changes in plasma glucose and control rates, and the secondary outcomes were improvements in diet control, physical activities, weight control, etc. RESULTS: A total of 42 messages covering five main domains: health awareness, diet control, physical activities, living habits and weight control were designed, and the average scores of the messages were 8.0 (SD 0.7), 8.5 (SD 0.6), 7.9 (SD 1.0), 8.0 (SD 0.7), and 8.4 (SD 0.9), respectively. In the SMS intervention, 171 patients with an average age of 55.1 years were involved, including 86 in the CG and 85 in the IG. At 12 months, compared with the control group (CG), the decrease of fasting plasma glucose (FPG) (1.5 vs. 0.4, P = 0.011) and control rate (49.4% vs. 33.3%, P = 0.034), the postprandial glucose (PPG) (5.8 vs. 4.2, P = 0.009) and control rate (57.8% vs. 33.7%, P = 0.002) were better in the intervention group (IG). In terms of self-management, improvements in weight control (49.3% vs. 28.2%, P = 0.031), vegetables consumption (87.3% vs. 29.0%, P < 0.001), fruits consumption (27.5% vs. 7.4%, P = 0.022), and physical activities (84.7% vs. 70.0%, P = 0.036) were better in the IG than in the CG.Conclusions: The overall quality of the messages was high. It was effective and feasible to carry out an SMS intervention to improve the behavioral habits of patients with chronic diseases in remote and undeveloped areas.Trial Registration: Clinicaltrials.gov, ChiCTR1900023445. Registered May 28, 2019--Retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Management of diabetes through improved glycemic control and risk factor modification can help prevent long-term complications. Much diabetes management is self-management, in which healthcare providers play a supporting role. Well-designed e-Health solutions targeting behavior change can improve a range of measures, including glycemic control, perceived health, and a reduction in hospitalizations. Methods: The primary objective of this study is to evaluate if a mobile application designed to improve self-management among patients with type 2 diabetes (T2DM) improves glycemic control compared to usual care. The secondary objectives are to determine the effects on patient experience and health system costs; evaluate how and why the intervention worked as observed; and gain insight into considerations for system-wide scale-up. This pragmatic, randomized, wait-list-control trial will recruit adult participants from three Diabetes Education Programs in Ontario, Canada. The primary outcome is glycemic control (measured by HbA1c). Secondary outcomes include patient-reported outcomes and patient-reported experience measures, health system utilization, and intervention usability. The primary outcome will be analyzed using an ANCOVA, with continuous secondary outcomes analyzed using Poisson regression. Direct observations will be conducted of the implementation and application-specific training sessions provided to each site. Semi-structured interviews will be conducted with participants, healthcare providers, organizational leaders, and system stakeholders as part of the embedded process evaluation. Thematic analysis will be applied to the qualitative data in order to describe the relationships between (a) key contextual factors, (b) the mechanisms by which they effect the implementation of the intervention, and (c) the impact on the outcomes of the intervention, according to the principles of Realist Evaluation. Discussion: The use of mobile health and virtual tools is on the rise in health care, but the evidence of their effectiveness is mixed and their evaluation is often lacking key contextual data. Results from this study will provide much needed information about the clinical and cost-effectiveness of a mobile application to improve diabetes self-management. The process evaluation will provide valuable insight into the contextual factors that influence the application effectiveness, which will inform the potential for adoption and scale. [ABSTRACT FROM AUTHOR]

Background: Around 300 million people worldwide have asthma and prevalence is increasing. Self-management can be effective in improving a range of outcomes and is cost effective, but is underutilised as a treatment strategy. Supporting optimum self-management using digital technology shows promise, but how best to do this is not clear. We aimed to develop an evidence based, theory informed, online resource to support self-management in adults with asthma, called 'Living well with Asthma', as part of the RAISIN (Randomized Trial of an Asthma Internet Self-Management Intervention) study. Methods: We developed Living well with Asthma in two phases. Phase 1: A low fidelity prototype (paper-based) version of the website was developed iteratively through input from a multidisciplinary expert panel, empirical evidence from the literature, and potential end users via focus groups (adults with asthma and practice nurses). Implementation and behaviour change theories informed this process. Phase 2: The paper-based designs were converted to a website through an iterative user centred process. Adults with asthma (n = 10) took part in think aloud studies, discussing the paper based version, then the web-based version. Participants considered contents, layout, and navigation. Development was agile using feedback from the think aloud sessions immediately to inform design and subsequent think aloud sessions. Think aloud transcripts were also thematically analysed, further informing resource development. Results: The website asked users to aim to be symptom free. Key behaviours targeted to achieve this include: optimising medication use (including inhaler technique); attending primary care asthma reviews; using asthma action plans; increasing physical activity levels; and stopping smoking. The website had 11 sections, plus email reminders, which promoted these behaviours. Feedback on the contents of the resource was mainly positive with most changes focussing on clarification of language, order of pages and usability issues mainly relating to navigation difficulties. Conclusions: Our multifaceted approach to online intervention development underpinned by theory, using evidence from the literature, co-designed with end users and a multidisciplinary panel has resulted in a resource which end users find relevant to their needs and easy to use. Living well with Asthma is undergoing evaluation within a randomized controlled trial. [ABSTRACT FROM AUTHOR]

Background: Around 300 million people worldwide have asthma and prevalence is increasing. Self-management can be effective in improving a range of outcomes and is cost effective, but is underutilised as a treatment strategy. Supporting optimum self-management using digital technology shows promise, but how best to do this is not clear. We aimed to develop an evidence based, theory informed, online resource to support self-management in adults with asthma, called ‘Living well with Asthma’, as part of the RAISIN (Randomized Trial of an Asthma Internet Self-Management Intervention) study. Methods: We developed Living well with Asthma in two phases. Phase 1: A low fidelity prototype (paper-based) version of the website was developed iteratively through input from a multidisciplinary expert panel, empirical evidence from the literature, and potential end users via focus groups (adults with asthma and practice nurses). Implementation and behaviour change theories informed this process. Phase 2: The paper-based designs were converted to a website through an iterative user centred process. Adults with asthma (n = 10) took part in think aloud studies, discussing the paper based version, then the web-based version. Participants considered contents, layout, and navigation. Development was agile using feedback from the think aloud sessions immediately to inform design and subsequent think aloud sessions. Think aloud transcripts were also thematically analysed, further informing resource development. Results: The website asked users to aim to be symptom free. Key behaviours targeted to achieve this include: optimising medication use (including inhaler technique); attending primary care asthma reviews; using asthma action plans; increasing physical activity levels; and stopping smoking. The website had 11 sections, plus email reminders, which promoted these behaviours. Feedback on the contents of the resource was mainly positive with most changes focussing on clarification of language, order of pages and usability issues mainly relating to navigation difficulties. Conclusions: Our multifaceted approach to online intervention development underpinned by theory, using evidence from the literature, co-designed with end users and a multidisciplinary panel has resulted in a resource which end users find relevant to their needs and easy to use. Living well with Asthma is undergoing evaluation within a randomized controlled trial. [ABSTRACT FROM AUTHOR]

Background: Chronic low back pain is a common chronic condition whose treatment success can be improved by active involvement of patients. Patient involvement can be fostered by web-based applications combining health information with decision support or behaviour change support. These so-called Interactive Health Communication Applications (IHCAs) can reach great numbers of patients at low financial cost and provide information and support at the time, place and learning speed patients prefer. However, high attrition often seems to decrease the effects of web-based interventions. Tailoring content and tone of IHCAs to the individual patient's needs might improve usage and therefore effectiveness. This study aims to evaluate a tailored IHCA for people with chronic low back pain combining health information with decision support and behaviour change support. Methods/Design: The tailored IHCA will be tested regarding effectiveness and usage against a standard website with identical content in a single-blinded randomized trial with a parallel design. The IHCA contains information on chronic low back pain and its treatment options including health behaviour change recommendations. In the intervention group the content is delivered in dialogue form, tailored to relevant patient characteristics (health literacy, coping style). In the control group there is no tailoring, a standard web-page is used for presenting the content. Participants are unaware of group assignment. Eligibility criteria are age ⩾ 18 years , self- reported chronic low back pain, and Internet access. To detect the expected small effect (Cohen's d = 0.2), the sample aims to include 414 patients, with assessments at baseline, directly after the first on-page visit, and at 3-month follow-up using online self-report questionnaires. It is expected that the tailored IHCA has larger effects on knowledge and patient empowerment (primary outcomes) compared to a standard website. Secondary outcomes are website usage, preparation for decision making, and decisional conflict. Discussion: IHCAs can be a suitable way to promote knowledge about chronic low back pain and self-management competencies. Results of the study can increase the knowledge on how to develop IHCAs which are more useful and effective for people suffering from chronic low back pain. [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes is an increasingly common chronic condition whose prognosis can be improved by patient involvement and self-management. Patient involvement can be fostered by web-based Interactive Health Communication Applications (IHCAs) combining health information with decision support, social support and/or behaviour change support. They reach great numbers of patients at low cost and provide high-quality information and support at the time, place and learning speed patients prefer. Still, online tools often suffer from high attrition. Tailoring content and tone of IHCAs to the individual patient's needs might improve their effectiveness. This study aims to test the effectiveness and usage of a tailored IHCA combining health information with decision support and behaviour change support for patients with type 2 diabetes. Methods/design: The effectiveness and usage of the tailored IHCA will be tested against a standard website with identical content in a single-blinded randomized trial with a parallel design. The content covers information on type 2 diabetes, its complications and sequelae, and its treatment options including health behaviour. In the intervention group the content is delivered in dialogue form, tailored to relevant patient characteristics (health literacy, attitudes towards self-care, and barriers to insulin treatment). In the control group the different sections are presented in a content tree, without any tailoring. Participants are blinded to group assignment. Eligibility criteria are age ⩾ 18 years, self-reported type 2 diabetes, and Internet access. The study aims to include 414 participants in order to detect the expected small effect (Cohen's d=0.2), with measurements at baseline, directly after the first visit, and at 3-month follow-up. The primary hypothesis is that the tailored IHCA has larger effects on diabetes knowledge and patient empowerment (primary outcomes) than the standard website. Secondary outcomes are website usage as well as decisional conflict and preparation for decision making. All measurements are online self-report questionnaires. Discussion: IHCAs are a promising way to foster diabetes knowledge and self-management competencies. The present trial tries to increase the knowledge on how to develop more effective IHCAs for patients with type 2 diabetes. [ABSTRACT FROM AUTHOR]

Background: Low adherence to chronic kidney disease (CKD) guidelines may be due to unrecognized CKD and lack of guideline awareness on the part of providers. The goal of this study was to evaluate the impact of provider education and access to a CKD registry on guideline adherence. Methods: We conducted a cluster randomized controlled trial at the Louis Stokes Cleveland VAMC. One of two primary care clinics was randomized to intervention. Providers from both clinics received a lecture on CKD guidelines at study initiation. Providers in the intervention clinic were given access to and shown how to use a CKD registry, which identifies patients with CKD and is automatically updated daily. Eligible patients had at least one primary care visit in the last year, had CKD based on eGFR, and had not received renal replacement therapy. The primary outcome was parathyroid hormone (PTH) adherence, defined by at least one PTH measurement during the 12 month study. Secondary outcomes were measurement of phosphorus, hemoglobin, proteinuria, achievement of goal blood pressure, and treatment with a diuretic or renin-angiotensin system blocker. Results: There were 418 and 363 eligible patients seen during the study in the control and intervention clinics, respectively. Compared to pre-intervention, measurement of PTH increased in both clinics (control clinic: 16% to 23%; intervention clinic: 13% to 28%). Patients in the intervention clinic were more likely to have a PTH measured during the study (adjusted odds ratio = 1.53; 95% CI (1.01, 2.30); P = 0.04). However, the intervention was not associated with a consistent improvement in secondary outcomes. Only 5 of the 37 providers in the intervention clinic accessed the registry. Conclusions: An intervention that included education on CKD guidelines and access to a CKD patient registry marginally improved guideline adherence over education alone. Adherence to the primary process measure improved in both clinics, but no improvement was seen in intermediate clinical outcomes. Improving the care of patients with CKD will likely require a multifaceted approach including system redesign. ClinicalTrials.Gov registration number: NCT00921687. [ABSTRACT FROM AUTHOR]

Background: Most breast cancer patients undergoing mastectomy are candidates for breast reconstruction. Deciding about breast reconstruction is complex and the preference-sensitive nature of this decision requires an approach of shared decision making between patient and doctor. Women considering breast reconstruction have expressed a need for decision support. We developed an online patient decision aid (pDA) to support decision making in women considering immediate breast reconstruction. The primary aim of this study is to assess the impact of the pDA in reducing decisional conflict, and more generally, on the decision-making process and the decision quality. Additionally, we will investigate the pDA's impact on health outcomes, explore predictors, and assess its cost-effectiveness.Methods: A multicenter, two-armed randomized controlled trial (1:1) will be conducted. Women with breast cancer or ductal carcinoma in situ who will undergo a mastectomy and are eligible for immediate breast reconstruction will be invited to participate. The intervention group will receive access to the online pDA, whereas the control group will receive a widely available free information leaflet on breast reconstruction. Participants will complete online questionnaires at: baseline (T0), 1 week after consultation with a plastic surgeon (T1), and 3 (T2) and 12 months (T3) after surgery. The primary outcome is decisional conflict. Secondary outcomes include other measures reflecting the decision-making process and decision quality (e.g., decision regret), patient-reported health outcomes (e.g., satisfaction with the breasts) and costs.Discussion: This study will provide evidence about the impact of an online pDA for women who will undergo mastectomy and are deciding about breast reconstruction. It will contribute to the knowledge on how to optimally support women in making this difficult decision.Trial Registration: This study is retrospectively registered at ClinicalTrials.gov ( NCT03791138 ). [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer (CRC) screening has shown to reduce incidence and mortality rates, and therefore is widely recommended for people above 50 years-old. However, despite the implementation of population-based screening programs in several countries, uptake rates are still low. Decision aids (DAs) may help patients to make informed decisions about CRC screening.Methods: We performed a randomized controlled trial to assess the effectiveness of a DA developed to promote CRC screening, with patients from two primary care centers in Spain who never had underwent CRC screening. Contrary to center B (n = 24), Center A (n = 83) attended patients from an area where the population-based screening program was not implemented at that moment. Outcome measures were decisional conflict, knowledge of the disease and available screening options, intention to uptake the test, and concordance between patients' goals/concerns and intention.Results: In center A, there were significant differences favoring the DA in decisional conflict (p < 0.001) and knowledge (p < 0.001). The absolute differences favoring DA group in intention to undergo fecal occult blood test (10.5%) and colonoscopy (13.7%) were significant only before correction for attenuation. In center B the differences were significant only for knowledge (p < 0.001). Patients' goals and concerns regarding the screening did not significantly predict their intention, and therefore we could not calculate a measure of concordance between the two constructs.Conclusions: A DA improved the decisional process of participants who had never been invited to participate in the Spanish public CRC screening program, replicating previous results in this field. Future research is needed to identify subgroups that could benefit more from these interventions.Trial Registration: International Standard Registered Clinical/social Study Number: ISRCTN98108615 (Retrospectively registered on 27 December 2018). [ABSTRACT FROM AUTHOR]