Qualitative study on shared decision making in cystitis management in general practice.

BACKGROUND: Cystitis is commonly treated with antibiotics, although non-antibiotic options could be considered for healthy non-pregnant women. Shared decision making (SDM) can be used in cystitis management to discuss the various treatment options but is not frequently applied in general practice. AIM: To identify barriers and facilitators for applying SDM in cystitis management in general practice. DESIGN & SETTING: Qualitative explorative research in general practice with healthcare professionals (HCPs; GPs and GP assistants) and healthy non-pregnant women with a recent history of cystitis (patients). METHOD: Individual semi-structured interviews were conducted between May and October 2022. We applied a combination of thematic and framework analysis. RESULTS: Ten GPs, seven GP assistants, and 15 patients were interviewed. We identified the following three main barriers and one key facilitator: (1) applying SDM is deemed inefficient; (2) HCPs assume that patients expect antibiotic treatment and some HCPs consider non-antibiotic treatment inferior; (3) patients are largely unaware of the various non-antibiotic treatment options for cystitis; and (4) HCPs recognise some benefits of applying SDM in cystitis management, including reduced antibiotic use and improved patient empowerment, and patients appreciate involvement in treatment decisions, but preferences for SDM vary. CONCLUSION: SDM is infrequently applied in cystitis treatment in general practice owing to the current focus on efficient cystitis management that omits patient contact, HCPs' perceptions, and patient unawareness. Nevertheless, both HCPs and patients recognise the long-term benefits of applying SDM in cystitis management. Our findings facilitate the development of tailored interventions to increase the application of SDM, which should be co-created with HCPs and patients, and fit into the current efficient cystitis management.

How does the external context affect an implementation processes? A qualitative study investigating the impact of macro-level variables on the implementation of goal-oriented primary care.

BACKGROUND: Although the importance of context in implementation science is not disputed, knowledge about the actual impact of external context variables on implementation processes remains rather fragmented. Current frameworks, models, and studies merely describe macro-level barriers and facilitators, without acknowledging their dynamic character and how they impact and steer implementation. Including organizational theories in implementation frameworks could be a way of tackling this problem. In this study, we therefore investigate how organizational theories can contribute to our understanding of the ways in which external context variables shape implementation processes. We use the implementation process of goal-oriented primary care in Belgium as a case. METHODS: A qualitative study using in-depth semi-structured interviews was conducted with actors from a variety of primary care organizations. Data was collected and analyzed with an iterative approach. We assessed the potential of four organizational theories to enrich our understanding of the impact of external context variables on implementation processes. The organizational theories assessed are as follows: institutional theory, resource dependency theory, network theory, and contingency theory. Data analysis was based on a combination of inductive and deductive thematic analysis techniques using NVivo 12. RESULTS: Institutional theory helps to understand mechanisms that steer and facilitate the implementation of goal-oriented care through regulatory and policy measures. For example, the Flemish government issued policy for facilitating more integrated, person-centered care by means of newly created institutions, incentives, expectations, and other regulatory factors. The three other organizational theories describe both counteracting or reinforcing mechanisms. The financial system hampers interprofessional collaboration, which is key for GOC. Networks between primary care providers and health and/or social care organizations on the one hand facilitate GOC, while on the other hand, technology to support interprofessional collaboration is lacking. Contingent variables such as the aging population and increasing workload and complexity within primary care create circumstances in which GOC is presented as a possible answer. CONCLUSIONS: Insights and propositions that derive from organizational theories can be utilized to expand our knowledge on how external context variables affect implementation processes. These insights can be combined with or integrated into existing implementation frameworks and models to increase their explanatory power.

Improving antibiotic prescribing quality in out-of-hours primary care: a mixed-methods study using participatory action research.

Background: During out-of-hours (OOH) primary care, GPs overprescribe antibiotics for respiratory tract infections (RTIs). Many interventions have been shown to improve antibiotic prescribing quality, but their implementation in practice remains difficult. Participatory action research (PAR) aims to explore, implement and evaluate change in practice with an active involvement of local stakeholders, while generating knowledge through experience. Objectives: To evaluate whether PAR improves antibiotic prescribing quality for RTIs during OOH primary care and simultaneously identify the pivotal lessons learned. Methods: A mixed-methods study with a PAR approach in three OOH GP cooperatives (GPCs). Each GPC co-created a multifaceted intervention focusing on improving antibiotic use for RTIs through plan-do-study-act cycles. We quantified antibiotic prescribing quality indicators and formulated the lessons learned from a qualitative process analysis. Results: Interventions were chosen with the GPs and adapted to be context-relevant. The willingness to work on quality and engagement of local stakeholders led to ownership of the project, but was time-consuming. In one GPC, antibiotic prescribing significantly decreased for tonsillitis, bronchitis, otitis media and acute upper RTI. In all three GPCs, use of guideline-recommended antibiotics for otitis media significantly increased. Conclusions: Implementing multifaceted interventions through PAR can lower total and increase guideline-recommended antibiotic prescribing for RTIs in OOH primary care. Co-creating interventions with GPs to suit local needs is feasible, but reaching all GPs targeted is challenging.

The experiences, needs and expectations of patients regarding participation at home: an explorative study in Belgium.

BACKGROUND: Patients have an important role in the improvement of their health. Patient participation is a key component to achieving this. Some form of patient participation is already present in home care, but this needs to be optimised. AIM: Gaining insight into the expectations, experiences and needs of patients regarding patient participation in home care. DESIGN: A qualitative design was used. SETTING: The study was conducted in the Flemish part of Belgium, in a purposeful sample of patients who have already received nursing care at home for at least 6 weeks. METHODS: Semi-structured face-to-face in-depth interviews were conducted and analysed using the Qualitative Analyse Guide of Leuven. RESULTS: Patient participation in home care is a dynamic process. A total of six components, which interact with each other, were identified that explain this process. CONCLUSION: Patient participation in home care is the interaction of different components of a whole mechanism. Within this mechanism, home nurses play a key role to facilitate participation for patients.

Series: Public engagement with research. Part 4: Maximising the benefits of involving the public in research implementation.

This final article in the four-part series focuses on the often neglected yet important role of the public in implementing research in General Practice and Primary Care more broadly. Experience in implementation of findings from research with public engagement in Primary Care has highlighted how partnership working with patients and the public is important in transitioning from 'what we know' from the evidence-base to 'what we do' in practice. Factors related to Primary Care research that make public engagement important are highlighted e.g. implementing complex interventions, implementing interventions that increase health equity, implementing interventions in countries with different primary healthcare system strengths. Involvement of patients and public can enhance the development of modelling and simulation included in studies on systems modelling for improving health services. We draw on the emerging evidence base to describe public engagement in implementation and offer some guiding principles for engaging with the public in the implementation in General Practice and Primary Care in general. Illustrative case studies are included to support others wishing to offer meaningful engagement in implementing research evidence.

Stakeholders' views and experiences on implementing new diagnostics in primary care to support management of community-acquired acute respiratory tract infections: a qualitative study.

Background: The majority of antibiotics are prescribed in primary care for respiratory tract infections. Point-of-care tests (POCTs) for the management of community-acquired acute respiratory tract infections (CA-ARTI) have been developed to help optimize antibiotic prescribing. While some countries in Europe have adopted these tests in primary care settings, most have not. Stakeholders, such as policy-makers, regulators, the diagnostic industry, and scientific associations, have roles in the implementation of new diagnostics in primary care. The aim of this study is to explore these stakeholders' views and experiences, and identify areas of unmet need relating to POCT implementation. Methods: Stakeholders were recruited using purposive sampling and snowballing. Between March 2021 and May 2022, semi-structured interviews were conducted online with stakeholders in Belgium, the UK and from European Union (EU) -level organizations. Interviews were audio recorded and transcribed verbatim. Transcripts were analysed inductively and deductively using thematic analysis. Results: Twenty-six stakeholders participated: eleven from EU-level organizations, seven from Belgium, and eight from the UK. Five themes were identified. Stakeholders felt a balance of top-down and bottom-up approaches were an optimal strategy to the implementation of POCTs. Stakeholders stressed the need to engage with clinicians to act as champions for tests to help raise awareness and generate new evidence on how tests are used. While acknowledging the potential of POCTs for improving patient outcomes and impacting antibiotic prescribing behavior, some raised concerns on how tests would be used in practice and wished to see national data on effectiveness. COVID-19 catalyzed the use of tests, but stakeholders were pessimistic that processes for approving diagnostics during the pandemic would be replicated in the future. Conclusion: Stakeholders provided recommendations for research and practice. Robust reimbursement policies could alleviate financial burden from clinicians and patients, encouraging practices to adopt POCTs. Industry is likely to benefit from engaging as early on as possible with other stakeholders. Due to uncertainty among stakeholders on the impact of POCTs on antibiotic prescribing, further evidence is needed to understand how practices adopt POCTs and the implications for stewardship. Monitoring how POCTs are used can inform future guidelines on successful diagnostic implementation.

Effect of malaria prevention education on bed net utilization, incidence of malaria and treatment seeking among school-aged children in Southern Ethiopia; cluster randomized controlled trial.

BACKGROUND: School-aged children (SAC) have an increased risk to contract malaria and play a major role in its transmission dynamics. However, their malaria prevention experience is poor. Thus, the effect of malaria prevention education (MPE) on bed net utilization, treatment seeking from a health facility and cumulative incidence of malaria was evaluated in Southern Ethiopia. METHODS: A two arm cluster randomized controlled trial was conducted by recruiting 2038 SAC from 32 schools. Structured questionnaire was used to collect data on socio-demographic, economic, bed net ownership, bed net utilization, whether the participated child suffered from malaria and has got treatment from a health facility. Generalized mixed effect logistic regression using school as random variable was used to assess the effect of the intervention on the outcome variables. RESULTS: The ownership of bed net in households of the control and intervention schools was similar respectively with 84.6 and 88.6% (Crude Odds Ratio (COR): 1.5; 95%CI: 0.5-4.8). The percentage of SAC slept under the bed net the night before the survey was also similar (55.1% versus 54.0%); COR:1.04; 95%CI: 0.5-2.4). Bed net utilization was affected by household size to the bed net ratio ≤ 2 (Adjusted Odds Ratio (AOR) = 1.6; 95%CI:1.3-2.1), bed net utilization at baseline of the study (AOR = 2.3; 95%CI:1.5-3.6), and history of malaria attack in the last twelve months (AOR = 1.3; 95%CI:1.01-1.8). Reported cumulative incidence of malaria and treatment seeking from a health facility by SAC was similar between intervention and control arms: -2.1% (COR = 0.8; 95%CI: 0.5-1.5) and 9.6% (COR = 1.4; 95%CI: 0.4-4.3) respectively. The reported incidence of malaria was affected by altitude (AOR = 0.5; 95%CI: 0.3-0.8), low and medium wealth index (AOR = 0.7; 95%CI: 0.5-0.96 and AOR = 0.7; 95%CI: 0.5-0.98), adequate bed net number for household members (AOR = 0.7; 95%CI:0.5-0.9) and bed net utilization (AOR = 1.3; 95%CI:1.1-1.8). CONCLUSIONS: MPE had no significant effect on the use of malaria prevention measures considered, treatment seeking from a health facility and reported cumulative incidence of malaria though bed net use was associated with malaria incidence. Before organizing any health education program, sustainable implementation efforts have to be warranted especially in SAC, a neglected but relevant vulnerable and reservoirs. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR202001837195738, registered 21/01/2020.

Will the implementation process for goal-oriented primary care succeed? A qualitative study investigating five perceived attributes of goal-oriented care.

Throughout the western world, goal oriented care (GOC) is increasingly promoted as a strategy towards more person-centered, integrated care. The implementation of goal-oriented care not only takes place at the micro-level with individual primary care providers (PCPs) changing their approach, but also requires meso- and macro-level investment. In this study, we zoom in on experiences and actions of various meso- and macro-level actors that are actively engaged with implementing GOC, both within their organization or at the policy level. In-depth interviews were conducted with n = 23 actors from a variety of different organizations (governmental institutions, provider organizations, patient organizations, health/social care organizations, primary care zones/care councils, etc.), using a semi- interview guide inspired by realist interviewing. Three main drivers for implementation were identified: recognition, commitment and coordination. On top of that, results were interpreted through Rogers' Diffusion of Innovations (Dol) theory in which five attributes are discussed that contribute to or hinder implementation success. Our findings can help define actions to support and facilitate the implementation process of an innovation such as GOC.

"At the time I only wanted to relieve stress": Exploring motivation for behaviour change in long-term hypnotic users.

Background: Motivating patients to discontinue long-term benzodiazepine receptor agonist (BZRA) use for insomnia remains an important challenge in primary care because of the medication's unfavourable risk-benefit profile. Previous studies have shown that understanding the complexity of patients' motivation is crucial to the primary care physician for providing effective interventions efficiently. Theoretical frameworks about behaviour change show that motivation is a multi-layered concept that interacts with other concepts, which aligns with a holistic perspective or implementation of the biopsychosocial model. Aim: Exploring primary care patients' views and ideas on what factors helped or hindered them in discontinuing long-term BZRA use, in relation to motivation as conceptualised in the Behaviour Change Wheel, and associated domains of the Theoretical Domains Framework. Design and setting: A qualitative study with semi-structured interviews in primary care in Belgium between September 2020 and March 2021. Method: Eighteen interviews with long-term hypnotic users were audio recorded, transcribed and thematically analyzed, using the Framework Method. Results: The success of discontinuation interventions does not solely rely on patients' spontaneous sense of striving for improvement. Reinforcement and identity were found to be important domains for motivation. Beliefs about personal capabilities, and about consequences of both BZRA intake and discontinuation, differed between previous and current users. Conclusion: Motivation is a multi-layered concept which is not fixed in time. Patient empowerment and goal setting could help long-term BZRA users to lower their intake. As well as public health interventions that might change social attitudes towards the use of hypnotic medication.

How Do Physiotherapists Explain Influencing Factors to Chronic Low Back Pain? A Qualitative Study Using a Fictive Case of Chronic Non-Specific Low Back Pain.

BACKGROUND: While pain is influenced by multiple factors including psychosocial factors, previous research has shown that physiotherapists still favour a biomedical approach. PURPOSE: To evaluate: (1) how physiotherapists explain the patient's chronic non-specific low back pain (LBP); (2) whether physiotherapists use one or multiple influencing factors, and (3) whether these factors are framed in a biopsychosocial or biomedical approach. MATERIALS AND METHODS: This exploratory qualitative study uses a vignette depicting chronic non-specific LBP and employs a flexible framework analysis. Physiotherapists were asked to mention contributing factors to the pain based on this vignette. Five themes were predefined ("Beliefs", "Previous experiences", "Emotions", "Patients behaviour", "Contextual factors") and explored. RESULTS: Physiotherapists use very brief explanations when reporting contributing factors to chronic pain (median 13 words). Out of 670 physiotherapists, only 40% mentioned more than two different themes and 2/3rds did not see any link between the patients' misbeliefs and pain. Only a quarter of the participants mentioned the patient's worries about pain and movement, which is considered to be an important influencing factor. CONCLUSION: The lack of a multifactorial approach and the persistent biomedical beliefs suggest that it remains a challenge for physiotherapists to fully integrate the biopsychosocial framework into their management of chronic LBP.

The experiences of patients ill with COVID-19-like symptoms and the role of testing for SARS-CoV-2 in supporting them: A qualitative study in eight European countries during the first wave of the pandemic.

BACKGROUND: Access to testing during the first wave of the COVID-19 pandemic was limited, impacting patients with COVID-19-like symptoms. Current qualitative studies have been limited to one country or were conducted outside Europe. OBJECTIVES: To explore - in eight European countries - the experiences of patients consulting in primary care with COVID-19-like symptoms during the first wave of the pandemic. METHODS: Sixty-six semi-structured interviews, informed by a topic guide, were conducted by telephone or in person between April and July 2020. Patients with COVID-19-like symptoms were purposively recruited in primary care sites in eight countries and sampled based on age, gender, and symptom presentation. Deductive and inductive thematic analysis techniques were used to develop a framework representing data across settings. Data adequacy was attained by collecting rich data. RESULTS: Seven themes were identified, which described the experiences of patients consulting. Two themes are reported in this manuscript describing the role of COVID-19 testing in this experience. Patients described significant distress due to their symptoms, especially those at higher risk of complications from COVID-19, and those with severe symptoms. Patients wanted access to testing to identify the cause of their illness and minimise the burden of managing uncertainty. Some patients testing positive for COVID-19 assumed they would be immune from future infection. CONCLUSION: Patients experiencing novel and severe symptoms, particularly those with comorbidities, experienced a significant emotional and psychological burden due to concerns about COVID-19. Testing provided reassurance over health status and helped patients identify which guidance to follow. Testing positive for SARS-CoV-2 led to some patients thinking they were immune from future infection, thus influencing subsequent behaviour.

Implementing Blended Care to Discontinue Benzodiazepine Receptor Agonist Use for Insomnia: Process Evaluation of a Pragmatic Cluster Randomized Controlled Trial.

BACKGROUND: Long-term use of benzodiazepine receptor agonists (BZRAs) remains common despite European guidelines advising that these drugs be used in the lowest possible dose and for the shortest possible duration. Half of all BZRAs are prescribed in family practice. This creates a window of opportunity for discontinuation in primary care. Therefore, the effectiveness of blended care for the discontinuation of long-term BZRA use in adult primary care patients with chronic insomnia disorder was tested in a multicenter, pragmatic, and cluster randomized controlled superiority trial in Belgium. In the literature, information on implementing blended care in a primary care setting is scarce. OBJECTIVE: The study aimed to contribute to a framework for the successful implementation of blended care in a primary care setting by increasing our understanding of this complex intervention through an evaluation of e-tool use and views and ideas of participants in a BZRA discontinuation trial. METHODS: Based on a theoretical framework, this study evaluated the processes of recruitment, delivery, and response using 4 components: a survey on recruitment (n=76), semistructured in-depth interviews with patients (n=18), web-based asynchronous focus groups with general practitioners (GPs; n=19), and usage data of the web-based tool. Quantitative data were analyzed descriptively, and qualitative data were analyzed thematically. RESULTS: For recruitment, the most common barriers were refusal by the patient and the lack of digital literacy, while facilitators were starting the conversation and the curiosity of patients. The delivery of the intervention to the patients was diverse, ranging from GPs who never informed the patient about their access to the e-tool to GPs consulting the e-tool in between consultations to have discussion points when the patient visited. Concerning response, patients' and GPs' narratives also showed much variety. For some GPs, daily practice changed because they received more positive reactions than expected and felt empowered to talk more often about BZRA discontinuation. Conversely, some GPs reported no changes in practice or among patients. In general, patients found follow-up by an expert to be the most important component in blended care, whereas GPs deemed the intrinsic motivation of patients to be the key element of success. An important barrier to implementation by the GP was time. CONCLUSIONS: Overall, the participants who had used the e-tool were positive about its structure and content. Nevertheless, many patients desired a more tailored application with feedback from an expert and personal tapering schedules. Strict pragmatic implementation of blended care seems to only reach GPs with an interest in digitalization. Although not superior to usual care, blended care could be a complementary tool that allows tailoring the discontinuation process to the personal style of the GP and the needs of the patient. TRIAL REGISTRATION: ClinicalTrials.gov NCT03937180; https://clinicaltrials.gov/ct2/show/NCT03937180.

Effectiveness of analgesic ear drops as add-on treatment to oral analgesics in children with acute otitis media: study protocol of the OPTIMA pragmatic randomised controlled trial.

INTRODUCTION: Ear pain is the most prominent symptom of childhood acute otitis media (AOM). To control the pain and reduce reliance on antibiotics, evidence of effectiveness for alternative interventions is urgently needed. This trial aims to investigate whether analgesic ear drops added to usual care provide superior ear pain relief over usual care alone in children presenting to primary care with AOM. METHODS AND ANALYSIS: This is a pragmatic, two-arm, individually randomised, open, superiority trial with cost-effectiveness analysis and nested mixed-methods process evaluation in general practices in the Netherlands. We aim to recruit 300 children aged 1-6 years with a general practitioner (GP) diagnosis of AOM and ear pain. Children will be randomly allocated (ratio 1:1) to either (1) lidocaine hydrochloride 5 mg/g ear drops (Otalgan) one to two drops up to six times daily for a maximum of 7 days in addition to usual care (oral analgesics, with/without antibiotics); or (2) usual care. Parents will complete a symptom diary for 4 weeks as well as generic and disease-specific quality of life questionnaires at baseline and 4 weeks. The primary outcome is the parent-reported ear pain score (0-10) over the first 3 days. Secondary outcomes include proportion of children consuming antibiotics, oral analgesic use and overall symptom burden in the first 7 days; number of days with ear pain, number of GP reconsultations and subsequent antibiotic prescribing, adverse events, complications of AOM and cost-effectiveness during 4-week follow-up; generic and disease-specific quality of life at 4 weeks; parents' and GPs' views and experiences with treatment acceptability, usability and satisfaction. ETHICS AND DISSEMINATION: The Medical Research Ethics Committee Utrecht, the Netherlands, has approved the protocol (21-447/G-D). All parents/guardians of participants will provide written informed consent. Study results will be submitted for publication in peer-reviewed medical journals and presented at relevant (inter)national scientific meetings. TRIAL REGISTRATION: The Netherlands Trial Register: NL9500; date of registration: 28 May 2021. At the time of publication of the study protocol paper, we were unable to make any amendments to the trial registration record in the Netherlands Trial Register. The addition of a data sharing plan was required to adhere to the International Committee of Medical Journal Editors guidelines. The trial was therefore reregistered in ClinicalTrials.gov (NCT05651633; date of registration: 15 December 2022). This second registration is for modification purposes only and the Netherlands Trial Register record (NL9500) should be regarded as the primary trial registration.

Exploring readiness for implementing goal-oriented care in primary care using normalization process theory.

AIM: To use normalization process theory (NPT) to build a strategy for the implementation of goal-oriented care (GOC) in primary care in Flanders, Belgium. BACKGROUND: GOC is a possible approach to more coordinated and integrated care and tailors care to patients' personal life goals. The concept has gained interest among policy makers and researchers, but the main drivers for successful implementation are the primary healthcare professionals (PHCPs) who need to see added value of GOC in order to embed it into their daily practice. NPT, developed to understand the processes of implementing new ways of organizing care, offers a useful lens to understand adoption of GOC in primary care practice. METHOD: PHCPs (n = 131) who participated in a 2-hour community meeting on GOC were asked to complete the Normalization MeAsure Development survey. This 23-item survey is based on NPT and describes participants' views about how an intervention would impact their work, their expectations about it, and whether it could become a routine part of their work. FINDINGS: The NPT constructs coherence (sense-making work) and cognitive participation (relational work) showed positive tendency toward implementation of GOC. The participants had an initial understanding on GOC and there was much interest in supporting and start working with this approach. The other constructs collective action (operational work) and reflexive monitoring (appraisal work) will need further efforts to trigger implementation. A common ground is needed to integrate GOC as a common practice which can be achieved by intensive interprofessional collaboration.

How do people living with chronic conditions and their informal caregivers experience primary care? A phenomenological-hermeneutical study.

AIMS AND OBJECTIVES: Gaining insight in how people living with chronic conditions experience primary healthcare within their informal network. BACKGROUND: The primary healthcare system is challenged by the increasing number of people living with chronic conditions. To strengthen chronic care management, literature and policy plans point to a person-centred approach of care (PCC). A first step to identify an appropriate strategy to implement PCC is to gain more insight into the care experiences of these people and their informal caregivers. DESIGN: A phenomenological-hermeneutical philosophy is used. The study is in line with the Consolidated Criteria for Reporting Qualitative Research Guidelines (COREQ). METHOD: In-depth, semi-structured interviews with people living with chronic conditions and informal caregiver dyads (PCDs) (n = 16; 32 individuals) were conducted. An open-ended interview guide was used to elaborate on the PCDs' experiences regarding primary care. A purposive, maximal variation sampling was applied to recruit the participants. RESULTS: Based on sixteen PCDs' reflections, ten themes were identified presenting their experiences with primary care and described quality care as listening and giving attention to what people with chronic conditions want, to what they strive for, and above all to promote their autonomy in a context wherein they are supported by a team of formal caregivers, family and friends. CONCLUSION: To meet the PCDs' needs, self-management should be addressed in an interprofessional environment in which the PCD is an important partner. The findings may facilitate a shift to encourage PCDs in their strengths by enabling them to share their personal goals and by working towards meaningful activities in team collaboration. RELEVANCE TO CLINICAL PRACTICE: Three strategies-self-management support, goal-oriented care, and interprofessional collaboration-have been suggested to improve the PCDs' primary care experiences. These strategies could guide nursing practice in using more and improve high-quality nursing care.

Blended care to discontinue benzodiazepine receptor agonists use in patients with chronic insomnia disorder: a pragmatic cluster randomized controlled trial in primary care.

STUDY OBJECTIVES: International guidelines recommend using benzodiazepine receptor agonists (BZRA) for maximally four weeks. Nevertheless, long-term use for chronic insomnia disorder remains a common practice. This study aimed to test the effectiveness of blended care for discontinuing long-term BZRA use in general practice. METHODS: A pragmatic cluster randomized controlled superiority trial compared blended care to usual care through urine toxicology screening. In the intervention, care by the general practitioner (GP) was complemented by an interactive e-learning program, based on cognitive behavioral therapy for insomnia. Adults using BZRA daily for minimally 6 months were eligible. Participants were clustered at the level of the GP surgery for allocation (1:1). Effectiveness was measured as the proportion of patients who had discontinued at one-year follow-up. Data analysis followed intention-to-treat principles. RESULTS: In total, 916 patients in 86 clusters, represented by 99 GPs, were randomized. Primary outcome data was obtained from 727 patients (79%). At one-year follow-up, 82 patients (18%) in blended care, compared to 91 patients (20%) in usual care, had discontinued. There was no statistically significant effect for the intervention (OR: 0.924; 95% CI: 0.60; 1.43). No adverse events were reported to the research team. CONCLUSIONS: The findings did not support the superiority of blended care over usual care. Both strategies showed clinical effectiveness, with an average of 19% of patients having discontinued at one-year follow-up. Further research is important to study the effect of structurally implementing digital interventions in general practice. CLINICAL TRIAL: Big Bird trial; KCE-17016. This trial is registered at clinicaltrials.gov (NCT03937180).

Developing evaluation capacities in integrated care projects: Lessons from a scientific support mission implemented in Belgium.

The capacity of self-assessment, to learn from experience, to make information-based decisions, and to adapt over time are essential drivers of success for any project aiming at healthcare system change. Yet, many of those projects are managed by healthcare providers' teams with little evaluation capacity. In this article, we describe the support mission delivered by an interdisciplinary scientific team to 12 integrated care pilot projects in Belgium, mobilizing a set of tools and methods: a dashboard gathering population health indicators, a significant event reporting method, an annual report, and the development of a sustainable "learning community." The article provides a reflexive return on the design and implementation of such interventions aimed at building organizational evaluation capacity. Some lessons were drawn from our experience, in comparison with the broader evaluation literature: The provided support should be adapted to the various needs and contexts of the beneficiary organizations, and it has to foster experience-based learning and requires all stakeholders to adopt a learning posture. A long-time, secure perspective should be provided for organizations, and the availability of data and other resources is an essential precondition for successful work.

Implementation of a malaria prevention education intervention in Southern Ethiopia: a qualitative evaluation.

BACKGROUND: Though school-aged children (SAC) are at high risk of malaria, they are the ones that benefit the least from malaria prevention measures. A cluster randomized controlled trial was conducted to evaluate the effect of malaria prevention education (MPE) on insecticide-treated bed net (ITN) utilization and prompt diagnosis, reported incidence and treatment (PDAT) of malaria. Qualitative evaluation of the implementation of such interventions is vital to explain its effectiveness and will serve as guidance for future interventions. Therefore, this study aimed to evaluate the implementation of the MPE in southern Ethiopia.  METHODS: The trial was registered in Pan African Clinical Trials Registry (PACTR202001837195738) on 21/01/2020. A descriptive qualitative study using semi-structured interview with participants of the MPE was conducted in January 2020 and January 2021. The collected data were transcribed verbatim and analyzed thematically. The analysis of the data was supported by NVivo. RESULTS: The four themes identified after evaluation of MPE training were the setup of the training, challenges for the success of the training, anticipated challenges for practice as per the protocol and experienced immediate influences of the training. Participants appreciated the training: content covered, way of delivery and the mix of the participants. The context specific facilitators to bed net use were the collateral benefits of ITN and perceived at high risk of malaria while its barriers were quality and quantity of the bed nets, bed net associated discomforts, malaria health literacy and housing condition. Severeness of malaria symptoms and malaria health literacy were reported as both barriers and facilitators of the PDAT of malaria. The identified facilitators of PDAT of malaria were health professionals' attitude and exposure to MPE while its barriers were poverty, use of traditional medicine, health facility problems and Coronavirus Disease 2019 (COVID-19) pandemic. CONCLUSION: Low attendance of parents in the training was the major challenge for the success of MPE. National malaria program should ensure the access to malaria prevention measures; and future studies using increased frequency of the intervention embedded with monitoring adherence to the intervention protocol shall be conducted to improve the gains from existing malaria interventions.

Saliva testing among teachers during the COVID-19 pandemic: Effects on health concerns, well-being, and precautionary behavior.

RATIONALE: At the start of 2021, several SARS-CoV-2 cluster outbreaks in schools threatened in-person education and created a fairly chaotic and frightening environment for school personnel. To keep the schools open while preventing COVID-19 outbreaks, intensive diagnostic testing in teachers and school personnel was strongly recommended but missing at the time. OBJECTIVES: A project was launched in Belgian schools to weekly analyze the morning saliva of school personnel using PCR-testing to detect and prevent COVID-19 positive cases. In this quasi-experimental study, we aimed to examine whether the implementation of this saliva testing project impacted school personnel's pandemic-related health concerns, well-being, and adherence to the health-protective measures, contrasting experimental with control schools. METHODS: The data were collected during the third wave (Alpha-wave, February-March 2021) of the pandemic. The sample consisted of 435 participants from 34 different schools across Flanders (Belgium) (78.8% female; M age = 43.87 years, range = 21-67) of which 82% participated in the weekly saliva tests (i.e., experimental group) and 18% took part in the control group. RESULTS: Results from a series of linear mixed regression models showed that saliva testing buffered against an increase in health concerns among tested school personnel but did not affect participants' general well-being. Slight declines in adherence to the health-protective behaviors were observed, yet this was only the case for participants who felt less supported by their school principal. High degrees of principals' support also fostered the sharpest decreases in school staff's pandemic-related health concerns. CONCLUSIONS: When keeping the schools open in unstable pandemic times, weekly saliva testing is a promising strategy to prevent cluster outbreaks while simultaneously safeguarding health concerns among school personnel. School principals appear to play a critical role in the implementation of saliva testing to secure positive effects.

Experiences of academic and professional burn-out in medical students and residents during first COVID-19 lockdown in Belgium: a mixed-method survey.

COVID-19 has presented a substantial burden on students and healthcare staff. This mixed-method, descriptive and correlational study aimed to: 1) describe academic; and 2) professional burnout levels; 3) their associations with working in COVID-19-related care; and 4) with perceived COVID-19 impact on studies and internships among medical students and residents. We hypothesized burnout levels to be high; those involved in COVID-19 care to experience higher impact of COVID-19 on studies and work, and to experience higher levels of academic and professional burnout than those not involved in COVID-19 care; academic and professional burnout to be higher when perceived burden due to COVID-19 was higher. During first lockdown in Belgium, a mixed-method cross-sectional survey assessed academic burnout (MBI-SS) and professional burnout in relation to internships and residency (MBI-HSS). Correlations and t-tests tested associations of burnout with involvement in COVID-19-related care and perceived impact of COVID-19 on studies and work (SPSS). Participants provided open-ended comments which were thematically analysed (NVivo). In total, 194 medical students and residents participated (79.5% female, M age = 24.9 ± 2.5). Emotional exhaustion and depersonalisation were high in professional burnout, but moderate in academic burnout. Those involved in COVID-19 related care perceived a higher impact of COVID-19 on their studies and internship/residency and have higher professional burnout, but do not show a higher academic burnout. Those who have a higher perceived impact of COVID-19 on their studies scored higher on academic burnout. Participants mentioned an increased workload (e.g., having to be constantly available and constantly adapt), distress (e.g., uncertainty, fatigue, fear for impact on significant others), fewer learning opportunities (e.g., cancelled internships, changing learning methods), lack of relatedness with patients and supervisors (e.g., lack of respect and understanding from supervisors, distance created by phone consultations with patients) and cynicism towards remote care or non-medical tasks (e.g., considering what they do is not useful or not what they trained for). Students and residents showed indications of professional and academic burnout in relation to the COVID-19 situation. Interventions are needed that can meet the needs of achieving learning outcomes, managing extreme situations and relatedness.