Developing a questionnaire to evaluate an automated audit & feedback intervention: a Rand-modified Delphi method.

BACKGROUND: Audit and feedback (A&F) is a widely used implementation strategy to evaluate and improve medical practice. The optimal design of an A&F system is uncertain and structured process evaluations are currently lacking. This study aimed to develop and validate a questionnaire to evaluate the use of automated A&F systems. METHODS: Based on the Clinical Performance Feedback Intervention Theory (CP-FIT) and the REFLECT-52 (REassessing audit & Feedback interventions: a tooL for Evaluating Compliance with suggested besT practices) evaluation tool a questionnaire was designed for the purpose of evaluating automated A&F systems. A Rand-modified Delphi method was used to develop the process evaluation and obtain validation. Fourteen experts from different domains in primary care consented to participate and individually scored the questions on a 9-point Likert scale. Afterwards, the questions were discussed in a consensus meeting. After approval, the final questionnaire was compiled. RESULTS: A 34-question questionnaire composed of 57 items was developed and presented to the expert panel. The consensus meeting resulted in a selection of 31 questions, subdivided into 43 items. A final list of 30 questions consisting of 42 items was obtained. CONCLUSION: A questionnaire consisting of 30 questions was drawn up for the assessment and improvement of automated A&F systems, based on CP-FIT and REFLECT-52 theory and approved by experts. Next steps will be piloting and implementation of the questionnaire.

Defining Vision and Mission of a Medical Psychiatry Unit (MPU) for Older Adults: A Focus Group Study.

This study aims to determine the vision and mission of an academic hospital's medical psychiatry unit (MPU) that exclusively treats geriatric patients. All healthcare providers working at an academic hospital's geriatric MPU were invited to reflect on formulate the vision and mission of this ward. Twenty-two of them took part in the focus group interviews. The interviews focused on defining the MPU's functioning, its objectives, how it will reach these objectives, and where the MPU aspires to go. The interviews were transcribed verbatim and analyzed according to the QUAGOL guide. The themes from the analysis emerged from these group discussions. The participants defined the MPU's vision as to excel in integrated mental and physical geriatric inpatient healthcare, inspiring others to shed the stigma related to this vulnerable patient population. The mission that emerged from the focus group discussions is to provide patient-centered, integrated healthcare for older adults with combined mental and physical disorders. To achieve this, involving the patient's network, interdisciplinarity, shared decision-making, clear communication between all stakeholders, and reintegration of patients into their communities emerged as important themes. This study provides a vision and mission of a geriatric MPU in an academic psychiatric hospital. Since there is no consensus in the literature about the characteristics of MPUs despite the international call for integrated care for older persons with combined mental and physical disorders, these vision and mission statements can feed the discussion on how to install excellent healthcare for this vulnerable patient population.

Reducing long-term use of benzodiazepine receptor agonists: In-depth interview study with primary care stakeholders.

AIMS: To increase our understanding of which factors contribute to long-term benzodiazepine receptor agonist (BZRA) use for insomnia in primary care, from a patients', general practitioners' (GP) and pharmacists' perspective. DESIGN: Qualitative research following a grounded theory approach. SETTING: Primary care in Belgium. PARTICIPANTS: Twenty-four participants were interviewed, including nine patients, six GPs and nine pharmacists. MEASUREMENTS: In-depth, semistructured interviews with iterative cycles of data collection and analysis. Transcripts were analysed using the framework method. Thematic findings were interpreted in the context of the Theoretical Domains Framework. FINDINGS: A reflexive relation was identified between views about hypnotic use at the level of society, healthcare and patients. Behaviour change appeared to depend strongly on context and social influence, including a need for supporting relationships by all stakeholders. Six key messages captured factors that contribute to long-term BZRA use for insomnia in primary care: societal beliefs as a game changer, the opportunity of nonpharmacological treatment, collaborative primary care, patient-centred goals, informed consent and self-management. CONCLUSIONS: Long-term BZRA use for insomnia is a complex and multifaceted public health problem that is not adequately addressed in primary care at this time. Although primary care professionals in this study found discontinuation of long-term BZRA use relevant to the patient's health, many organisational and personal barriers were reported. Moreover, the current social and healthcare context is not empowering patients and professionals to reduce long-term BZRA use for insomnia. Specifically, for primary care, all stakeholders reported the need for a nonmedicalised relationship between the patient and GP to lower prescribing rates. PATIENT OR PUBLIC CONTRIBUTION: The Flemish Patient Platform, a patient representative organisation, assisted with recruitment by launching a call for participants in their newsletter and volunteered to disseminate the results. The call for recruitment was also published online in social media groups regarding insomnia and via posters in public pharmacies. Patients or public were not involved in designing or conducting the interview study.

"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.

Trends in the registration of anxiety in Belgian primary care from 2000 to 2021: a registry-based study.

BACKGROUND: Anxiety is frequently encountered in general practice, but figures regarding prevalence and incidence in this healthcare setting remain scarce. AIM: To provide insight about the trends in prevalence and incidence of anxiety in Belgian general practice, as well as the comorbidities and treatment of anxiety in this context. DESIGN AND SETTING: Retrospective cohort study using the INTEGO morbidity registration network, with clinical data from over 600 000 patients in Flanders, Belgium. METHOD: Trends in age-standardised prevalence and incidence of anxiety from 2000 to 2021 as well as prescriptions in patients with prevalent anxiety were analysed with joinpoint regression. Comorbidity profiles were analysed using the Cochran-Armitage test and the Jonckheere-Terpstra test. RESULTS: During the 22-year study period, 8451 unique patients with anxiety were identified. The prevalence of anxiety diagnoses rose significantly during this period, from 1.1% in 2000 to 4.8% in 2021. The overall incidence rate rose from 1.1/1000 patient-years (PY) in 2000 to 9.9/1000 PY in 2021. The average chronic disease count per patient increased significantly during the study period, from 1.5 to 2.3 chronic conditions. The most frequent comorbidities in patients with anxiety in 2017-2021 were malignancy (20.1%), hypertension (18.2%), and irritable bowel syndrome (13.5%). The proportion of patients treated with psychoactive medication rose from 25.7% to almost 40% over the study period. CONCLUSION: A significantly increasing prevalence and incidence of physician-registered anxiety was found in the study. Patients with anxiety tend to become more complex, with more comorbidities. Treatment for anxiety in Belgian primary care is very dependent on medication.

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.

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).

Evolution of benzodiazepine receptor agonist prescriptions in general practice: A registry-based study.

Background: Contrary to most European guidelines, benzodiazepine receptor agonists (BZRA) are often used continuously at a low dosage, being the most common form of long-term use. In Belgium, BZRA use is monitored by analyzing self-report data about medication use in the last 24 h. This method provides insufficient insight into the terms of use of these psychoactive drugs. Aim: To describe trends in BZRA prescribing in Flanders, Belgium, between 2000 and 2019. Design and setting: Population-based trend analysis and a case-control study for the year 2019 were done with data from a morbidity registry in general practice. Methods: Repeated cross-sectional and joinpoint regression analyses revealed trends in sex- and age-standardized prescription rates among adult patients (18+). Results: Overall, BZRA prescriptions increased. The highest overall increase was found among male patients 18-44 years old, with an average annual percentage change of 2.5 (95% CI: 0.9, 4.3). Among 65+ female patients, a decrease was found since 2006, with an annual percentage change of -0.7 (95% CI: -1.3, -0.1). In 2019, 12% of registered patients received minimally one prescription, long-term use was observed in 5%, back pain was the most common morbidity significantly associated with a rise in BZRA prescriptions, and zolpidem was the most prescribed BZRA (22%). Conclusion: Despite some statistically significant decreasing trends, an overall increase in BZRA prescriptions was observed throughout the 19-year study period, especially among long-term users of 18-44 years and 65-plus. Zolpidem became the most prescribed BZRA and warrants more attention.

Co-design to increase implementation of insomnia guidelines in primary care.

BACKGROUND: Sleep disorders, including insomnia, are widespread problems, which have increased during the COVID-19 pandemic. Guidelines for the treatment of insomnia prioritize non-pharmacological interventions. Nevertheless, primary care professionals lack well-developed material for patient education, that could help implement the treatment guidelines in Flanders, Belgium. OBJECTIVE: This project's purpose is to develop complementary, written educational material, grounded in the principles of evidence-based practice, for primary care. PATIENT INVOLVEMENT: This co-design project involved patients and health professionals. Special attention was given to including patients with low health literacy, and empowering patients when designing in mixed groups. METHODS: Based on the framework of Sanders and Stappers (2014), data were collected and analyzed in four phases. Pre-design, needs were explored using think-aloud studies and focus groups. Next, for generative purposes, the design studio method was used. Then, evaluation of the prototype happened with another series of think-aloud studies. Finally, post-design, implementation of the product was evaluated with a short survey. RESULTS: Twenty-five participants (10 patients and 15 healthcare professionals) contributed to the development of an educational patient leaflet called Sssssst. How do you sleep (at night)? Out of 30 professionals who received the printed leaflet for use in practice, 17 provided feedback after six months. Generally, the leaflet was well received. Visual design aspects stimulated use in practice. DISCUSSION: Written and visual materials aid primary care professionals to educate patients on sleep and insomnia. This supporting tool also stimulates self-management in patients. Although inspiring and educational for all stakeholders, a co-design approach is no guarantee for the product to "fit all".

Co-creation with research participants to inform the design of electronic informed consent.

Objective: This study aimed to provide recommendations for a personalized electronic informed consent interface that is adapted to research participants' needs and could enable a longitudinal interaction between the participants and the research team. Methods: The co-creation process consisted of three co-creation workshops, one focus group discussion, and four semi-structured interviews. In total, 24 participants, who had taken part in four disparate clinical studies in Belgium, were involved. Descriptive statistics and qualitative content analysis were applied to analyze the survey data and audio recordings. Results: Varying perceptions on the type and amount of information described in an informed consent form were reported. Other findings were related to the structure and presentation of information, setting preferences for data sharing, and electronically signing new informed consent versions. Regarding the long-term interaction, most of the participants wanted to receive progress updates, including the results, of the study in which they had taken part. They proposed to receive a notification, preferably via email, in case new information is made available on the electronic informed consent interface. Conclusions: To optimally support the design of an electronic informed consent interface, it is key to understand the research participants' needs. Study findings suggest that an electronic informed consent interface may be a promising technological application to interactively provide study-related information and to keep participants informed during and after the clinical study.

Trends in the epidemiology of depression and comorbidities from 2000 to 2019 in Belgium.

BACKGROUND: Depression is a common mental disorder in family practice with an impact on global health. The aim of this study is to provide insight in the trends of epidemiological measures as well as pharmacological treatments and comorbidities of depression. METHODS: A study using data from INTEGO, a family practice registration network in Flanders, Belgium. Trends in age-standardized prevalence and incidence of depression from 2000 to 2019 as well as antidepressant prescriptions in prevalent depression cases were analyzed with join point regression. Comorbidity profiles were explored using the Cochran-Armitage test and the Jonckheere-Terpstra test. RESULTS: We identified 538 299 patients older than 15 years during the study period. We found an increasing trend in the age-standardized prevalence of depression from 6.73 % in 2000 to 9.20 % in 2019. For the incidence of depression, a decreasing trend was observed from 2000 to 2015 with an incidence of 9.42/1000 in 2000 and 6.89/1000 in 2015, followed by an increasing trend from 2015 to 2019 (incidence of 13.64/1000 in 2019). The average number of chronic diseases per patient with depression increased significantly during the study period (from 1.2 to 1.8), and the proportion of patients relative to the whole study population that received at least one antidepressant prescription per year increased between 2000 and 2019 from 26.44% to 40.16%. CONCLUSIONS: The prevalence of depression increases while the incidence sharply rises, but only in recent years. Patients with depression tend to have more comorbidities, making a multi-faceted approach to these patients more important.

Effectiveness of a blended care programme for the discontinuation of benzodiazepine use for sleeping problems in primary care: study protocol of a cluster randomised trial, the Big Bird trial.

INTRODUCTION: Problematic benzodiazepine use is a global health issue. Although the adverse side effects of long-term use of benzodiazepines are well known, it remains difficult to implement interventions for discontinuation in primary care. Considering the success of blended care for the treatment of sleeping disorders and the support of substance use disorders, evidence suggests that a blended care approach, combining face-to-face consultations with the general practitioner with web-based self-learning by the patient, is beneficial for the discontinuation of chronic benzodiazepine use for primary insomnia in general practice. Therefore, the aim of this study is to evaluate the effectiveness of such an approach for the discontinuation of benzodiazepine and zolpidem, zopiclone and zaleplon drugs ((z-)BZD) use in the long term and evaluate the implementation process. METHODS AND ANALYSIS: This study is a multicentre, pragmatic, cluster randomised controlled trial with 1200 patients, included by 120 general practitioners. Allocation to usual or blended care happens at the level of the general practice in a 1:1 ratio using a block randomisation system stratified per language. The study population consists of adult primary care patients who have been using (z-)BZD for primary insomnia on a daily basis for at least 6 months. Primary outcome measure is the proportion of patients that discontinued (z-)BZD at 12 months assessed by toxicological screening for (z-)BZD in urine. Secondary outcomes include discontinuation of (z-)BZD at 6 months, quality of life and the number of defined daily doses of (z-)BZD prescribed. Data will be collected using a study-specific online platform and analysed using the intention-to-treat approach. The process of implementing blended care will be evaluated in a nested study. ETHICS AND DISSEMINATION: This trial was approved by the Ethics Committee for Research of UZ/KU Leuven (ref. S61194). Study results will be disseminated via open-access, peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT03937180.