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Background: Depression and panic disorders have high prevalence rates in primary care. Given the crucial role of general practitioners in diagnosing and treating mental disorders, the two-arm cluster-randomized, controlled PREMA trial was designed. PREMA was aimed at investigating a new intervention combining cognitive behavioral therapy, case management and eHealth components for patients with depression and/or panic disorder with or without agoraphobia in primary care practices in Germany. This qualitative study, embedded in the PREMA trial, explores primary healthcare professionals' lived experiences in using the new treatment program. Using a qualitative design, we conducted eleven interviews with general practitioners and medical assistants from Hesse, Germany, between July 2021 and March 2022. For both groups we relied on a semi-structured interview guide covering the following subjects: study procedures, implementation, practicality, and individual components of the treatment program. Interviews were audio-recorded, transcribed verbatim and analyzed by two researchers using content analysis. A deductive-inductive approach was used for the analysis according to Kuckartz. Results: We narratively summarized the facilitators and barriers from two different stakeholders across five key themes regarding experiences of feasibility and practicability of the new treatment program: study instruction materials, individual components of the treatment program, practicality, target population, and benefits of the treatment program. Facilitators to become familiar with the study include study instruction materials that are easy to understand and not too complex, considering the limited time resources available; barriers included text-heavy instruction materials, lack of collegial exchange, and issues especially with digital materials also involved access and log-in difficulties on the online platform. Facilitators for using the treatment program include the combination of face-to-face consultations and the use of an online platform, enabling a structured approach and regularity; barriers included patients feeling unsupported in performing anxiety exercises independently at home. For practicality, the professional skills of medical assistants and their central role as points of contact for patients facilitated the implementation; barriers included time-intensive organization and planning of monitoring phone calls and consultations. Regarding the target population, general practitioners and medical assistants state that the treatment program would be most appropriate for patients with mild to moderate depression and for those waiting for psychotherapeutic treatment; it would be less suitable for older patients, and those with negative attitudes towards technological tools. For benefits of the program, facilitating factors included free and low-threshold access to the online platform and strengthening the relationship between medical assistants and patients; barriers included a preference for in-person conversations and the inability of some people to use online applications. Conclusions: The complexity of the new treatment program and the associated high workload underline the need for further adjustments to the treatment approach. Team-based care and the expanded responsibilities of medical assistants demonstrated promising results. Trial registration: The study was registered in the German Clinical Trials Register (DRKS00016622) on February 22, 2019. [ABSTRACT FROM AUTHOR]

Vaccines against COVID-19 and influenza are highly recommended for the chronically ill. They often suffer from co-morbid mental health issues. This cross-sectional observational study analyzes the associations between depression (PHQ-9) and anxiety (OASIS) with vaccination readiness (5C) against COVID-19 and influenza in chronically ill adults in primary care in Germany. Sociodemographic data, social activity (LSNS), patient activation measure (PAM), and the doctor/patient relationship (PRA) are examined as well. Descriptive statistics and linear mixed-effects regression models are calculated. We compare data from n = 795 study participants. The symptoms of depression are negatively associated with confidence in COVID-19 vaccines (p = 0.010) and positively associated with constraints to get vaccinated against COVID-19 (p = 0.041). There are no significant associations between symptoms of depression and vaccination readiness against influenza. Self-reported symptoms of a generalized anxiety disorder seem not to be associated with vaccination readiness. To address confidence in COVID-19 vaccines among the chronically ill, targeted educational interventions should be elaborated to consider mental health issues like depression. As general practitioners play a key role in the development of a good doctor/patient relationship, they should be trained in patient-centered communication. Furthermore, a standardized implementation of digital vaccination management systems might improve immunization rates in primary care. [ABSTRACT FROM AUTHOR]

A practice team-based exercise programme with elements of cognitive behavioural therapy (CBT) and case management for patients with panic disorder with or without agoraphobia in primary care showed significant positive effects. Here, we analyse the long-term effects (>5 years) of this intervention in the stressful context of the Covid-19 pandemic. All participants of the original PARADIES cluster randomized controlled trial (cRCT; 2012–2016) were invited to participate in a follow-up during the Covid-19 pandemic. Clinical outcomes were anxiety symptoms, number and severity of panic attacks, agoraphobic avoidance behaviour, Covid-specific anxiety symptom severity, depression, and patient assessment of chronic illness care. Data were analysed cross-sectionally for group differences (intervention, control) and longitudinally (T0: baseline, T1: 6 months and TCorona: >60 months). Of the original 419 participants, 100 participated in the 60 months follow-up (October 2020-May 2021). In the cross-sectional analysis, the anxiety symptom severity in the intervention group was lower than in the control group (p =.011, Cohen's d =.517). In the longitudinal analysis, both groups showed an increase of anxiety and depression symptoms compared to pre-pandemic level. The intervention may have had a lasting impact regarding anxiety severity despite the challenging context of the Covid-19 pandemic. However, we cannot say to what extend the intervention still played a role in participants' lives; other factors may also have helped with coping. The increase of anxiety and depression symptoms in both groups over time could be attributed to external circumstances. [ABSTRACT FROM AUTHOR]

Background: Two to 4% of emergency hospital admissions are caused by preventable adverse drug events. The estimated costs of such avoidable admissions in England were £530 million in 2015. The data-driven quality improvement in primary care (DQIP) intervention was designed to prompt review of patients vulnerable from currently prescribed non-steroidal anti-inflammatory drugs (NSAIDs) and anti-platelets and was found to be effective at reducing this prescribing. A process evaluation was conducted parallel to the trial, and this paper reports the analysis which aimed to explore response to the intervention delivered to clusters in relation to participants' perceptions about which intervention elements were active in changing their practice.Methods: Data generation was by in-depth interview with key staff exploring participant's perceptions of the intervention components. Analysis was iterative using the framework technique and drawing on normalisation process theory.Results: All the primary components of the intervention were perceived as active, but at different stages of implementation: financial incentives primarily supported recruitment; education motivated the GPs to initiate implementation; the informatics tool facilitated sustained implementation. Participants perceived the primary components as interdependent. Intervention subcomponents also varied in whether and when they were active. For example, run charts providing feedback of change in prescribing over time were ignored in the informatics tool, but were motivating in some practices in the regular e-mailed newsletter. The high-risk NSAID and anti-platelet prescribing targeted was accepted as important by all interviewees, and this shared understanding was a key wider context underlying intervention effectiveness.Conclusions: This was a novel use of process evaluation data which examined whether and how the individual intervention components were effective from the perspective of the professionals delivering changed care to patients. These findings are important for reproducibility and roll-out of the intervention.Trial Registration: ClinicalTrials.gov, NCT01425502 . [ABSTRACT FROM AUTHOR]

Background: The escalating use of prescribed drugs has increasingly raised concerns about polypharmacy. This study aims to examine changes in rates of polypharmacy and potentially serious drug-drug interactions in a stable geographical population between 1995 and 2010. Methods: This is a repeated cross-sectional analysis of community-dispensed prescribing data for all 310,000 adults resident in the Tayside region of Scotland in 1995 and 2010. The number of drug classes dispensed and the number of potentially serious drug-drug interactions (DDIs) in the previous 84 days were calculated, and age-sex standardised rates in 1995 and 2010 compared. Patient characteristics associated with receipt of =10 drugs and with the presence of one or more DDIs were examined using multilevel logistic regression to account for clustering of patients within primary care practices. Results: Between 1995 and 2010, the proportion of adults dispensed ≥5 drugs doubled to 20.8%, and the proportion dispensed ≥10 tripled to 5.8%. Receipt of ≥10 drugs was strongly associated with increasing age (20-29 years, 0.3%; ≥80 years, 24.0%; adjusted OR, 118.3; 95% CI, 99.5-140.7) but was also independently more common in people living in more deprive dare as (adjusted OR most vs. least deprived quintile, 2.36; 95% CI, 2.22-2.51), and in people resident in a care home (adjusted OR, 2.88; 95% CI, 2.65-3.13). The proportion with potentially serious drug-drug interactions more than doubled to 13% of adults in 2010, and the number of drugs dispensed was the characteristic most strongly associated with this (10.9% if dispensed 2-4 drugs vs. 80.8% if dispensed ≥15 drugs; adjusted OR, 26.8; 95% CI 24.5-29.3). Conclusions: Drug regimens are increasingly complex and potentially harmful, and people with polypharmacy need regular review and prescribing optimisation. Research is needed to better understand the impact of multiple interacting drugs as used in real-world practice and to evaluate the effect of medicine optimisation interventions on quality of life and mortality. [ABSTRACT FROM AUTHOR]

Background Medication assessment tools (MATs) may be implemented in routine electronic data sources in order to identify patients with opportunities for optimisation of medication therapy management (MTM) and follow-up by a multi-disciplinary team. Objective (1) To demonstrate the use of a MAT for cardiovascular conditions (MAT CVC) as a means of profiling potential opportunities for MTM optimisation in primary care and (2) to assess the performance of MAT CVC in identifying actual opportunities for better care. Setting Members of a pharmacotherapy discussion group, i.e. two single-handed general practitioners (GPs), three GP partners, and community pharmacists (CPs) from each of two community pharmacies, in a rural part of the Netherlands. Methods MAT CVC comprises 21 medication assessment criteria, each of which is designed to detect a specific care issue and to check whether it is ‘addressed’ by provision of guideline recommended care or ‘open’ in the presence (‘open explained’) or absence (‘open unexplained’) of pre-specified explanations for guideline deviations. (1) Relevant data was extracted from linked GP and CP electronic records and MAT CVC assessment was conducted to profile the population of CVC patients registered with both, participating CPs and GPs, in terms of ‘open unexplained’ care issues. (2) A purposive sample of patients with ‘open unexplained’ care issues was reviewed by each patient’s GP. Main outcome measures Number and proportion of ‘open unexplained’ care issues per MAT CVC criterion and per patient. The number of patients with MAT CVC detected ‘open unexplained’ care issues to be reviewed (NNR) in order to identify one that requires changes in MTM. Results In 1,876 target group patients, MAT CVC identified 6,915 care issues, of which 2,770 (40.1 %) were ‘open unexplained’. At population level, ten MAT CVC criteria had particularly high potential for quality improvement. At patient level, 1,277 (68.1 %) target group patients had at least one ‘open unexplained’ care issue. For patients with four or more ‘open unexplained’ care issues, the NNR was 2 (95 % CI 2–2). Conclusion The study demonstrates potential ways of using MAT CVC as a key component of a collaborative MTM system. Strategies that promote documentation and sharing of explanations for deviating from guideline recommendations may enhance the utility of the approach. [ABSTRACT FROM AUTHOR]

Background: Trials of complex interventions are criticized for being 'black box', so the UK Medical Research Council recommends carrying out a process evaluation to explain the trial findings. We believe it is good practice to pre-specify and publish process evaluation protocols to set standards and minimize bias. Unlike protocols for trials, little guidance or standards exist for the reporting of process evaluations. This paper presents the mixed-method process evaluation protocol of a cluster randomized trial, drawing on a framework designed by the authors. Methods/design: This mixed-method evaluation is based on four research questions and maps data collection to a logic model of how the data-driven quality improvement in primary care (DQIP) intervention is expected to work. Data collection will be predominately by qualitative case studies in eight to ten of the trial practices, focus groups with patients affected by the intervention and quantitative analysis of routine practice data, trial outcome and questionnaire data and data from the DQIP intervention. Discussion: We believe that pre-specifying the intentions of a process evaluation can help to minimize bias arising from potentially misleading post-hoc analysis. We recognize it is also important to retain flexibility to examine the unexpected and the unintended. From that perspective, a mixed-methods evaluation allows the combination of exploratory and flexible qualitative work, and more pre-specified quantitative analysis, with each method contributing to the design, implementation and interpretation of the other.As well as strengthening the study the authors hope to stimulate discussion among their academic colleagues about publishing protocols for evaluations of randomized trials of complex interventions. [ABSTRACT FROM AUTHOR]

Chronically ill are vulnerable to vaccine preventable infections. Consequently, their vaccination behavior is highly relevant. Depressive comorbidities are frequent in these patients. Furthermore, these patients are mainly diagnosed, treated and vaccinated in primary care. Therefore, we aimed to investigate the associations between depression and vaccination behavior (COVID-19 and influenza) in adult chronically ill primary care patients. In a cross-sectional survey, we examined depression (PHQ9), psychological antecedents of vaccinations (Confidence and Constraints), health care utilization, and vaccination status. Based on an effect model, descriptive statistics and mixed linear/logistic models were calculated. (German Clinical Trials Register, DRKS00030042). n = 795 patients were analyzed. Both psychological antecedents of vaccinations (Confidence and Constraints) mediated a negative association between depression and vaccination behavior, healthcare utilization mediated a positive association. The total effect of depression was negligible. As the effects of vaccination readiness and healthcare utilization are opposing, different total effects depending on the study population are possible. Further studies are needed to investigate additional predictors of vaccination behavior. We suggest tackling vaccine acceptance in chronically ill through increasing confidence using communication-based interventions, for which primary care is the suitable setting. Constraints might be reduced by reminder and recall systems. • Psychological antecedents of vaccinations are negatively associated with vaccination behavior in depressive chronically. • Higher healthcare utilization is positively associated with vaccination behavior in depressive chronically ill. • Vaccination behavior in depressive chronically ill might be improved communication-based interventions in primary care. [ABSTRACT FROM AUTHOR]