Challenges in reaching patients with severe mental illness for trials in general practice-a convergent mixed methods study based on the SOFIA pilot trial.

BACKGROUND: Patients with severe mental illness (SMI) die prematurely due to undetected and inadequate treatment of somatic illnesses. The SOFIA pilot study was initiated to mend this gap in health inequity. However, reaching patients with SMI for intervention research has previously proven difficult. This study aimed to investigate the recruitment of patients with SMI for the SOFIA pilot study in 2021. METHODS: We used a mixed-method convergent design. The qualitative material comprised 20 interviews with general practitioners (GPs) and staff, during patient recruitment. The quantitative data consisted of process data on baseline characteristics, GPs reported reasons for excluding a patient, reported reasons for patients declining participation, and registered data from a Danish population of patients with SMI. We used thematic analysis in the qualitative analysis and descriptive statistics for the quantitative analysis. Pillar integration was used for integrating the material. RESULTS: Our findings show that selection bias occurred in the pilot study. We describe four main themes based on the integrated analysis that highlights selection issues: (1) poor data quality and inconsistency in defining severity definitions troubled identification and verification, (2) protecting the patient and maintaining practice efficiency, (3) being familiar with the patient was important for a successful recruitment, and (4) in hindsight, the GPs questioned whether the target population was reached. CONCLUSIONS: In the light of theories of professions and street-level bureaucracy, we find that the main drivers of the patient selection bias occurring in the SOFIA pilot study were that 1) GPs and staff mended eligibility criteria to protect certain patients and/or to minimize workload and maintain efficiency in the practice 2) the data from the GP record systems and the digital assessment tool to assist recruitment was not optimal. Interventions targeting this patient group should carefully consider the recruitment strategy with a particular focus on professionals' discretionary practices and information technology pitfalls. TRIAL REGISTRATION: The pilot trial protocol was registered on the 5th of November 2020. The registration number is NCT04618250 .

The SOFIA pilot study: assessing feasibility and fidelity of coordinated care to reduce excess mortality and increase quality of life in patients with severe mental illness in a general practice setting; a cluster-randomised pilot trial.

OBJECTIVE: To evaluate the feasibility and fidelity of implementing and assessing the SOFIA coordinated care program aimed at lowering mortality and increasing quality of life in patients with severe mental illness by improving somatic health care in general practice. DESIGN: A cluster-randomised, non-blinded controlled pilot trial. SETTING: General Practice in Denmark. INTERVENTION: The SOFIA coordinated care program comprised extended structured consultations carried out by the GP, group-based training of GPs and staff, and a handbook with information on signposting patients to relevant municipal, health, and social initiatives. PATIENTS: Persons aged 18 years or older with a diagnosis of psychotic, bipolar, or severe depressive disorder. MAIN OUTCOME MEASURES: We collected quantitative data on the delivery, recruitment and retention rates of practices and patients, and response rates of questionnaires MMQ and EQ-5D-5 L. RESULTS: From November 2020 to March 2021, nine practices were enrolled and assigned in a 2:1 ratio to the intervention group (n = 6) or control group (n = 3). Intervention group practices included 64 patients and Control practices included 23. The extended consultations were delivered with a high level of fidelity in the general practices; however, thresholds for collecting outcome measures, and recruitment of practices and patients were not reached. CONCLUSION: Our findings suggest that delivering the coordinated care program in a fully powered trial in primary care is likely feasible. However, the recruitment methodology requires improvement to ensure sufficient recruitment and minimize selective inclusion. TRIAL REGISTRATION: The date of pilot trial protocol registration was 05/11/2020, and the registration number is NCT04618250.

Disentangling concepts of inappropriate polypharmacy in old age: a scoping review.

INTRODUCTION: Polypharmacy is a common concern, especially in the older population. In some countries more that 50% of all individuals over 60 receive five or more drugs, most often due to multimorbidity and increased longevity. However, polypharmacy is associated with multiple adverse events, and more medication may not always be the answer. The terms "appropriate" and "inappropriate" are often used to distinguish between "much" and "too much" medications in relation to polypharmacy in research and practice, but no explicit definition exists to describe what these terms encompass. The aim of this review is to unfold the different understandings of and perspectives on (in)appropriate polypharmacy and suggest a framework for further research and practice. METHOD: A scoping review was conducted using the framework of Arksey and O'Malley and Levac et al. Pubmed, Embase, PsycINFO, CINAHL, Cochrane database, Scopus and Web of Science were searched for references in English, Danish, Norwegian and Swedish using the search string "Polypharmacy" AND "Appropriate" OR "Inappropriate". Data was extracted on author information, aims and objectives, methodology, study population and setting, country of origin, main findings and implications, and all text including the words "appropriate," "inappropriate," and "polypharmacy." Qualitative meaning condensation analysis was used and data charted using descriptive and thematic analysis. RESULTS: Of 3982 references, a total of 92 references were included in the review. Most references were from 2016-2021, from fields related to medicine or pharmacy, and occurred within primary and secondary healthcare settings. Based on the qualitative analysis, a framework were assembled consisting of Context, three domains (Standardization, Practices and Values & Concerns) and Patient Perspective. CONCLUSION: Inappropriate polypharmacy is a concept loaded by its heterogeneity and the usefulness of a single definition is doubtful. Instead, the framework suggested in this article representing different dimensions of inappropriate polypharmacy may serve as an initial strategy for focusing research and practice on polypharmacy in old age.

Making sense of and working with COVID-19 related guidelines and information in Danish general practice-A qualitative study.

BACKGROUND: Attempts to manage the COVID-19 pandemic have involved a massive flow of guidelines and information to health professionals on how to reorganize clinical work and handle patients with COVID-19. The aim of this paper is to investigate how Danish general practitioners (GPs) made sense of and worked with guidelines and associated information on COVID-19 in the first months of the pandemic. METHODS: We conducted qualitative interviews with 13 GPs in the beginning of the pandemic and again approximately three months later. Between the two interviews, they wrote daily notes for 20 days. Interviews were audio-recorded and transcribed, and the material was analyzed using thematic network analysis. RESULTS: The interviewed GPs found the situation urgent and serious, and they spent a lot of time reading and working with COVID-19 related guidelines and associated information. Keeping up-to-date with and implementing guidelines was challenging due to the many sources of information and the constant guideline revisions. The GPs were able to assess patients' risk status but were challenged by the changing guidelines regarding this. The GPs found that deciding whether a COVID-19 patient needed to be admitted to hospital was relatively straightforward. An important final challenge was discrepancies between the government's public announcements regarding which patients could be tested for COVID-19, the guidelines provided to GPs, and the local testing capacities, which gave GPs extra work. CONCLUSION: In an urgent situation like the COVID-19 pandemic it is crucial to secure good communication between the government, health authorities, professional medical societies, and health professionals. Improved practices of collaboration between health authorities and professional societies could improve communication in future health crises and relieve GPs of some of the work involved in keeping up-to-date with information flows, constantly reviewing new guidelines, and dealing with communicative inconsistencies.

The survey visit as a key evaluative event in accreditation-a qualitative study of survey visit experiences among surveyors and general practice professionals.

BACKGROUND: Accreditation is a widely employed quality assurance concept in health care and the survey visit is the central method for assessing participating organisations' compliance with accreditation standards. Despite this, research on the survey visit as a method for assessing compliance is scarce. In Denmark a mandatory accreditation programme was introduced for general practice clinics in 2016. We performed a qualitative, explorative study of the reflections and actions of surveyors and general practice professionals (GPs and staff) concerning the production of information about compliance with the accreditation standards in relation to the survey visit. METHODS: We conducted qualitative interviews with GPs and staff from general practices in two Danish regions before and after their survey visit. We also interviewed the surveyors. We observed survey visits to qualify the interviews and analysis. All interviews were audio recorded, transcribed, and analysed using an integrative approach. RESULTS: The surveyors combined documents, questioning of the professionals, and visual impressions of the clinic to assess compliance. They sought to de-dramatise the survey visit and to generate a natural conversation with attention to workflows. Trust in the professionals' statements was fundamental to the surveyors' approach, and they were confident in their ability to assess compliance. Their level of scrutiny was influenced by their observations and the quality of documents. The general practice professionals had generally sought to comply with the standards and to give an authentic portrait of the clinic. The few cases of misrepresention concerned standards that the professionals found too excessive. CONCLUSION: The validity of the survey visit as a method to assess compliance was highly dependent on the professionals' willingness to convey a realistic picture of their practice. Since they were generally willing to do so, the trust-based approach seemed suitable for identifying cases of non-compliance caused by insufficient understanding of the standards. However, it can be difficult for the surveyors to detect when the professionals engage in misrepresentation due to disagreements with the standards. Thus, when adopting a trust-based approach to the survey visit, it seems particularly important to ensure that the professionals view the standards as meaningful and manageable.

Use of alternative consultation forms in Danish general practice in the initial phase of the COVID-19 pandemic - a qualitative study.

BACKGROUND: Attempts to manage the COVID-19 pandemic have led to radical reorganisations of health care systems worldwide. General practitioners (GPs) provide the vast majority of patient care, and knowledge of their experiences with providing care for regular health issues during a pandemic is scarce. Hence, in a Danish context we explored how GPs experienced reorganising their work in an attempt to uphold sufficient patient care while contributing to minimizing the spread of COVID-19. Further, in relation to this, we examined what guided GPs' choices between telephone, video and face-to-face consultations. METHODS: This study consisted of qualitative interviews with 13 GPs. They were interviewed twice, approximately three months apart in the initial phase of the pandemic, and they took daily notes for 20 days. All interviews were audio recorded, transcribed, and inductively analysed. RESULTS: The GPs re-organised their clinical work profoundly. Most consultations were converted to video or telephone, postponed or cancelled. The use of video first rose, but soon declined, once again replaced by an increased use of face-to-face consultations. When choosing between consultation forms, the GPs took into account the need to minimise the risk of COVID-19, the central guidelines, and their own preference for face-to-face consultations. There were variations over time and between the GPs regarding which health issues were dealt with by using video and/or the telephone. For some health issues, the GPs generally deemed it acceptable to use video or telephone, postpone or cancel appointments for a short term, and in a crisis situation. They experienced relational and technical limitations with video consultation, while diagnostic uncertainty was not regarded as a prominent issue CONCLUSION: This study demonstrates how the GPs experienced telephone and video consultations as being useful in a pandemic situation when face-to-face consultations had to be severely restricted. The GPs did, however, identify several limitations similar to those known in non-pandemic times. The weighing of pros and cons and their willingness to use these alternatives shifted and generally diminished when face-to-face consultations were once again deemed viable. In case of future pandemics, such alternatives seem valuable, at least for a short term.

Experiences of accreditation impact in general practice - a qualitative study among general practitioners and their staff.

BACKGROUND: Accreditation is a widespread tool for quality management in health care. However, there is lack of research on the impact of accreditation, particularly in general practice. This study explores how general practitioners and their staff experienced the impact of a mandatory accreditation program in Denmark. METHODS: Qualitative interviews with general practitioners and staff from 11 clinics. The respondents were interviewed twice: during preparation and after the survey visit. The interviews were analyzed using thematic analysis, and all specific changes and other types of impact were extracted from the transcribed interview data from each clinic. RESULTS: The impact of accreditation varied markedly among the clinics as did the participants' overall assessments of accreditation. Concerning specific changes in behavior and physical infrastructure, some clinics had only implemented a few minor changes in response to accreditation, some had made a relatively moderate number of changes, and a few clinics had made relatively many changes including a few pronounced ones. Further, some participants experienced that accreditation had enhanced knowledge sharing or upgraded competencies, and increased job satisfaction. However, the workload related to accreditation was emphasized as a problem by a majority of the professionals and for a few, accreditation had influenced job satisfaction negatively. CONCLUSION: Accreditation may affect general practice clinics in very different ways. In spite of several examples of positive impact, the results suggest that it is difficult to design a mandatory accreditation program for general practice in which most professionals experience that the benefits of accreditation equal the resources used in the process.

Understanding accreditation standards in general practice - a qualitative study.

BACKGROUND: Accreditation is a widely adopted tool for quality control and quality improvement in health care, which has increasingly been employed for general practice. However, there is lack of knowledge of how accreditation is received and experienced by health professionals in general practice. This study explores how general practitioners (GPs) and their staff experienced the comprehensibility of accreditation standards and how they worked to increase their understanding of the standards. The study was conducted in Denmark where accreditation was mandatory in general practice from 2016 to 2018. METHODS: The study consists of qualitative interviews with general practitioners and staff from 11 general practices that were strategically sampled among practices set to receive their survey visit in 2017. Participants were interviewed twice; once during the preparation phase and once after the survey visit. GPs and staff were interviewed separately. The interviews were analysed inductively using thematic analysis. RESULTS: Understanding the requirements of the accreditation standards was a major challenge for the professionals when preparing for the accreditation survey visit. The participants attempted to increase their understanding of the standards in several ways including the use of regional support options and seeking out experts and colleagues. However, participants had mixed experiences with the various support options and many found the sense making work frustrating and time consuming. CONCLUSION: The results point to the importance of considering the level of specificity in accreditation standards and how to ensure an organisational set-up that can offer appropriate support to primary care clinics in terms of understanding what is required to meet the standards.

'More constricting than inspiring' - GPs find chronic care programmes of limited clinical utility. A qualitative study.

BACKGROUND: As in other countries, Danish health authorities have introduced disease management programmes (DMPs) to improve care quality. These contain clinical practice guidelines (CPGs) and guidelines for patient stratification based on doctors' assessments of disease severity and self-care. However, these programmes are challenged when patients have complex chronic conditions. AIM: To explore how GPs experience the clinical applicability of disease management programmes for patients with multiple chronic conditions and lowered self-care ability. DESIGN & SETTING: A qualitative study from general practice, conducted in rural areas of Denmark with economically disadvantaged populations. METHOD: Data were collected through case-based, semi-structured interviews with 12 GPs. The principles of systematic text condensation were used in the analysis. RESULTS: GPs found DMPs inadequate, particularly for patients with multiple conditions and lowered self-care ability. Their experience was that adhering to multiple programmes' CPGs resulted in too much medication, conflicting treatments, an overload of appointments, and fragmented health care. They disregarded stratifying according to guidelines because they deemed stratification criteria to reflect neither patients' need for self-care support, nor flexible referral options to hospitals and municipalities. Therefore, GPs were often solely responsible for treatment of patients with very complex chronic conditions. CONCLUSION: GPs found DMPs to be of limited clinical applicability due to challenges related to CPGs, patient stratification, and lack of adequate health services to support patients with complex healthcare needs. To increase the benefits of these programmes, they should be more flexible, and adjusted to the needs of patients with multiple chronic conditions and lowered self-care ability.

Influences of peer facilitation in general practice - a qualitative study.

BACKGROUND: Practice facilitation is increasingly used to support guideline implementation and practice development in primary care and there is a need to explore how this implementation approach works in real-life settings. We focus on a facilitation intervention from the perspective of the visited practices to gain a more detailed understanding of how peer facilitation influenced practices and how they valued the facilitation. METHODS: The facilitation intervention was conducted in general practice in the Capital Region of Denmark with the purpose of supporting the implementation of chronic disease management programmes. We carried out a qualitative study, where we observed 30 facilitation visits in 13 practice settings and interviewed the visited practices after their first and last visits. We then performed a thematic analysis. RESULTS: Most of the respondents reported that facilitation visits had increased their knowledge and skills as well as their motivation and confidence to change. These positive influences were ascribed to a) the facilitation approach b) the credibility and know-how associated with the facilitators' being peers c) the recurring visits providing protected time and invoking a sense of commitment. Despite these positive influences, both the facilitation and the change process were impeded by several challenges, e.g. competing priorities, heavy workload, problems with information technology and in some cases inadequate facilitation. CONCLUSION: Practice facilitation is a multifaceted, interactive approach that may affect participants in several ways. It is important to attune the expectations of all the involved actors through elaborate discussions of needs, capabilities, wishes, and approaches, and to adapt facilitation interventions according to an analysis of influential contextual conditions and change opportunities.

How well do general practitioners know their elderly patients' social relations and feelings of loneliness?

BACKGROUND: Social relationships are important to people and affect their quality of life, morbidity and mortality. The aim of this study was to examine the correlation between elderly patients' descriptions of their social relations and feelings of loneliness, and their general practitioners' assessments of these. METHODS: Cross-sectional study in 12 general practices in the Capital Region of Denmark. During a three-week period each practice asked their patients aged 65 and older to fill out a questionnaire regarding health, social relations and loneliness; the general practitioner (GP) filled out a matching questionnaire regarding their perception of the patient's social relations and loneliness. Data were collected from February to September 2014. RESULTS: Of the 767 eligible patients 476 were included in the study. For 447 patients both GP and patient had answered at least one question on loneliness or social participation. The correlations between patients' and GPs' answers regarding social participation and loneliness were low (0.04-0.26). While GPs were less able to identify lonely patients and patients with low social participation, they were better at identifying not-lonely patients or those with high social participation. It was especially difficult for GPs to identify lonely patients when they were not living alone or if the GP believed the patient had high social participation. CONCLUSION: GPs have difficulty identifying patients who are lonely or have low social participation and this ability is further diminished when the patients do not live alone or if the GP believes them to have high social participation. Given the consequences of loneliness and limited social participation on patients' health and well-being, and GPs' limited ability to identify these patients, GPs' obligations and resources in this area need to be clarified.

Role enactment of facilitation in primary care - a qualitative study.

BACKGROUND: Facilitation is a widely used implementation method in quality improvement. Reviews reveal a variety of understandings of facilitation and facilitator roles. Research suggests that facilitation interventions should be flexible and tailored to the needs and circumstances of the receiving organisations. The complexity of the facilitation field and diversity of potential facilitator roles fosters a need to investigate in detail how facilitation is enacted. Hence, the purpose of this study was to explore the enactment of external peer facilitation in general practice in order to create a stronger basis for discussing and refining facilitation as an implementation method. METHODS: The facilitation intervention under study was conducted in general practice in the Capital Region of Denmark in order to support an overall strategy for implementing chronic disease management programmes. We observed 30 facilitation visits in 13 practice settings and had interviews and focus groups with facilitators. We applied an explorative approach in data collection and analysis, and conducted an inductive thematic analysis. RESULTS: The facilitators mainly enacted four facilitator roles: teacher, super user, peer and process manager. Thus, apart from trying to keep the process structured and focused the facilitators were engaged in didactic presentations and hands-on learning as they tried to pass on factual information and experienced based knowledge as well as their own enthusiasm towards implementing practice changes. While occasional challenges were observed with enacting these roles, more importantly we found that a coaching based role which was also envisioned in the intervention design was only sparsely enacted meaning that the facilitators did not enable substantial internal group discussions during their facilitation visits. CONCLUSION: Facilitation is a complex phenomenon both conceptually and in practice. This study complements existing research by showing how facilitation can be enacted in various ways and by suggesting that some facilitator roles are more likely to be enacted than others, depending on the context and intervention design and the professional background of the facilitators. This complexity requires caution when comparing and evaluating facilitation studies and highlights a need for precision and clarity about goals, roles, and competences when designing, conducting, and reporting facilitation interventions.

Social relations and loneliness among older patients consulting their general practitioner.

INTRODUCTION: Social relations are important for people and affect their quality of life, morbidity and mortality. This holds true especially for older persons. General practitioners (GPs) are in a unique position to address social relations and loneliness; however, no GP population-based studies have assessed older patients' social relations and loneliness. The aim of this study was to analyse the social relations and loneliness of patients aged 65 years and above consulting their GP. METHODS: This survey counted the participation of 12 general practices in the Capital Region of Denmark. During a three-week period, the practices invited their patients to fill out a questionnaire on health, social relations and loneliness. RESULTS: Of 767 eligible patients, 474 were included and 461 answered one or more items about social participation or loneliness. A total of 36.2% had a high, 45.5% had a medium and 18.3% had a low social participation; and 17.9% often or occasionally felt lonely. Higher social participation was associated with a lower degree of loneliness. However, several patients answered in a manner not fitting the expected association. Anxiety and depressive symptoms, living alone and low social participation were the most important predictive variables for loneliness. Only 15.2% of the lonely patients had talked to their GP about their loneliness. CONCLUSIONS: A total of 17.9% of older patients stated that they were lonely either often or occasionally. The most important predictors were: anxiety and depressive symptoms, living alone and low social participation. The lonely patients rarely shared these issues with their GP. The study also reveals a need to discuss the assessment of social participation and loneliness in both research and practice. FUNDING: Danish Agency for Culture and Palaces. The EGV Foundation. The Committee of Multipractice Studies in General Practice. TRIAL REGISTRATION: not relevant.

The effectiveness of a semi-tailored facilitator-based intervention to optimise chronic care management in general practice: a stepped-wedge randomised controlled trial.

BACKGROUND: The Danish health care sector is reorganising based on disease management programmes designed to secure integrated and high quality chronic care across hospitals, general practitioners and municipalities. The disease management programmes assign a central role to general practice; and in the Capital Region of Denmark a facilitator-based intervention was undertaken to support the implementation of the programmes in general practice. The purpose of the study was to assess the effectiveness of this semi-tailored facilitator-based intervention. METHOD: The study was a stepped-wedge, randomised, controlled trial among general practices in the Capital Region of Denmark. The intervention group was offered three one-hour visits by a facilitator. The intervention was semi-tailored to the perceived needs as defined by each general practice, and the practices could choose from a list of possible topics. The control group was a delayed intervention group. The primary outcome was change in the number of annual chronic disease check-ups. Secondary outcomes were: changes in the number of annual check-ups for type 2 diabetes (DM2) and chronic obstructive pulmonary disease (COPD); changes in the number of spirometry tests, changes in the use of ICPC diagnosis coding and patient stratification; sign-up for a software program for patient overview; and reduction in number of practices with few annual chronic disease check-ups. RESULTS: We randomised 189 general practices: 96 practices were allocated to the intervention group and 93 to the delayed intervention group. For the primary outcome, 94 and 89 practices were analysed. Almost every outcome improved from baseline to follow-up in both allocation groups. At follow-up there was no difference between allocation groups for the primary outcome (p = 0.1639). However, some secondary outcomes favoured the intervention: a higher reported use of ICPC diagnosis coding for DM2 and COPD (p = 0.0050, p = 0.0243 respectively), stratification for COPD (p = 0.0185) and a faster initial sign-up rate for the software program. CONCLUSION: The mixed results from this study indicate that a semi-tailored facilitator-based intervention of relatively low intensity is unlikely to add substantially to the implementation of disease management programmes for DM2 and COPD in a context marked by important concurrent initiatives (including financial incentives and mandatory registry participation) aimed at moving all practices towards changes in chronic care. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01297075.