Person-centred medicine in the care home setting: development of a complex intervention.

BACKGROUND: Person-centred medicine is recommended in the care of older patients. Yet, involvement of care home residents and relatives in medication processes remains limited in routine care. Therefore, we aimed to develop a complex intervention focusing on resident and relative involvement and interprofessional communication to support person-centred medicine in the care home setting. METHODS: The development took place from October 2021 to March 2022 in the Municipality of Aarhus, Denmark. The study followed the Medical Research Council guidance on complex intervention development using a combination of theoretical, evidence-based, and partnership approaches. The patient involvement tool, the PREparation of Patients for Active Involvement in medication Review (PREPAIR), was included in a preliminary intervention model. Study activities included developing programme theory, engaging stakeholders, and exploring key uncertainties through interviews, co-producing workshops, and testing with end-users to develop the intervention and an implementation strategy. The Consolidated Framework for Implementation Research and the Interprofessional Shared Decision Making Model were used. Data were analysed using a rapid analysis approach. RESULTS: Before the workshops, six residents and four relatives were interviewed. Based on their feedback, PREPAIR was modified to the PREPAIR care home to fit the care home population. In total, ten persons participated in the co-producing workshops, including health care professionals and municipal managerial and quality improvement staff. The developed intervention prototype was tested for three residents and subsequently refined to the final intervention, including two fixed components (PREPAIR care home and an interprofessional medication communication template) delivered in a flexible three-stage workflow. Additionally, a multi-component implementation strategy was formed. In line with the developed programme theory, the intervention supported health care professionals´ awareness about resident and relative involvement. It provided a structure for involvement, empowered the residents to speak, and brought new insights through dialogue, thereby supporting involvement in medication-related decisions. The final intervention was perceived to be relevant, acceptable, and feasible in the care home setting. CONCLUSION: Our results indicate that the final intervention may be a viable approach to facilitate person-centred medicine through resident and relative involvement. This will be further explored in a planned feasibility study.

Factors promoting and impeding efforts to deprescribe antidepressants among nursing home residents with dementia- a process evaluation guided by normalization process theory.

BACKGROUND: Despite recommendations against psychotropic medication in older nursing homes residents with behavioral and psychological symptoms of dementia (BPSD), antidepressants and other psychotropic drugs are still prescribed. We performed a cluster-randomized controlled trial to evaluate the effect of a complex intervention aiming to promote the deprescribing of antidepressants in institutionalized older persons with dementia. To understand the underlying mechanisms of trial outcomes, we conducted a process evaluation exploring the interventions implementation, areas of impact, and contextual factors. The aim of this study was to explore the implementation process and the key factors that promoted and inhibited intervention implementation in the care home setting (Clinicaltrials.gov: NCT04985305. Registered 30 July 2021). METHODS: Qualitative interviews were conducted between August 2022 and February 2023 with four general practitioners and eight nursing home staff from four associated nursing homes in the Capital Region of Denmark. We coded the interview data according to the four constructs of the Normalization Process Theory (coherence, cognitive participation, collective action, and reflexive monitoring). RESULTS: There was a common understanding of the intervention aim. We observed a raised awareness concerning the deprescription of antidepressants among healthcare professionals with good collaboration (coherence). An overall buy-in to a deprescribing mentality was seen (cognitive participation). There were barriers to the GPs and nursing home staff's use of the intervention elements and how they implemented it, but to some, a common language was created (collective action). Professionals overall valued the idea of deprescribing, but lack of time, high staff turnover, and low education level among nursing home staff hampered the integration (reflexive monitoring). CONCLUSION: Successful implementation seemed to be dependent on the quality of the relationship between the single GP and the single nursing home professional. A common deprescribing mentality promoted the uptake of the intervention. However, several barriers related to lack of resources hindered implementation. It is imperative to adapt complex interventions to the available resources and context.

Deprescribing in primary care without deterioration of health-related outcomes: A real-life, quality improvement project.

Medication reviews focusing on deprescribing can reduce potentially inappropriate medication; however, evidence regarding effects on health-related outcomes is sparse. In a real-life quality improvement project using a newly developed chronic care model, we investigated how a general practitioner-led medication review intervention focusing on deprescribing affected health-related outcomes. We performed a before-after intervention study including care home residents and community-dwelling patients affiliated with a large Danish general practice. The primary outcomes were changes in self-reported health status, general condition and functional level from baseline to 3-4 months follow-up. Of the 105 included patients, 87 completed the follow-up. From baseline to follow-up, 255 medication changes were made, of which 83% were deprescribing. Mean self-reported health status increased (0.55 [95% CI: 0.22 to 0.87]); the proportion with general condition rated as 'average or above' was stable (0.06 [95% CI: -0.02 to 0.14]); and the proportion with functional level 'without any disability' was stable (-0.05 [95% CI: -0.09 to 0.001]). In conclusion, this general practitioner-led medication review intervention was associated with deprescribing and increased self-reported health status without the deterioration of general condition or functional level in real-life primary care patients. The results should be interpreted carefully given the small sample size and lack of control group.

Tailoring a complex intervention to reduce antidepressants in institutionalized older persons with dementia.

INTRODUCTION: First-line treatment for behavioral and psychiatric symptoms of dementia is non-pharmacological. Still, psychotropic medication is widely used, despite its limited effect and harmful side-effects. More than half of all nursing home residents with dementia receive antidepressants, even though deprescribing is safe and feasible. Interventions to promote deprescribing of antidepressants in nursing homes are few and complex. To optimize the deprescribing process through an intervention, transparency for the development of the intervention is needed. We aim to describe the steps in the development and tailoring of an intervention targeting GPs, nursing home staff, and relatives to enhance collaboration on reducing the use of antidepressants in institutionalized older persons with dementia in Denmark. METHOD: A step-wise process guided by the core elements in the Medical Research Council constituted the tailoring process. Five steps were included; 1) a literature search, 2) interviews with stakeholders, 3) drafting the intervention prototype, 4) professionals' assessment of the intervention, and 5) refinement of the intervention. The steps were conducted from June 2020 to June 2022. RESULTS: Based on the literature search, interviews with stakeholders, and professionals' assessment of the intervention, four main themes were identified; 1) focusing on antidepressants, 2) importance of professional qualifications, 3) collaboration and communication, and 4) patient and relative involvement. They guided intervention development and refinement of the final intervention, which included 1) a case-based training course and 2) a dialog tool including a symptom assessment scale to be used in a structured consultation at the nursing home. CONCLUSION: This study presents a detailed account of the tailoring process for a complex intervention to optimize deprescribing of antidepressants for older persons with dementia at nursing homes. By presenting a thorough development process, we expect to achieve increased adherence to the intervention which is currently being tested in an ongoing cluster randomized controlled trial. The transparency of the process will also increase the future development of other similar complex interventions.

Involving patients in medicines optimisation in general practice: a development study of the "PREparing Patients for Active Involvement in medication Review" (PREPAIR) tool.

BACKGROUND: Many patients have multiple health conditions and take multiple medications (polypharmacy). Active patient involvement may improve treatment outcomes and ensure patient-centred care. Yet, patient involvement remains a challenge in clinical practice. We aimed to develop and pilot test a questionnaire-based preparation and dialogue tool, the PREparing Patients for Active Involvement in medication Review (PREPAIR) tool, to encourage the involvement of patients with polypharmacy in medicines optimisation in general practice. METHODS: We conducted a literature review followed by a co-production process to develop the tool: a workshop with six GPs and pilot testing, including observations and interviews, with 22 patients, three GPs and three practice staff. During this process, we made continuous adaptations to the prototype. We analysed the qualitative data thematically, focusing on the development process and mechanisms of impact. FINDINGS: The final PREPAIR tool included five items concerning the patient's experience of 1) adverse drug reactions, 2) excess medication, 3) unnecessary medication, 4) medication satisfaction and 5) medication-related topics to discuss with the GP (open-ended question). The applied workflow during testing was as follows; the patient completed the PREPAIR tool at home, to encourage reflection on the medication, and brought it to the GP consultation. During the consultation, the GP and the patient reviewed the patient's responses and discussed potential medication-related problems. For some patients, the increased reflection led to worries about the medications. Still, the pilot testing showed that, when using the PREPAIR tool, the patients arrived at the clinic well prepared and empowered to speak. From the PREPAIR-supported dialogue, the GPs obtained a better understanding of patients' perspectives and provided a more patient-centred consultation. For the patients, the PREPAIR-supported dialogue ultimately promoted an increased sense of security, satisfaction and insight into their medication, despite initial worries for some patients. CONCLUSIONS: We developed a brief tool to support active patient involvement in medication review in general practice. The PREPAIR-tool was well received by both patients and GPs and fitted well into the existing clinical practice. Our findings suggest that the PREPAIR-tool can support patient involvement during consultations and facilitate patient-centred care.

External validation of the Medication Risk Score in polypharmacy patients in general practice: A tool for prioritizing patients at greatest risk of potential drug-related problems.

Drug-related problems are important causes of patient harm and increased healthcare costs. To assist general practitioners in prioritizing patients in need of a critical medication review, we aimed to assess the ability of the Medication Risk Score (MERIS) to stratify patients with polypharmacy in general practice according to their risk of drug-related problems. We conducted a cross-sectional multi-centre external validation study. Patients receiving more than five concomitant medications (polypharmacy) were eligible. The outcome was potentially serious drug-related problems as evaluated by expert consensus. Performance was assessed in terms of calibration and discrimination indices. Of 497 patients, 489 were included in the main analysis. The median age (interquartile range) was 70.5 years (60-79). In total, 372 potentially serious drug-related problems were observed in 253 patients (52%). The MERIS was well calibrated above a score level of 10. The area under the receiver operating characteristic curve was 0.70 (95% confidence interval: 0.65-0.74). The performance of the MERIS was fair in patients with polypharmacy in general practice. Given the scale of drug-related problems and the lack of efficient prioritization tools in this setting, the MERIS could be a useful risk indicator to complement usual practice.

Exploring implementation processes in general practice in a feedback intervention aiming to reduce potentially inappropriate prescribing: a qualitative study among general practitioners.

BACKGROUND: Potentially inappropriate prescribing (PIP) has been linked with adverse health outcomes and increased healthcare costs. Feedback interventions targeting PIP have shown promising results. However, translation from research to everyday practice remains a challenge. With the Normalisation Process Theory (NPT) as overarching framework, we aimed to explore the implementation processes performed by general practices in a real-life, quality improvement intervention using feedback on practice-level prescribing. METHODS: All 376 general practices in the Central Denmark Region received a prescribing feedback intervention targeting selected types of PIP. Six months later, they received an evaluation questionnaire, to which 45% responded. Among 102 practices reporting to have made changes in response to the intervention, we conducted individual, semi-structured interviews with ten GPs. Maximum variation was sought in terms of baseline prescribing status, implementation activities, practice type and geographical location. The interviews were analysed thematically using NPT. RESULTS: The implementation processes in general practice reflected the four NPT constructs. Key motivators for implementation included the GPs' professional values and interests, but pragmatic considerations were also of importance (coherence). A collective versus an individual approach to the engagement and planning of the implementation process (cognitive participation) was observed. Similarly, a distinction was evident between practice-level actions involving the entire practice team as opposed to individual-level actions performed by the individual GP (collective action). Several challenges to the implementation processes were identified, including patient influences and competing priorities at multiple levels (reflexive monitoring). Additionally, internal evaluation and normalisation of new practices occurred in varying degrees. CONCLUSION: NPT provided a useful framework for understanding implementation processes in general practice. Our results emphasise that clear professional aims and feasible content of interventions are key for GP motivation. This may be ensured through cooperation with GPs' professional organisation, which may strengthen intervention legitimacy and uptake. Two main implementation strategies were identified: practice-level and GP-level strategies. Intervention developers need to recognise both strategies to deliver intervention content and implementation support that promote sustainable improvements in prescribing practice. Competing demands and patient influences remain important challenges that need to be addressed in future studies to further facilitate the reduction of PIPs.

[Deprescribing of inappropriate medication in primary care].

Multimorbidity and polypharmacy increasingly challenge healthcare systems. In this review, we discuss the deprescribing of inappriopriate medication, which is essential for improved patient care and optimal use of healthcare resources. Barriers of deprescribing in primary care are multifaceted and exist not only at the general practitioner level or the patient level but also at the organizational, structural, and sociocultural levels. New approaches and tools are emerging. However, the complexity of this challenge calls for broad healthcare initiatives and policies to reduce inappropriate prescribing.

The effect of cardiorespiratory fitness assessment in preventive health checks: a randomised controlled trial.

Background: Poor cardiorespiratory fitness (CRF) increases morbidity and mortality risks. Routine CRF assessment in clinical practice has thus been advocated, but little is known about the effect. In this study, we investigated the effect of CRF assessment on CRF in a preventive health check programme. Methods: We used a randomised design, in which we invited 4153 middle-aged adults and included 2201 participants who received a preventive health check with CRF assessment (intervention) or without CRF assessment (control). After 1 year, participants were examined. The primary outcomes were adjusted absolute (l/min), relative (ml/kg/min), and poor (%) CRF assessed by the Astrand-Ryhming test. We adjusted for baseline physical activity and intra-cluster correlation within general practices. Results: A total of 901 attended the 1-year follow-up. In the intervention group, absolute CRF, relative CRF, and poor CRF were 2.7 l/min (95% confidence interval [CI]: 2.6; 2.8), 34.5 ml/kg/min (95% CI: 33.5; 35.4), and 31.0% (95% CI: 26.8; 35.2). In the control group, the corresponding figures were 2.8 l/min (95% CI: 2.7; 2.9), 35.2 ml/kg/min (95% CI: 34.2; 36.1), and 25.9% (95% CI: 21.8; 30.0). Adjusted absolute CRF was lower in the intervention group (-0.1 l/min [95% CI: -0.2; -0.01]). Adjusted relative CRF (-0.7 ml/kg/min [95% CI: -2.0; 0.6]) and poor CRF (5.0% [95% CI: -0.002; 10.1]) did not differ between groups. No differences were found when adjusting for potential confounding factors. Conclusion: Preventive health checks with CRF assessment did not provide higher CRF levels at 1-year follow-up than preventive health checks without CRF assessment.

High prevalence of poor fitness among Danish adults, especially among those with high cardiovascular mortality risk.

Background: : Poor cardiorespiratory fitness (CRF) is an independent predictor of cardiovascular and all-cause mortality. Yet, our knowledge about the prevalence of poor CRF is limited. We investigated the prevalence of poor CRF among middle-aged Danish adults from a community-based health promotion program, including identification of a subgroup with high cardiovascular mortality risk. This cross-sectional study included 2,253 middle-aged adults, who completed a preventive health check including CRF testing. CRF (ml O 2 /min/kg) was assessed using the Astrand-Ryhming cycle ergometer test. High 10-year cardiovascular mortality risk as defined in the Danish 2016 guidelines was assessed using questionnaires, health examinations, and prescription data from the Danish National Prescription Registry. The prevalence of poor CRF was 51.7% (95% confidence interval [CI] 48.7-54.7) among men and 31.3% (95% CI 28.7-34.1) among women. A total of 216 (19.4%) men and 220 (19.3%) women were identified with a high 10-year cardiovascular mortality risk. Among these, 65.0% of men (95% CI 58.2-71.3) and 44.1% of women (95% CI 37.4-50.9) had poor CRF. Half of men and one third of women participating in a community-based health promotion program were identified with poor CRF. Among high-risk individuals, two thirds of men and almost every second woman had a poor CRF. Our results emphasise the need for effective public health strategies and interventions to increase CRF in the general population and among high-risk individuals in particular in order to improve public health and reduce mortality.

Effect of including fitness testing in preventive health checks on cardiorespiratory fitness and motivation: study protocol of a randomized controlled trial.

BACKGROUND: Preventive health checks may identify individuals with an unhealthy lifestyle and motivate them to change behaviour. However, knowledge about the impact of the different components included in preventive health checks is deficient. The aim of this trial is to evaluate whether including cardiorespiratory fitness testing in preventive health checks 1) increases cardiorespiratory fitness level and motivation to change physical activity behaviour and 2) reduces physical inactivity prevalence and improves self-rated health compared with preventive health checks without fitness testing. METHODS/DESIGN: An open-label, household-cluster, randomized controlled trial with a two-group parallel design is used. The trial is embedded in a population-based health promotion program, "Check your Health Preventive Program", in which all 30-49 year-old citizens in a Danish municipality are offered a preventive health check. In each arm of the trial, 750 citizens will be recruited (1,500 in total). The primary outcome is cardiorespiratory fitness level assessed by submaximal cycle ergometer testing after one year. An intermediate outcome is the percentage of participants increasing motivation for physical activity behaviour change between baseline and two-weeks follow-up assessed using the Transtheoretical Model's stages of change. Secondary outcomes include changes from baseline to one-year follow-up in physical inactivity prevalence measured by a modified version of the questions developed by Saltin and Grimby, and in self-rated health measures using the Short-Form 12, Health Survey, version 2. DISCUSSION: This trial will contribute to a critical appraisal of the value of fitness testing as part of preventive health checks. The conduction in real-life community and general practice structures makes the trial findings applicable and transferable to other municipalities providing support to decision-makers in the development of approaches to increase levels of physical activity and improve health. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02224248. Registered 8 August 2014.

[Primary autoimmune neutropenia in children]. / Primær autoimmun neutropeni hos børn.

Primary autoimmune neutropenia (AIN) is characterised by severe neutropenia and the presence of granulocyte reactive autoantibodies. The pathogenesis of the disease remains unknown and the disease is believed to be underdiagnosed. AIN occurs predominantly at the age of 6-24 months and despite severe neutropenia the symptomatology covers mainly benign infections. Serious bacterial infections might occur and some patients thus may benefit from treatment with prophylactic antibiotics or granulocyte growth factor. Spontaneous remission usually occurs within 30 months from the time of diagnosis.

[Neonatal alloimmune neutropenia is a frequently overlooked diagnosis in neonates]. / Neonatal alloimmun neutropeni er en overset diagnose.

Neonatal alloimmune neutropenia (NIN) results from the destruction of foetal neutrophils by maternal immunoglobulin G-class neutrophil-reactive antibodies crossing the foeto-placental barrier. We report two cases of neonatal patients presenting with unspecific symptoms and persisting neutropenia accompanied by thrombocytosis. Both were subsequently diagnosed with NIN. These two cases of persisting neutropenia highlight the diversity of symptoms and the diagnostic challenges remaining in NIN. Furthermore, the cases remind us that neutropenia in neonates may be rooted in several different pathophysiological mechanisms.