PELICAN: a quality of life instrument for childhood asthma: Study Protocol of two Randomized Controlled Trials in Primary and Specialized Care in the Netherlands

BACKGROUND Asthma is one of the major chronic health problems in children in the Netherlands. The Pelican is a paediatric asthma-related quality of life instrument for children with asthma from 6-11 years old, which is suitable for clinical practice in primary and specialized care. Based on this instrument, we developed a self-management treatment to improve asthma-related quality of life. The Pelican intervention will be investigated in different health care settings. Results of intervention studies are often extrapolated to other health care settings than originally investigated. Because of differences in organization, disease severity, patient characteristics and care provision between health care settings, extrapolating research results could lead to unnecessary health costs without the desired health care achievements. Therefore, interventions have to be investigated in different health care settings when possible. This study is an example of an intervention study in different health care settings. In this article, we will present the study protocol of the Pelican study in primary and specialized care. METHOD/DESIGN This study consists of two randomized controlled trials to assess the effectiveness of the Pelican intervention in primary and specialized care. The trial in primary care is a multilevel design with 170 children with asthma in 16 general practices. All children in one general practices are allocated to the same treatment group. The trial in specialized care is a multicentre trial with 100 children with asthma. Children in one outpatient clinic are randomly allocated to the intervention or usual care group. In both trials, children will visit the care provider four times during a follow-up of nine months. This study is registered and ethically approved. DISCUSSION This article describes the study protocol of the Pelican study in different health care settings. If the Pelican intervention proves to be effective and efficient, implementation in primary and specialized care for paediatric asthma in the Netherlands will be recommended. TRIAL REGISTRATION This study is registered by clinicaltrial.gov (NCT01109745).This trial is funded by grants of the Dutch Asthma Foundation (NAF 3.4.07.043), fonds NutsOhra (0802–74), Nijmegen Centre for Evidence Based Practice (NCEBP) and Radboud University Nijmegen Medical Centre

Matching Adherence Interventions to Patient Determinants Using the Theoretical Domains Framework

Introduction: Despite much research, interventions to improve medication adherence report disappointing and inconsistent results. Tailored approaches that match interventions and patient determinants of non-adherence were seldom used in clinical trials. The presence of a multitude of theoretical frameworks and models to categorize interventions and patient determinants complicated the development of common categories shared by interventions and determinants. We retrieved potential interventions and patient determinants from published literature on medication adherence, matched them like locks and keys, and categorized them according to the Theoretical Domains Framework (TDF). Methods: We identified the most relevant literature reviews on interventions and determinants in a pragmatic literature search, extracted all interventions and determinants, grouped similar concepts to umbrella terms and assigned them to TDF categories. All steps were finalized in consensus discussion between the authors. Results: Sixteen articles (5 with determinants, 11 with interventions) were included for analysis. We extracted 103 interventions and 42 determinants that we divided in 26 modifiable and 16 unmodifiable determinants. All interventions and modifiable determinants were matched within 11 categories (Knowledge; Skills; Social/professional role and identity; Beliefs about capabilities; Beliefs about consequences; Intentions; Memory, Attention and decision processes; Environmental context and resources; Social influences; Emotion; and Behavioral regulation). Conclusion: In published trials on medication adherence, the congruence between interventions and determinants can be assessed with matching interventions to determinants. To be successful, interventions in medication adherence should target current modifiable determinants and be tailored to the unmodifiable determinants. Modifiable and unmodifiable determinants need to be assessed at inclusion of intervention studies to identify the patients most in need of an adherence intervention. Our matched categories may be useful to develop interventions in trials that investigate the effectiveness of adherence interventions

Supporting adherence to oral anticancer agents : clinical practice and clues to improve care provided by physicians, nurse practitioners, nurses and pharmacists

Background: Healthcare provider (HCP) activities and attitudes towards patients strongly influence medication adherence. The aim of this study was to assess current clinical practices to support patients in adhering to treatment with oral anticancer agents (OACA) and to explore clues to improve the management of medication adherence. Methods: A cross-sectional, observational study among HCPs in (haemato-) oncology settings in Belgium and the Netherlands was conducted in 2014 using a composite questionnaire. A total of 47 care activities were listed and categorised into eight domains. HCPs were also asked about their perceptions of adherence management on the items: insight into adherence, patients' communication, capability to influence, knowledge of consequences and insight into causes. Validated questionnaires were used to assess beliefs about medication (BMQ) and shared decision making (SDM-Q-doc). Results: In total, 208 HCPs (29% male) participated; 107 from 51 Dutch and 101 from 26 Belgian hospitals. Though a wide range of activities were reported, certain domains concerning medication adherence management received less attention. Activities related to patient knowledge and adverse event management were reported most frequently, whereas activities aimed at patient's self-efficacy and medication adherence during ongoing use were frequently missed. The care provided differed between professions and by country. Belgian physicians reported more activities than Dutch physicians, whereas Dutch nurses and pharmacists reported more activities than Belgian colleagues. The perceptions of medication adherence management were related to the level of care provided by HCPs. SDM and BMQ outcomes were not related to the care provided. Conclusions: Enhancing the awareness and perceptions of medication adherence management of HCPs is likely to have a positive effect on care quality. Care can be improved by addressing medication adherence more directly e. g., by questioning patients about (expected) barriers and discussing strategies to overcome them, by asking for missed doses and offering (electronic) reminders to support long-term medication adherence. A multidisciplinary approach is recommended in which the role of the pharmacist could be expanded

A multifaceted clinical decision support intervention to improve adherence to thromboprophylaxis guidelines

Background Venous thromboembolism is a potentially fatal complication of hospitalisation, affecting approximately 3% of non-surgical patients. Administration of low molecular weight heparins to the appropriate patients adequately decreases venous thromboembolism incidence, but guideline adherence is notoriously low. Objective To determine the effect of a multifaceted intervention on thromboprophylaxis guideline adherence. The secondary objective was to study the effect on guideline adherence specifically in patients with a high venous thromboembolism risk. As an exploratory objective, we determined how many venous thromboembolisms may be prevented. Setting A Dutch general teaching hospital. Method A prospective study with a pre- and post-intervention measurement was conducted. A multifaceted intervention, consisting of Clinical Decision Support software, a mobile phone application, monitoring of duplicate anticoagulants and training, was implemented. Guideline adherence was assessed by calculating the Padua prediction and Improve bleeding score for each patient. The number of preventable venous thromboembolisms was calculated using the incidences of venous thromboembolism in patients with and without adequate thromboprophylaxis and extrapolated to the annual number of admitted patients. Main outcome measure Adherence to thromboprophylaxis guidelines in pre- and post-intervention measurements. Results 170 patients were included: 85 in both control and intervention group. The intervention significantly increased guideline adherence from 49.4 to 82.4% (OR 4.78; 95%CI 2.37-9.63). Guideline adherence in the patient group with a high venous thromboembolism risk also increased significantly from 54.5 to 84.3% (OR 2.46; 95%CI 1.31-4.62), resulting in the potential prevention of +/- 261 venous thromboembolisms per year. Conclusions Our multifaceted intervention significantly increased thromboprophylaxis guideline adherence

Teaching ethics when working with geocoded data:a novel experiential learning approach

Research ethics are not the favourite subject of most undergraduate geography students. However, in the light of increasing mixed-methods research, as well as research using geocodes, it is necessary to train students in the field of ethics. Experiential learning is an approach to teaching that is potentially suitable for teaching ethics. The aim of this article is to discuss how the experiential learning process in a course on Ethics & GPS-tracking contributed to the ethical awareness of third-year undergraduate geography students. We conducted a qualitative study in which we held four focus group discussions with two cohorts of students (2016 and 2017). We explored the students' views on the learning environment in relation to ethics in GPS-based and mixed-methods research. Our findings show how an informal learning environment and collaborative learning in a small group contributed to deep understanding of research ethics. These aspects of the learning environment are tied to an ethical framework that consists of three dimensions: (1) the ethics of collaborative research between staff and students; (2) the ethics of privacy raised by the geo-technology adopted in this research case study; and (3) the ethics of the research process with respect to informed consent and data storage

Exploring the Prescribing Process of Domperidone for Low Milk Supply:A Qualitative Study Among Mothers, IBCLCs, and Family Doctors

BACKGROUND: When mothers are confronted with milk supply problems, taking domperidone is regularly suggested. However, domperidone has been associated with sudden cardiac death and caution in prescribing is advised. In 2016, a multidisciplinary group of authors from a tertiary academic hospital (Erasmus MC) published a clinical protocol in a leading Dutch physicians’ journal to support Dutch family physicians in prescribing domperidone to stimulate lactation. RESEARCH AIM: To explore consumer and health care provider perspectives and experiences regarding the prescribing of domperidone for lactation insufficiency following publication of a national clinical protocol. METHODS: A cross-sectional qualitative study was performed using semi-structured interviews (N = 40) based on a topic list covering the prescribing process. Participants were mothers (n = 18) who had been advised to try domperidone to boost their milk supply between November 2016 and May 2018, their International Board Certified Lactation Consultants (n = 9), and their family physicians (n = 15). Another group of participants (mothers; n = 6) answered short questionnaires. All interviews were recorded, transcribed and analyzed using ATLAS.ti software. The resulting list of codes was organized according to the topics. RESULTS: In the process leading to domperidone use to stimulate lactation, participant family physicians relied on the IBCLC, pharmacist, or mother to guide the prescription of domperidone, often citing the published national clinical protocol as back up. The medical safeguards incorporated in the protocol (e.g., taking medical history, physical exam, performing electrocardiograms, limiting dosage) were usually not implemented. CONCLUSIONS: Though the availability of a national clinical protocol in which the prescribing of domperidone for lactation is supported appeared to increase the willingness of participant family physicians to prescribe, gaps were identified between clinical practice and this clinical protocol for prescribing domperidone

Noncompliance with guidelines on proton pump inhibitor prescription as gastroprotection in hospitalized surgical patients who are prescribed NSAIDs

Background and aims As NSAIDs can cause serious upper gastrointestinal harm, guidelines have been established for the prescribing of proton pump inhibitors (PPIs) in high-risk patients using NSAIDs. Studies examining guideline compliance in surgical patients are scarce. Therefore, a retrospective cross-sectional database study was carried out aimed at determining the proportion of noncompliance with the Dutch guideline and determining the association of several factors with this noncompliance. Materials and methods Hospital admissions of patients on surgical wards of Erasmus University Medical Center between 1 January 2013 and 1 August 2014 were included in which an NSAID was newly prescribed. Preadmission PPI use was excluded. The main outcome was the proportion of noncompliance with the guideline. As a secondary outcome, the association of several potential risk factors with noncompliance was assessed. The proportion of guideline noncompliance was calculated as the percentage of all included surgical ward admissions. For the secondary analysis, univariate and multivariable logistic regression analyses were carried out. R

The effect of a transitional pharmaceutical care program on the occurrence of ADEs after discharge from hospital in patients with polypharmacy

Introduction: Transitional care programs (i.e. interventions delivered both in hospital and in primary care), could increase continuity and consequently quality of care. However, limited studies on the effect of these programs on Adverse Drug Events (ADEs) post-discharge are available. Therefore, the aim of this study was to investigate the effect of a transitional pharmaceutical care program on the occurrence of ADEs 4 weeks post-discharge. Methods: A multicentre prospective before-after study was performed in a general teaching hospital, a university hospital and 49 community pharmacies. The transitional pharmaceutical care program consisted of: teach-back to the patient at discharge, a pharmaceutical discharge letter, a home visit by a community pharmacist and a clinical medication review by both the community and the clinical pharmacist, on top of usual care. Usual care consisted of medication reconciliation at admission and discharge by pharmacy teams. The primary outcome was the proportion of patients who reported at least 1 ADE 4 weeks post-discharge. Multivariable logistic regression was used to adjust for potential confounders. Results: In total, 369 patients were included (control: n = 195, intervention: n = 174). The proportion of patients with at least 1 ADE did not statistically significant differ between the intervention and control group (general teaching hospital: 59% vs. 67%, ORadj 0.70 [95% CI 0.38–1.31], university hospital: 63% vs 50%, OR adj 1.76 [95% CI 0.75–4.13]). Conclusion: The transitional pharmaceutical care program did not decrease the proportion of patients with ADEs after discharge. ADEs after discharge were common and more than 50% of patients reported at least 1 ADE. A process evaluation is needed to gain insight into how a transitional pharmaceutical care program could diminish those ADEs

Application of intervention mapping to develop and evaluate a pharmaceutical discharge letter to improve information transfer between hospital and community pharmacists

Background: Insufficient information transfer is a major barrier in the transition from hospital to home. This study describes the systematic development and evaluation of an intervention to improve medication information transfer between hospital and community pharmacists. Objective: To develop and evaluate an intervention to improve the medication information transfer between hospital and community pharmacists based on patients', community and hospital pharmacists’ needs. Methods: The intervention development and evaluation was guided by the six-step Intervention Mapping (IM) approach: (1) needs assessment to identify determinants of the problem, with a scoping review and focus groups with patients and healthcare providers, (2) formulation of intervention objectives with an expert group, (3) inventory of communication models to design the intervention, (4) using literature review and qualitative research with pharmacists and patients to develop the intervention (5) pilot-testing of the intervention in two hospitals, and (6) a qualitative evaluation of the intervention as part of a multicenter before-after study with hospital and community pharmacists. Results: Barriers in the information transfer are mainly time and content related. The intervention was designed to target a complete, accurate and timely medication information transfer between hospital and community pharmacists. A pharmaceutical discharge letter was developed to improve medication information transfer. Hospital and community pharmacists were positive about the usability, content, and comprehensiveness of the pharmaceutical discharge letter, which gave community pharmacists sufficient knowledge about in-hospital medication changes. However, hospital pharmacists reported that it was time-consuming to draft the discharge letter and not always feasible to send it on time. The intervention showed that pharmacists are positive about the usability, content and comprehensiveness. Conclusion: This study developed an intervention systematically to improve medication information transfer, consisting of a discharge letter to be used by hospital and community pharmacists supporting continuity of care