Elisa Giulia Liberati

Barriers and facilitators to the uptake of computerized clinical decision support systems in specialty hospitals: protocol for a qualitative cross-sectional study

BackgroundComputerized clinical decision support systems (CDSSs) have been shown to improve the efficiency and quality of patient care by connecting healthcare professionals with high quality, evidence-based information at the point-of-care. The mere provision of CDSSs, however, does not guarantee their uptake. Rather, individual and institutional perceptions can foster or inhibit the integration of CDSSs into routine clinical workflow. Current studies exploring health professionals’ perceptions of CDSSs focus primarily on technical and usability issues, overlooking the social or cultural variables as well as broader administrative or organizational roles that may influence CDSS adoption. Moreover, there is a lack of data on the evolution of perceived barriers or facilitators to CDSS uptake across different stages of implementation.MethodsWe will conduct a qualitative, cross-sectional study in three Italian specialty hospitals involving frontline physicians, nurses, information technology staff, and members of the hospital board of directors. We will use semi-structured interviews following the Grounded Theory framework, progressively recruiting participants until no new information is gained from the interviews.DiscussionCDSSs are likely to become an integral and diffuse part of clinical practice. Various factors must be considered when planning their introduction in healthcare settings. The findings of this study will guide the development of strategies to facilitate the successful integration of CDSSs into the regular clinical workflow. The evaluation of diverse health professionals across multiple hospital settings in different stages of CDSS uptake will better capture the complexity of roles and contextual factors affecting CDSS uptake.

Preactivated thiolated glycogen as mucoadhesive polymer for drug delivery

Graphical abstract Figure. No Caption available. Abstract The purpose of this study was to synthesize and characterize a novel thiolated glycogen, so‐named S‐preactivated thiolated glycogen, as a mucosal drug delivery systems and the assessment of its mucoadhesive properties. In this regard, glycogen–cysteine and glycogen‐cysteine‐2‐mercaptonicotinic acid conjugates were synthesized. Glycogen was activated by an oxidative ring opening with sodium periodate resulting in reactive aldehyde groups to which cysteine was bound via reductive amination. The obtained thiolated polymer displayed 2203.09 ± 200 &mgr;mol thiol groups per gram polymer. In a second step, the thiol moieties of thiolated glycogen were protected by disulfide bond formation with the thiolated aromatic residue 2‐mercaptonicotinic acid (2MNA). In vitro screening of mucoadhesive properties was performed on porcine intestinal mucosa using different methods. In particular, in terms of rheology investigations of mucus/polymer mixtures, the S‐preactivated thiolated glycogen showed a 4.7‐fold increase in dynamic viscosity over a time period of 5 h, in comparison to mucus/Simulated Intestinal Fluid control. The S‐preactivated polymer remained attached on freshly excised porcine mucosa for 45 h. Analogous results were obtained with tensile studies demonstrating a 2.7‐fold increase in maximum detachment force and 3.1‐ fold increase in total work of adhesion for the S‐preactivated polymer compared to unmodified glycogen. Moreover, water‐uptake studies showed an over 4 h continuing weight gain for the S‐preactivated polymer, whereas disintegration took place for the unmodified polymer within the first hour. Furthermore, even in the highest tested concentration of 2 mg/ml the new conjugates did not show any cytotoxicity on Caco‐2 cell monolayer using an MTT assay. According to these results, S‐preactivated glycogen represents a promising type of mucoadhesive polymers useful for the development of various mucosal drug delivery systems.

Implementing an evidence-based computerized decision support system to improve patient care in a general hospital: the CODES study protocol for a randomized controlled trial

BackgroundComputerized decision support systems (CDSSs) are information technology-based software that provide health professionals with actionable, patient-specific recommendations or guidelines for disease diagnosis, treatment, and management at the point-of-care. These messages are intelligently filtered to enhance the health and clinical care of patients. CDSSs may be integrated with patient electronic health records (EHRs) and evidence-based knowledge.Methods/designWe designed a pragmatic randomized controlled trial to evaluate the effectiveness of patient-specific, evidence-based reminders generated at the point-of-care by a multi-specialty decision support system on clinical practice and the quality of care. We will include all the patients admitted to the internal medicine department of one large general hospital. The primary outcome is the rate at which medical problems, which are detected by the decision support software and reported through the reminders, are resolved (i.e., resolution rates). Secondary outcomes are resolution rates for reminders specific to venous thromboembolism (VTE) prevention, in-hospital all causes and VTE-related mortality, and the length of hospital stay during the study period.DiscussionThe adoption of CDSSs is likely to increase across healthcare systems due to growing concerns about the quality of medical care and discrepancy between real and ideal practice, continuous demands for a meaningful use of health information technology, and the increasing use of and familiarity with advanced technology among new generations of physicians. The results of our study will contribute to the current understanding of the effectiveness of CDSSs in primary care and hospital settings, thereby informing future research and healthcare policy questions related to the feasibility and value of CDSS use in healthcare systems. This trial is seconded by a specialty trial randomizing patients in an oncology setting (ONCO-CODES).Trial registrationClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT02577198?term=NCT02577198&rank=1

Natural dendrimers: Synthesis and in vitro characterization of glycogen-cysteamine conjugates

&NA; The aim of this study was to synthesize, characterize and evaluate the mucoadhesive properties of the first thiolated hyperbranched natural polysaccharide with biodegradability and biocompatibility features. In detail, glycogen‐cysteamine conjugates were synthesized through a first step of oxidative ring opening applying increasing concentrations of sodium periodate, to obtain polymers with different degrees of oxidation, and a second step of reductive amination with a constant amount of cysteamine. The obtained glycogen‐cysteamine conjugates were characterized regarding their content of free and total thiol groups by Ellmans assay, biocompatibility, swelling/erosion behavior, rheological synergism and mucoadhesive properties in comparison to the unmodified glycogen. The higher the concentration of periodate was, the higher was the content of total thiol groups being in the range of 255.7 ± 12–1194.5 ± 82 &mgr;mol/g, biocompatibility remained unaffected by these structural changes. On the contrary, the mucoadhesive properties, evaluated by tensile, rheological synergism and rotating cylinder studies, appear to be influenced by the thiol groups concentration on the glycogen. In particular the glycogen‐cysteamine conjugate exhibiting the highest degree of thiolation showed a 79‐fold increase in viscosity over a time period of 8 h, as well as, remained attached on freshly excised porcine mucosa 32‐fold longer than the unmodified polymer. The higher was the amount of conjugated thiol groups, the higher was the water absorption capacity of glycogen‐cysteamine tablets in Simulated Intestinal Fluid pH 6.8 (SIF). The introduction of thiol moieties on polymer changed the characteristics of the polysaccharide by improving mucoadhesion properties. Therefore, this work represents the first study describing thiolated natural dendrimers as potential platform useful to realize appropriate mucoadhesive nanocarrier systems suitable to prolong mucosal residence time. Graphical abstract Figure. No caption available.

Reorganising hospitals to implement a patient-centered model of care: Effects on clinical practice and professional relationships in the Italian NHS

The Patient-Centred Model (PCM) is described as an attempt to redesign the hospitals around the needs of the patients, thus contributing to costs reduction, increased efficiency, and improved care. However, the introduction of the PCM may have a profound impact on the social organisation of work, changing lines of demarcation, challenging well established inter-/intra-professional relationships, and prompting the development of new roles and modes of working. This thesis explores the mutual effects between the new organisational model and the pre-existent social organisation of hospital work. The research design is organised in three phases: an extensive document analysis; an interview study; an in-depth ethnographic case study conducted for over one year in a PCM hospital. The findings are organised in three studies. The first shows that the PCM was interpreted differently by hospital managers and by frontline clinicians, thus giving rise to two divergent narratives of change. The second study focuses on the boundaries to collaboration and care integration in newly created hospital teams within PCM hospitals. The third study looks at the impact of the PCM on the medical-nursing boundary. The thesis contributes to management learning and practice by providing recommendations on how to accompany complex innovations, comprising of both their expected and unexpected consequences. It also enriches academic debates on professional boundaries, relations, and identities in healthcare.

Learning from high risk industries may not be straightforward: a qualitative study of the hierarchy of risk controls approach in healthcare.

Abstract Objective Though healthcare is often exhorted to learn from ‘high-reliability’ industries, adopting tools and techniques from those sectors may not be straightforward. We sought to examine the hierarchies of risk controls approach, used in high-risk industries to rank interventions according to supposed effectiveness in reducing risk, and widely advocated as appropriate for healthcare. Design Classification of risk controls proposed by clinical teams following proactive detection of hazards in their clinical systems. Classification was based on a widely used hierarchy of controls developed by the US National Institute for Occupational Safety and Health (NIOSH). Setting and participants A range of clinical settings in four English NHS hospitals. Results The four clinical teams in our study planned a total of 42 risk controls aimed at addressing safety hazards. Most (n = 35) could be classed as administrative controls, thus qualifying among the weakest type of interventions according to the HoC approach. Six risk controls qualified as ‘engineering’ controls, i.e. the intermediate level of the hierarchy. Only risk control qualified as ‘substitution’, classified as the strongest type of intervention by the HoC. Conclusions Many risk controls introduced by clinical teams may cluster towards the apparently weaker end of an established hierarchy of controls. Less clear is whether the HoC approach as currently formulated is useful for the specifics of healthcare. Valuable opportunities for safety improvement may be lost if inappropriate hierarchical models are used to guide the selection of patient safety improvement interventions. Though learning from other industries may be useful, caution is needed.

Reorganising hospitals to implement a patient-centered model of care

The Patient-Centred Model (PCM) is described as an attempt to redesign the hospitals around the needs of the patients, thus contributing to costs reduction, increased efficiency, and improved care. However, the introduction of the PCM may have a profound impact on the social organisation of work, changing lines of demarcation, challenging well established inter-/intra-professional relationships, and prompting the development of new roles and modes of working. This thesis explores the mutual effects between the new organisational model and the pre-existent social organisation of hospital work. The research design is organised in three phases: an extensive document analysis; an interview study; an in-depth ethnographic case study conducted for over one year in a PCM hospital. The findings are organised in three studies. The first shows that the PCM was interpreted differently by hospital managers and by frontline clinicians, thus giving rise to two divergent narratives of change. The second study focuses on the boundaries to collaboration and care integration in newly created hospital teams within PCM hospitals. The third study looks at the impact of the PCM on the medical-nursing boundary. The thesis contributes to management learning and practice by providing recommendations on how to accompany complex innovations, comprising of both their expected and unexpected consequences. It also enriches academic debates on professional boundaries, relations, and identities in healthcare.

A New Space for Patients – How Space Enters Innovation Translation Processes

In Chapter 2, Gorli, Mengis and Liberati focus on an innovation – the one towards patient-centred care – that has gained prominence in recent healthcare reforms. Drawing on data from an ethnographic study, the authors focus on the spatial translation of the innovation; that is, the process through which a large, multi-specialty hospital was redesigned and rebuilt to enact a new care paradigm. The findings show that different aspects of the organizational space affected the ways in which the concept of patient-centredness was translated into practice. These included the architectural trends that informed the hospital design, the new material walls that shaped the organization of medical wards, and the way in which the new space was experienced by organizational actors (staff, patients and family members). The authors propose that, when innovative ideas and care paradigms are translated into practice, the role of organizational space (including its material, symbolic, practised and lived qualities) should be considered carefully.

Sistemi computerizzati di supporto alle decisioni cliniche: l’EBM al letto del malato

Introduction One of the aims of Evidence-Based Medicine is to improve quality and appropriateness of care by the expedition of the knowledge transfer process. Computerized Decision Support Systems (CDSSs) are computer programs that provide alerts to the prescribing doctor directly at the moment of medical examination. In fact, alerts are integrated within the single patient electronic health record. CDSS based on the best available and updated evidence and guidelines may be an efficient tool to facilitate the transfer of the latest results from clinical research directly at the bedside, thus supporting decision-making. Objectives The CODES (COmputerized DEcision Support) trial is a research program funded by the Italian Ministry of Health and the Lombardy Region. It aims to evaluate the feasibility of the implementation of a CDSS at the hospital level and to assess its efficacy in daily clinical practice. Methods The CODES project includes two pragmatic RCTs testing a CDSS (i.e. the EBMeDS - MediDSS) in two large Italian hospitals: the first is a general hospital in Vimercate (Lombardy), the second is an oncologic research center in Meldola (Emilia Romagna). The CDSS supports a full spectrum of decisions: therapy, drug interactions, diagnosis, and management of health care services are covered by a hundreds of reminders. However only few reminders are activated per patient, highlighting crucial problems in the delivery of high-quality care. The two trials have similar design and primary outcome, the rate at which alerts detected by the software are resolved by a decision of the clinicians. The project also includes the assessment of barriers and facilitators in the adoption of these new technologies by hospital staff members and the retrospective evaluation of the repeated risks in prescription habits. Results The trials are ongoing and currently more than 10,000 patients have been randomized. The qualitative analysis revealed a progressive shift in the perception of the tool. Doctors are now seeing it as a trusted second opinion, available 24/7, which is tailored to the needs of the patient. The retrospective analysis showed the opportunity to achieve a better healthcare quality through an active risk management. Aggregating data from whole hospitals emerge rare drug interactions that otherwise would not be recognizable. Discussion CDSS are promising tools to support clinicians in everyday practice. They can be used as a real time app or to perform retrospective analyses. These data can provide unique resources to hospital management.INTRODUCTION One of the aims of Evidence-Based Medicine is to improve quality and appropriateness of care by the expedition of the knowledge transfer process. Computerized Decision Support Systems (CDSSs) are computer programs that provide alerts to the prescribing doctor directly at the moment of medical examination. In fact, alerts are integrated within the single patient electronic health record. CDSS based on the best available and updated evidence and guidelines may be an efficient tool to facilitate the transfer of the latest results from clinical research directly at the bedside, thus supporting decision-making. OBJECTIVES The CODES (COmputerized DEcision Support) trial is a research program funded by the Italian Ministry of Health and the Lombardy Region. It aims to evaluate the feasibility of the implementation of a CDSS at the hospital level and to assess its efficacy in daily clinical practice. METHODS The CODES project includes two pragmatic RCTs testing a CDSS (i.e. the EBMeDS - MediDSS) in two large Italian hospitals: the first is a general hospital in Vimercate (Lombardy), the second is an oncologic research center in Meldola (Emilia Romagna). The CDSS supports a full spectrum of decisions: therapy, drug interactions, diagnosis, and management of health care services are covered by a hundreds of reminders. However only few reminders are activated per patient, highlighting crucial problems in the delivery of high-quality care. The two trials have similar design and primary outcome, the rate at which alerts detected by the software are resolved by a decision of the clinicians. The project also includes the assessment of barriers and facilitators in the adoption of these new technologies by hospital staff members and the retrospective evaluation of the repeated risks in prescription habits. RESULTS The trials are ongoing and currently more than 10,000 patients have been randomized. The qualitative analysis revealed a progressive shift in the perception of the tool. Doctors are now seeing it as a trusted second opinion, available 24/7, which is tailored to the needs of the patient. The retrospective analysis showed the opportunity to achieve a better healthcare quality through an active risk management. Aggregating data from whole hospitals emerge rare drug interactions that otherwise would not be recognizable. DISCUSSION CDSS are promising tools to support clinicians in everyday practice. They can be used as a real time app or to perform retrospective analyses. These data can provide unique resources to hospital management.

[Computerized decision support systems: EBM at the bedside].

Introduction One of the aims of Evidence-Based Medicine is to improve quality and appropriateness of care by the expedition of the knowledge transfer process. Computerized Decision Support Systems (CDSSs) are computer programs that provide alerts to the prescribing doctor directly at the moment of medical examination. In fact, alerts are integrated within the single patient electronic health record. CDSS based on the best available and updated evidence and guidelines may be an efficient tool to facilitate the transfer of the latest results from clinical research directly at the bedside, thus supporting decision-making. Objectives The CODES (COmputerized DEcision Support) trial is a research program funded by the Italian Ministry of Health and the Lombardy Region. It aims to evaluate the feasibility of the implementation of a CDSS at the hospital level and to assess its efficacy in daily clinical practice. Methods The CODES project includes two pragmatic RCTs testing a CDSS (i.e. the EBMeDS - MediDSS) in two large Italian hospitals: the first is a general hospital in Vimercate (Lombardy), the second is an oncologic research center in Meldola (Emilia Romagna). The CDSS supports a full spectrum of decisions: therapy, drug interactions, diagnosis, and management of health care services are covered by a hundreds of reminders. However only few reminders are activated per patient, highlighting crucial problems in the delivery of high-quality care. The two trials have similar design and primary outcome, the rate at which alerts detected by the software are resolved by a decision of the clinicians. The project also includes the assessment of barriers and facilitators in the adoption of these new technologies by hospital staff members and the retrospective evaluation of the repeated risks in prescription habits. Results The trials are ongoing and currently more than 10,000 patients have been randomized. The qualitative analysis revealed a progressive shift in the perception of the tool. Doctors are now seeing it as a trusted second opinion, available 24/7, which is tailored to the needs of the patient. The retrospective analysis showed the opportunity to achieve a better healthcare quality through an active risk management. Aggregating data from whole hospitals emerge rare drug interactions that otherwise would not be recognizable. Discussion CDSS are promising tools to support clinicians in everyday practice. They can be used as a real time app or to perform retrospective analyses. These data can provide unique resources to hospital management.INTRODUCTION One of the aims of Evidence-Based Medicine is to improve quality and appropriateness of care by the expedition of the knowledge transfer process. Computerized Decision Support Systems (CDSSs) are computer programs that provide alerts to the prescribing doctor directly at the moment of medical examination. In fact, alerts are integrated within the single patient electronic health record. CDSS based on the best available and updated evidence and guidelines may be an efficient tool to facilitate the transfer of the latest results from clinical research directly at the bedside, thus supporting decision-making. OBJECTIVES The CODES (COmputerized DEcision Support) trial is a research program funded by the Italian Ministry of Health and the Lombardy Region. It aims to evaluate the feasibility of the implementation of a CDSS at the hospital level and to assess its efficacy in daily clinical practice. METHODS The CODES project includes two pragmatic RCTs testing a CDSS (i.e. the EBMeDS - MediDSS) in two large Italian hospitals: the first is a general hospital in Vimercate (Lombardy), the second is an oncologic research center in Meldola (Emilia Romagna). The CDSS supports a full spectrum of decisions: therapy, drug interactions, diagnosis, and management of health care services are covered by a hundreds of reminders. However only few reminders are activated per patient, highlighting crucial problems in the delivery of high-quality care. The two trials have similar design and primary outcome, the rate at which alerts detected by the software are resolved by a decision of the clinicians. The project also includes the assessment of barriers and facilitators in the adoption of these new technologies by hospital staff members and the retrospective evaluation of the repeated risks in prescription habits. RESULTS The trials are ongoing and currently more than 10,000 patients have been randomized. The qualitative analysis revealed a progressive shift in the perception of the tool. Doctors are now seeing it as a trusted second opinion, available 24/7, which is tailored to the needs of the patient. The retrospective analysis showed the opportunity to achieve a better healthcare quality through an active risk management. Aggregating data from whole hospitals emerge rare drug interactions that otherwise would not be recognizable. DISCUSSION CDSS are promising tools to support clinicians in everyday practice. They can be used as a real time app or to perform retrospective analyses. These data can provide unique resources to hospital management.