A realist synthesis of educational outreach visiting and integrated academic detailing to influence prescribing in ambulatory care: why relationships and dialogue matter

Background Many quality improvement initiatives in healthcare employ educational outreach visits, integrating academic detailing to bridge evidence-practice gaps and accelerate knowledge translation. Replicability of their outcomes in different contexts varies, and what makes some visiting programmes more successful than others is unclear. Objective We conducted a realist synthesis to develop theories of what makes educational outreach visiting integrating academic detailing work, for whom, under which circumstances and why, focusing on the clinician-visitor interaction when influencing prescribing of medicines in ambulatory care settings. Methods The realist review was performed in accordance with RAMESES standards. An initial programme theory was generated, academic databases and grey literature were screened for documents with detail on contexts, intervention and outcomes. Using realist logic of analysis, data from 43 documents were synthesised in the generation of a refined programme theory, supported by additional theoretical frameworks of learning and communication. Results Twenty-seven interdependent context-mechanism-outcome configurations explain how clinicians engage with educational outreach visits integrating academic detailing through programme design, what matters in programme design and the educational visitor-clinician interaction and how influence extends beyond the visit. They suggest that in addition to relevance, credibility and trustworthiness of a visit’s contents, communication and clinical skills of educational visitors, the relationship between the educational visitor and clinician, built on a dialogue of learning from and sense-making with each other, creates conditions of critical thinking which are conducive to facilitating prescribing practice change when necessary. Conclusion This realist synthesis elucidates that the quality of clinician-educational visitor interactions is pivotal to educational outreach visiting programmes. Building and sustaining relationships, and establishing an open dialogue are important; neglecting these undermines the impact of visits. Educational visitors can facilitate clinicians’ reflection on practice and influence their prescribing. Clinicians value the discussion of individualised, tailored information and advice they can translate into their practice. PROSPERO registration number CRD42021258199

Use of a patient-centred educational exchange (PCEE) to improve patient's self-management of medicines after a stroke: a randomised controlled trial study protocol

Introduction: National and international guidelines make recommendations for secondary prevention of stroke including the use of medications. A strategy which engages patients in a conversation to personalise evidence-based educational material (patient-centred educational exchange; PCEE) may empower patients to better manage their medications. Methods and analysis: This protocol outlines a non-blinded randomised controlled trial. Consenting patients admitted with a diagnosis of stroke or transient ischaemic attack will be randomised 1:1 to receive either a PCEE composed of two sessions, one at the bedside before discharge and one by telephone at least 10 days after discharge from hospital in addition to usual care (intervention) or usual care alone (control). The primary aim of this study is to determine whether a PCEE improves adherence to antithrombotic, antihypertensive and lipid-lowering medications prescribed for secondary prevention of stroke over the 3 months after discharge, measured using prescription-refill data. Secondary aims include investigation of the impact of the PCEE on adherence over 12 months using prescription-refill data, self-reported medication taking behaviour, self-reported clinical outcomes (blood pressure, cholesterol, adverse medication events and readmission), quality of life, the cost utility of the intervention and changes in beliefs towards medicines and illness. Ethics and dissemination: Communication of the trial results will provide evidence to aid clinicians in conversations with patients about medication taking behaviour related to stroke prevention. The targeted audiences will be health practitioners and consumers interested in medication taking behaviour in chronic diseases and in particular those interested in secondary prevention of stroke. The trial has ethics approval from Metro South Human Research Ethics Committee (HREC/15/QPAH/531) and The University of Queensland Institutional Human Research Ethics (2015001612). Trial registration number: ACTRN12615000888561; Pre-results

In search for gold - The relevance of realist reviews and evaluations to pharmacy research and policy development

Pharmacy services and programs can be regarded as complex interventions which are developed and implemented within the open, complex system of overall healthcare. Realist research considers matters of complexity and provides insights into what programs and interventions work, why and in which contexts. Based on the philosophy of science of critical realism, realist evaluations and realist reviews generate causative explanations which inform pharmacy practitioners, educators and policy makers in which context programs and services achieve particular outcomes. This more nuanced understanding of how pharmacy services contribute to overall healthcare provides guidance for the refinement and targeting of programs, interventions and practice models. This article outlines key aspects of realist research approaches and provides insight into how realism can contribute to research in and the practice of pharmacy

An international initiative to create a collaborative for pharmacovigilance in hospice and palliative care clinical practice

Background: Medication registration currently requires evidence of safety and efficacy from adequately powered phase 3 studies. Pharmacovigilance (phase 4 studies, postmarketing data, adverse drug reaction reporting) provide data on more widespread and longer term use. Historically, voluntary reporting systems for pharmacovigilance have had low reporting rates, relying on ad hoc reporting and retrospective chart reviews, or prospective registries have often been limited to specific drugs or clinical conditions. Furthermore, these data are often irrelevant in hospice and palliative care due to the timeliness of which such data become available and the unique characteristics of our population and prescribing: compounding comorbidities, progressive organ failure, accumulation of symptom-specific medications, tendency to attribute toxicity to disease progression, use of old, off-patent medications, and incorporation of evolving evidence. There is a need for prospective, systematic pharmacovigilance in hospice and palliative care. Method: Here we describe an international, Web-based, 128-bit secure initiative to collect pharmacovigilance data documenting net clinical benefit and safety of common medications. The intention is for a diverse and large group of clinical units to record data prospectively on a small deidentified consecutive cohort of patients started on the medication of interest. A new medication would be studied every 3 months. Three key time points (different for each medication) will be assessed for each patient, collecting easily codefiable data at baseline, a point at which clinical benefit should be experienced, and a point at which short- to medium-term toxicities may occur. Toxicities can additionally be recorded at any time they occur. Data collection will take a maximum of 10 minutes per patient. Conclusion: The intention is to create an efficient, relevant system to improve hospice and palliative care with maximally generalizable results

Pharmacovigilance in hospice/palliative care: rapid report of net clinical effect of metoclopramide

Background: Understanding the performance of prescribed medications in day-to-day practice is important to minimize harm, maximize clinical benefits, and, eventually, better target the people who are most likely to benefit, especially in hospice/palliative care where there may be limited time to optimize prescribing. Metoclopramide, a benzamide prokinetic antiemetic, is widely used for a number of indications including nausea, vomiting, hiccups, and reflux. It has recently had a new ‘‘black box’’ warning issued by the Food and Drug Administration in relation to tardive dyskinesia to limit use to 12 weeks. Methods: A consecutive cohort of patients from 12 participating centers in two countries who were having metoclopramide initiated had data collected at three time points—baseline, 2 days (clinical benefit), and day 7 (clinical harm). Additionally, harms could be recorded at any time. Results: Of the 53 people included in the cohort, 23 (43%) reported benefit at 48 hours, but only 18 (34%) of these people were still using it one week after commencing it. For the other 5, the medication was ceased due to harms. The most frequent harms were akathisia (n = 4), headache (n = 4), and abdominal pain (n = 4). Nine people (17%) had no clinical benefit and experienced harms. Conclusion: Overall, one in three people gained net clinical benefit at one week. Limiting effects include sideeffects that need to be sought actively in clinical care

Off-label prescribing in palliative care – a cross-sectional national survey of Palliative Medicine doctors

Background: Regulatory bodies including the European Medicines Agency register medications (formulation, route of administration) for specific clinical indications. Once registered, prescription is at clinicians’ discretion. Off-label use is beyond the registered use. While off-label prescribing may, at times, be appropriate, efficacy and toxicity data are often lacking. Aim: The aim of this study was to document off-label use policies (including disclosure and consent) in Australian palliative care units and current practices by palliative care clinicians. Design: A national, cross-sectional survey was conducted online following an invitation letter. The survey asked clinicians their most frequent off-label medication/indication dyads and unit policies. Dyads were classified into unregistered, off-label and on-label, and for the latter, whether medications were nationally subsidised. Setting/participants: All Australian palliative medicine Fellows and advanced trainees. Results: Overall, 105 clinicians responded (53% response rate). The majority did not have policies on off-label medications, and documented consent rarely. In all, 236 medication/indication dyads for 36 medications were noted: 45 dyads (19%) were for two unregistered medications, 118 dyads (50%) were for 26 off-label medications and 73 dyads (31%) were for 12 on-label medications. Conclusions: Off-label prescribing with its clinical, legal and ethical implications is common yet poorly recognised by clinicians. A distinction needs to be made between where quality evidence exists but registration has not been updated by the pharmaceutical sponsor and the evidence has not been generated. Further research is required to quantify any iatrogenic harm from off-label prescribing in palliative care

Clinicians\u27 delirium treatment practice, practice change, and influences: A national online survey

Background: Recent studies cast doubt on the net effect of antipsychotics for delirium. Aim: To investigate the influence of these studies and other factors on clinicians’ delirium treatment practice and practice change in palliative care and other specialties using the Theoretical Domains Framework. Design: Australia-wide online survey of relevant clinicians. Setting/participants: Registered nurses (72%), doctors (16%), nurse practitioners (6%) and pharmacists (5%) who cared for patients with delirium in diverse settings, recruited through health professionals’ organisations. Results: Most of the sample (n=475): worked in geriatrics/aged (31%) or palliative care (30%); in hospitals (64%); and saw a new patient with delirium at least weekly (61%). More (59%) reported delirium practice change since 2016, mostly by increased non-pharmacological interventions (53%). Fifty-five percent reported current antipsychotic use for delirium, primarily for patient distress (79%) and unsafe behaviour (67%). Common Theoretical Domains Framework categories of influences on respondents’ delirium practice were: emotion (54%); knowledge (53%) and physical (43%) and social (21%) opportunities. Palliative care respondents more often reported: awareness of any named key study of antipsychotics for delirium (73% vs 39%, p\u3c0.001); decreased pharmacological interventions (60% vs 15%, p\u3c0.001); off-label medication use (86% vs 51%, p\u3c0.001); antipsychotics 79% vs 44%, p\u3c0.001); benzodiazepines 61% vs 26%, p\u3c0.001); and emotion as an influence (82% vs 39%, p\u3c0.001). Conclusion: Clinicians’ use of antipsychotic during delirium remains common and is primarily motivated by distress and safety concerns for the patient and others nearby. Supporting clinicians to achieve evidence-based delirium practice requires further work

The Prospective Evaluation of the Net Effect of Red Blood Cell Transfusions in Routine Provision of Palliative Care.

"Final publication is available from Mary Ann Liebert, Inc., publishers http://dx.doi.org/10.1089/jpm.2017.0072” This author accepted manuscript is made available following 12 month embargo from date of publication (June 2017) in accordance with the publisher’s archiving policyBackground Red Blood Cell (RBC) transfusions are commonly used in palliative care. RBCs are a finite resource, transfusions carry risks, and the net effect (benefits and harms) is poorly defined for people with life-limiting illnesses. Aim The aim of this study was to examine the indications and the effects of RBC transfusion in palliative care patients. Design This international, multisite, prospective consecutive cohort study assessed target symptoms (fatigue, breathlessness, generalised weakness, or dizziness) prior to transfusion and at day 7 by treating clinicians, using National Cancer Institute Common Terminology Criteria for Adverse Events. Assessment of harms was made at day 2. Setting/participants One-hundred and one transfusions with day 7 followup were collected. Median age was 72·0 (IQR 61·5-83·0) years, 58% male, and mean Australian-modified Karnofsky Performance Status of 48 (SD 17). Results A mean 2·1 (SD 0·6) units was transfused. The target symptom was fatigue (61%), breathlessness (16%), generalized weakness (12%), dizziness (6%) or other (5%). Forty-nine percent of transfusions improved the primary target symptom, and 78% of transfusions improved at least one of the target symptoms. Harms were infrequent and mild. An AKPS of 40-50% was associated with higher chances of symptomatic benefit in the target symptom, however no other predictors of response were identified. Conclusions In the largest prospective consecutive case series to date, clinicians generally reported benefit, with minimal harms. Ongoing work is required to define the optimal patient- and clinician-reported haematological and functional outcome measures to optimise the use of donor blood and minimise transfusion-associated risk

An outreach intervention to implement evidence based practice in residential care: a randomized controlled trial [ISRCTN67855475]

BACKGROUND: The aim of this project was to assess whether outreach visits would improve the implementation of evidence based clinical practice in the area of falls reduction and stroke prevention in a residential care setting. METHODS: Twenty facilities took part in a randomized controlled trial with a seven month follow-up period. Two outreach visits were delivered by a pharmacist. At the first a summary of the relevant evidence was provided and at the second detailed audit information was provided about fall rates, psychotropic drug prescribing and stroke risk reduction practices (BP monitoring, aspirin and warfarin use) for the facility relevant to the physician. The effect of the interventions was determined via pre- and post-intervention case note audit. Outcomes included change in percentage patients at risk of falling who fell in a three month period prior to follow-up and changes in use of psychotropic medications. Chi-square tests, independent samples t-test, and logistic regression were used in the analysis. RESULTS: Data were available from case notes at baseline (n = 897) and seven months follow-up (n = 902), 452 residential care staff were surveyed and 121 physicians were involved with 61 receiving outreach visits. Pre-and post-intervention data were available for 715 participants. There were no differences between the intervention and control groups for the three month fall rate. We were unable to detect statistically significant differences between groups for the psychotropic drug use of the patients before or after the intervention. The exception was significantly greater use of "as required" antipsychotics in the intervention group compared with the control group after the pharmacy intervention (RR = 4.95; 95%CI 1.69–14.50). There was no statistically significant difference between groups for the numbers of patients "at risk of stroke" on aspirin at follow-up. CONCLUSIONS: While the strategy was well received by the physicians involved, there was no change in prescribing patterns. Patient care in residential settings is complex and involves contributions from the patient's physician, family and residential care staff. The project highlights challenges of delivering evidence based care in a setting in which there is a paucity of well controlled trial evidence but where significant health outcomes can be attained

Interprofessional communication training: benefits to practicing pharmacists

Background Interprofessional communication skills are important for pharmacists to build collaborative relationships with other health professionals, integrate into healthcare teams, maximise their effectiveness in patient care in addressing complex care needs and meet the demands of health care reforms. Objective This qualitative study explores clinical pharmacists' experiences and reflections after completing a learning and practice module which introduced them to a framework for successful interprofessional communication. Setting The postgraduate clinical pharmacy program at The University of Queensland and the clinical pharmacy practice environments of forty-eight hospital and seven community based pharmacists. Method A learning and practice module outlining a framework for successful interprofessional communication was designed and integrated into a postgraduate clinical pharmacy program. Enrolled pharmacists applied newly learnt communication skills in pro-actively initiated, clinical discussions with a health professional in their practice environment. They provided written reflections on their experiences which were analysed using thematic analysis. Main outcome Pharmacists' perceptions of the impact of applying the communication framework during their interaction with a health professional in their practice setting. Results Themes which emerged from reflections described pharmacists' confidence and capabilities to successfully conduct a clinical discussion with a health professional after initial apprehension and nervousness about the scheduled interaction. The application of the communication framework enhanced their perception of their professional identity, credibility and ability to build a collaborative working relationship with other health professionals. Conclusions Pharmacists perceived that a learning and practice module for successful interprofessional practice integrated into a postgraduate clinical pharmacy program enhanced their interprofessional communication skills. The development of pro-active, interprofessional communication skills has the potential to increase interprofessional collaboration and pharmacists' personal role satisfaction. Pharmacists also observed it added value to their professional contribution in health care teams when addressing the demands of increasingly complex health care needs and reforms