Participant and GP perspectives and experiences of screening for undiagnosed type 2 diabetes in community pharmacy during the Pharmacy Diabetes Screening Trial.

BACKGROUND: The Pharmacy Diabetes Screening Trial (PDST) evaluated three approaches to screening for undiagnosed type 2 diabetes mellitus (T2DM) in community pharmacy: (1) paper-based risk assessment (AUSDRISK) alone; and AUSDRISK followed by a point of care test if AUSDRISK ≥ 12; with either (2) HbA1c; or (3) small capillary blood glucose Test (scBGT). This paper reports the perspectives and experiences of the pharmacy screening service of two key stakeholder groups: screening participants and general practitioners (GPs). METHODS: All referred participants (n = 2242) received an online survey to determine the outcome of the referral, as well as their level of satisfaction with the service. In addition, a random sample of 2,989 (20%) of non-referred participants were surveyed to determine their overall experience and level of satisfaction with the service. GPs to whom participants were referred were contacted to establish if, since the date of the screening service, their patient had (1) been to see them; (2) had further tests performed (FBG, RBG, OGTT, HbA1c); or (3) been diagnosed with diabetes or prediabetes. Descriptive statistics were reported for quantitative data. Factors associated with visiting the GP following screening were assessed using multivariable logistic regression. Qualitative data were analysed using content analysis. RESULTS: Response rates 16% (n = 369) and 17% (n = 520) were achieved for the three-month referred and non-referred participant surveys, respectively. Over 90% of respondents were very positive about the screening service (n = 784/853) and would recommend it to a family member or friend (n = 784/853). Participants also reported making significant improvements in diet and exercise, because of the screening. Among referred respondents, those who received a POC test were twice as likely to visit their GP compared to those who received a risk assessment only (OR 2.11 95% CI 1.46-3.06). GPs (15.8% response rate, n = 57/361) indicated that the referral worked well and that recommendations for follow-up care by the pharmacist were appropriate. CONCLUSION: Opportunistic screening of individuals during routine encounters with the community pharmacy in a previously undiagnosed population has been shown to foster positive engagement with consumers and GPs, which may assist in reducing the burden of T2DM on the individual and the community.

Pharmacy diabetes screening trial (PDST): Outcomes of a national clustered RCT comparing three screening methods for undiagnosed type 2 diabetes (T2DM) in community pharmacy.

AIMS: To compare the effectiveness of three pharmacy-based screening methods for type 2 diabetes (T2DM): (1) risk assessment (AUSDRISK) alone (Group A); AUSDRISK followed by a point of care test if AUSDRISK ≥12; either (2) HbA1c (Group B); or (3) small capillary blood glucose test (Group C). METHODS: A cluster RCT with a nationally representative sample of Australian pharmacies was implemented with random allocation of eligible pharmacies to Groups A, B or C. GP referral was based on prespecified cut offs. Diagnoses were considered positive if confirmed by a GP, pathology laboratory, or national diabetes register. RESULTS: Of the 14,093 people screened in 339 pharmacies, 3059 participants met group-specific referral criteria: 1775 (45%) (Group A); 893 (17%) (Group B); and 391 (8%) (Group C). For the total screened population rates of T2DM diagnoses were significantly higher in Group B (1.5%), compared with Groups A (< 0.8%) and C (< 0.6%) with the odds of detection in Group B compared with Group A (1.8 [1.0;3.0]), and no difference between Groups A and C. CONCLUSIONS: In community pharmacy, the most effective method to uncover undiagnosed T2DM was a stepwise approach; initial risk assessment; and if appropriate an HbA1C POC test and referral.

A Multi-Mode Education Program to Enhance Asthma Care by Pharmacists.

Objective. To provide optimal asthma care, community pharmacists must have advanced, contemporary knowledge, and the skills to translate that knowledge into practice. The development and evaluation of an innovative multi-mode education program to enhance pharmacists' clinical knowledge and practical skills is described.Methods. The online education modules were collaboratively developed alongside asthma and pharmacy organizations. The education program was comprised of five evidence-based education modules delivered online and a skills review conducted either in-person with real-time feedback (urban pharmacists) or via video upload and scheduled video-conference feedback (regional and remote pharmacists). A mixed methods approach was used to evaluate the feedback obtained from pharmacists to assess the content, efficacy, and applicability of the education.Results. Ninety-seven pharmacists opted into the program and successfully completed all education requirements. A larger proportion of pharmacists did not pass trial protocol-based education modules on their first attempts compared to the number that passed the asthma and medication knowledge-based modules. Prior to skills review, the proportion of pharmacists demonstrating device technique competency was suboptimal. Pharmacists rated the education modules highly in both quantitative and qualitative evaluations and reported that the program adequately prepared them to better deliver care to asthma patients.Conclusion. We developed, implemented, and evaluated a novel multi-mode asthma education program for community pharmacists that supports knowledge and practical skill development in this crucial area of patient care. The education program was well received by pharmacists. This form of education could be used more broadly in international collaborative trials.

A standard enteral formula versus an iso-caloric lower carbohydrate/high fat enteral formula in the hospital management of adolescent and young adults admitted with anorexia nervosa: a randomised controlled trial.

BACKGROUND: The nutritional rehabilitation of malnourished patients hospitalised with anorexia nervosa is essential. The provision of adequate nutrition must occur, while simultaneously, minimising the risk of refeeding complications, such as electrolyte, metabolic, and organ dysfunction. The aim of this study was to compare the efficacy and safety of an iso-caloric lower carbohydrate/high fat enteral formula (28% carbohydrate, 56% fat) against a standard enteral formula (54% carbohydrate, 29% fat). METHODS: Patients (aged 15-25 years) hospitalised with anorexia nervosa were recruited into this double blinded randomised controlled trial. An interim analysis was completed at midpoint, when 24 participants, mean age 17.5 years (± 1.1), had been randomly allocated to lower carbohydrate/high fat (n = 14) or standard (n = 10) feeds. RESULTS: At baseline, there was no significant difference in degree of malnutrition, medical instability, history of purging or serum phosphate levels between the two treatment arms. A significantly lower rate of hypophosphatemia developed in patients who received the lower carbohydrate/high fat formula compared to standard formula (5/14 vs 9/10, p = 0.013). The serum phosphate level decreased in both feeds, however it decreased to a larger extent in the standard feed compared to the lower carbohydrate/high fat feed (standard feed 1.11 ± 0.13 mmol/L at baseline vs 0.88 ± 0.12 mmol/L at week 1; lower carbohydrate/high fat feed 1.18 ± 0.19 mmol/L at baseline vs 1.06 ± 0.15 mmol/L at week 1). Overall, serum phosphate levels were significantly higher in the lower carbohydrate/high fat feed compared with standard feed treatment arm at Week 1 (1.06 ± 0.15 mmol/L vs 0.88 ± 0.12 mmol/L, p < 0.001). There was no significant difference in weight gain, number of days to reach medical stability, incidence of hypoglycaemia, or hospital length of stay. CONCLUSIONS: The results of this study indicate that enteral nutrition provided to hospitalised malnourished young people with anorexia nervosa using a lower carbohydrate/high fat formula (28% carbohydrate, 56% fat) seems to provide protection from hypophosphatemia in the first week compared to when using a standard enteral formula. Further research may be required to confirm this finding in other malnourished populations. TRIAL REGISTRATION: ANZCTR, ACTRN12617000342314. Registered 3 March 2017, http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617000342314.

Patients hospitalised with anorexia nervosa require nutrition support as part of their treatment, whilst refeeding complications are prevented. Of particular concern, is the reintroduction of carbohydrate to malnourished patients, which has been proposed to cause a surge in insulin levels and disturbance in electrolytes, particularly a decrease in blood phosphate levels. This double-blinded randomised controlled trial measured the occurrence of low phosphate blood levels and other refeeding complications, in adolescent and young adult patients hospitalised with anorexia nervosa. These patients were provided either a lower carbohydrate/high fat feed (28% carbohydrate, 56% fat) or a standard enteral feed (54% carbohydrate, 29% fat). Fewer patients in the lower carbohydrate/high fat feed group (5/14) than standard feed group (9/10) developed a low phosphate level. There was no significant difference in weight gain, number of days to reach medical stability, occurrence of hypoglycaemia, or hospital length of stay.

A Targeted Approach to Improve Asthma Control Using Community Pharmacists.

Background: Building on lessons learnt from evidence-based community pharmacy asthma management models, a streamlined and technology supported Pharmacy Asthma Service (PAS) was developed to promote the integration of the service into routine practice. Objective: This study investigates the efficacy of the PAS in improving asthma symptom control and other health outcomes. Methods: A two-arm pragmatic cluster randomized controlled trial was implemented in 95 pharmacies across three Australian States. Participants were adults with poorly controlled asthma as per the Asthma Control Questionnaire (ACQ), with or without allergic rhinitis. Patients within the PAS arm engaged in four consultations with the pharmacist over a 12-month period. An evidence-based algorithm guided pharmacies, via a trial specific software, to deliver a series of interventions targeting three issues underpinning uncontrolled asthma (medication use and adherence, inhaler technique, and allergic rhinitis management) to patient clinical asthma status and patient need. Comparator arm patients received a minimal intervention likened to usual practice involving referral of eligible patients to the GP and two follow-up consultations with their pharmacist to collect comparative data. Results: In total, 143 of 221 PAS patients (65%) and 111 of 160 comparator patients (69%) completed the trial. Improvements in asthma control were achieved in both the PAS (mean difference (MD) in ACQ from baseline = -1.10, p <.0001) and comparator (MD in ACQ from baseline = -0.94, p <.0001) arms at the trial end; however, there were no significant differences between the two arms (MD = -0.16, 95% CI -0.41 to 0.08, p = 0.19). Patients' quality of life in the PAS arm improved significantly when compared with the comparator arm (MD in Impact of Asthma on Quality-of-Life Questionnaire (IAQLQ) = -0.52, 95% CI -0.89 to -0.14, p = 0.0079). Conclusion: Despite the PAS achieving a greater improvement in patients' quality of life, the pharmacist-led service and usual practice arm produced comparable improvements in asthma control. These results ask us to reflect on current standards of usual care, as it appears the standard of asthma care in usual practice has evolved beyond what is reported in the literature.

Medication Adherence in a Community Population with Uncontrolled Asthma.

It is well documented that the use of medications in asthma and allergic rhinitis is often suboptimal, and consequently, patients remain symptomatic. This study aimed to determine the extent and type of medication-related issues contributing to poor asthma control by profiling medication management in those most at risk-a population with clinically uncontrolled asthma. Participants (n = 363) were recruited from Australian community pharmacies, and a dispensed medication history report for the previous 12 months was collected to examine medication adherence and factors affecting adherence. Information was also collected regarding participant asthma control and asthma/allergic rhinitis (if applicable) management. The participants' mean asthma control score was 2.49 (± 0.89 SD, IQR = 1.20) (score ≥ 1.5 indicative of poorly controlled asthma), and 72% were either non-adherent or yet to initiate preventer therapy. Almost half had been prescribed high doses of inhaled corticosteroid and 24% reported use of oral corticosteroids. Only 22% of participants with concomitant allergic rhinitis were using first line treatment. A logistic regression model highlighted that participant health care concession status and hospital admissions were associated with better adherence. Suboptimal medication management is evident in this at-risk population.

Study protocol for a randomised controlled trial investigating two different refeeding formulations to improve safety and efficacy of hospital management of adolescent and young adults admitted with anorexia nervosa.

INTRODUCTION: Providing effective nutritional rehabilitation to patients hospitalised with anorexia nervosa (AN) is challenging, partly due to conservative recommendations that advocate feeding patients at low energy intakes. An 'underfeeding syndrome' can develop when patients are not provided with adequate nutrition during treatment, whereby malnourished patients fail to restore weight in a timely matter, and even lose weight. Of particular concern, the reintroduction of carbohydrate in a starved patient can increase the risk of developing electrolyte, metabolic and organ dysfunction. The proposed trial assesses the efficacy and safety of a lower carbohydrate enteral formula (28% carbohydrate) against a standard enteral formula (54% carbohydrate), in adolescent and young adult patients (aged 15-25 years), hospitalised with AN. METHODS AND ANALYSIS: The study employs a double-blind randomised controlled trial design. At admission to hospital, malnourished adolescent and young adults with AN will be randomly allocated to commence feeding on a standard enteral feeding formula (1.5 kcal/mL, 54% carbohydrate) or a lower carbohydrate isocaloric enteral feeding formula (1.5 kcal/mL, 28% carbohydrate). Assessments of nutritional intake, weight and biochemistry (phosphate, magnesium, potassium) will be conducted at baseline and during the first 3 weeks of hospital admission. The primary outcome measure will be incidence of hypophosphatemia. Secondary outcomes include weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters. ETHICS AND DISSEMINATION: The protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee and institutional research governance approvals were granted. Written informed consent will be sought prior to study enrolment. Study findings will be widely disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12617000342314); Pre-results.

Community pharmacy modifications to non-prescription medication requests: A simulated patient study.

BACKGROUND: Self-care, and hence self-medication, is becoming an increasingly popular practice worldwide. Community pharmacies are an important destination for those seeking non-prescription medicines, and pharmacists and their staff are in a prime position to facilitate appropriate and safe self-medication. PURPOSE: To determine what modifications (for example, a change in brand, change in drug, or non-supply) pharmacy staff make when presented with a request for a non-prescription medicine, and to determine what factors influence whether a modification is made. METHODS: Sixty-one third year Bachelor of Pharmacy students from The University of Sydney were trained as mystery shoppers to make 9 visits once a week to 36 community pharmacies in the metropolitan region of Sydney, Australia from March-October 2015. Students presented to a different, pre-allocated pharmacy once a week with a direct product request for a non-prescription medicine relating to a common ailment (e.g. asthma, insomnia, allergic rhinitis) for 9 weeks. Student mystery shoppers audio-recorded each visit and collected the details of the interaction and product sold. Descriptive statistics, chi-squared analyses, and binary logistic regression were performed to find factors influencing modifications made by pharmacy staff to the simulated patient initial request. RESULTS: Of 540 completed visits, 497 were eligible for analysis. Modification (change in brand, intra/interclass change, companion sale, or no product supplied) occurred in 49% (n = 245) of visits. Whether the product requested was deemed "not appropriate" given the scenario outline was the only significant predictor of whether a modification to the request occurred (42% modification, "appropriate" scenarios vs. 57% modification, "not appropriate" scenarios; χ2 = 8.90; p < 0.01). CONCLUSIONS: Modification from the original non-prescription medicine request occurred in approximately half the reported requests. A request for a product that was considered "not appropriate" was more likely to elicit a modification than a request for an "appropriate" non-prescription medicine.

Mystery shopping and coaching as a form of audit and feedback to improve community pharmacy management of non-prescription medicine requests: an intervention study.

OBJECTIVES: To determine whether repeated mystery shopping visits with feedback improve pharmacy performance over nine visits and to determine what factors predict an appropriate outcome. DESIGN: Prospective, parallel, repeated intervention, repeated measures mystery shopping (pseudopatient) design. SETTING: Thirty-six community pharmacies in metropolitan Sydney, Australia in March-October 2015. PARTICIPANTS: Sixty-one University of Sydney pharmacy undergraduates acted as mystery shoppers. Students enrolled in their third year of Bachelor of Pharmacy in 2015 were eligible to participate. Any community pharmacy in the Sydney metropolitan region was eligible to take part and was selected through convenience sampling. INTERVENTION: Repeated mystery shopping with immediate feedback and coaching. OUTCOME MEASURES: Outcome for each given scenario (appropriate or not) and questioning scores for each interaction. RESULTS: Five hundred and twenty-one visits were analysed, of which 54% resulted in an appropriate outcome. Questioning scores and the proportion of interactions resulting in an appropriate outcome significantly improved over time (P<0.001). Involvement of pharmacists, visit number, increased questioning score and the prescribed scenario were predictors of an appropriate outcome (P=0.008, P=0.022, P<0.001 and P<0.001, respectively). Interactions involving a pharmacist had greater scores than those without (P<0.001). CONCLUSIONS: Repeated mystery shopping visits with feedback were associated with improved pharmacy performance over time. Future work should focus on the role of non-pharmacist staff and design interventions accordingly.

Pharmacy Diabetes Screening Trial: protocol for a pragmatic cluster-randomised controlled trial to compare three screening methods for undiagnosed type 2 diabetes in Australian community pharmacy.

INTRODUCTION: With the rising prevalence of type 2 diabetes in Australia, screening and earlier diagnosis is needed to provide opportunities to intervene with evidence-based lifestyle and treatment options to reduce the individual, social and economic impact of the disease. The objectives of the Pharmacy Diabetes Screening Trial are to compare the clinical effectiveness and cost-effectiveness of three screening models for type 2 diabetes in a previously undiagnosed population. METHODS AND ANALYSIS: The Pharmacy Diabetes Screening Trial is a pragmatic cluster randomised controlled trial to be conducted in 363 community pharmacies across metropolitan, regional and remote areas of Australia, randomly allocated by geographical clusters to one of three groups, each with 121 pharmacies and 10 304 screening participants. The three groups are: group A: risk assessment using a validated tool (AUSDRISK); group B: AUSDRISK assessment followed by point-of-care glycated haemoglobin testing; and group C: AUSDRISK assessment followed by point-of-care blood glucose testing. The primary clinical outcome measure is the proportion of newly diagnosed cases of type 2 diabetes. Primary outcome comparisons will be conducted using the Cochran-Mantel-Haenszel test to account for clustering. The secondary clinical outcomes measures are the proportion of those who (1) are referred to the general practitioner (GP), (2) take up referral to the GP, (3) are diagnosed with pre-diabetes, that is, impaired glucose tolerance or impaired fasting glucose and (4) are newly diagnosed with either diabetes or pre-diabetes. The economic outcome measure is the average cost (direct and indirect) per confirmed new case of diagnosed type 2 diabetes based on the incremental net trial-based costs of service delivery and the associated incremental longer term health benefits from a health funder perspective. ETHICS AND DISSEMINATION: The protocol has been approved by the Human Research Ethics Committees at University of Sydney and Deakin University. Results will be available on the Sixth Community Pharmacy Agreement website and will be published in peer reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12616001240437; Pre-results.

Management of common ailments requiring referral in the pharmacy: a mystery shopping intervention study.

Background Pharmacists can play a key role in managing ailments through their primary roles of supplying over-the-counter (non-prescription) medicines and advice-giving. It must be ensured that pharmacy staff practise in an evidence-based, guideline-compliant manner. To achieve this, mystery shopping can be used as an intervention to assess and train pharmacy staff. Objective To determine if repeated student pharmacist mystery shopping with immediate feedback affected the outcome of scenarios requiring referral to a medical practitioner. To determine what, if any, factors may influence whether referral occurred. Setting Thirteen community pharmacies across metropolitan Sydney, Australia. Methods Sixty-one student pharmacist mystery shoppers visited 13 community pharmacies across metropolitan Sydney once weekly over nine weeks between March-October 2015 to conduct audio-recorded mystery shopping visits with assigned scenarios (asthma, dyspepsia, diarrhoea). Students returned to the pharmacy immediately to provide staff members with feedback. Pharmacy staff were scored by mystery shoppers according to a standardised scoresheet. Score data and other characteristics, such as the assigned scenario, were analysed via correlation and logistic regression modelling. Main outcome measure Whether a student mystery shopper was appropriately referred to a medical practitioner based on the presenting symptoms. Results 158 visits were eligible for analysis. Referral to a medical practitioner was appropriately made in 66% of visits. The regression model provided an R2 value of 0.73; the questioning score of the interaction and if a pharmacist was involved in the interaction were significant predictor of appropriate outcome (p < 0.001 and p < 0.01 respectively). Statistically significant differences were found between median questioning and total scores of interactions involving a pharmacist compared to those that did not (p < 0.001). No statistically significant correlation was found between the number of visits and appropriate outcome (p > 0.05). Conclusions Mystery shopping with feedback did not improve pharmacy staff performance over time. Increased questioning and involvement of a pharmacist in the interaction were significant predictors of referral to a medical practitioner occurring.

Understanding commissioning for non-commissioners.

Commissioning is vital to a patient-led NHS. The knowledgeable practitioner, a non-commissioner, can become involved to influence commissioners to improve the population's health and well-being. Commissioning and the activities related towards improving the health and wellbeing of a given population follow a decision-making model. Depicted as a cyclical process each stage of commissioning is examined. At the centre of commissioning are service-users for whom commissioned services are tailored. Securing the service-user at the centre enables people to become involved and have their voices heard. This article provides an exploration of the issues surrounding commissioning and provides examples of how practitioners can engage with the concept of commissioning to inform and influence commissioners.