ABSTRACT
INTRODUCTION: Antibiotic overuse is directly related to antibiotic resistance, and primary care is one of the main reasons for this overuse. This study aims to demonstrate that including experts on infectious diseases (ID) within the antimicrobial stewardship (AMS) programme team in primary care settings achieves higher reductions in overall antibiotic consumption and increases the quality of prescription. METHODS AND ANALYSIS: A multicentre, cluster-randomised, blinded clinical trial will be conducted between 2021 and 2023. Six primary care centres will be randomly assigned to an advanced or a standard AMS programme. The advanced AMS programme will consist of a standard AMS programme combined with the possibility that general practitioners (GP) will discuss patients' therapies with ID experts telephonically during working days and biweekly meetings. The main endpoint will be overall antibiotic consumption, defined as daily defined dose per 1000 inhabitants per day (DHD). Secondary end-points will be: (1) unnecessary antibiotic prescriptions in patients diagnosed with upper respiratory tract or urinary tract infection, (2) adequacy of antibiotic prescription, (3) reattendance to GP or emergency room within 30 days after the initial GP visit and (4) hospital admissions for any reason within 30 days after the GP visit. Two secondary endpoints (unnecessary antibiotic therapy and adequacy of therapy) will be evaluated by blinded investigators.We will select three clusters (centres) per arm (coverage of 147 644 inhabitants) which will allow the rejection of the null hypothesis of equal consumption with a power of 80%, assuming a moderate intracluster correlation of 0.2, an intracluster variance of 4 and a mean difference of 1 DHD. The type I error will be set at 5%. ETHICS AND DISSEMINATION: The protocol was reviewed and approved by local ethics committees. The results of this study will be published in peer-reviewed journals and presented at medical conferences. TRIAL REGISTRATION NUMBER: NCT04848883.
Subject(s)
Antimicrobial Stewardship , Communicable Diseases , Urinary Tract Infections , Drug Resistance, Microbial , Humans , Multicenter Studies as Topic , Primary Health Care , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: In view of rapidly increasing prescription costs, case-mix adjustment should be considered for effective control of costs. We have estimated the variability in pharmacy costs explained by ACG in centers using patient electronic records, profiled centers and physicians and analyzed the correlation between cost and quality of prescription. METHODS: We analyzed 65,630 patient records attending five primary care centers in Spain during 2005. Variables explored were age, gender, registered diagnosed episodes of care during 2005, total cost of prescriptions, physician and center. One ACG was assigned to each patient with ACG case-mix software version 7.1. In a two-part model, logistic regression was used to explain the incurrence of drug expenditure at the first stage and a linear mixed model that considered the multilevel structure of data modeled the cost, conditional upon incurring any expense. Risk and efficiency indexes in pharmacy cost adjusted for ACG were obtained for centers and physicians. Spearman rank correlation between physician expenditure, adjusted for ACG, and a prescription quality index was also obtained. Pediatric and adult data were analyzed separately. RESULTS: No prescription was recorded for 13% of adults and 39.6% of children. The proportion of variance of the incurrence of expenditure explained by ACGs was 0.29 in adults and 0.21 in children. For adults with prescriptions, the variance of cost explained by ACGs was 35.4%, by physician-center was 1.8% and age 10.5% (residual 52.3%). For children, ACGs explained 22.4% of cost and physician-center 10.9% (residual 66.7%). Center efficiency index for adults ranged 0.58 to 1.22 and for children 0.32 to 2.36. Spearman correlation between expenditure and prescription quality index was -0.36 in family physicians (p = 0.019, N = 41) and -0.52 in pediatricians (p = 0.08, N = 12). CONCLUSION: In our setting, ACG is the variable studied that explains more variability in pharmacy cost in adults compared to physician and center. In children there is greater variability among physicians and centers not related to case-mix. In our sites, ACG is useful to profile physicians and centers using electronic records in real practical conditions. Physicians with lower pharmaceutical expenditure have higher scores for a prescription quality index.
Subject(s)
Diagnosis-Related Groups/economics , Health Expenditures , Primary Health Care/economics , Adult , Child , Cost Control , Cross-Sectional Studies , Drug Costs/statistics & numerical data , Female , Humans , Linear Models , Logistic Models , Male , Medical Records Systems, Computerized , SpainABSTRACT
The purpose of the study was to assess patients' acceptability of the substitution of brand-name drugs for generic drugs in the primary health care prescribing practices for chronic conditions. A prospective randomised multicentre study was conducted over a 12-month period in which patients taking medications for chronic disorders received an educational intervention on generic drugs at the time they attended different general practices in the city of Barcelona (Spain) for repeat prescribing. Twenty-seven public primary care centres were randomised to the intervention group (eight centres) or the control group (19 centres). Of 4620 patients in the intervention group that received verbal information and handout materials on advantages and disadvantages of generic equivalents and brand-name drugs, 98.9% of them agreed to receive a generic formulation. The primary care centre and the class of drug were associated with statistically significant differences in the percentage of acceptance of generic drugs. In the overall population, generic prescribing in the intervention practices increased to 5.9 as compared with 2.8% in controls. In summary, individual educational intervention in patients with repeat prescribing resulted in a high rate of generic acceptability. The intervention might stimulate the practitioner's motivation, behaviour and knowledge of generic forms.