Implementation fidelity in a multifaceted program to foster rational antibiotics use in primary care: an observational study.

BACKGROUND: The ARena study (Sustainable Reduction of Antimicrobial Resistance in German Ambulatory Care) is a three-arm, cluster randomized trial to evaluate a multifaceted implementation program in a German primary care setting. In the context of a prospective process evaluation conducted alongside ARena, this study aimed to document and explore fidelity of the implementation program. METHODS: This observational study is based on data generated in a three-wave survey of 312 participating physicians in the ARena program and attendance documentation. Measures concerned persistence of participation in the ARena program and adherence to intervention components (thematic quality circles, e-learning, basic expenditure reimbursements, additional bonus payments and a computerized decision support system). Participants' views on five domains of the implementation were also measured. Binary logistic and multiple linear regression analyses were used to explore which views on the implementation were associated with participants' adherence to quality circles and use of additional bonus compensation. RESULTS: The analysis of fidelity showed overall high persistence of participation in the intervention components across the three intervention arms (90,1%; 97,9%; 92,9%). 96.4% of planned quality circles were delivered to study participants and, across waves, 30.4% to 93% of practices participated; 56.1% of physicians attended the maximum of four quality circles. 84% of the practices (n = 158) with a minimum of one index patient received a performance-based additional bonus payment at least once. In total, bonus compensation was triggered for 51.8% of affected patients. Participation rate for e-learning (a prerequisite for reimbursement of project-related expenditure) covered 90.8% of practices across all intervention arms, with the highest rate in arm II (96.5%). Uptake of expenditure reimbursement was heterogeneous across study arms, with a mean rate of 86.5% (89.1% in arm I, 96.4% in arm II and 74.1% in arm III). Participants' views regarding participant responsiveness (OR = 2.298) 95% CI [1.598, 3.305] and Context (OR = 2.146) 95% CI [1.135, 4.055] affected additional bonus payment. Participants' views on participant responsiveness (Beta = 0.718) 95% CI [0.479, 0.957], Context (Beta = 0.323) 95% CI [0.055, 0.590] and Culture of shared decision-making (Beta = -0.334) 95% CI [-0.614, -0.053] affected quality circle attendance. CONCLUSION: This study showed an overall high fidelity to the implementation program. Participants' views on the implementation were associated with degree of intervention fidelity. TRIAL REGISTRATION: ISRCTN, ISRCTN58150046.

Assessing Reduction of Antibiotic Prescribing for Acute, Non-Complicated Infections in Primary Care in Germany: Multi-Step Outcome Evaluation in the Cluster-Randomized Trial ARena.

The three-armed cluster-randomized trial ARena (sustainable reduction of antibiotic-induced antimicrobial resistance) aimed to foster appropriate antibiotic use and reduce overprescribing in German ambulatory care to counter antibiotic resistance. Multi-faceted interventions targeted primary care physicians, teams and patients. This study examined the effectiveness of the implementation program. ARena was conducted in 14 primary care networks with 196 practices. All arms received data-based feedback on antibiotics prescribing and quality circles. Arms II and III received different add-on components each. Primary outcome examined is the prescribing rate for systemic antibiotics for cases with non-complicated acute infections (upper respiratory tract, bronchitis, sinusitis, tonsillitis, otitis media). Secondary outcomes refer to the prescribing of quinolones and guideline-recommended antibiotics. Based on pseudonymized quarterly claims data, mixed logistic regression models examined pre-post intervention antibiotic prescribing rate changes and compared to matched standard care. A significant rate reduction (arm I 11.7%; arm II 9.9%; arm III 12.7%) and significantly lower prescribing rates were observed for all arms (20.1%, 18.9% and 23.6%) compared to matched standard care (29.4%). Fluoroquinolone prescribing was reduced in all intervention arms and rates for recommended substances generally increased. No significant post-interventional difference between intervention arms was detected. Findings indicate implementation program impact compared to standard care.

Antibiotic prescribing for acute, non-complicated infections in primary care in Germany: baseline assessment in the cluster randomized trial ARena.

BACKGROUND: Antimicrobial resistance is fueled by inappropriate use of antibiotics. Global and national strategies support rational use of antibiotics to retain treatment options and reduce resistance. In Germany, the ARena project (Sustainable reduction of antibiotic-induced antimicrobial resistance) intended to promote rational use of antibiotics for acute non-complicated infections by addressing network-affiliated physicians, primary care teams and patients through multiple interacting interventions. The present study documented patterns of antibiotic prescribing for patients with acute non-complicated infections who consulted a physician in these networks at the start of the ARena project. It explored variation across subgroups of patients and draws comparisons to prescribing patterns of non-targeted physicians. METHODS: This retrospective cross-sectional analysis used mixed logistic regression models to explore factors associated with the primary outcome, which was the percentage of patient cases with acute non-complicated respiratory tract infections consulting primary care practices who were treated with antibiotics. Secondary outcomes concerned the prescribing of different types of antibiotics. Descriptive methods were used to summarize the data referring to targeted physicians in primary care networks, non-targeted physicians (reference group), and patient subgroups. RESULTS: Overall, antibiotic prescribing rates were 32.0% in primary care networks and 31.7% in the reference group. General practitioners prescribed antibiotics more frequently than other medical specialist groups (otolaryngologists vs. General practitioners OR = 0.465 CI = [0.302; 0.719], p < 0.001, pediatricians vs. General practitioners: OR = 0.369 CI = [0.135; 1.011], p = 0.053). Quinolone prescribing rates were 9.9% in primary care networks and 8.1% in reference group. Patients with comorbidities had a higher likelihood of receiving an antibiotic and quinolone prescription and were less likely to receive a guideline-recommended substance. Younger patients were less likely to receive antibiotics (OR = 0.771 CI = [0.636; 0.933], p = 0.008). Female gender was more likely to receive an antibiotic prescription (OR = 1.293 CI = [1.201, 1.392], p < 0.001). CONCLUSION: This study provided an overview of observed antibiotic prescribing for acute non-complicated respiratory tract infections in German primary care at the start of the ARena project. Findings indicate potential for improvement and will serve as comparator for the post-interventional outcome evaluation to facilitate describing of potential changes.

Fostering Appropriate Antibiotic Use in a Complex Intervention: Mixed-Methods Process Evaluation Alongside the Cluster-Randomized Trial ARena.

The cluster randomized trial ARena (sustainable reduction of antibiotic-induced antimicrobial resistance, 2017-2020) promoted appropriate use of antibiotics for acute non-complicated infections in primary care networks (PCNs) in Germany. A process evaluation assessed determinants of practice and explored factors associated with antibiotic prescribing patterns. This work describes its findings on uptake and impacts of the complex intervention program and indicates potential implementation into routine care. In a nested mixed-methods approach, a three-wave study-specific survey for participating physicians and medical assistants assessed potential impacts and uptake of the complex intervention program. Stakeholders received a one-time online questionnaire to reflect on network-related aspects. Semi-structured, open-ended interviews, with a purposive sample of physicians, medical assistants and stakeholders, explored program component acceptance for daily practice and perceived sustainability of intervention component effects. Intervention components were perceived to be smoothly integrable into practice routines. The highest uptake was reported for educational components: feedback reports, background information, e-learning modules and disease-specific quality circles (QCs). Participation in PCNs was seen as the motivational factor for guideline-oriented patient care and adoption of new routines. Future approaches to fostering appropriate antibiotics use by targeting health literacy competencies and clinician's therapy decisions should combine evidence-based information sources, audit and feedback reports and QCs.

Promoting rational antibiotic prescribing for non-complicated infections: understanding social influence in primary care networks in Germany.

BACKGROUND: Primary care networks in Germany are formalized regional collaborations of physicians and other healthcare providers. Common goals are optimized healthcare processes and services for patients, enhanced communication, agency for professional concerns and strengthened economic power. In the ARena study (Sustainable reduction of antibiotic-induced antimicrobial resistance), 14 primary care networks in two federal German states aimed to promote appropriate antibiotics use for acute non-complicated infections by fostering awareness and understanding. Factors related to the role of primary care networks were to be identified. METHODS: For this study, audio-recorded telephone interviews were conducted with physicians, non-physician health professionals and stakeholder representatives. Pseudonymized verbatim transcripts were coded using thematic analysis. In-depth analysis was based on the inductive categories 'social support', 'social learning', 'social normative pressures' and 'social contagion' to reflect social influence processes. Data generated through a survey with physicians and non-physician health professionals were analyzed descriptively to foster understanding of the networks' potential impact on antibiotic prescribing. RESULTS: Social influence processes proved to be relevant regarding knowledge transfer, manifestation of best-practice care and self-reflection. Peer communication was seen as a great asset, the main reason for membership and affirmative for own perspectives. All interviewed physicians (n = 27) considered their network to be a strong support factor for daily routines, introduction of new routines, and continuity of care. They utilized network-offered training programs focusing on best practice guideline-oriented use of antibiotics and considered their networks supportive in dealing with patient expectations. A shared attitude combined with ARena intervention components facilitated reflective management of antibiotic prescribing. Non-physician health professionals (n = 11) also valued network peer exchange. They assumed their employers joined networks to offer improved and continuous care. Stakeholders (n = 7) expected networks and their members to be drivers for care optimization. CONCLUSION: Primary care networks play a crucial role in providing a platform for professional peer exchange, social support and reassurance. With regards to their impact on antibiotic prescribing for acute non-complicated infections, networks seem to facilitate and amplify quality improvement programs by providing a platform for refreshing awareness, knowledge and self-reflection among care providers. They are well suited to promote a rational use of antibiotics. TRIAL REGISTRATION: ISRCTN, ISRCTN58150046. Registered 24 August 2017.

The complex phenomenon of dysrational antibiotics prescribing decisions in German primary healthcare: a qualitative interview study using dual process theory.

Background: Antibiotic prescription rates in primary care in Germany are moderate, but still considered too high. The ARena study (Sustainable reduction of antibiotic-induced antimicrobial resistance) was initiated to foster awareness and understanding of the growing challenge and promotes rational antibiotics use for acute, non-complicated and self-limiting infections. Methods: The present study was performed as part of the process evaluation of the ARena study. Interviews were conducted with a purposive sample of physicians participating in the ARena study to identify factors relevant to primary care physicians' decision-making when prescribing antibiotics for acute non-complicated infections. Generated data were audio-recorded. Pseudonymized verbatim transcripts were coded using a pre-defined framework. The Dual Process Theory was applied to provide understanding of individual health professional factors that induce dysrational prescribing decisions. Results: Based on medical as well as non-medical considerations, physicians developed habits in decision making on antibiotics prescribing. They acknowledged inadequate antibiotics prescribing for acute, non-complicated infections in situations involving uncertainty regarding diagnosis, prognosis, continuity of care, patient expectations and when not knowing the patient. Educative efforts empowered physicians to override habitual prescribing. A theory-driven model provides transparency as to how dysrational prescribing decisions occur and suggests remedy by providing new experiences and new recognizable patterns through educative efforts. Conclusions: Educational interventions may only change prescribing behaviours if they result in active rational rather than routine-based decision-making on antibiotics prescribing. Trial registration: ISRCTN, ISRCTN58150046.

[Measuring, assessing, acting: A practice test of quality indicators for coronary heart disease]. / Messen, Bewerten, Handeln: Qualitätsindikatoren zur Koronaren Herzkrankheit im Praxistest.

BACKGROUND: There are only limited possibilities for doctors in outpatient services to establish quality management that is based on data-driven feedback regarding the quality of health care. However, transparency about one's own activities is a prerequisite for refining this quality. The aim of this project was to make the quality of care for patients with coronary heart disease (CHD) more transparent, use this as a basis to initiate improvement processes, and explore the framework conditions and factors promoting or inhibiting the intended improvement of health care quality. METHOD: 48 general practitioners (GPs) in 32 GP practices from a Bavarian doctors' network (Qualität und Effizienz, QuE) participated in the project. On the basis of claims data from the AOK-Bayern (a statutory health insurance in Bavaria), data from disease management programs (DMP) and medically documented data, 11 quality indicators for patients with CHD were calculated. The indicator scores were individually presented in feedback reports for each doctor's practice. These were the basis for two quality circles. The indicators were measured again after 12 months, and changes against the baseline measurement were registered. GPs from Bavaria formed the control group. Focus groups with the quality circle moderators and two participant surveys were used to identify promoting and inhibiting factors. RESULTS: The baseline values showed a good level of care. Potential for improvement became apparent for pharmacotherapy with beta blockers and statins. After conducting the quality circles four of the eleven indicators showed an increase as intended ("beta blockers for CHD and cardiac insufficiency", "beta blockers after myocardial infarction", "statins", "successful blood pressure control"). For three of these indicators the increase rates were higher than those in the Bavarian control group. One indicator ("statins") was striking because of the wide variation of practice values suggesting differences in care within the network. The majority of participating doctors regarded the database as valid. Quality circles were highly appreciated as an opportunity for professional exchange among colleagues. The data-based feedback reports helped to make deficits in health care transparent and to identify actions that need to be taken. Barriers to implementing quality improvement measures in clinical practice became apparent. DISCUSSION: Reflecting quality indicators in quality circles can effectively trigger quality improvement processes. Barriers would appear to exist, in particular, to the implementation of measures into daily practice routine. Additional organizational support offered by higher-level quality management structures, IT solutions for patient-related data processing as well as a system of financial compensation, which rewards professional concern for quality, may help to overcome the existing barriers.

Sustainable reduction of antibiotic-induced antimicrobial resistance (ARena) in German ambulatory care: study protocol of a cluster randomised trial.

BACKGROUND: Despite many initiatives to enhance the rational use of antibiotics, there remains substantial room for improvement. The overall aim of this study is to optimise the appropriate use of antibiotics in German ambulatory care in patients with acute non-complicated infections (respiratory tract infections, such as bronchitis, sinusitis, tonsillitis and otitis media), community-acquired pneumonia and non-complicated cystitis, in order to counter the advancing antimicrobial resistance development. METHODS: A three-armed cluster randomised trial will be conducted in 14 practice networks in two German federal states (Bavaria and North Rhine-Westphalia) and an added cohort that reflects standard care. The trial is accompanied by a process evaluation. Each arm will receive a different set of implementation strategies. Arm A receives a standard set, comprising of e-learning on communication with patients and quality circles with data-based feedback for physicians, information campaigns for the public, patient information material and performance-based additional reimbursement. Arm B receives this standard set plus e-learning on communication with patients and quality circles with data-based feedback tailored for non-physician health professionals of the practice team and information material for tablet computers (culture sensitive). Arm C receives the standard set as well as a computerised decision support system and quality circles in local multidisciplinary groups. The study aims to recruit 193 practices which will provide data on 23,934 patients each year (47,867 patients in total). The outcome evaluation is based on claims data and refers to established indicators of the European Surveillance of Antimicrobial Consumption Network (ESAC-Net). Primary and secondary outcomes relate to prescribing of antibiotics, which will be analysed in multivariate regression models. The process evaluation is based on interviews with surveys among physicians, non-physician health professionals of the practice team and stakeholders. A patient survey is conducted in one of the study arms. Interview data will be qualitatively analysed using thematic framework analysis. Survey data of physicians, non-physician health professionals of the practice team and patients will use descriptive and exploratory statistics for analysis. DISCUSSION: The ARena trial will examine the effectiveness of large scale implementation strategies and explore their delivery in routine practice. TRIAL REGISTRATION: ISRCTN, ISRCTN58150046 . Registered 24 August 2017.

[Quality circles in German ambulatory care: results of a continuous documentation in the regions of Bremen, Saxony-Anhalt, Schleswig-Holstein and Westphalia-Lippe 1995-2007]. / Qualitätszirkel in der vertragsärztlichen Versorgung: Ergebnisse der kontinuierlichen Basisdokumentation in Bremen, Sachsen-Anhalt, Schleswig-Holstein und Westfalen-Lippe 1995 bis 2007.

BACKGROUND: Quality circles (QC) are viewed as one of the most important tools of quality improvement and continuing education in ambulatory care. Yet, little is known about the quality of QC work. METHODS: From 1995 to 2007, an external assessment of QC work took place at four regional Associations of Statutory Health Insurance (SHI) Physicians. After each meeting, QC leaders completed questionnaires. This basic documentation focused on important features of QC work--continuity, topics, methods, results and satisfaction. RESULTS: 28,800 meetings in 1,640 quality circles were documented, and 27,255 documents from 1,241 groups analysed. Continuity was high over long periods, and medical topics were dealt with in more than 80% of the time. The use of appropriate methods, however, have room for improvement. Participants were very satisfied. CONCLUSIONS: For the first time the quality of QC structures, processes and results was assessed in Germany using a broad dataset. The working principles of QC appear to be well-established. Using the basic documentation practical recommendations are made to improve the quality of QC.

Quality circles to improve prescribing patterns in primary medical care: what is their actual impact?

RATIONALE, AIMS AND OBJECTIVES: Quality circles comprise small group sessions of doctors and written feedback on their individual practice patterns. Although 50% of German primary care doctors participate in quality circles, their effectiveness has hardly been evaluated in Germany. This study determined the impact of a large-scale programme of quality circles on quality and costs of prescribing. METHOD: A controlled before-after study was performed, in which primary care doctors were allocated to a quality circles group or a control group. Subjects were 100,000 patients in 1996 and in 1998, who had visited one of 177 doctors in the 3 month registration periods in one region in Germany. The intervention comprised a quality circles programme, comprising 11 sessions and repeated feedback on prescribing. Main outcome measures were proportion of patients who received a prescription, mean prescription costs per patient and proportion of generic prescriptions. RESULTS: The absolute numbers of prescriptions decreased in both groups, but the mean prescription costs per patient increased. The quality circles reduced the proportion of patients who received a prescription (OR = 0.86) and the mean prescription costs per patient (B = -3.99 euro), while it increased the proportion of generic drugs (OR = 1.10). The intervention had intended effects on four of the 15 secondary indicators. CONCLUSIONS: Large-scale application of quality circles had intended effects on prescribing decisions in primary care in Germany. The effects found in this study may reflect better what improvements can be achieved than randomized trials of similar interventions.