Adherence to Evidence-Based Outpatient Antimicrobial Prescribing Guidelines at a Tribal Health System.

Background: In 2019, the Tuba City Regional Health Care Corporation on the Navajo Reservation in northeastern Arizona established facility-wide, evidence-based outpatient antimicrobial guidelines. We aimed to evaluate adherence to these guidelines. Methods: A retrospective chart review of the electronic health record for all ages was conducted from August 1, 2020, to August 1, 2021, to evaluate antimicrobials prescribed for indications covered by the facility prescribing guidelines. The appropriateness of the antimicrobial prescribed was assessed and reported as a percentage. An educational intervention and a survey were then distributed from March 2, 2022, to March 31, 2022, to all prescribers. Results: Overall adherence to prescribing guidelines over the period assessed was 86%, 4% short of the study goal of 90%. Before the educational intervention, 61.5% of prescribers used the prescribing guidelines to guide their antibiotic choice, while after the educational intervention, 87.1% of prescribers indicated a willingness to use the guidelines to guide their antibiotic choice. Conclusions: Adherence to the facility guidelines was already high at 86%. Educational interventions were performed but their efficacy could not be assessed within the time constraints of the study.

Current interventions to promote safe and appropriate pain management.

PURPOSE: Describe patient-, clinician-, system-, and community-level interventions for pain management developed and employed by 9 healthcare systems across the United States and report on lessons learned from the implementation of these interventions. SUMMARY: The high cost associated with pain coupled with the frequent use of opioid analgesics as primary treatment options has made novel pain management strategies a necessity. Interventions that target multiple levels within healthcare are needed to help combat the opioid epidemic and improve strategies to manage chronic pain. Patient-level interventions implemented ranged from traditional paper-based educational tools to videos, digital applications, and peer networks. Clinician-level interventions focused on providing education, ensuring proper follow-up care, and establishing multidisciplinary teams that included prescribers, pharmacists, nurses, and other healthcare professionals. System- and community-level interventions included metric tracking and analytics, electronic health record tools, lockbox distribution for safe storage, medication return bins for removal of opioids, risk assessment tool utilization, and improved access to reversal agents. CONCLUSION: Strategies to better manage pain can be implemented within health systems at multiple levels and on many fronts; however, these changes are most effective when accepted and widely used by the population for which they are targeted.

Assessing the reliability and validity of direct observation and traffic camera streams to measure helmet and motorcycle use.

There is a need to develop motorcycle helmet surveillance approaches that are less labour intensive than direct observation (DO), which is the commonly recommended but never formally validated approach, particularly in developing settings. This study sought to assess public traffic camera feeds as an alternative to DO, in addition to the reliability of DO under field conditions. DO had high inter-rater reliability, κ=0.88 and 0.84, respectively, for cycle type and helmet type, which reinforces its use as a gold standard. However, traffic camera-based data collection was found to be unreliable, with κ=0.46 and 0.53 for cycle type and helmet type. When bicycles, motorcycles and scooters were classified based on traffic camera streams, only 68.4% of classifications concurred with those made via DO. Given the current technology, helmet surveillance via traffic camera streams is infeasible, and there remains a need for innovative traffic safety surveillance approaches in low-income urban settings.

Relative cost effectiveness of the SPHERE intervention in selected patient subgroups with existing coronary heart disease.

Heterogeneity exists within the patient population with coronary heart disease and the cost effectiveness of treatment may vary across subgroups within the overall population. This study compares the cost effectiveness of a secondary prevention intervention for a combined patient population relative to three selected subgroups: patients aged over 70 years; patients with a diagnosis other than angina only (that is, patients with a history of myocardial infarction, coronary artery bypass graft and/or percutaneous transluminal coronary angioplasty); and patients with diabetes. The results for the general population have been published elsewhere, but ongoing budget constraints require consideration of the appropriateness of targeting resources to patient subgroups. We adopt a probabilistic model to combine within trial and beyond trial impacts of treatment to estimate the lifetime health care costs and quality-adjusted life years of two primary care-based secondary prevention strategies: SPHERE Intervention--tailored practice and patient care plans and Control--standardised usual care. In all cases, the intervention was associated with mean cost savings and mean QALYs gains, when compared to the control, though statistical significance was never achieved. However, the probability of the intervention being cost effective was higher than 85% in all analyses across a range of potential cost-effectiveness threshold values. There is no compelling statistical evidence to support the targeting of specific subgroups across the general population. However, if affordability constraints are binding, the results do allow a tentative ranking of priorities based on the probabilistic subgroup analysis.

The cost-effectiveness of the SPHERE intervention for the secondary prevention of coronary heart disease.

OBJECTIVES: The Secondary Prevention of Heart disEase in geneRal practicE (SPHERE) trial has recently reported. This study examines the cost-effectiveness of the SPHERE intervention in both healthcare systems on the island of Ireland. METHODS: Incremental cost-effectiveness analysis. A probabilistic model was developed to combine within-trial and beyond-trial impacts of treatment to estimate the lifetime costs and benefits of two secondary prevention strategies: Intervention - tailored practice and patient care plans; and Control - standardized usual care. RESULTS: The intervention strategy resulted in mean cost savings per patient of euro512.77 (95 percent confidence interval [CI], -1086.46-91.98) and an increase in mean quality-adjusted life-years (QALYs) per patient of 0.0051 (95 percent CI, -0.0101-0.0200), when compared with the control strategy. The probability of the intervention being cost-effective was 94 percent if decision makers are willing to pay euro45,000 per additional QALY. CONCLUSIONS: Decision makers in both settings must determine whether the level of evidence presented is sufficient to justify the adoption of the SPHERE intervention in clinical practice.

Service organisation for the secondary prevention of ischaemic heart disease in primary care.

BACKGROUND: Ischaemic heart disease (IHD) is a major cause of mortality and morbidity and its prevalence is set to increase. Secondary prevention aims to prevent subsequent acute events in people with established IHD. While the benefits of individual medical and lifestyle interventions is established, the effectiveness of interventions which seek to improve the way secondary preventive care is delivered in primary care or community settings is less so. OBJECTIVES: To assess the effectiveness of service organisation interventions, identifying which types and elements of service change are associated with most improvement in clinician and patient adherence to secondary prevention recommendations relating to risk factor levels and monitoring (blood pressure, cholesterol and lifestyle factors such as diet, exercise, smoking and obesity) and appropriate prophylactic medication. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2007, Issue 4), MEDLINE (1966 to Feb 2008), EMBASE (1980 to Feb 2008), and CINAHL (1981 to Feb 2008). Bibliographies were checked. No language restrictions were applied. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials of service organisation interventions in primary care or community settings in populations with established IHD. DATA COLLECTION AND ANALYSIS: Analyses were conducted according to Cochrane recommendations and Odds Ratios (with 95% confidence intervals) reported for dichotomous outcomes, mean differences (with 95% CIs) for continuous outcomes. MAIN RESULTS: Eleven studies involving 12,074 people with IHD were included. Increased proportions of patients with total cholesterol levels within recommended levels at 12 months, OR 1.90 (1.04 to 3.48), were associated with interventions that included regular planned appointments, patient education and structured monitoring of medication and risk factors, but significant heterogeneity was apparent. Results relating to blood pressure within target levels bordered on statistical significance. There were no significant effects of interventions on mean blood pressure or cholesterol levels, prescribing, smoking status or body mass index. Few data were available on the effect on diet. There was some suggestion of a "ceiling effect" whereby interventions have a diminishing beneficial effect once certain levels of risk factor management are reached. AUTHORS' CONCLUSIONS: There is weak evidence that regular planned recall of patients for appointments, structured monitoring of risk factors and prescribing, and education for patients can be effective in increasing the proportions of patients within target levels for cholesterol control and blood pressure. Further research in this area would benefit from greater standardisation of the outcomes measured.

A mixed-methods prospective study of death certification in general practice.

BACKGROUND: Accurate completion of death certificates is important for compiling national and regional statistics. Determining actual cause of death can be extremely difficult; internationally, uncertainty has been acknowledged in many cases. We set out to explore the issue of uncertainty further: in what circumstances do GPs feel more or less certain, and how do they feel about this? OBJECTIVES: The study aimed (i) to focus on death certification issues faced by GPs and their related attitudes, and (ii) to assess GPs' confidence in stated diagnosis and reasons influencing certification. METHODS: This was a prospective, cross-sectional, mixed-methods study. Participants were 15 GP trainers in Ireland. Two focus groups, held 1 year apart, explored issues surrounding, and attitudes towards, death certification. A one-page questionnaire, completed after the death of every patient for 6 months, recorded patient age and gender, place and certified cause of death, certifier, and level of certainty about cause of death (on a 10-point scale). RESULTS: There were 168 deaths across the 15 practices during the study period. Overall confidence in certified cause of death was relatively high but varied significantly according to certifier, and place and cause of death. The main issues surrounded the varying level of certainty with diagnosis, concerns regarding the family of the deceased, and the perceived gap in education about death certification, including legal matters. CONCLUSIONS: GPs appear to feel in an ambivalent or invidious position where death certification is required, a situation that could be addressed in postgraduate training settings.

Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care.

BACKGROUND: Recruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs) is important in order to determine the effectiveness of interventions. However, failure to achieve recruitment targets is common and reasons why a particular recruitment strategy works for one study and not another remain unclear. We sought to describe a strategy used in a multicentre RCT in primary care, to report researchers' and participants' experiences of its implementation and to inform future strategies to maximise recruitment and retention. METHODS: In total 48 general practices and 903 patients were recruited from three different areas of Ireland to a RCT of an intervention designed to optimise secondary prevention of coronary heart disease. The recruitment process involved telephoning practices, posting information, visiting practices, identifying potential participants, posting invitations and obtaining consent. Retention involved patients attending reviews and responding to questionnaires and practices facilitating data collection. RESULTS: We achieved high retention rates for practices (100%) and for patients (85%) over an 18-month intervention period. Pilot work, knowledge of the setting, awareness of change in staff and organisation amongst participant sites, rapid responses to queries and acknowledgement of practitioners' contributions were identified as being important. Minor variations in protocol and research support helped to meet varied, complex and changing individual needs of practitioners and patients and encouraged retention in the trial. A collaborative relationship between researcher and practice staff which required time to develop was perceived as vital for both recruitment and retention. CONCLUSION: Recruiting and retaining the numbers of practices and patients estimated as required to provide findings with adequate power contributes to increased confidence in the validity and generalisability of RCT results. A continuous dynamic process of monitoring progress within trials and tailoring strategies to particular circumstances, whilst not compromising trial protocols, should allow maximal recruitment and retention. TRIAL REGISTRATION: ISRCTN24081411.

Monitoring treatment fidelity in a randomized controlled trial of a complex intervention.

AIM: This paper is a report of a study to describe how treatment fidelity is being enhanced and monitored, using a model from the National Institutes of Health Behavior Change Consortium. BACKGROUND: The objective of treatment fidelity is to minimize errors in interpreting research trial outcomes, and to ascribe those outcomes directly to the intervention at hand. Treatment fidelity procedures are included in trials of complex interventions to account for inferences made from study outcomes. Monitoring treatment fidelity can help improve study design, maximize reliability of results, increase statistical power, determine whether theory-based interventions are responsible for observed changes, and inform the research dissemination process. METHODS: Treatment fidelity recommendations from the Behavior Change Consortium were applied to the SPHERE study (Secondary Prevention of Heart DiseasE in GeneRal PracticE), a randomized controlled trial of a complex intervention. Procedures to enhance and monitor intervention implementation included standardizing training sessions, observing intervention consultations, structuring patient recall systems, and using written practice and patient care plans. The research nurse plays an important role in monitoring intervention implementation. FINDINGS: Several methods of applying treatment fidelity procedures to monitoring interventions are possible. The procedure used may be determined by availability of appropriate personnel, fiscal constraints, or time limits. Complex interventions are not straightforward and necessitate a monitoring process at trial stage. CONCLUSION: The Behavior Change Consortium's model of treatment fidelity is useful for structuring a system to monitor the implementation of a complex intervention, and helps to increase the reliability and validity of evaluation findings.

Development of a complex intervention for secondary prevention of coronary heart disease in primary care using the UK Medical Research Council framework.

OBJECTIVE: To apply the UK Medical Research Council (MRC) framework for development and evaluation of trials of complex interventions to a primary healthcare intervention to promote secondary prevention of coronary heart disease. STUDY DESIGN: Case report of intervention development. METHODS: First, literature relating to secondary prevention and lifestyle change was reviewed. Second, a preliminary intervention was modeled, based on literature findings and focus group interviews with patients (n = 23) and staff (n = 29) from 4 general practices. Participants' experiences of and attitudes toward key intervention components were explored. Third, the preliminary intervention was pilot-tested in 4 general practices. After delivery of the pilot intervention, practitioners evaluated the training sessions, and qualitative data relating to experiences of the intervention were collected using semistructured interviews with staff (n = 10) and patient focus groups (n = 17). RESULTS: Literature review identified 3 intervention components: a structured recall system, practitioner training, and patient information. Initial qualitative data identified variations in recall system design, training requirements (medication prescribing, facilitating behavior change), and information appropriate to the prospective study participants. Identifying detailed structures within intervention components clarified how the intervention could be tailored to individual practice, practitioner, and patient needs while preserving the theoretical functions of the components. Findings from the pilot phase informed further modeling of the intervention, reducing administrative time, increasing practical content of training, and omitting unhelpful patient information. CONCLUSION: Application of the MRC framework helped to determine the feasibility and development of a complex intervention for primary care research.

The SPHERE Study. Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411].

BACKGROUND: The aim of the SPHERE study is to design, implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease (CHD) in general practice across two different health systems on the island of Ireland. CHD is a common cause of death and a significant cause of morbidity in Ireland. Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives. Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the island of Ireland. The review literature recommends structured programmes with continued support and follow-up of patients; the provision of training, tailored to practice needs of access to evidence of effectiveness of secondary prevention; structured recall programmes that also take account of individual practice needs; and patient-centred consultations accompanied by attention to disease management guidelines. METHODS: SPHERE is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups, recruiting 960 patients from 48 practices in three study centres (Belfast, Dublin and Galway). Primary outcomes are blood pressure, total cholesterol, physical and mental health status (SF-12) and hospital re-admissions. The intervention takes place over two years and data is collected at baseline, one-year and two-year follow-up. Data is obtained from medical charts, consultations with practitioners, and patient postal questionnaires. The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice. It is a multi-faceted intervention that has been developed to respond to barriers and solutions to optimal secondary prevention identified in preliminary qualitative research with practitioners and patients. General practitioners and practice nurses attend training sessions in facilitating behaviour change and medication prescribing guidelines for secondary prevention of CHD. Patients are invited to attend regular four-monthly consultations over two years, during which targets and goals for secondary prevention are set and reviewed. The analysis will be strengthened by economic, policy and qualitative components.