Use of Asthma APGAR Tools in Primary Care Practices: A Cluster-Randomized Controlled Trial.

PURPOSE: The purpose of this study was to assess patient and practice outcomes after introducing the Asthma APGAR (Activities, Persistent, triGGers, Asthma medications, Response to therapy) tools into primary care practices. METHODS: We used a pragmatic cluster-randomized controlled design in 18 US family medicine and pediatric practices to compare outcomes in patients with persistent asthma aged 5 to 45 years after introduction of the Asthma APGAR tools vs usual care. Patient outcomes included asthma control, quality of life, and emergency department (ED), urgent care, and inpatient hospital visits. The practice outcome was adherence to asthma guidelines. RESULTS: We enrolled 1,066 patients: 245 children, 174 adolescents, and 647 adults. Sixty-five percent (692 patients) completed both baseline and 12-month questionnaires, allowing analysis for patient-reported outcomes. Electronic health record data were available for 1,063 patients (99.7%) for practice outcomes. The proportion of patients reporting an asthma-related ED, urgent care, or hospital visit in the final 6 months of the study was lower in the APGAR practices vs usual care practices (10.6% vs 20.9%, P = .004). The percentage of patients with "in control" asthma increased more between baseline and 1 year in the APGAR group vs usual care group (13.5% vs 3.4%, P =.0001 vs P =.86) with a trend toward better control scores and asthma-related quality of life in the former at 1 year (P ≤.06 and P = .06, respectively). APGAR practices improved their adherence to 3 or more guideline elements compared with usual care practices (20.7% increase vs 1.9% decrease, P = .001). CONCLUSIONS: Introduction of the Asthma APGAR tools improves rates of asthma control; reduces asthma-related ED, urgent care, and hospital visits; and increases practices' adherence to asthma management guidelines.

Obesity, low levels of physical activity and smoking present opportunities for primary care asthma interventions: an analysis of baseline data from The Asthma Tools Study.

BACKGROUND: Asthma prevalence, severity and outcomes are associated with various patient characteristics and lifestyle choices. AIMS: To identify potentially modifiable factors associated with poor asthma outcomes among US primary care patients. METHODS: Using baseline data from the Asthma Tools Study, we calculated cross-sectional frequencies of activity levels, smoking, secondhand smoke exposure and the presence of obesity, as well as rates of out-of-control asthma and asthma exacerbations. Frequencies were stratified by sex, and into three age groups: 5-11 years, 12-18 years and 19 years and older. Logistic regression was used to identify factors associated with each of the asthma outcomes. RESULTS: In the 901 individuals enrolled in this asthma study, tobacco smoke exposure, obesity, low activity levels, poverty, inadequately controlled asthma and high asthma-related health-care utilisation were common. Across all age groups, obesity was associated with poorer asthma outcomes: either poor asthma control (odds ratio (OR)=2.3, 95% confidence interval (CI) 1.1-4.7 in 5- to 11-year-olds and OR=1.5, 95% CI 1.1-2.2 in adults) or asthma exacerbations (OR 2.9, 95% CI 1.6-5.1 in 12- to 18-year-olds and OR 1.7, 95% CI 1.1-2.5 in adults). Among adults, smoking was associated with both measures of poorer asthma outcomes; inadequate asthma control (OR=2.3, 95% CI 1.5-3.5), and asthma exacerbations (OR 1.7, 95% CI 1.1-2.6), and low physical activity were associated with poor asthma control (OR=1.5, 95% CI 1.1-2.2). CONCLUSIONS: Obesity, low levels of physical activity and smoking are common, and they are associated with poor asthma outcomes in a sample of primary care patients, suggesting important targets for intervention.

Practice-based research network studies and institutional review boards: two new issues.

BACKGROUND: Practice-based research network (PBRN) study investigators must interface with multiple Institutional Review Boards (IRBs), many of which are unfamiliar with PBRN research. OBJECTIVE: To present 2 IRB-related issues that have not appeared in the literature but occurred during the course of a large 5-year PBRN study involving 32 sites dispersed around the United States. RESULTS: Our study required IRB approval from a total of 19 local, hospital, academic center, and professional organization-based IRBs that reviewed a protocol of postpartum depression screening and follow-up completed in English or Spanish. Initial approval of the protocol and consent forms proceeded with only the usual barriers of submitting 19 different forms, and no protocol amendments were required. However, 2 unanticipated IRB issues provided significant additional work for the study team and the local practice sites. First, several IRBs required staff to repeat human subjects training every 1 to 2 years, resulting in 92 practicing physicians, residents, and members of the nursing staff spending time completing the exact same human subjects' training at least twice during the course of this study. Second, 17 of the 19 IRBs required that the patient be given consent forms that were newly stamped and dated each year, requiring the central site to reprint and replace consent forms yearly. Because not all IRBs returned the newly stamped and dated forms in a timely fashion, study enrollment with valid consent forms was interrupted in 4 sites for periods of 2 to 13 weeks. CONCLUSIONS: IRB requirements not directly responsive to federal regulations can add significant costs, frustrations, and burdens to PBRN studies. Non-federally mandated IRB requirements should be based on an identified need with evidence to support the solution.

Asthma treatment in a population-based cohort: putting step-up and step-down treatment changes in context.

OBJECTIVE: To assess the frequency and types of visits related to modifications in the intensity of asthma medications. PATIENTS AND METHODS: We retrospectively reviewed the medical records of adults (aged 18-40 years) and children (aged 6-17 years) living in Olmsted County, Minnesota, to evaluate changes in asthma medications by dose and drug class and site and type of visit (routine vs unscheduled) at the time of changes. All records from all visits were reviewed for each patient to identify asthma-related visits at all sites of care from January 1, 2002, through December 31, 2003. RESULTS: The study consisted of 397 adults and children. In 255 patients, 597 asthma medication changes occurred. Step-up changes usually occurred because of an exacerbation or loss of control of asthma and adhered to the medication hierarchy in the national asthma guidelines. Twenty step-up changes involved skipping inhaled corticosteroid (ICS) monotherapy and moving directly to combined ICSs plus a long-acting beta-agonist (LABA). Lack of documentation of asthma symptom frequency or interference with activities made it impossible to determine whether these 'skips' were appropriate. Only 78 physician-directed step-down changes were documented, usually to a lower dose of combined ICSs and LABAs or a move from combined ICSs and LABAs to anti-inflammatory monotherapy. Patients initiated additional step-down changes between encounters. Step-down changes occurred at routine or follow-up asthma visits, but the limited number of such visits provided few opportunities for step-down care. CONCLUSION: The continuing episodic-style treatment of asthma aimed at exacerbation management facilitates step-up changes in asthma therapy. The dearth of asthma evaluation visits limited opportunities to step down use of asthma medications and to provide long-term asthma management.