Pediatric Asthma Clinical Pathway: A Cluster Randomized Controlled Trial
Background: Primary care physicians,who manage the care of most children with asthma,frequently enough do not optimally assess disease control,prescribe asthma controller medications,or provide family asthma education. We developed a pediatric asthma clinical pathway embedded in an electronic medical record (EMR) for use by primary care practices, and we sought to evaluate its effects on prescription and use of asthma controller medication for children with asthma.
Methods: We conducted a cluster randomized controlled trial, enrolling primary care practices in Alberta that used Wolf or Med Access EMRs, and managed at least 50 children with asthma. The multifaceted intervention included an EMR-based pathway for pediatric asthma, Web-based education modules for physicians, and train-the-trainer sessions for practice staff to provide patient education. The control intervention was standard care. We extracted study data from participating practices’ EMRs, and standard emergency department and hospital administrative data sets. The primary and main secondary outcomes were improvement in the proportion of children prescribed and dispensed controller medications, respectively.
Results: Eleven practices were randomly assigned to each of the intervention and control groups. The intervention did not substantially change the proportion of children prescribed (mean difference 4.3%, 95% confidence interval [CI] −2.0% to 10.5%) or dispensed (mean difference −0.1%, 95% CI −7.1% to 6.9%) controller medications.
Interpretation: Our multifaceted intervention did not improve the proportion of children in primary care who were prescribed or dispensed a controller medication for asthma. These results suggest that such interventions may require active alerts and targeting of walk-in and urgent care clinics to have a meaningful impact on clinical practice.
As manny as 1 in 7 children in Canada has asthma1–3 These children often experience poor disease control,with emergency department visits,hospital admissions,missed school days,and low quality-of-life ratings3–11 Evidenced-based guidelines highlight that appropriate prescription of controller medications,guided by standardized assessments,and asthma education to increase child and parental understanding and compliance,can achieve better disease control and reduce emergency department visits and hospital admissions12–17 However,evidence suggests that primary care physicians,who manage the care of most children with asthma,often do not optimally assess disease control16,18,19 prescribe controller medications12,13 or provide family asthma education.
## Methods
### Study Design and Setting
this was a cluster randomized controlled trial conducted in 22 primary care practices across Alberta, Canada, between February 2018 and December 2020. Participating practices were recruited through the Alberta Primary Care Network and represented a range of practice sizes and geographic locations. The unit of randomization was the primary care practice.### Intervention
The multifaceted intervention aimed to improve the quality of asthma care for children aged 2-18 years in primary care settings. The core component was a clinical pathway for the assessment and management of pediatric asthma, which was built into 2 commonly used EMRs.28 The pathway was designed to assess asthma control, to provide therapeutic recommendations, and provide patient resources (written asthma action plans and prescriptions). The pathway algorithms and example screenshots from the EMR are shown in Appendix 1.
The other parts of the multifaceted intervention included a Web-based professional teaching module and train-the-trainer sessions for practice staff to provide patient education (Appendix 1). The Web-based teaching modules were designed to ensure primary care practitioners understood the underlying rationale and evidence behind the growth of the pathway).29,30 The Web-based learning modules were designed to be asynchronous, allowing both physicians and allied health team members to complete the modules at their own pace. The modules focused on evidence-based management of pediatric asthma in primary care and incorporating the pathway into their practice. Train-the-trainer sessions were used to educate allied health team members to enable them to provide asthma education to parents and children with asthma.31,32
The control was standard care. although this was highly variable, none of the participating practices routinely included formal assessments of asthma control; standardized algorithms for diagnosing asthma, managing exacerbations, or follow-up visits; medication dosing guidelines; or in-practice asthma education.
A Theoretical Domains Framework study was conducted to facilitate a theory-based approach to design our implementation strategy.33 The strategies we used to ensure primary care physicians provided optimal evidenced-based care included incorporation of the pathway into the EMR to facilitate its use and the development of Web-based professional education learning modules for physicians and other staff to improve their confidence in managing asthma in children. The Theoretical Domains Framework study also identified ways to optimize the above implementation strategies.33
### Randomization and blinding
The consented 22 primary care practices were stratified according to academic status (academic v. nonacademic) and geographic location (urban v. rural) before randomization. We used postal codes to determine rurality, and university affiliation of physicians to determine academic status.after stratification into 4 blocks, the Microsoft Excel RAND function (2016) was used to randomly allocate practices to control or intervention groups within each block. The treatment allocation for each practice was generated and kept by an individual who was not a member of the study team. When the study team was ready to commence implementation at a given practice, they were informed of the practice allocation. Primary care practice physicians and staff were aware of their allocation status.Retrospective data extraction, data linkage, and statistical analyses were carried out by personnel who were blind to study objectives and practice allocation. Specifically,a trained abstractor was granted access to each practice EMR and extracted the data elements outlined below for children who met our definition of asthma outlined above. These data were securely transferred to the Health Quality Council of Alberta (HQCA), and an HQCA analyst (J.P.) extracted and linked Alberta health administrative data from their data repository to the study EMR practice data. The linked master data set was deidentified and provided to a biostatistician (Q.M.D.) for analysis. Patient identifiers were not available to any other study team members.
### Data sources and linkage
As noted above, study data came from participating practices’ EMRs and health administrative data sets. Practice
Study Participant & Practice Characteristics
Eleven family practices,each with 44 physicians (59.5% female, median 18 years in practice), were randomly assigned to either an intervention or control group. The control group comprised 11 practices and 32 physicians (60.6% female, median 14.5 years in practice). All practices operated on a fee-for-service model, with most clusters containing a single physician, though some had multiple. (Figure 1)
Two practices and four physicians withdrew from the study,but no parents withdrew their child’s data. The intervention group collected data from 706 children pre-intervention and 737 post-intervention, while the control group had data from 805 and 851 children respectively (Figure 1). A total of 1511 children contributed data to both periods, representing 95% of all children evaluated (1511/1588), with 31 and 46 new children added during the post-intervention period in the intervention and control groups, respectively.
Children in the control group were more likely to be younger then 7 years and receive care in academic urban or nonacademic rural practices (Table 1). Pre-intervention, 42 children in the intervention group and 39 in the control group received care from a pediatrician, respirologist, or allergist; post-intervention, these numbers decreased to 14 and 13 respectively.
Asthma controller medications were prescribed to 202 (28.6%) children in the intervention group pre-intervention and 212 (28.8%) post-intervention. in the control group, prescriptions were given to 212 (26.3%) pre-intervention and 189 (22.2%) post-intervention. There was no meaningful difference in the change in controller medication prescriptions between the groups (mean difference 4.3%,95% CI −2.0% to 10.5%) (Table 2). This difference was smaller than the minimally clinically significant difference (MCID) of 15% identified in a physician survey. A subgroup analysis focusing on children prescribed reliever medications yielded similar results (mean difference −5.6%, 95% CI −18.0% to 6.9%). The intraclass correlation coefficient (ICC) was calculated at 0.04, exceeding the value used for sample size calculation.
## Discussion
Our findings do not support the hypothesis that an EMR-based clinical pathway would increase controller medication prescriptions for children with asthma. This contrasts with findings from other studies evaluating clinical decision-support systems,36 and asthma action plan delivery,35,36 as well as those of a systematic review of clinical decision-support systems, which showed that most studies achieved small-to-moderate improvements in care processes. 28 Two of the studies referenced above35,37 show potential factors that may have resulted in such differences. Both of these studies included the use of active alerts (e.g., “the patient’s asthma appears to be OUT OF CONTROL”)32 or reminders to providers to enhance the uptake of decision-support tools.Additionally, Tamblyn and colleagues37 used “smart-analytics,” whereby real-time point-of-care clinical data were used to monitor disease status. It is possible the absence of active alerts and reminders in our intervention may explain, at least in part, our negative results. In fact, in our qualitative evaluation,38 the absence of active alerts and reminders was reported as a barrier to pathway uptake.
Our negative findings may also be explained by some additional factors. First, the uptake of the EMR-based pathway varied across intervention sites, with clinicians citing challenges with implementation, including a small pediatric asthma population in their practices, limited integration into practice flow, and, as a consequence, difficulty in remembering to use the pathway because its use was required so infrequently.38 Second, just over 50% of children were prescribed their controller medication from nonstudy physicians, likely indicating they accessed walk-in clinics or urgent care services. The high proportion of families seeking care outside of their primary care practice suggests that interventions targeting these providers alone may be limited in their ability to increase controller prescriptions. Walk-in clinics and urgent care services may represent important locations for interventions to be implemented. In contrast to our overall finding of no effect from our intervention, the 10% increase (albeit less than the MCID of 15%) in dispensed controller medication prescribed by a study primary care physician from the preintervention to the postintervention period in the intervention arm, with no effect in the control arm, is notable. it is possible that the increase in dispensed controller medications prescribed by study physicians within the intervention practices is a result of family asthma education causing more families to fill their prescriptions.
### limitations
Abstracting data from clinics’ EMRs meant we relied on clinic documentation practices, which may vary significantly between practices and physicians.Such as, the limitations of the data available through the EMRs did not allow us to reliably classify individual children into asthma subtypes, and thus we could not make graded judgments about whether a given child needed to be treated with a controller medication.
Most practices had more than 1 physician per practice. our analysis was unable to account for the nesting of multiple physicians within clusters.
Our criteria for a minimum of 50 children with asthma may have included a recruitment bias toward physicians with a greater interest in managing childhood asthma, and thus our findings may not be representative of all practices.