A provider who prescribes a Step 5 treatment for an asthmatic child age 4-11 years on non-preferred Step 4 therapy receives a recommendation to prescribe medium-dose ICS-formoterol single maintenance and reliever therapy (SMART) as the preferred Step 4 treatment before advancing to Step 5 care. In addition, the provider is advised to verify patient adherence to treatment and proper use of inhalers, advise use of a spacer or chamber inhaler device, and recommend referral to an asthma care specialist if the patient has not had one in the prior 6 months. A pre-checked age-appropriate order for the preferred SMART treatment is proposed, and a selectable order for referral to an asthma care specialist is provided. If the patient has no active persistent asthma condition on their problem list, then the provider is also offered a pre-checked action to add "Persistent asthma" to the patient's problem list.
Artifact Creation and Usage
This artifact was developed by Elimu Informatics, Inc. in collaboration with representatives from:
- the NHLBI’s National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC) expert panel working group,
- staff from the National Heart, Lung, and Blood Institute (NHLBI), and
Distribution and Use of Artifacts and Associated Documentation Unlimited
The ECA rule conforms to the FHIR R4 PlanDefinition resource and includes a reference to the FHIR Library resource which references the CQL library file. The CQL library file uses the FHIR R4 data model and uses US Core v3 profiles where applicable. Valuesets referenced in the CQL library file are published at the Value Set Authority Center. Rule logic has undergone unit testing; see Test Patients in Purpose and Usage.
Structured code that is interpretable by a computer (includes data elements, value sets, logic)
Provide CDS for select prioritized recommendations in the NHLBI NAEPP 2020 Focused Updates to the Asthma Management Guidelines. The ECA rule is one of 8 rules which provide CDS for Recommendations #10, #12, #13, and #16 of the 2020 Focused Updates, and for changes in the preferred treatment recommendation in Steps 2 – 5 of the Stepwise Approach For Management of Asthma in children (age 5 – 11 years) and adults (age 12+ years).
Individuals age 4-11 years with persistent asthma.
An asthmatic child who is uncontrolled on (non-preferred Step 4 therapy of) medium-dose ICS-LABA + prn SABA or medium-dose ICS + LAMA/LTRA/theo/zileuton + prn SABA should be treated with (preferred Step 4 therapy of) a medium-dose ICS-formoterol SMART combo inhaler before advancing to Step 5 care.
Rule logic has been unit-tested but the CDS rule has not been clinically piloted.
The approach assumes that inhaled corticosteroid (ICS) preparations may be partitioned into mutually exclusive valuesets of low dose, medium-dose, and high-dose ICS preparations for maintenance therapy of adult (age 12+ years) vs child (age 5-11 years) asthmatics. The utility of this assumption has not been clinically validated. Use of an ICS preparation for maintenance therapy in an atypical fashion (greater orfewer inhalations per day than is typical or expected) may not align with the partitioning of an ICS preparation into a dose-ranged (low/medium/high) valueset. The rationale for this approach comes from our observations of inconsistency and lack of usability of structured dosage information for inhaled medications in CDA and FHIR data across vendor systems and implementations.
The rule recommends a medication class and proposes an order for provider convenience, but the suggested medication is only a specific example of the recommended class. Any of the suggested orders can and should be reviewed and changed to align with local preferences.
Implements Recommendation #12 in the 2020 Focused Updates to the Asthma Management Guidelines
In individuals aged 4 y and older with moderate to severe persistent asthma, the Expert Panel recommends ICS-formoterol in a single inhaler used as both daily controller and reliever therapy compared to either:
- Higher-dose ICS as daily controller therapy and SABA for quick-relief therapy, or
- Same-dose ICS-LABA as daily controller therapy and SABA for quick-relief therapy.
Strong (Most individuals should receive the intervention. Formal decision aids are not likely to be needed to help individuals make decisions consistent with their values and preferences.)
Moderate for ages 4-11 y (Authors of the recommendation are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.)
1. Due to observed and acknowledged imprecision in the maintenance of EHR condition lists, Expert Panel members advised that a condition (problem or diagnosis) of "Asthma" (i.e., a condition in the "Asthma" valueset) should satisfy inclusion criteria rather than a condition of "Persistent asthma" (i.e., a condition in the "Persistent asthma" valueset).
2. Assessment of asthma control is important in using the Stepwise Approach For Management of Asthma Therapy. Clinical studies may use a validated instrument (e.g., ACT or ACQ) to assess asthma control, but the 2020 Focused Updates to the Asthma Management Guidelines make no recommendation about using such a tool in clinical practice. Rule logic does not depend upon any quantitative assessment of, or (coded) qualitative assertion of, asthma control.
3. Expert Panel members advised that, for an asthmatic on an ICS inhaler (preferred Step 2 therapy or higher), one may presume the use of a SABA inhaler; i.e., rule logic does not need to explicitly check for an active SABA inhaler medication.
A named-event of ‘medication-prescribe’; the exact medications prescribed are passed as a parameter and analyzed in logic to determine compliance with Preferred Therapy recommendations in the NHLBI Stepwise Approach For Asthma Management diagram.
Patient is age 4-11 years with a condition of asthma treated with a non-preferred Step 4 asthma therapy (not medium-dose ICS-formoterol SMART), and is newly prescribed any treatment recommended in Step 5 of the NHLBI Stepwise Approach For Asthma Management diagram.
Patient is on the preferred Step 4 therapy or any treatment recommended in Steps 5 of the Step Care diagram.
- Recommend single maintenance and reliever therapy (SMART) with a medium-dose inhaled corticosteroid-formoterol preparation as the preferred Step 4 therapy for moderate persistent asthma before advancing to Step 5 care. Verify patient adherence to treatment and proper use of inhalers, including use of a spacer or chamber inhaler device. Recommend consultation with an asthma care specialist if the patient has had none in the prior 6 months;
- Offer an order for 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler with instructions to take 1 inhalation by mouth BID and 1 inhalation by mouth prn asthma symptoms up to a max of 8 inhalations per day;
- Offer an order for a spacer or holding chamber device with mask for use with MDI/HFA inhalers;
- If patient had no encounter with an asthma care specialist within the prior 6 months and none is scheduled for the following 3 months, then offer an order for consultation with an asthma care specialist as mutually-exclusive non-prechecked orders for referral to a pediatric pulmonologist or to a clinical allergist; and
- If the patient does not have a condition of “Persistent asthma” on their problem list, then offer to add “Persistent asthma” to the problem list.