Email UpdatesA provider who prescribes Step 4 treatment for an asthmatic patient (age 4+ years) on a non-preferred Step 3 therapy receives a recommendation to prescribe low-dose ICS-formoterol single maintenance and reliever therapy (SMART) as the preferred Step 3 treatment before advancing to Step 4 therapy. 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 consider consultation with an asthma care specialist. A pre-checked age-appropriate order for the preferred SMART treatment is proposed. 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
- Westat.
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 12+ years with persistent asthma.
An asthma patient who is uncontrolled on (nonpreferred Step 3 therapies of) medium-dose ICS, low-dose ICS-LABA, or low-dose ICS with LAMA/LABA/LTRA/theophylline/zileuton + prn SABA should be treated with (the preferred Step 3 treatment of) a low-dose ICS-formoterol SMART combo inhaler before advancing to Step 4 therapy.
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 or fewer 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 Recommendations #12 and #13 in the 2020 Focused Updates to the AsthmaManagement 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.)
High for ages 12+ y (Authors of the recommendation are very confident that the true effect lies close to that of the estimate of the effect.)
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.)
In individuals aged 12 y and older with moderate to severe persistent asthma, the Expert Panel conditionally recommends ICS-formoterol in a single inhaler used as both daily controller and reliever therapy compared to higher-dose ICS-LABA as daily controller therapy and SABA for quick-relief therapy.
Conditional (Different choices will be appropriate for individuals consistent with their values and preferences. Use shared decision making. Decision aids may be useful in helping individuals make decisions consistent with their risks, values, and preferences.)
High (Authors of the recommendation are very confident that the true effect lies close to that of the estimate of the effect.)
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.
4. Expert Panel members advise that, for an uncontrolled asthmatic on medium-dose ICS, the lower-dose SMART combo inhaler (low-dose ICS-formoterol) is preferred and should be recommended for use before advancing Step therapy.
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 years or older with a condition of asthma treated with a non-preferred Step 3 asthma therapy (not low-dose ICS-formoterol SMART), and is newly prescribed any treatment recommended in Steps 4-5 of the NHLBI Stepwise Approach For Asthma Management diagram.
Patient is on the preferred Step 3 therapy or any treatment recommended in Steps 4-5 of the Step Care diagram.
- Recommend single maintenance and reliever therapy (SMART) with a low-dose inhaled corticosteroid-formoterol preparation as the preferred Step 3 therapy for moderate persistent asthma before advancing to Step 4 care. Verify patient adherence to treatment and proper use of inhalers, including use of a spacer or chamber inhaler device. Consider consultation with an asthma care specialist;
- Offer an order for 120 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler with age-specific dosing as follows:
- if patient is age 4-11 years, take 1 inhalation by mouth BID and 1 inhalation by mouth prn asthma symptoms up to a max of 8 inhalations per day;
- if patient is age 12+ years, take 2 inhalations by mouth BID and 1 inhalation by mouth prn asthma symptoms up to a max of 12 inhalations per day;
- Offer an order for an age-appropriate spacer or holding chamber device for use with MDI/HFA inhalers as follows:
- if patient is age 4-11 years, offer a spacer or holding chamber device with mask;
- If patient is age 12+ years, offer a spacer or holding chamber device without mask; 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.