SMART Implementation-Effectiveness Trial 1 (SMART & SIMPLE)

Children's Hospital of Philadelphia (CHOP)

Status: Begins enrollment this month

Conditions: Asthma in Children

Treatments: Other: Control; Behavioral: Clinical decision support + education (CDS+)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07137923

23-021702 A

R01HL173600 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

While single maintenance and reliever therapy (SMART) has been the preferred management strategy for Step 3 and 4 (moderate/severe) asthma management since the 2020 NIH asthma guideline updates, adoption of SMART has not been rigorously assessed. This study will test electronic medical record clinical decision support and education implementation strategies (CDS+) to increase adoption of SMART in pediatric primary care. This is the first of two related records.

Full description

Asthma is a leading cause of childhood morbidity nationwide. Limited provider adoption of and patient adherence to the prevailing evidence-based recommendations for chronic management represent tractable areas for care improvement and implementation focus. In their 2020 Focused Updates, the NHLBI codified a new paradigm of asthma management - single maintenance and reliever therapy (SMART) - as the preferred management strategy for Steps 3 and 4 (moderate/severe) asthma management. In addition to its efficacy and safety, SMART has demonstrated real-world effectiveness in international settings, likely due in part to better adherence to daily therapy and less inhaler confusion. However, SMART has not been widely implemented in practice in the U.S. This hybrid type II implementation-effectiveness study will sequentially compare the effects of usual care to (1) electronic health record-based clinical decision support plus education (CDS+) (Study 1 - current study) and then (2) CDS+ with population health management (PHM) strategies (community health worker and nurse care manager) on SMART adoption (Study 2). Randomization for this study is at the clinic-level. Results will be reported at visit-, patient-, and clinic-levels.

Enrollment: 18 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Clinic Inclusion Criteria:

• The clinic is a pediatric primary care clinic that is part of the Children's Hospital of Philadelphia (CHOP) Pediatric Research Consortium (PeRC).
• The clinic agrees to participate in SMART & SIMPLE study.

Clinic Exclusion Criteria:

• The clinic is not willing to participate in SMART & SIMPLE study interventions.

Patient Inclusion Criteria:

• Ages 5-18 years;
• Has clinic visit at participating practice during study interval (sick, well, or follow-up)
• Prescribed at least one prescription for an inhaled corticosteroid (ICS) or ICS-long-acting beta agonist (ICS-LABA) for maintenance asthma therapy in the past year;
• Evidence of uncontrolled asthma as determined by: (1) uncontrolled Asthma Control Tool score in the past 6 months OR (2) two or more systemic corticosteroids prescribed for an asthma exacerbation in the past 12 months (one occurring in the past 6 months)

Patient Exclusion Criteria:

• Transferred clinics or left the CHOP Pediatric Care Network.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Intervention

Experimental group

Description:

Clinics in Arm 1 will receive the intervention in Interval 1. Interval 1 intervention: clinical decision support and education (CDS+).

Treatment:

Behavioral: Clinical decision support + education (CDS+)

Control

Active Comparator group

Description:

Clinics in Arm 2 will not be exposed to the interventions.

Treatment:

Other: Control