Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
NCT Number: NCT07138027
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 population health management (PHM; asthma community health worker, asthma nurse care manager) implementation strategies building on electronic medical record clinical decision support and education implementation strategies (CDS+), to increase adoption of SMART. This is the second of two related records.
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Request Info5 year–18 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
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) and then (2) CDS+ with population health management (PHM) strategies (community health worker and nurse care manager) on SMART adoption (Study 2 - current study). Randomization for this study is at the clinic-level. Results will be reported at visit-, patient-, and clinic-levels.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Clinic Inclusion Criteria:
Clinic Exclusion Criteria:
Patient Inclusion Criteria:
Patient Exclusion Criteria:
In Interval 1, intervention clinic providers will experience nudges in the electronic medical record to encourage prescribing SMART where clinically-appropriate and intervention clinic providers, families/patients, and nurses will receive education (collectively CDS+). In Interval 2, intervention clinics will have CDS+ and population health management (PHM) strategies, including an asthma community health worker and an asthma nurse care manager.
Other names: CDS+ and PHM
Clinics in Arm 2 will not be exposed to the interventions.
Time frame: Assessment of rates from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).
The difference in the rate of SMART prescribing (initiation) among eligible primary care visits (i.e., when a child is eligible to start SMART) where SMART is first prescribed (initiated) comparing the second intervention period (Interval 2) and the first intervention period (Interval 1). Adoption is visit-level. The denominator represents eligible primary care visits, and the numerator represents visits where SMART is first prescribed (initiated).
Time frame: Assessment of proportions from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).
The difference in the proportion of patients who are prescribed (initiated) SMART who continue on SMART for at least 6 months comparing the second intervention period (Interval 2) and the first intervention period (Interval 1). Sustainment is patient-level. The denominator represents patients who are prescribed (initiated) SMART, and the numerator represents patients who continue on SMART for at least 6 months.
Time frame: Assessment of proportions from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).
The difference in the clinic-level proportion of SMART-eligible patients who are prescribed (initiated) and not subsequently discontinued from SMART by the end of the interval comparing the second intervention period (Interval 2) and the first intervention period (Interval 1). Penetration is clinic-level. The denominator represents patients who are SMART-eligible in each interval, and the numerator represents patients who are prescribed (initiated) during the interval and still on SMART at the end of the interval.
Contact information is provided by the study sponsor or research team.
Children's Hospital of Philadelphia
Other
Single Maintenance And Reliever Therapy Strategies for IMPLementation and Effectiveness (SMART & SIMPLE) Trial
Acronym: SMART SIMPLE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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