Älykäs toteutuksen tehokkuuskoe 1 (SMART & SIMPLE)
Yhden ylläpito- ja lievittäjäsiterapiastrategiat toteuttamiseen ja tehokkuuteen (älykäs ja yksinkertainen) kokeilu
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Chén Kenyon, MD, MSHP
- Puhelinnumero: 267-426-6339
- Sähköposti: kenyonc@chop.edu
Opiskelupaikat
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Yhdysvallat, 19104
- Rekrytointi
- Children's Hospital of Philadelphia
-
Ottaa yhteyttä:
- Chén Kenyon, MD, MSHP
- Puhelinnumero: 267-426-6339
- Sähköposti: kenyonc@chop.edu
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
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)
Clinic Exclusion Criteria:
- The clinic is not willing to participate in SMART & SIMPLE study interventions.
Patient Exclusion Criteria:
- Transferred clinics or left the CHOP Pediatric Care Network.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Intervention
Clinics in Arm 1 will receive the intervention in Interval 1. Interval 1 intervention: clinical decision support and education (CDS+). |
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+).
Muut nimet:
|
|
Active Comparator: Control
Clinics in Arm 2 will not be exposed to the interventions. |
Clinics in Arm 2 will not be exposed to the interventions. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in the Rate of Visit-Level SMART Adoption
Aikaikkuna: Assessment of rates from two study intervals: Interval 0 (baseline; 11 months), Interval 1 (CDS+; 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 first intervention period (Interval 1) and the baseline period (Interval 0). Adoption is visit-level. The denominator represents eligible primary care visits, and the numerator represents visits where SMART is first prescribed (initiated). |
Assessment of rates from two study intervals: Interval 0 (baseline; 11 months), Interval 1 (CDS+; 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).
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in the Proportion of Patient-Level SMART Sustainment
Aikaikkuna: Assessment of proportions from two study intervals: Interval 0 (baseline; 11 months), Interval 1 (CDS+; 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 first intervention period (Interval 1) and baseline period (Interval 0). 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. |
Assessment of proportions from two study intervals: Interval 0 (baseline; 11 months), Interval 1 (CDS+; 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).
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in the Proportion of Clinic-Level SMART Penetration
Aikaikkuna: Assessment of proportions from two study intervals: Interval 0 (baseline; 11 months), Interval 1 (CDS+; 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 first intervention period (Interval 1) and the baseline period (Interval 0). 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. |
Assessment of proportions from two study intervals: Interval 0 (baseline; 11 months), Interval 1 (CDS+; 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).
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 23-021702 A
- R01HL173600 (Yhdysvaltain NIH-apuraha/sopimus)
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .