Sustainable Inhaler Prescribing in Intermediate Care Units (INHAVERD)
Potential of Intermediate Care Units to Reduce Environmental Impact Through Sustainable Inhaler Prescribing: a Quasi-experimental Study of a Multidisciplinary Clinical Intervention
The goal of this clinical trial is to learn if a multidisciplinary review of inhaler treatment can increase the use of inhalers with a lower environmental impact in adults admitted to intermediate care units who use inhalers. The main questions it aims to answer are:
- Does the intervention change the percentage of each type of inhaler prescribed (pressurized metered-dose inhalers, dry powder inhalers, and soft mist inhalers) between admission and discharge?
- Does the intervention improve treatment adherence and inhaler technique, reduce the use of rescue inhalers, and reduce carbon dioxide (CO2) emissions? Researchers will compare patients cared for by physicians who apply the intervention with patients cared for by physicians who do not yet apply it, to see if more patients switch to inhalers with a lower environmental impact.
Participants will:
- Have their inhaler prescription reviewed by a physician, who may change it when clinically appropriate, taking environmental impact into account
- Have their adherence and inhaler technique assessed by a healthcare professional
- Receive individual education on how to use their inhalers, if needed
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
The health sector generates about 5% of global greenhouse gas emissions, and pressurized metered-dose inhalers (pMDIs), which contain propellants with a high global warming potential, are a relevant part of this footprint. Dry powder inhalers (DPIs) and soft mist inhalers (SMIs) are more sustainable alternatives. In 2025, the Spanish Ministry of Health issued recommendations on sustainable inhaler prescribing that include reviewing the indication, optimizing inhaler technique and adherence, and switching to lower-impact devices when appropriate.
This quasi-experimental study with two arms and stepped implementation over three periods will be conducted in the intermediate care units of Hospital Sant Antoni Abat. Allocation is determined by the treating geriatrician: patients of two of the four geriatricians form group 1 and those of the other two form group 2. In period 1 (3 months, retrospective data), neither group receives the intervention; in period 2 (about 6 months), only group 2 receives it; in period 3 (about 3 months), both groups receive it.
The intervention, delivered within one week of inclusion, consists of: (1) a physician review of the inhaled therapy prescription in the electronic prescription system, with changes if needed, also considering environmental criteria; (2) assessment of adherence with the Test of Adherence to Inhalers (TAI), classifying adherence (good, intermediate, poor) and type of non-adherence (erratic, deliberate, unwitting); (3) assessment of inhaler technique with device-specific checklists (GINA, UK Inhaler Group); and (4) individualized education and, if the device is not suitable or rescue inhaler use is excessive, a switch to a lower-impact inhaler.
The primary analysis will compare, in period 2, the percentage of prescriptions of each inhaler type at admission and at discharge. Assuming a switch from pMDI to DPI in 5% of the control group and 20% of the intervention group, 50 patients per group are needed for period 2 (two-sided alpha 0.05, power above 80%), with an expected 10% loss to follow-up. CO2 emissions will be estimated from the Spanish database on the environmental impact of inhalers. Analysts will be blinded to the study period.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Noemí Casaponsa
- Puhelinnumero: 43197 0034938960025
- Sähköposti: recerca@csapg.cat
Opiskelupaikat
-
-
Barcelona
-
Vilanova i la Geltrú, Barcelona, Espanja
- Hospital Sant Antoni Abat-Consorci Sanitari Alt Penedès Garraf (CSAPG)
-
Ottaa yhteyttä:
- Noemí Casaponsa
- Puhelinnumero: 43197 0034938960025
- Sähköposti: recerca@csapg.cat
-
Päätutkija:
- Anna Soler
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Aged 18 years or older
- Admitted to an intermediate care unit with a minimum stay of one week
- Active prescription of a pressurized metered-dose inhaler in the electronic prescription system
Exclusion Criteria:
- End-of-life situation (last days or hours of life)
- Admission to the psychogeriatric unit
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Ei satunnaistettu
- Inventiomalli: Peräkkäinen tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Muut: delayed intervention
Patients of two geriatricians; usual care in periods 1 and 2, multidisciplinary inhaler intervention in period 3 |
Within one week of admision, a physician reviews the inhaled therapy prescription (indication, duration) and changes it if needed, also considering environmental impact. A healthcare professional assesses adherence with the Test of Adherence to Inhalers (TAI) and inhaler technique with device-specific checklists (GINA, UK Inhaler Group), and provides individualized education. If the device is not suitable or rescue inhaler use is excessive, the physician considers switching to a lower-impact inhaler (dry powder or soft mist inhaler). |
|
Muut: early intervention
Patients of the other two geriatricians; usual care in period 1, multidisciplinary inhaler intervention in periods 2 and 3 |
Within one week of admision, a physician reviews the inhaled therapy prescription (indication, duration) and changes it if needed, also considering environmental impact. A healthcare professional assesses adherence with the Test of Adherence to Inhalers (TAI) and inhaler technique with device-specific checklists (GINA, UK Inhaler Group), and provides individualized education. If the device is not suitable or rescue inhaler use is excessive, the physician considers switching to a lower-impact inhaler (dry powder or soft mist inhaler). |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Percentage of prescriptions of each inhaler type
Aikaikkuna: At admission and at discharge from the intermediate care unit, maximal up to 1 year from admission
|
Percentage of prescriptions of pressurized metered-dose inhalers (pMDI), dry powder inhalers (DPI), and soft mist inhalers (SMI) in the electronic prescription system, compared between admission and discharge in the intervention and control groups during period 2. |
At admission and at discharge from the intermediate care unit, maximal up to 1 year from admission
|
Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
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
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Patologiset prosessit
- Krooninen sairaus
- Sairauden ominaisuudet
- Immuunijärjestelmän sairaudet
- Hengityselinten sairaudet
- Keuhkoputken sairaudet
- Keuhkosairaudet, obstruktiiviset
- Hengitysteiden yliherkkyys
- Yliherkkyys, välitön
- Yliherkkyys
- Patologiset tilat, merkit ja oireet
- Käyttäytyminen
- Hoidon noudattaminen ja noudattaminen
- Terveyskäyttäytyminen
- Potilaan noudattaminen
- Potilaiden terveydenhuollon hyväksyminen
- Keuhkosairaudet
- Keuhkosairaus, krooninen obstruktiivinen
- Astma
- Sairaus
- Lääkkeen noudattaminen
Muut tutkimustunnusnumerot
- CSAPG-92
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
IPD-jaon aikakehys
After publication of main results of the study.
IPD-jaon käyttöoikeuskriteerit
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
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 .