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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Noemí Casaponsa
- Telefonnummer: 43197 0034938960025
- E-post: recerca@csapg.cat
Studiesteder
-
-
Barcelona
-
Vilanova i la Geltrú, Barcelona, Spania
- Hospital Sant Antoni Abat-Consorci Sanitari Alt Penedès Garraf (CSAPG)
-
Ta kontakt med:
- Noemí Casaponsa
- Telefonnummer: 43197 0034938960025
- E-post: recerca@csapg.cat
-
Hovedetterforsker:
- Anna Soler
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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). |
|
Annen: 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). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of prescriptions of each inhaler type
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Kronisk sykdom
- Sykdomsattributter
- Sykdommer i immunsystemet
- Sykdommer i luftveiene
- Bronkiale sykdommer
- Lungesykdommer, obstruktiv
- Respiratorisk overfølsomhet
- Overfølsomhet, Umiddelbar
- Overfølsomhet
- Patologiske tilstander, tegn og symptomer
- Oppførsel
- Behandlingsoverholdelse og etterlevelse
- Helseatferd
- Pasientens etterlevelse
- Pasientens aksept av helsehjelp
- Lungesykdommer
- Lungesykdom, kronisk obstruktiv
- Astma
- Sykdom
- Medisinoverholdelse
Andre studie-ID-numre
- CSAPG-92
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
After publication of main results of the study.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
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