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Sustainable Inhaler Prescribing in Intermediate Care Units (INHAVERD)

11 de noviembre de 2026 actualizado por: Consorci Sanitari de l'Alt Penedès i Garraf

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

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

110

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Noemí Casaponsa
  • Número de teléfono: 43197 0034938960025
  • Correo electrónico: recerca@csapg.cat

Ubicaciones de estudio

    • Barcelona
      • Vilanova i la Geltrú, Barcelona, España
        • Hospital Sant Antoni Abat-Consorci Sanitari Alt Penedès Garraf (CSAPG)
        • Contacto:
          • Noemí Casaponsa
          • Número de teléfono: 43197 0034938960025
          • Correo electrónico: recerca@csapg.cat
        • Investigador principal:
          • Anna Soler

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: 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).

Otro: 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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of prescriptions of each inhaler type
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de enero de 2027

Finalización primaria (Estimado)

1 de diciembre de 2028

Finalización del estudio (Estimado)

1 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

6 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de noviembre de 2026

Publicado por primera vez (Actual)

12 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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).

Marco de tiempo para compartir IPD

After publication of main results of the study.

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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