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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Noemí Casaponsa
- 전화번호: 43197 0034938960025
- 이메일: recerca@csapg.cat
연구 장소
-
-
Barcelona
-
Vilanova i la Geltrú, Barcelona, 스페인
- Hospital Sant Antoni Abat-Consorci Sanitari Alt Penedès Garraf (CSAPG)
-
연락하다:
- Noemí Casaponsa
- 전화번호: 43197 0034938960025
- 이메일: recerca@csapg.cat
-
수석 연구원:
- Anna Soler
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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). |
|
다른: 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). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of prescriptions of each inhaler type
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CSAPG-92
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
After publication of main results of the study.
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .