Research with human participants

Overview of medical research in the Netherlands

The Dutch national inhaler care pathway for patients with asthma/COPD: a hybrid type III implementation study

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Last updated:

The aim of this study is to identify barriers and facilitators for successful implementation of the care pathway, to ultimately inform national scale-up of the pathway.

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Ethical review
Positive opinion
Status
Recruitment stopped
Health condition type
Respiratory disorders NEC
Study type
Observational non invasive

ID

NL-OMON26085

Source

NTR

Brief title

LAN inhaler pathway

Condition

  • Respiratory disorders NEC

Synonym

Chronic Obstructive Pulmonary Disease, Asthma

Health condition

asthma, COPD

Research involving

Human

Sponsors and support

Primary sponsor :
Lung Alliance Netherlands (LAN) and University Medical Center Groningen
Source(s) of monetary or material Support :
Multiple industry sources

Intervention

  • Other intervention
Explanation

Outcome measures

Primary outcome

Barriers and facilitators for optimal implementation of the national inhaler care pathway

Secondary outcome

Clinical outcomes: relievers/controller ratio, medication adherence, uniformity in inhaler devices, exacerbations. Qualitative outcomes: Implementation of inhaler care pathway elements, agreements between healthcare providers made, time investment, patient satisfaction, healthcare provider satisfaction

Background summary

Strategies to enhance inhaler technique and medication adherence to inhaled respiratory medication have been proven effective and cost-effective. In 2019, the Lung Alliance Netherlands (LAN) designed a national multidisciplinary care pathway for patients using inhaled medication by integrating these strategies. Yet, optimal implementation remains to be uncovered. 

Study objective

The aim of this study is to identify barriers and facilitators for successful implementation of the care pathway, to ultimately inform national scale-up of the pathway.

Study design

This is a hybrid type III implementation study

Intervention

Inhaler care pathway implementation

Public
University Medical Center Groningen
Job Van Boven

+31503617893
j.f.m.van.boven@umcg.nl
Scientific
University Medical Center Groningen
Job Van Boven

+31503617893
j.f.m.van.boven@umcg.nl

Age

Adults (18-64 years)
Adults (18-64 years)
Elderly (65 years and older)
Elderly (65 years and older)

Inclusion criteria

(i) patients >=18 years having asthma and/or COPD (ii) using inhaled medication for at least three months; (iii) understanding the Dutch language

Exclusion criteria

<18 years; not understanding Dutch

Design

Study phase :
N/A
Study type :
Observational non invasive
Intervention model
:
Single
Allocation :
Non-randomized controlled trial
Masking :
Open (masking not used)
Control :
N/A , unknown
Primary purpose :
Health services research

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
500
Type :
Actual

IPD sharing statement

Plan to share IPD :
No

Positive opinion
Date :
Application type :
First submission
Review commission :
nWMO adviescommissie UMC Groningen

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL9560
Other METC UMCG : METc 2020/593

Results posted :
Actual enrolment :
602

Summary results

At least 104 general practitioners, 33 pulmonologists and 33 pharmacies were involved within the four pilot regions. A total of 602 patient questionnaires were completed, of which 159 were new patients and 432 patients with follow-up inhalation medication. After three rounds, there seemed to be tentative regional changes and improvements. Facilitators for good implementation were the set-up of the multidisciplinary training courses, and the interim measurements and associated feedback. The barriers of the implementation were: making and maintaining good cooperation agreements, and embedding the care pathway in the daily routine care. The care pathway has not yet been fully implemented within the pilot regions, but it has been well received so far: The regions have received training, multidisciplinary working groups have been set up, work agreements have been made, and local (and regional) changes have been made. Embedding the care pathway is the biggest bottleneck in the regions.

Baseline characteristics

N=602 patients included. 40.3% male; mean age (SD) 59.7 years ± 17.2; Diagnosis: asthma: 43.6%; COPD: 31.7%; ACO: 15.5%;

Participant flow

Not applicable (single visit)

Adverse events

Not applicable

Outcome measures

Facilitators for good implementation were the set-up of the multidisciplinary training courses, and the interim measurements and associated feedback. The barriers of the implementation were: making and maintaining good cooperation agreements, and embeddin

First publication