Implementation strategies of internet-based asthma self-management support in usual care. Study protocol for the IMPASSE cluster randomized trial
Implementation strategies of internet-based asthma self-management support in usual care. Study protocol for the IMPASSE cluster randomized trial
Johanna L van Gaalen 0
Moira J Bakker 0
Leti van Bodegom-Vos 0
Jiska B Snoeck-Stroband 0
Willem JJ Assendelft 2
Ad A Kaptein 1
Victor van der Meer 0
Christian Taube 4
Bart P Thoonen 3
Jacob K Sont 0
for the IMPASSE study group
0 Department of Medical Decision Making, Leiden University Medical Centre , P.O. Box 9600, 2300, RC, Leiden , the Netherlands
1 Department of Medical psychology, Leiden University Medical Centre , P.O. Box, 9600, 2300, RC, Leiden , the Netherlands
2 Department of Public health and Primary care, Leiden University Medical Centre , P.O. Box, 9600, 2300, RC, Leiden , the Netherlands
3 Department of General Practice, Radboud University Nijmegen Medical Centre , P.O. Box 9101, 6500, HB, Nijmegen , the Netherlands
4 Department of Pulmonology, Leiden University Medical Centre , P.O. Box, 9600, 2300, RC, Leiden , the Netherlands
Background: Internet-based self-management (IBSM) support cost-effectively improves asthma control, asthma related quality of life, number of symptom-free days, and lung function in patients with mild to moderate persistent asthma. The current challenge is to implement IBSM in clinical practice. Methods/design: This study is a three-arm cluster randomized trial with a cluster pre-randomisation design and 12 months follow-up per practice comparing the following three IBSM implementation strategies: minimum strategy (MS): dissemination of the IBSM program; intermediate strategy (IS): MS + start-up support for professionals (i.e., support in selection of the appropriate population and training of professionals); and extended strategy (ES): IS + additional training and ongoing support for professionals. Because the implementation strategies (interventions) are primarily targeted at general practices, randomisation will occur at practice level. In this study, we aim to evaluate 14 primary care practices per strategy in the Leiden-The Hague region, involving 140 patients per arm. Patients aged 18 to 50 years, with a physician diagnosis of asthma, prescription of inhaled corticosteroids, and/or montelukast for 3 months in the previous year are eligible to participate. Primary outcome measures are the proportion of referred patients that participate in IBSM, and the proportion of patients that have clinically relevant improvement in the asthma-related quality of life. The secondary effect measures are clinical outcomes (asthma control, lung function, usage of airway treatment, and presence of exacerbations); self-management related outcomes (health education impact, medication adherence, and illness perceptions); and patient utilities. Process measures are the proportion of practices that participate in IBSM and adherence of professionals to implementation strategies. Cost-effective measurements are medical costs and healthcare consumption. Follow-up is six months per patient. Discussion: This study provides insight in the amount of support that is required by general practices for cost-effective implementation of IBSM. Additionally, design and results can be beneficial for implementation of other self-management initiatives in clinical practice. Trial registration: the Netherlands National Trial Register NTR2970
Asthma; Self-management; Telemanagement; E-health; Self-management; Implementation; Chronic care
Asthma is a common chronic inflammatory disease of
the airways, typically characterized by symptoms such as
wheeze, shortness of breath, and coughing . Despite
the wide availability of effective therapy, long-term
management of asthma falls for short of the goals set in
guidelines , and many patients do experience a
profound burden of disease .
Self-management is an essential component in the
proactive management of asthma [1,4] because it helps
patients to reach their treatment goals and enables
patients to manage symptoms, treatment, physical and
psychosocial consequences, and lifestyle changes
inherent in living with a chronic condition . However, the
uptake of self-management in clinical practice may be
hampered because easy-use tools that enhance sustained
uptake of action plan usage by patients are lacking in
todays practice , and patients can experience a lack of
ownership of these action plans . Not surprisingly, a
minority of general practices provide patients with
written action plans [8,9].
Internet technology is increasingly being seen as an
appealing tool for self-management for patients with
chronic disease [10-12]. Telehealth care in asthma is
defined as healthcare being delivered from a distance,
facilitated electronically, and involving the exchange of
information through the personalized interaction
between a healthcare professional using their skills,
judgment, and the patient providing information .
Telehealth care may overcome barriers towards optimal
care in patients with mild to moderate asthma .
More specifically, internet technology can be employed
for ongoing individualized management of the patient
Internet-based self-management (IBSM) support in
asthma consists of the following components:
internetbased asthma monitoring, internet-based goal setting,
decision support with a treatment plan, online medical
review, tailored online information, and
communication with a healthcare provider. Recently, we have
shown that such IBSM can improve asthma-related
quality of life, asthma control, the number of
symptom-free days, and lung function in patients with
mild to moderate persistent asthma, as compared to
usual care . In a cost-utility analysis , it was
demonstrated that IBSM support can be as effective as
current asthma care with regard to quality of life in
terms of patient utilities, and costs are similar over a
Therefore, the current challenge is to implement IBSM
support in routine asthma management within primary
care. Patients that are most likely to be willing to
participate and benefit from (internet-based) self-management
are those with partially controlled or uncontrolled
asthma [18-20]. These patients constitute about
twothirds of the asthma population in primary care .
A structured implementation strategy is needed to
incorporate IBSM in current clinical practice and
subsequently into a patients daily life. Implementation
strategies for IBSM, consisting of several components
(so-called multi-faceted implementation strategy) are
suggested to be more effective in changing current
clinical practices . In addition, tailoring the
implementation strategy to barriers and facilitators experienced by
the target grouppatients with asthma, practice nurses
(PNs), and general practitioners (GPs)is recommended
[22-24]. Such barriers can be identified at different levels
of healthcare system : innovation, the individual
patient (i.e., illness perceptions), professional level, societal
context (opinion of colleagues), organisational context
(organisation of care process), and economic and
Prior to this project, we conducted focus groups and
interviews with patients and professionals for exploring
barriers and facilitators for usage of IBSM in primary
care . These barriers were identified at patient and
professional/organizational level. Main barriers at the
patient level were unawareness of their level of asthma
control and subsequent possibility for improvement, and
patients often do not perceive asthma as a chronic
condition and experience difficulties of integrating
selfmanagement activities into daily life. Main barriers at
the professional level (PN, GP) and organizational level
were unawareness of the level of asthma control of
patients, lack of structure of asthma care, and lack of
structure of routine asthma consultations within general
practice and lack of time. Consequently, we developed
three implementation strategies (the strategies will be
described in more detail below):
1. Minimum strategy (MS): dissemination of the IBSM program.
2. Intermediate strategy (IS): MS + start-up support for
professionals (i.e., support in selection of the
appropriate population and training of professionals).
3. Extended strategy (ES): IS + additional training and
ongoing support for professionals.
In summary, the MS strategy has not been tailored to
previously identified barriers and corresponds with
commonly used implementation strategies (i.e.,
dissemination of the innovation only). This is in contrast with the
IS strategy, which specifically have been developed for
addressing previous identified barriers. The ES strategy
is the most extensive and time-intensive strategy.
Currently, there are only sparse data on the effectiveness
and cost-effectiveness of implementation strategies for
IBSM in primary care. This information is particularly
important for the time-intensive implementation
interventions, such as selection of the appropriate population,
professional training, and ongoing support for
professionals in IBSM support.
To evaluate the impact of these three different
implementation strategies for IBSM in current clinical
practice, we have proposed four hypotheses, which are
constructed to compare the effect of tailoring
implementation strategies to identified barriers (IS and ES) versus
a commonly used, non-tailored strategy (MS):
1. More general practices will participate in IBSM in the IS or ES strategy as compared with the MS strategy;
2. The proportion of referred patients who participate
in the IBSM program in the ES or IS strategy will be
greater as compared with the MS strategy;
3. The proportion of referred patients who participate
in the IBSM program in the ES or IS strategy will be
greater as compared to the MS strategy;
4. The ES and the IS strategy will be more cost-effective as compared to the MS strategy.
The objectives of this study are to investigate the
effectiveness and cost-effectiveness of a MS strategy, as
compared to an IS strategy and an ES strategy in a
threearm, cluster randomized trial. Because these different
implementation strategies have a sequence of effects, the
evaluation is aimed to assess to what extent: practices
participate in IBSM; IBSM improves asthma related
quality of life; patients participate in IBSM; and the
various implementation strategies are cost-effective.
This study is a three-arm, cluster randomized trial with
a cluster pre-randomisation design  (Figure 1).
Because the implementation strategies are primarily
targeted at general practices, randomisation will occur at
practice level (CONSORT guidelines for cluster trials,
Table 1 ). Prior to obtaining informed consent from
GPs and patients, practices will be allocated to one of
the strategies. Follow-up per practice is 12 months. At
patient level, follow-up duration is six months. In the ES
and IS strategies, individual patient outcomes will be
evaluated at baseline (first visit of a patient to the
Figure 1 Study design.
Table 1 Consort checklist 
Standard Checklist item
Description of the trial design
(e.g., parallel, cluster, non-inferiority)
Eligibility criteria for participants
and the settings where the data
Specific objective or hypothesis
Implementation strategies of internet-based asthma self-management support in usual care.
Study protocol of the IMPASSE study - a cluster randomized trial
Cluster-randomized trial with a cluster pre-randomization design.
Eligibility criteria for general practices:
Location within the Leiden - the Hague region. General practitioner/practice nurse that is
willing and available to support patients in internet-based self-management.
Patient eligibility criteria: Age 18 to 50 years; a doctor diagnosis of asthma; prescription of
inhaled corticosteroids and/or montelukast three months within 12 months prior to
enrolment; internet access; ability to understand written and oral Dutch instructions. Patient
exclusion criteria: Severe co-morbidities, daily or alternate day oral corticosteroid therapy for
1 month prior to entering the study and being primarily under treatment by a respiratory
Data will be collected in a research module of the internet-based self-management support
program (PatientCoach.nl) using web-based questionnaires (SurveyGizmo, Boulder, Colorado).
Internet-Based Self-Management (IBSM) support program :
PatientCoach.nl consists of both a generic web-based system and an instruction visit for
patients. PatientCoach includes modules for self-monitoring (asthma control and lung
function), a treatment plan (medication,), motivational feedback, e-consultation, personalized
information (i.e., inhalation technique), reminders and forums for patients and professionals.
PatientCoach has been developed by the LUMC. Patient Coach will be integrated in the
general practice information system. Additionally PatientCoach contains a research module
which consists of electronic versions of questionnaires.
The implementation strategies for internet-based self-management support are primarily
targeted general practices:
1. Minimum strategy (MS): dissemination of the IBSM program.
2. Intermediate strategy (IS): MS + start-up support for professionals (i.e., support in selection of the appropriate population and training of professionals).
3. Extended strategy (ES): IS + additional training and ongoing support for professionals. All general practices will be asked to invite at least 10 patients to participate in PatientCoach. Follow-up duration at general practice level is one year. Patient level:
Instruction visit on how to use PatientCoach, particularly focusing the essential
selfmanagement skills in asthma (i.e., monitoring, inhalation technique). Patients will be
instructed to monitor their level of asthma control at least once per month, preferably once
weekly using the Asthma Control Questionnaire. General practices themselves can decide
whether the practice nurse and/or general practitioner guide patients in using PatientCoach.
Follow-up per patient is six months. However, patients will have the possibility to continue
using PatientCoach.nl after this period.
The objectives of this study are to investigate the effectiveness and cost- effectiveness of a
Minimum strategy, as compared to an Intermediate strategy and an Extended strategy in a
three arm cluster-randomized trial. Since these different implementation strategies have a
sequence of effects, the evaluation is aimed to assess to what extent: 1. practices participate
in IBSM (practice level); 2. IBSM improves asthma related quality of life (patient level);
3. patients participate in IBSM (patient level); and 4. The various implementation strategies are
cost-effective (societal/organisational level)
Primary outcome measures are a) the proportion of referred patients that participate in IBSM
(general practice (cluster) and patient level) and b) the proportion of patients that have
clinically relevant improvement in the asthma-related quality of life as measured by the
Asthma Quality of Life Questionnaire .Patient usage of IBSM is defined as two out of three
months ACQ-monitoring compliance.
Table 1 Consort checklist  (Continued)
Randomisation How participants were allocated
As the implementation strategies (interventions) are primarily targeted at general practices,
randomisation will occur at practice level.
Whether or not participants,
care givers, and those
assessing the outcomes were
blinded to group assignment
Number of participants
randomized to each group
For the primary outcome, a result
for each group and the estimated
effect size and its precision
General practices (i.e., 2,300 patients per standard practice) are the unit of randomisation.
Prior to informed consent all general practices in the Leiden-the Hague region will be
allocated to one of the three strategies (1:1:1 ratio). General practices receive a letter with
information on the allocated strategy and an invitation to participate in the project.
Randomization will be conducted by Jacob Sont using a computer-generated,
permutedblock scheme. Practices will be stratified according the following characteristics: postal code
(area) and practice size (practices with < 4 general practitioners are defined as a small practice,
practices with 4 general practitioners as a large practice.
General practices will be enrolled by Moira Bakker, Johanna van Gaalen and Jiska
SnoeckStroband. Patients will be enrolled by general practices.
All general practices and patients are blinded to group allocation. Researchers are not blinded
for group allocation.
For all three strategies, 12 general practices (clusters) will be recruited, involving 10 patients
per practice to be invited for using PatientCoach per general practice.
Recruitment of patients is ongoing
the Netherlands National Trial Register NTR2970
This study is supported by grants from: - The Netherlands Organisation for Health Research
and Development (ZON-MW 80-82315-97-10004) - The Netherlands Asthma Foundation (NAF
3.4.09.011) - Funding for this publication was obtained from the Netherlands Organisation for
Scientific Research (NWO) Incentive fund Open Access publications - - Hand-held electronic
lung function meters for patients (PikO-1, Ferraris Respiratory, Hertford, United Kingdom) were
provided by GlaxoSmithKline (GSK), Zeist, the Netherlands
General interpretation of the results This study provides insight in the amount of support that is required by general practices for
cost-effective implementation of IBSM. Additionally, design and results can be beneficial for
implementation of other self-management initiatives in clinical practice.
general practice for instruction on IBSM), and three and
six months after a patients start with IBSM. Individual
patient outcomes in the MS strategy will be evaluated at
six months (end-point evaluation) after a patients start
know this is feasible . Those patients not willing to
participate in IBSM will be asked informed consent to
participate in an endpoint evaluation at six months.
Informed consent will be obtained during a consultation
with a patients PN or GP.
Recruitment of general practices and patients
Eligibility criteria general practices
All general practices located within the Leiden the
Hague region and a GP/PN that is willing and available
to support patients in IBSM will be eligible. Additionally,
at least one GP per practice needs to give consent for
Patients in practices randomized to the MS strategy, and
those patients in the IS and ES strategy not willing to
participate in IBSM support, will only be approached for
an endpoint evaluation at six months after their start
Eligibility criteria patients
General practices will be asked to invite at least ten 10
patients per practice to participate in IBSM. Based on
previous studies on asthma within general practice, we
Patients, age 18 to 50 years, with a doctor diagnosis of
asthma and prescription of inhaled corticosteroids and/or
montelukast for at least three months in the previous
Exclusion criteria patients
Those who have severe co-morbidities (i.e., terminal
illness or a severe psychiatric disease), daily or alternate
day oral corticosteroid therapy for at least a month
before entering the study, or who are primarily under
treatment by a respiratory physician are not eligible.
Furthermore, the IBSM support program is not suitable for
those who are unable to understand written and oral
Blinding and strategy allocation
General practices (i.e., 2,300 patients per standard
practice) will be the unit of randomisation. Practices will be
stratified according the following characteristics: postal
code (area) and practice size (practices with <4 GPs are
defined as a small practice, practices with 4 GPs as a
large practice). Prior to informed consent, practices will
be randomized into one of the strategies (1:1:1 ratio), in
order to assess the participation level of practices per
strategy. Practices will receive a letter containing
information on the allocated implementation strategy and an
invitation to participate in the project.
Both practices and patients will be blinded to group
allocation. Researchers will not be blinded for group
allocation. Randomisation will be conducted by Jacob Sont
using a computer-generated, permuted-block scheme.
General practices will be invited until enough practices
per strategy are participating. General practices will be
enrolled by Moira Bakker, Johanna van Gaalen, and Jiska
Snoeck-Stroband. Patients will be enrolled by general
Sample size calculation
The sample size is based on patient participation in
IBSM (primary outcome). We assume that one-third of
the 15% to 20% of patients who have a written action
plan  are actually using it to conduct
selfmanagement activities. Assuming that with the MS, 5%
of the patients are frequently using the IBSM to monitor
their asthma, we will consider the IS and ES successful if
an increase of 25% is achieved (alpha 0.05 and beta
0.20). Using a correction for clustering of patients in
practice (intra-cluster correlation coefficient: 0.25), we
calculated that we need 10 patients in each of 42
practices 14 practices in the MS, IS, and ES, respectively to
be invited to participate in IBSM using PatientCoach.
This gives a total of 420 patients.
IBSM support program
The IBSM support program consists of both a generic
web-based system and an instruction visit for patients.
Patientcoach.nl is a generic web-based system that
supports self-management of patients with a chronic
condition. It includes modules for coaching, personalized
information (i.e., inhalation technique), self-monitoring,
reminders, treatment plan, (motivational) feedback,
econsultations and a forum. PatientCoach has been
developed by the Leiden University Medical Centre (LUMC)
. The program includes options for weekly
assessment of the level of asthma control [28,29] and a
quarterly-assessment of asthma-related quality of life
. Furthermore, it offers tools for professionals and
patients, to help them to incorporate IBSM respectively
into routine asthma care and daily life, such as: reminder
options for home monitoring by ACQ and lung
function; reminder options for routine consultations (i.e.,
digital agenda); reminder options (i.e., a general agenda)
for regional educative sessions on asthma, i.e., hosted by
the patient association of the Netherlands Asthma
association; and a forum for professionals.
PatientCoach contains a research module that consists
of electronic versions of questionnaires for assessment
of quality of life , health education impact ,
selfreported medication adherence , illness perceptions
 and costs .
Self-management support session for patients on
Patients participating in PatientCoach will be supported
by their PN and/or GP. PNs will be asked to invite the
patient for at least one consultation (double-consultation)
that aims to inform patients on how to use PatientCoach,
particularly focusing the essential self-management skills
in asthma (i.e., monitoring, inhalation technique).
PNs in all strategies will be asked to conduct follow-up
on patients in concordance with the Dutch guideline for
general practice on asthma in adults, which recommends
a medical review and treatment adjustment every two to
four weeks in unstable asthma and medical review once
or twice a year for patients whose asthma is not under
control . The guideline states that routine asthma
consultations include assessment of asthma control,
medication, adverse events, adherence, and
measurement of lung function. The guideline is concordant with
current international guidelines, such as the Global
Initiative for Asthma guideline .
The implementation period is divided in a start-up and
an execution phase (Tables 2 and 3).
All strategies consist of patient-directed (i.e., reminders
for consultations), professional-directed (i.e., training of
Table 2 Overview of implementation strategies
* MS = Minimum strategy; IS = Intermediate strategy; ES = extended strategy;
IBSM = internet-based self-management support program (PatientCoach).
professionals, support on patient selection), and
organisational components (i.e., helpdesk).
Minimum strategy (MS)
Start-up phase basic components
Practice recruitment: practices receive an information
letter on IBSM support by using PatientCoach. Practices
will receive a reminder letter within four weeks.
Participating physicians will be asked whether their
non-responding colleagues in their practices would be
Table 3 Study phases and time schedule
interested in participation. On meetings for professional
groups and patient organisations PatientCoach team
members will present information on self-management
and web-based support.
Patient recruitment: GPs are asked to invite at least
ten patients to use PatientCoach.
PatientCoach information session for participating
practices: In addition to a general announcement,
professionals receive a manual on PatientCoach.
Professionals (GP and/or PN) have the opportunity to join a
PatientCoach information session. This information
session is focused on the principles and usage of the IBSM
program by the PN and patients, including home
measurement of lung function as forced expiratory volume in
one second (FEV1) using an electronic hand-held
spirometer (PiKo-1: Ferraris; Hertford, UK). Finally, a short
on-site training in usage of the PatientCoach system
focusing on integration within the local primary care
information system is offered to practices.
Execution phase basic components
Practices have access to a web-based helpdesk for
technical issues. For issues related to IBSM in asthma,
professionals can consult the PatientCoach team by email
Intermediate strategy (IS)
This includes a start-up support package that is
additional to the components of the MS in the start-up
phase. During the execution phase the IS does not differ
from the MS.
Start-up support package
The start-up support intermediate package consists of:
Practice recruitment. General practices receive an
invitation letter that includes all components of the Start-up
Support Implementation strategy. Non-responding
practices receive a reminder letter within four weeks and if
necessary, practices are phoned.
On-site support for patient recruitment. PatientCoach
team members offer practices the opportunity to make a
patient selection in the patient registries of participating
PatientCoach start-up training. PNs and GPs are
invited for an interactive session (duration: two hours)
with colleagues. In this session, professionals are
stimulated to discuss with each other on how to apply IBSM
in their own practice. This training is focused on a
proactive attitude toward patients and supporting them in
their self-management skills by using IBSM support:
1. Exploration of a patients knowledge about asthma,
illness perceptions [36,37], and the ability to integrate
(internet-based) self-management activities into their
daily life; i.e., by exploring difficulties and discussing
2. Asthma control: assessment of the level of asthma
control; patients are invited to discuss their most
recent ACQ-score. Reasons for poor asthma control
in patients are discussed, and the subsequent
management strategy will be discussed.
3. Medication: information on side-effects; instruction, exploration of therapy adherence, and checking correct inhaler technique.
4. Asthma related lifestyle: smoking cessation,
avoidance of triggers, regular exercise;
5. Asking about and treating rhinitis, which is known to influences asthma outcomes .
Extended strategy (ES)
The ES does not differ from the IS during the
startup phase. However, this strategy includes a patient
coach package that is additional to the components of
the MS/IS during the execution phase.
Practice coach package
The practice coach package consists of the following
components:Ongoing support: follow-up by
PatientCoach team members at one, three, and five months
after baseline by email, telephone, or face-to-face.
During these planned consultations, members of the
PatientCoach team will explore whether practices experience
difficulties. Solutions and future recommendations are
given. An outreach visit [23,39], both PatientCoach team
initiated (planned) or professional initiated (unplanned),
will be conducted when necessary.
Interactive session with professionals: within three
months after starting to use PatientCoach, professionals
will have the opportunity to participate in an interactive
session with colleagues. This session will be focused on
identifying problems for PatientCoach implementation,
and solutions will be discussed.
Measurements and outcomes
Primary outcome measures are the proportion of
referred patients that participate in IBSM and the
proportion of patients that have clinically relevant
improvement in the asthma-related quality of life as
measured by the Asthma Quality of Life Questionnaire
. Patient usage of IBSM is based on monitoring of
the level of asthma control using the Asthma Control
Questionnaire [28,29]; monitoring of ACQ during two
out of three months ACQ-monitoring compliance.
Demographic characteristics (i.e., educational level,
atopy, smoking status, and symptom-free days) are
obtained at baseline (Table 4). The effect evaluation
includes clinical outcomes (asthma control, lung
function, usage of airway treatment, and the presence of
exacerbations) and self-management related outcomes
(health education impact, self-reported medication
adherence and illness perceptions) and patient utilities
(asthma symptom utilities).
Asthma control is using the 7-item Asthma Control
Questionnaire (ACQ), the optimal cut-point for
controlled is 0.75 and a value of 1.50 confirms not
controlled asthma . Lung function will be measured as
the Forced Expiratory Volume in one second (FEV1).
Patients receive a handheld electronic spirometer
(PiKo1: Ferraris; Hertford, UK) and are instructed to report
the highest value of three measurements in the morning
before taking medication . The presence of
exacerbations is assessed; they are defined as deterioration in
asthma that required emergency treatment or
hospitalization (collected by quarterly questionnaire) or
the need for oral steroids for three days or more
(collected by pharmacy records) or the need for oral
steroids for asthma as judged by the attending physician.
Exacerbations are defined according to ATS/ERS
Severe exacerbations require at least one of the
following: systemic corticosteroids (tablets, suspension, or
injection) usage or an increase from a stable maintenance
dose, for three or more days; or a hospitalization or
emergency room visit because requiring systemic
Moderate exacerbations require 1 of the following
features, lasting for two or more days: deterioration in
Table 4 Outcome measures
A = all strategies; X = Intermediate and Extended strategy;
N = non-participating practices.
symptoms, deterioration in lung function, and/or
increased rescue bronchodilator use.
Health education impact is assessed by the health
education impact questionnaire (heiQ) . Self-reported
medication adherence is measured by the Medication
Adherence Report Scale . Illness perceptions are
assessed by using the Brief Illness Perception
Questionnaire (Brief IPQ) . In addition, asthma symptom
utilities are obtained from the Asthma Quality of Life
Questionaire (AQLQ) , EQ-5D [31,43] and a visual
analogue scale (VAS).
Professional and organizational level
Characteristics of general practices are assessed,
including information on area, type of practice, years of
establishment, age of GPs, and structure of asthma care. PN
characteristics include gender, age, education, and years
of experience with asthma consultations. The process
evaluation contains outcomes on the adherence of
professionals to the implementation strategy and can be
considered as a feasibility evaluation. Attendance to
training sessions of professionals is registered. Active
referral of patients by professionals to PatientCoach is
registered as active participation of practices. Actual
treatment advice by the care provider and the treatment
advice by the system are registered. Furthermore,
frequency and time of IBSM usage by care providers are
The economic evaluation includes outcomes on
costeffectiveness and cost-utility. Medical costs, such as
prescribed medication are assessed from electronic patient
records (with written patient permission) complemented
with the patients report on medication purchased
elsewhere . In addition, actual treatment advice by the
care provider and treatment advice by the system are
registered. Healthcare consumption, absenteeism and
productivity loss, and the number of limited activity days
are measured by using the Cost Questionnaire .
Furthermore, data on patient contacts (frequency of
inpractice routine asthma consultations, telephone/email
consultations, and unscheduled visits) are registered.
The analysis is carried out on an intention-to-treat basis.
Analyses include descriptive statistics and comparisons
on process and effect evaluation. Differences are
compared between implementation strategies using a
random-effects analysis accounting for within-patient
repeated measurements and clustering on general
practice, or nonparametric comparisons, such as chi-square,
as appropriate. All data are analyzed using STATA.
Analysis of clinical data
The number of patients with a clinically relevant
improvement in asthma-related quality of life is based on
a minimal clinical importance of difference (MCID) of
0.5 for the AQLQ .Patient utilities: asthma
symptom utilities are obtained from the AQLQ ; indirect
utilities from the general public are obtained using the
EQ-5D [31,43]. This allows the calculation of
qualityadjusted life years (Qalys). In the base case analysis,
Qalys are estimated using societal utilities obtained
using the Dutch EQ-5D tariff . For sensitivity
analyses, Qalys are estimated using a VAS (transformed
using a power transformation). Data on healthcare
provider utilization and other related costs provide input
for calculation of the contract price that GPs will have
to negotiate for this improved service. Ideally, this is in
the form of a primary care diagnosis and treatment
The economic evaluation compares differences in
societal costs to differences in the number of limited activity
days (CEA) and quality-adjusted life years (CUA). The
analysis has a six-month time horizon, without
discounting. Group averages are statistically compared using
two-sided bootstrapping and net-benefit analyses are
used to compare costs to patient outcome. Sensitivity
analyses are performed on the perspective (societal
versus healthcare perspective) and the applied utility
measure (Dutch EQ5D, VAS).
Cost-effectiveness of treatment strategies is evaluated by
incremental net-benefit analysis . Net health benefit
addresses cost-effectiveness ratios by assuming values
for the willingness to pay per unit of effectiveness. The
cost analysis includes both medical (medication, visits,
and hospitalizations) and non-medical costs
(productivity losses, informal care). Other costs are estimated using
quarterly cost questionnaires  Costs are valued
according to standard prices charges  including time
and travel costs.
This study is designed to investigate the effectiveness
and cost effectiveness of implementing IBSM by
comparing three different implementation strategies (MS, IS,
and ES) in a three-arm cluster-randomized trial with a
cluster pre-randomization design. The IBSM application
contains functionalities that are characterized by some
innovative aspects, such as options for e-consultation
and integration of results into the general practice
system. These functionalities address previously stated
requirements for both patients and professionals. The
findings of this study will lead to recommendations for a
potential cost-effective strategy that can be used for the
implementation of IBSM in practice.
This study has been designed for translation of
research findings into actual practice. Primarily, the
precluster randomization design allows us to study the
effect of the different implementation strategies on the
number of primary care practices that participate in
IBSM. Second, the impact of the different strategies at
both professional and patient level on actual
implementation (i.e., participation, patient outcomes, and
costeffectiveness). Third, general practices are given a
leading role to adapt and internalize IBSM in clinical
practice: the project team will only act as facilitators to
these practices. Additionally, the influence of research
activities on implementation has been incorporated in
the design of this study, because these might function
as an extra stimulus for both practices and patients to
adapt and internalize IBSM during the study period.
Therefore, the content of the MS strategy is not only
similar to commonly used (non-tailored)
implementation strategies, but also the number and amount of
research activities are minimized. This is in contrast to
the IS and ES strategies, which are specifically designed
to address previous identified barriers. These
differences give us the opportunity to study how much
support is required by general practices for IBSM
implementation. Finally, this study evaluates the costs
of the implementation from a societal perspective,
which is in contrast to other implementation studies
[18,48]. Therefore, we will include costs for asthma
care from both non-participating practices and
The results of this study will help to determine the most
effective way of implementing IBSM. Both the
precluster randomization and the inclusion of the IS and ES
strategies provide a more detailed view of the
implementation process and thereby direction to the focus for
future implementation processes in primary care. For
example, it may provide information on: the quality and
intensity of support professionals need to identify
eligible patients; whether it is sufficient to focus only on
the start-up period of implementation; and whether
continuing support of professionals has additional value in
The results of this study can enhance a broad
implementation of IBSM in current clinical care, based on a
cost-effective strategy. Thereby it can contribute to
improved care for patients with asthma. Furthermore,
design and results of this trial can contribute to
development of effective implementation strategies for
selfmanagement initiatives for other chronic diseases.
This study has been approved by the Medical Ethics
Committee of the Leiden University Medical Centre.
All authors declare that they have no competing interests. JKS received
unrestricted research grants by the Netherlands Asthma Foundation, the
Netherlands Organisation for Health Research and Development (ZonMW),
Fonds NutsOhra, GlaxoSmithKline NL and study equipment by AstraZeneca
NL and Aerocrine, Sweden.
JB, JG, JS, LB, and MB were involved in the design of the study; JG, JB. JS,
and LB drafted the manuscript, which was reviewed by AK, BT, CT, BT, MB
and VM. The manuscript has been read and been approved by all authors.
This study is supported by grants from the Netherlands Organisation for
Health Research and Development (ZON-MW 80-82315-97-10004) and the
Netherlands Asthma Foundation (NAF 3.4.09.011). Funding for this
publication was obtained from the Netherlands Organisation for Scientific
Research (NWO) Incentive fund Open Access publications. The authors thank
Professor E.F. Juniper for her permission for usage of the web-based versions
of the Asthma Control Questionnaire and the Asthma related Quality of Life
Questionnaire. The IMPASSE (IMPlementation strategies of internet-based
Asthma Self-management Support in usual care) study group consists of :
W.J.J. Assendelft, M.J. Bakker, L. van Bodegom-Vos, J.L. van Gaalen, A.A. Kaptein,
V. van der Meer, J.K. Sont, J.B. Snoeck-Stroband, C. Taube and B. Thoonen.
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