Comparing the Impacts of Two Versions of a Continuing Education Activity Targeted at COPD Case Managers on Educational Outcomes
Phase: NA
Conditions: Lung Diseases, Obstructive
Sponsor: Laval University

STUDY PROTOCOL
Open Access
Comparative impact of two continuing
education activities targeted at COPD
educators on educational outcomes:
protocol for a non-randomized controlled
study using mixed methods
Myriam Gagné1,2, Jocelyne Moisan3,4, Sophie Lauzier3,4, Christine Hamel5, Patricia Côté6, Jean Bourbeau6,7,8
and Louis-Philippe Boulet1,2,6,9*
Abstract
Background: Therapeutic patient education (TPE) improves quality of life and reduces health care utilization
among patients with chronic obstructive pulmonary disease (COPD). However, benefits from TPE might depend on
the performance of the educators and training is needed to ensure the effective delivery of TPE interventions.
Based on the framework by Moore et al. (J Contin Educ Health Prof 29:1-15, 2009), we will compare the impact of two
continuing education (CE) activities on TPE in regard to the following educational outcomes: (1) learning, (2) self-report
of competence, (3) performance of the educators, and (4) outcomes of COPD patients who will meet the newly trained
educators for TPE.
Methods: We will conduct a non-randomized controlled study using mixed methods. Educators will first participate in
a CE activity on TPE that will include a role-playing simulation (experimental group) or in a lecture on TPE (comparison
group) and then will perform TPE in COPD patients. Among educators, we will assess: (1) learning, by measuring
knowledge about TPE, and (2) self-report of competence using self-administered questionnaires before and after the
activity. Then, after the CE activity, we will assess (3) educators’ performance levels in delivering TPE by rating a
videotaped TPE intervention. In COPD patients who will meet the newly trained educators for TPE after either CE
activity, we will assess (4) quality of life and resource utilization using interviewer-administered questionnaires, before
and after TPE. Statistical analyses will compare the experimental group against the comparison group using
multivariate models. Using a semi-structured interview guide, we will conduct interviews with educators and perform
content analysis. Results will be integrated in order that qualitative results further explain the quantitative ones.
Discussion: To the best of our knowledge, this is the first controlled mixed methods study to compare the impact of
two CE activities on TPE in regard to four educational outcomes. We believe this study will serve as a model for
evaluating CE activities on TPE. Results from this study could increase educators’ performance levels in delivering
effective TPE interventions, and, in turn, COPD patient outcomes.
Trial registration: The study was registered on https://clinicaltrials.gov/ (NCT02870998) on March 15, 2016.
Keywords: Education, continuing, Pulmonary disease, chronic obstructive, Patient education as topic, Revised Bloom’s
taxonomy
* Correspondence: lpboulet@med.ulaval.ca
1Knowledge Translation, Education and Prevention Chair in Respiratory and
Cardiovascular Health, Laval University, Quebec City, QC, Canada
2Quebec Heart and Lung Institute, Laval University, Quebec City, QC, Canada
Full list of author information is available at the end of the article
© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Gagné et al. BMC Health Services Research  (2018) 18:460 
https://doi.org/10.1186/s12913-018-3284-6

Background
Chronic obstructive pulmonary disease (COPD) is an irre-
versible, but treatable disease that is characterized by air-
flow limitation and persistent respiratory symptoms [1].
The global prevalence of COPD is estimated at 12% (95%
confidence interval, or CI, 8–15%) among individuals aged
30 years or over [2].
The global burden of COPD is considered to be high
[3]. In particular, results from a systematic review indicate
that COPD is responsible for a large number of emer-
gency room visits and hospitalizations, profoundly im-
pacts patients’ quality of life, and results in expensive total
costs per COPD patient from both the patient and societal
perspective [4].
To reduce COPD-related morbidity, COPD patients
need to develop several self-management skills, including:
using their inhalers correctly, monitoring the control of
their disease, preventing and controlling exacerbations,
and using breathing techniques [1].
Therapeutic patient education (TPE) is an active,
evidence-based, and patient-centered process by which
health care professionals, also referred to as educators, guide
and support patients in developing these self-management
skills [5]. When compared to usual care, TPE results in im-
provement of quality of life among COPD patients, as well
as in reduction of dyspnoea and hospitalizations [6].
Nevertheless, not all TPE programs have a positive im-
pact on COPD health outcomes. For instance, in 2012, a
randomized controlled trial by Fan et al. [7] was termi-
nated before its planned completion date, due to the ex-
cess mortality estimated within the participants allocated
to TPE, compared to guideline-concordant usual care.
Although a subsequent meta-analysis concluded that
TPE does not result in an increased risk of mortality in
patients with COPD [8], Fan et al. [7] were unable to ex-
plain why the number of deaths was higher in the TPE
group than in the comparison group, nor were they able
to assess the quality of TPE when reporting the results
of their study. In this context, authors have hypothesized
that benefits from TPE could depend on the performance
of the educators and especially on the training that they re-
ceived to deliver effective TPE interventions [9]. Hence, en-
suring the optimal training of COPD educators is crucial.
Continuing education (CE) activities (including: lec-
tures, conferences, seminars, workshops, symposia, and
courses) have been widely used in order to improve health
care professional practice and, subsequently, patient out-
comes [10]. CE activities can be described through their
learning objectives, activities, and assessments, and classi-
fied into six cognitive processes and four knowledge types
according to the Revised Bloom’s Taxonomy for Learning,
Teaching, and Assessing [11]. Conceptually, to promote
translation of knowledge into practice, the learning objec-
tives of a particular CE activity should be classified into
the higher-order cognitive processes [11]. The correspond-
ence between the learning objectives, activities, and assess-
ments is defined as alignment. Described as strong, weak,
or misalignment, alignment ensures the following two char-
acteristics: (1) the learning activities enable attendees to
perform adequately in assessments, and (2) the results of
the assessments reflect the achievement of the learning ob-
jectives [11].
CE activities can also be described through some com-
ponents of a CE activity that have been reported to impact
on health care professional performance [12–14] and pa-
tients’ outcomes [13, 14]. These components include the
following:
(1) the number of attendees in a CE activity: small
groups of < 10 attendees might result in better
educational outcomes than moderate-to-large
groups of ≥10 attendees [14];
(2) the format of the CE activity: an active learning
format that includes role play simulations, case
discussions, or opportunities to practice skills might
result in better educational outcomes than a passive
learning format that includes: lectures or
presentations, with or without question and answer
periods [13, 14];
(3) the organizational support [12].
Moore et al. [15] developed the Expanded Outcomes
Framework
for
Planning
and
Assessing
Continuing
Medical Education Activities to evaluate the achievement
of desired educational results. This framework includes
several levels of assessment (Table 1). Based on this
framework, our study will aim to compare the impact of
two CE activities on TPE that target COPD educators.
One CE activity will include a role-playing simulation
and involve a small group of attendees (experimental
group). The other CE activity will consist of a lecture on
TPE that will be presented to a moderate-to-large group
of attendees (comparison group).
Specifically, we will compare both activities in regard
to the following educational outcomes: (1) satisfaction,
(2) learning, (3) self-report of competence, (4) perform-
ance of the COPD educators who will attend either CE ac-
tivity, and (5) outcomes of COPD patients who will meet
the newly trained COPD educators for TPE after the CE
activity.
As reported in other studies assessing satisfaction with
a CE activity [16–19], we hypothesize that (1) satisfaction
with the CE activity will be similar in the experimental
and comparison groups immediately after the CE activity.
In view of the fact that a small number of attendees and
an active learning format have been reported to improve
health care professional performance and patient out-
comes [13, 14], we hypothesize that: (2) improvements in
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educators’ learning before and after the CE activity will
be greater in the experimental group (small group of
educators + active learning format), compared to the com-
parison group (moderate-to-large group of educators +
passive learning format), as will be (3) improvements in
educators’ self-reports of competence before and after the
CE activity, and (4) educators’ performance levels after the
CE activity. Similarly, we believe that (5) improvements in
patient outcomes before and after TPE will be greater in
the experimental group (TPE delivered by educators who
attended the experimental CE activity), compared to the
comparison group (TPE delivered by educators who
attended the comparison CE activity).
Methods
The following study protocol adheres to the SPIRIT
guidelines [20].
Study design
We will conduct a pragmatic non-randomized controlled
study using explanatory sequential mixed methods [21].
From June 2016 to October 2017, moderate-to-large
groups of ≥10 educators will participate in a lecture on
TPE (comparison group). From November 2017, and
thereafter, small groups of < 10 educators will be involved
in a CE activity on TPE that will include a role-play simu-
lation (experimental group). In educators, quantitative
and qualitative measurements will be undertaken before
and after the CE activity. Four months after the CE activ-
ity, educators will provide COPD patients with TPE in
their work settings. Measurements will be undertaken in
COPD patients before and after TPE.
Our
study
was
registered
in
ClinicalTrials.gov
(NCT02870998) on March 15, 2016.
Eligibility criteria
All French-speaking educators (e.g. nurses, respiratory
therapists, and other allied health professionals) who will
attend either CE activity on TPE organized on behalf of
the Quebec Respiratory Health Education Network in
June 2016, and thereafter, will be eligible to partici-
pate in the study. Most of these educators work in
family medicine groups, local community service centers,
or in hospitals, which include emergency departments.
Physician-diagnosed COPD patients, who will meet the
newly trained COPD educators for TPE after either CE ac-
tivity, will be eligible to participate in the study.
Interventions
Educators will be allocated to a CE activity on TPE that
will include a role-playing simulation and involve a small
group of attendees (experimental group) or to a lecture
on TPE that will be presented to a moderate-to-large
group of attendees (comparison group). Hence, the CE
activities differ in their number of participants and
learning format.
Both CE activities will be similar in regard to their
content and learning objectives. The content of the CE
activities will pertain to TPE and the general learning
objective of both CE activities can be described as: to be
able to deliver effective TPE interventions to COPD pa-
tients. The specific learning objectives are adapted from
the Canadian Network for Respiratory Care’s National
Certified Respiratory Educator Learning Objectives [22].
They are presented in Table 2.
The study coordinator (M.G.) will attend the CE activ-
ities to ensure adherence to intervention protocols.
Experimental group: small groups of < 10 educators
attending a CE activity on TPE that will include a role-playing
simulation
In the experimental group, small groups of ≈6 educators
will participate in a seven-hour CE activity on TPE that
will include a role-playing simulation. As part of the de-
velopment phase of this activity, the learning activities
and assessments were reviewed by experienced case
managers (n = 4) and physicians (n = 2). On four occa-
sions, the activity was pretested among both experienced
and non-experienced educators (n ≈4 per occasion).
Table 1 The expanded outcomes framework for planning and assessing continuing medical education activities by Moore et al.
[15]: Definitions
Educational
outcome
Definition
Satisfaction
“The degree to which the expectations of the participants about the setting and delivery of the [CE] activity were met.”
Learning
“The degree to which the participants state what the [CE] activity intended them to know [or] the degree to which participants
state how to do what the [CE] activity intended them to know how to do [it].”
Competence
“The degree to which participants show in an educational setting how to do what the [CE] activity intended them to be able
to do.”
Performance
“The degree to which participants do what the [CE] activity intended them to be able to do in their practices.”
Patient outcome
“The degree to which the health status of patients improves due to changes in the practice behavior of participants.”
Definitions are quoted from Moore et al. [15]
CE Continuing education
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Before the activity, educators will be asked to read a
necessary online document on TPE. Learning activities
will include the following:
 a lecture on core concepts of TPE (1.5 h; passive
learning format);
 a group discussion about TPE (0.5 h; active learning
format);
 demonstrations and case studies on how to
demonstrate TPE skills while taking a COPD
patient’s medical history and interpreting an action
plan (two hours; passive and active learning format);
 demonstrations and practices of how to ensure TPE
skills while teaching a patient to use and maintain
medication delivery devices (one hour; passive and
active learning format);
 a role-playing simulation relating to a COPD patient’s
initial and follow-up TPE visits (two hours; active
learning format).
As part of the evaluation of the CE activity, partici-
pants will be asked the following two requests: (1) to fill
a questionnaire assessing their comprehension of the
core concepts of TPE, and (2) to perform an objective
structured clinical examination with a standardized pa-
tient. Hence, the learning objectives, activities, and assess-
ments will be strongly aligned, according to the Revised
Bloom’s Taxonomy [11] (see Fig. 1a).
Comparison group: moderate-to-large group of ≥10
educators attending a lecture on TPE
In the comparison group, moderate or large groups of
≈12–25 educators will participate in a seven-hour lecture
on TPE. Although the animator will encourage educators’
active participation during the presentation, learning will
be mostly passive, because a lecture format does not easily
allow for an attendee-animator dialogue [23]. The evalu-
ation of this CE activity will include a questionnaire that
assesses the memorization of TPE concepts and proce-
dures. Based on the Revised Bloom’s Taxonomy [11], there
will be a weak alignment or a misalignment of the learning
objectives, activities, and assessments (see Fig. 1b).
Educational outcomes
Satisfaction
Educators will complete a questionnaire assessing the
extent to which their expectations about the CE activity
were met. The questionnaire (©Formaeva, an organization
that develops evaluation tools to assess training activities;
additional information available at: https://www.formae-
va.com/) evaluates the degree to which participants appre-
ciate the activity (1 item, 1 = absolutely no, 10 = absolutely
yes) and rate its upstream preparation (n = 3 items),
organization (n = 2 items), content (n = 4 items), animation
(n = 3 items), structure (n = 2 items), and usefulness (n = 2
items), using a 5-point Likert scale (either 1 = strongly dis-
agree, 5 = strongly agree or 1 = too short, 5 = too long).
Two open-ended questions assess the CE
activity
strengths and areas of improvement. Formaeva can
provide the questionnaire to the reader upon request.
Learning
Change from baseline knowledge about TPE will be assessed
among educators, who will be asked to complete pre- and
post-tests of knowledge about TPE. The questionnaire, com-
prising eight open-ended questions aligned with the specific
objectives of the CE activity (please refer to Additional file 1).
Questions were based on current literature on TPE [5, 24].
The questionnaire was pretested among formerly trained
educators (n = 6) and experienced respiratory educators
(n = 3) to ensure its face validity. It was also reviewed
by experts on TPE (n = 1) and CE (n = 1), and by the
CE activity animators (n = 2) for preliminary content
validity assessment. The overall score ranges from 0 to 25.
A higher score indicates greater knowledge.
Self-report of competence
Change from baseline self-report of competence will be
assessed in educators using a questionnaire (©Formaeva).
This questionnaire measures pre−/post-activity self-report
of competence in regard to the following three CE activity
objectives: (1) to define TPE, (2) to demonstrate TPE skills
while teaching a patient to use and maintain medication
delivery devices, and (3) to deliver effective TPE interven-
tion. Again, Formaeva can provide the questionnaire to
the reader upon request.
Table 2 Specific objectives of the two CE activities
1.
To define TPE
2
To demonstrate TPE skills while:
a.
Demonstrating how to take a patient’s medical history
b.
Demonstrating how to teach a patient to use an action plan
c.
Demonstrating how to teach a patient to complete a symptom
diary form
d.
Interpreting a patient symptom diary as to whether COPD
control is acceptable
e.
Demonstrating how to teach a patient to use and maintain
medication delivery devices
f.
Demonstrating pursued lip breathing techniques, diaphragmatic
breathing, controlled cough and forced expiration techniques,
and relaxation techniques
g.
Performing a follow-up visit
These specific objectives are based on the Canadian Network for Respiratory
Care’s National Certified Respiratory Educator Learning Objectives [22]
CE Continuing education, COPD Chronic obstructive pulmonary disease, TPE
Therapeutic patient education
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Performance
We will measure educators’ post-CE activity perform-
ance in delivering high-quality TPE interventions to a
real patient by using a published effective TPE rating
scale [25, 26]. Twenty operationally defined teaching be-
haviors assess the following four effective TPE skills: (1)
interpersonal skills (n = 3 items; e.g. showing respect for
patients), (2) presentation skills (n = 9 items; e.g. stating
learning objectives), (3) essential teaching functions (n = 4
items; e.g. providing patients with feedback), and (4) ad-
herence counseling strategies (n = 4 items; e.g. negotiating
treatment plans) [25]. Each item is scored on a 4-point
scale (0 = absent, 1 = poor, 2 = adequate/good, 3 = excellent
use of the skill). Item scores are averaged to calculate a
subscale score (range 0–3, higher scores indicating greater
effective TPE skills) [25].
Patient outcomes: health status and health resource
utilization
After the completion of either CE activity, the newly
trained educators will deliver one or several TPE interven-
tions to COPD patients in their professional practice.
Among these COPD patients, we will assess change from
baseline health status and health resource utilization.
Health status Health status will be measured using the
activity and impact components of the COPD-specific
version of the St. George’s Respiratory Questionnaire
(SGRQ-C) [27] and the COPD Assessment Test (CAT).
Validated French-Canadian versions will be used [28].
Both the SGRQ-C and the CAT are suitable for evaluat-
ing COPD patient health status in recent times [27, 29].
The impact dimension of the SGRQ-C will be consid-
ered as our primary patient health outcome.
The activity and impact components of the SGRQ-C
are comprised of 13 and 20 closed-ended items, respectively
[27]. For each component, a weighted score, ranging from 0
(perfect health) to 100 (most severe status), is derived [27].
A difference in SGRQ-C score equivalent to 4 points is con-
sidered clinically significant [30]. The SGRQ-C has been de-
veloped from the original SGRQ using Rasch analyses [27].
The SGRQ has been previously validated, using correlations
with appropriate comparison measures [31].
The CAT is an 8-item instrument that measures health
status using 5-point Likert scales [29]. Response options
are summed, and the overall CAT score ranges from 0 to
40 (lower scores are better) [29]. The minimal clinically
important difference in the CAT score is −2 [32]. The
CAT has been validated using Rasch analyses [33]. Its in-
ternal consistency has been shown to be excellent, and its
test/re-test reliability has been shown to be good [33]. It
has demonstrated responsiveness to change [34].
Health education impacts The eight independent di-
mensions of the Health Education Impact Questionnaire
(heiQ), a 40-item questionnaire developed to evaluate
proximal TPE outcomes [35], will be measured. These di-
mensions are: (1) health-directed behaviors, (2) skill and
technique acquisition, (3) self-monitoring and insight, (4)
positive and active engagement in life, (5) constructive
attitudes and approaches, (6) health services navigation,
(7) social integration and support, and (8) emotional
well-being. Each item of the heiQ uses a 4-point Likert
scale (1 = strongly disagree, 4 = strongly agree, except for
the eighth dimension, which uses a reversed scale) [35].
Response options are averaged, and higher scores are bet-
ter [35]. The heiQ development was based on a Program
Logic Model, Concept Mapping, and interviews with stake-
holders [35]. Item response theory and structural equation
Fig. 1 Alignment of the objectives, learning, and evaluation activities in the experimental and comparison groups. In accordance with the Revised
Bloom’s Taxonomy [11], dark shading indicates that there is a strong alignment between the objectives, learning activities, and assessment (all
present in the same cell), as in the experimental group (a). Light shading indicates that there only is a weak alignment. When the objectives,
activities, and assessments are not in the same cell, there is a misalignment, as in the comparison group (b)
Gagné et al. BMC Health Services Research  (2018) 18:460 
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modeling were used to assess its psychometric properties
[35]. The heiQ was found to have high construct validity
and to be reliable [35]. In this study, we will use the
Canadian-French version of the heiQ [36].
Health resource utilization The number of unsched-
uled doctor visits, emergency room visits, and hospi-
talizations
in
the
six
preceding
months
will
be
measured using three items derived from the Survey
on Living with Chronic Diseases in Canada (SLCDC)
[37] and available at: http://www23.statcan.gc.ca/imdb-bmdi/
instrument/5160_Q6_V1-eng.pdf. To ensure the face validity
of the SLCDC, questions were framed in collaboration with
respiratory experts and qualitatively tested using face-to-face
interviews [37].
Confounding, professional, clinical, and
sociodemographic variables
Determinants of educational outcomes identified a priori
will be measured (see Table 3). To characterize study partici-
pants, we will collect data on attendees’ jobs, undergraduate
studies, the number of years of professional practice, and
former participation in CE activities, using a standardized
form. In COPD patients, we will measure disease severity
that is classified by symptoms and disability [38], along with
marital status, highest attained level of education, and an-
nual family income, using items derived from the Quebec
Survey on Cardiovascular Health (QSCH) [39].
Participant timeline
Figure 2 illustrates the schedule for enrollment, inter-
ventions,
and
assessments.
The
measurement
time
points have been chosen in accordance with the Ex-
panded Outcomes Framework for Planning and Assessing
Continuing Medical Education Activities [15] (e.g. satis-
faction and self-report of competence are measured im-
mediately after a CE activity) and feasibility issues (e.g.
time for institutional feasibility approval for performance
and patient outcome assessments). As illustrated in
Fig. 2a, educators will be enrolled and will be asked to
complete baseline measurements on the morning of the
CE activity (t-1, educators). Among educators, post-activity
measurements will be undertaken immediately after the
CE activity (t1, educators), for satisfaction and self-report
Table 3 List of possible confounding factors
Educational outcome
Confounding variable
Units, categories, or range
Instrument
Educators’ satisfaction
Educators’ learning
Educators’ competence
Educators’ performance
Age [12]
in years
Standardized form
Level of education [12]
<University
Standardized form
≥University
Motivation to participate in
the CE activity [12]
Score: 0–6
Adapted from the MSLQ [58]
COPD patients’ outcomes
Smoking history [59]
in packs-year
SLCDC [37]
Dyspnea [60]
Medical Research Council dyspnea
scale, grade: 1–5
SLCDC [37]
Social support [59]
Yes
SLCDC [37]
No
Comorbidity [60]
Yes
SLCDC [37]
No
Respiratory tract infections [59]
Yes
SLCDC [37]
No
Body mass index [60]
< 21
QSCH [39]
≥21 kg/m2
Age [61],
in years
QSCH [39]
Gender [62]
Women
QSCH [39]
Men
Previous exacerbations in the six
preceding months [59, 60]
Yes
Telephone interviewer-administered
questionnaire [63]
No
Levels of anxiety [60, 64]
Score: 0–21
HADS [65]
Levels of depression [60, 64]
Score: 0–21
HADS [65]
Depending on the educational outcome, these variables will be measured in educators or in COPD patients
HADS Hospital Anxiety and Depression Scale, MSLQ Motivated Strategies for Learning Questionnaire, QSCH Quebec Survey on Cardiovascular Health, SLCDC Survey
on Living with Chronic Diseases in Canada
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of competence, at 1-month post-activity (t2, educators), for
learning, and at 2-month post-activity (t3, educators), for per-
formance. Interviews will be conducted among educators
at (t4, educators), after quantitative measurements (details
on the interviews will be given in section “Interviews with
educators” below).
Four months after the CE activity, newly trained educators
will deliver TPE to COPD patients. In COPD patients, mea-
surements will be undertaken prior to TPE, at (t-1, patients),
and six months after TPE, at (t1, patients).
Sample sizes
The size of our sample of educators was calculated on
the basis of our fourth study hypothesis, that predicted
that post-CE activity performance levels will be higher in
the experimental group compared to the other [13, 14].
In a previous study, educators were found to have a
score of 0.89 on the effective TPE rating scale [25]. We
think that the educators of the comparison group will
also have this score. We expect the educators of the ex-
perimental group to have a score of 2.00, that is consid-
ered as good on this scale [25]. Therefore, we calculated
that a sample size of seven educators per group was re-
quired to detect a group difference of 1.11 point (standard
deviation, or SD = 0.63; type II error = 0.20, or 80% power;
type I error = 0.05; two-sided test).
The size of our sample of COPD patients was calcu-
lated on the basis of our fifth study hypothesis, that pre-
dicted that patient outcomes will be further enhanced in
COPD individuals who will meet the newly trained
COPD educators of the experimental group, compared
to the other [13, 14]. We expect the COPD patients,
who will meet the newly trained COPD educators of the
comparison group, to experience a change at 6-month
follow-up equivalent to −2 points on the impact dimen-
sion of the SGRQ-C, similar to the patients who were al-
located to a previous usual care intervention [40].
Consistent with previous results [40], we expect the
COPD patients, who will meet the newly trained COPD
educators of the experimental group, to make an improve-
ment equivalent to + 9 points. Using the SAS generalized
estimating equation macro for controlled clinical trials
with repeated measurements on the same individuals [41],
we estimated that a sample size of 94 patients per group
was required to detect a between-group difference of 11
points (SD = 19; type II error = 0.20, or 80% power; type I
error = 0.05; two-sided test).
To account for possible losses to follow-up, to ensure
Gaussian distributions, and because it was considered as
feasible to recruit ≈5 COPD patients per educator, we hope
to recruit 25 educators per group and 125 COPD patients
per group (≈5 patients per educator). The CE activities will
be delivered on several occasions from June 2016, and
thereafter, to achieve the required sample sizes of both edu-
cators and patients.
Assignment of interventions
The CE activities will be organized on behalf of the Quebec
Respiratory Health Education Network twice per year, either
in Quebec City or Montreal, Quebec, Canada. Upon re-
quest, the Quebec Respiratory Health Education Network
may decide to schedule additional CE activities outside
these two cities. Educators, who will participate in the CE
activities held from June 2016 to October 2017, will be allo-
cated the comparison group, whereas those attending the
activity after November 2017 will be assigned to the experi-
mental group.
Blinding
Data analysts will be blinded to interventions, along with
study participants, who will not be aware that there will
be two different CE activities.
Recruitment
Before either CE activity, the study coordinator (M.G.)
will invite all educators to participate in the study and
will be in charge of their recruitment. Four months after
the CE activity, the newly trained educators will invite
their COPD patients to participate in the study. Educators
will communicate the names and contact information of
the COPD patients who will accept the invitation to take
part in the study to the study coordinator. Then, trained
research assistants will be responsible for the recruitment
of COPD patients. We plan to stop the recruitment when
we will reach the targeted sample sizes of both educators
and COPD patients.
Data collection methods
Questionnaires measuring educators’ satisfaction, learn-
ing (baseline/post-activity knowledge), competence, and
confounding factors will be self-administered. For satisfac-
tion, baseline knowledge, pre−/post-activity self-report of
competence, and confounding factors, data will be col-
lected on the CE activity site. Data on post-activity know-
ledge will be collected on the educators’ work site. We
will send reminders to educators who will not return the
post-activity knowledge questionnaire.
To measure performance for each educator, we will
videotape one TPE intervention delivered to a real COPD
patient in each educator’s professional practice. The study
coordinator will send the camera to the educator by mail.
Upon reception of the camera, the educator will invite the
first patient to whom he or she will deliver TPE to partici-
pate in the study. If the patient refuses, then the educator
will ask the following patient, and so on. We will ask edu-
cators to place a GoPro HERO Session™camera (GoPro,
San Mateo, CA, USA) on their desk. The camera has the
Gagné et al. BMC Health Services Research  (2018) 18:460 
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height of 38 mm, the width of 38 mm, and the depth of
36.4 mm. It starts recording when pushing a single button
and captures up to a 2-h ultra-wide field of view video in
.mp4 file format.
Data on COPD patient health status, resource utilization,
and confounding factors will be collected via telephone
interviews with trained research assistants. The SLCDC
is an interviewer-administered instrument. Previous
studies have shown that the SGRQ and the CAT produce
similar results when interviewer-administered [42, 43].
The heiQ, along with the Hospital Anxiety and Depression
Scale (HADS), used to measure two confounding factors,
will be mailed to patients and self-administered at each of
the patients’ homes. Both the heiQ and the HADS could
be interviewer-administered, upon request, to avoid miss-
ing data.
Fig. 2 SPIRIT flow diagram: Educators’ and patients’ timelines for the schedule of enrolment, interventions, and assessments Derived from the
SPIRIT statement [57]. a. Educator timeline Educators will be enrolled and will be asked to complete baseline measurements on the morning of
the CE activity (t-1, educators). Post-CE activity measurements will be undertaken immediately after the CE activity (t1, educators), for satisfaction and
self-report of competence, at 1-month post-activity (t2, educators), for learning, and at 2-month post-activity (t3, educators), for performance. Interviews
will be conducted among educators 5 months after the CE activity (t4, educators). b. Patient timeline. Four months after attending either CE activity,
educators will perform TPE in COPD patients. Patient outcomes will be measured prior to TPE, at (t-1, patients). Six months later, at (t1, patients), post-TPE
measurements will be undertaken in COPD patients
Gagné et al. BMC Health Services Research  (2018) 18:460 
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Data management
We will perform independent double data entry for nu-
meric data (satisfaction, self-report of competence, patient
outcomes, confounding factors). Two individuals will in-
dependently rate attendees’ learning and performance.
When attributing knowledge scores, independent raters
will be blinded to the measurement time point. They will
score videotapes in random order. We will calculate inter-
rater reliability using an intra-class correlation coefficient
[44, 45]. Consensus will resolve disagreements. If neces-
sary, a third reviewer will be consulted. All data will be
stored on a secure server to prevent unauthorized access
and loss of participant data.
Statistical analyses
Data will be analyzed by intention-to-treat [46]. The ex-
perimental group will be compared to the comparison
group for all statistical analyses. To compare participant
characteristics, we will use χ2 test for binary outcomes
and t-test for continuous outcomes. In educators, we will
compare post-CE activity satisfaction and performance
scores using multivariate linear regression models [47].
We will compare, in educators, change from baseline
knowledge scores and change from baseline self-report of
competence scores, and, in COPD patients, change from
baseline patient outcome scores or counts, using general-
ized linear or Poisson mixed models with appropriate
interaction terms (group × time) [48]. We will assume a
specified form of covariance structure among the two
repeated measurements (knowledge: t2, educators versus
t-1, educators; competence: t1, educators versus t-1, educators;
COPD patient outcomes: t1, patients versus t-1, patients).
We will assume a specified form of covariance struc-
ture among the two repeated measurements (know-
ledge: t2,
educators versus t-1,
educators; competence: t1,
educators versus t-1,
educators; COPD patient outcomes:
t1,
patients versus t-1,
patients). Estimates and standard
errors will be based on a restricted likelihood function
given the observed data. Specifying an unstructured co-
variance matrix, we will handle possible missing values at
follow-up [49]. Depending on the variable type, we will
calculate differences in means and counts with corre-
sponding 95% confidence intervals [47, 48]. Model as-
sumptions will be assessed. Determinants of educational
outcomes identified a priori will be included in statistical
models if they result in a > 10% change in the differences
in means and counts [50]. We will examine the residuals
to assess goodness-of-fit [47, 48]. We also plan to per-
form independent variable transformations if model as-
sumptions are not met [51] or to use ordinal or
binomial regression models. We will use an up-to-date
version of SAS (Cary, NC, USA) to conduct all statis-
tical analyses and two-sided p-values with α ≤0.05 level
of significance for all tests.
Interviews with educators
We will conduct telephone interviews with educators of
both the experimental and comparison groups to further
explain our quantitative results [21]. We will purpose-
fully select educators for interviews, based, for instance,
on their performance scores or their professional charac-
teristics. Based on the levels of assessment of the Ex-
panded Outcomes Framework for Planning and Assessing
Continuing Medical Education Activities [15], we will
develop a semi-structured interview guide. The guide
will also question the educators about the organizational
support that they receive in their work setting in regard
to TPE intervention delivery.
Qualitative analyses
We will audiotape the interviews, transcribe interviews
verbatim, and randomly check selected extracts of tran-
scripts to ensure that there are no mistakes [21]. We will
import data to QSR NVivo 11 software® and conduct
content analysis [52]. Two members of our team will in-
dependently read and code three interviews’ transcripts,
using an inductive approach [52]. They will compare
their coding and debrief in order to develop the first ver-
sion of the codebook. Based on this first version, they will
independently assign codes to the data of the other inter-
views. We will compare their codes, resolve disagreements
by consensus, and refine the codebook. Codes will be
sorted into categories and the categories into themes. We
will conduct interviews until saturation is reached [21].
Findings from the final analysis will be presented to edu-
cators to determine their accuracy [21].
Integration
In the discussion section of the published articles, results
will be integrated in order that qualitative findings help
expand or explain the quantitative ones [21].
Dissemination
We plan to communicate our results to the Quebec
Respiratory Health Education Network, which designed
and delivers the CE activities. We will also communicate
them to study participants, Quebec Ministry of Health,
and researchers, via publications and presentations in
local, provincial, national, and international meetings.
We intend to have no publication restriction.
Discussion
Based on the framework by Moore et al. [15], our study
will aim to compare the impacts of two CE activities on
TPE that target COPD educators in regard to five educa-
tional outcomes.
Gagné et al. BMC Health Services Research  (2018) 18:460 
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Strengths
Previous pre/post studies [53–55] have evaluated the im-
pact of CE activities targeted at COPD educators on
some, but not all educational outcomes, as defined by
Moore et al. [15]. None of these previous studies evalu-
ated educators’ organizational support in regard to TPE
intervention delivery, even though the organizational
support is a major factor to consider when assessing the
impact of a CE activity [12]. To the best of our knowledge,
this study is the first controlled mixed methods study to
compare the impact of two CE activities on TPE in regard
to five educational outcomes, while qualitatively document-
ing how educators are supported by their organization.
In contrast to previous studies [53–55], our study will
objectively assess educators’ learning, using pre- and
post-tests of knowledge, as suggested by Moore et al.
[15]. Our study will also evaluate educators’ performance
levels in delivering high-quality TPE interventions, based
on observation measures of performance in each of the
educator’s professional practice.
Limitations
We
expect
our
study
to
have
limitations.
First,
non-differential measurement errors might occur, because:
(1) we designed an ad hoc assessment test to measure
educators’ learning, due to the fact that we wanted
the knowledge questionnaire to be aligned with the
learning objectives of both CE activities;
(2) we will assess educators’ performance levels in
delivering high-quality TPE education to a single
real patient, instead of videotaping educator en-
counters with both real and standardized patients,
as it has been suggested [56];
(3) educators’ performance will only be measured after
the CE activity;
(4) we will only perform a subjective assessment of
changes in patient outcomes, due to organizational
constraints.
Second, because the study is a pragmatic one, we ex-
pect that there could be some heterogeneity between the
TPE interventions that will be delivered by each of the
educators’ professional practice. Because what is referred
to TPE may differ from a setting to another, heterogeneity
is likely to have an impact on changes from baseline pa-
tient outcomes. Nevertheless, interviews with attendees
will help to describe the implementation of TPE programs
better, and, in turn, to explain our study results better.
Finally, we will compare, in the present study, two CE
activities that will include two independent components:
(1) the number of attendees (< 10 versus ≥10) and (2)
the learning format (active versus passive). In contrast to
a factorial design, our study design will not allow us to
understand the effect of each independent component
upon the educational outcomes.
Perspectives
To the best of our knowledge, our study is the first con-
trolled mixed methods study to compare the impact of
two CE activities on TPE in regard to five educational
outcomes. The experimental CE activity was designed to
promote the achievement of higher-order cognitive pro-
cesses and align its learning objectives, activities, and as-
sessments. We believe this study will serve as a model
for evaluating CE activities on TPE. Results from this
study could increase COPD educators’ performance
levels in delivering effective TPE interventions, and, in
turn, COPD patient outcomes.
Additional file
Additional file 1: Questionnaire on attendees’ learning. The
questionnaire on attendees’ learning comprises eight open-ended
questions aligned with the CE activity specific objectives. A professional
translator translated the items from French to English. (DOCX 46 kb)
Abbreviations
CAT: COPD Assessment test; CE: Continuing education; CI: Confidence
interval; COPD: Chronic obstructive pulmonary disease; HADS: Hospital
anxiety and depression scale; heiQ: Health education impact questionnaire;
MSLQ: Motivated strategies for learning questionnaire; QSCH: Quebec survey
on cardiovascular health; SD: Standard deviation; SGRQ-C: COPD-specific
version of the St. George’s respiratory questionnaire; SLCDC: Survey on living
with chronic diseases in Canada; TPE: Therapeutic patient education
Acknowledgements
The authors wish to thank Marie-Ève Boulay, M.Sc., Françoise Proust, Ph.D.,
and Julie Turmel, Ph.D. for assistance in revising the study protocol. We are
grateful to Erica Pridoehl, M.Ed. for editing the English manuscript. The
authors thank Barbara Pattison, trad.a. for translating the questionnaire used
to measure attendees’ learning from French to English.
Funding
The Laval University Knowledge Translation, Education and Prevention Chair
in Respiratory and Cardiovascular Health has received funding from
GlaxoSmithKline through its Medical Education Support Program for the
development, deployment, and evaluation of the educational component
(please refer to http://ca.gsk.com/en-ca/healthcare-professionals/independent-
medical-education/). The present study is funded by Dr. Louis-Philippe Boulet’s
local funds.
Availability of data and materials
We plan to include all quantitative data generated or analyzed during this
study in the published articles and their supplementary information files.
Audio-visual datasets generated or analyzed during the current study will
not be publicly available due to confidentially issues.
Authors’ contributions
All authors contributed to the study design. MG wrote the initial draft and
JM, SL, CH, PC, JB, and LPB revised it for important intellectual content. All
authors have given final approval of the version to be published and agree
to be accountable for all aspects of the work.
Authors’ information
M.G. will coordinate the present research project as part of her PhD thesis.
Gagné et al. BMC Health Services Research  (2018) 18:460 
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Ethics approval and consent to participate
The study, including the French version of the protocol (dated June 27, 2016),
has been approved by the Quebec Heart and Lung Institute Institutional Ethics
Committee (MP-10-2016-2591). Any protocol amendments will be approved by
the Quebec Heart and Lung Institute research ethics committee. The study
coordinator (M.G.) will be responsible for communicating any of these
amendments to coinvestigators and study participants.
We will obtain implied informed consent from educators who participate in
the satisfaction and learning assessments.
Before videotaping TPE interventions, we will ask educators for written
informed consent, whereas COPD patients, who will not be seen on the
videos, will provide verbal informed consent.
Educators will also provide written informed consent to participate in
interviews.
Before patient outcome assessments, we will obtain verbal informed consent
from COPD patients.
The consent form and other related documentation given to participants
and authorized surrogates can be obtained upon request from the Quebec
Heart and Lung Institute Institutional Ethics Committee at:
gur@criucpq.ulaval.ca.
Consent for publication
We will assure confidentiality by giving all participants a unique identifier.
We will remove any potentially identifiable information prior to reporting
and publishing our findings. We will obtain consent to publish from the
participant to report individual data.
Competing interests
The authors alone are responsible for the content and writing of this paper.
The Laval University Knowledge Translation, Education and Prevention Chair
in Respiratory and Cardiovascular Health is supported by unrestricted grants
from AstraZeneca. The Chair has received funding from GlaxoSmithKline for
the development and deployment of the educational component. The
program funds will not be used in connection with the research. The
funding body has no role in the study design, collection, analysis or
interpretation of data. The publication of our study results will not be
contingent on our sponsor’s approval or censorship of the manuscript. M.G.
considers having no conflict of interest, but wishes to declare what could be
perceived as potential conflicts of interest. Conference (honorarium):
AstraZeneca. J.M., S.L., C.H., P.C., and J.B. declare that they have no
competing interests in this work. L.P.B. considers having no conflict of
interest, but wishes to declare what can be perceived as potential conflicts
of interest. Advisory Boards: GlaxoSmithKline, Novartis. Conferences
(honoraria): AstraZeneca, GlaxoSmithKline, Merck, Novartis. Sponsorship for
investigator-generated research: AstraZeneca, GlaxoSmithKline, Merck Frosst,
Schering. Sponsorship for research funding for participating in multicenter
studies: AllerGen, Altair, Amgen, Asmacure, AstraZeneca, Boehringer-Ingelheim,
Genentech, GlaxoSmithKline, Novartis, Ono Pharma, Pharmaxis, Schering, Wyeth.
Support for the production of educational materials: AstraZeneca,
GlaxoSmithKline, Merck Frosst, Boehringer-Ingelheim, Novartis.
Organizational: Chair of the Global Initiative for Asthma (GINA) Guidelines
Dissemination and Implementation Committee, Knowledge Translation,
Education and Prevention Chair in Respiratory and Cardiovascular Health,
Member of the Executive Committee of Interasma (Global Asthma
Organization).
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in
published maps and institutional affiliations.
Author details
1Knowledge Translation, Education and Prevention Chair in Respiratory and
Cardiovascular Health, Laval University, Quebec City, QC, Canada. 2Quebec
Heart and Lung Institute, Laval University, Quebec City, QC, Canada.
3Population Health and Optimal Health Practices Research Unit, CHU de
Quebec Research Center, Quebec City, QC, Canada. 4Faculty of Pharmacy,
Laval University, Quebec City, QC, Canada. 5Faculty of Education, Laval
University, Quebec City, QC, Canada. 6Quebec Respiratory Health Education
Network, Quebec City, QC, Canada. 7Respiratory Epidemiology and Clinical
Research Unit, Research Institute of the McGill University Health Center,
McGill University, Montreal, QC, Canada. 8Faculty of Medicine, McGill
University, Montreal, QC, Canada. 9Faculty of Medicine, Laval University,
Quebec City, QC, Canada.
Received: 8 May 2017 Accepted: 8 June 2018
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