"Sufficiency, Accuracy, Clarity, Contextualization, and Interpersonal Adaptation - Safe, Digitally Supported Communication in Gynecology and Obstetrics: TeamBaby"
Phase: NA
Conditions: Pregnancy Related
Sponsor: Jacobs University Bremen gGmbH

STUDY PROTOCOL
Open Access
Communication and patient safety in
gynecology and obstetrics - study protocol
of an intervention study
Sonia Lippke1*
, Julian Wienert1
, Franziska Maria Keller1, Christina Derksen1
, Annalena Welp1
, Lukas Kötting1,
Kerstin Hofreuter-Gätgens2, Hardy Müller2,3, Frank Louwen4, Marcel Weigand3, Kristina Ernst5, Katrina Kraft5
,
Frank Reister6, Arkadius Polasik6, Beate Huener nee Seemann6, Lukas Jennewein4, Christoph Scholz6 and
Annegret Hannawa7
Abstract
Background: Patient safety is a key target in public health, health services and medicine. Communication between
all parties involved in gynecology and obstetrics (clinical staff/professionals, expectant mothers/patients and their
partners, close relatives or friends providing social support) should be improved to ensure patient safety, including
the avoidance of preventable adverse events (pAEs). Therefore, interventions including an app will be developed in
this project through a participatory approach integrating two theoretical models. The interventions will be designed
to support participants in their communication with each other and to overcome difficulties in everyday hospital
life. The aim is to foster effective communication in order to reduce the frequency of pAEs. If communication is
improved, clinical staff should show an increase in work satisfaction and patients should show an increase in
patient satisfaction.
Methods: The study will take place in two maternity clinics in Germany. In line with previous studies of complex
interventions, it is divided into three interdependent phases. Each phase provides its own methods and data. Phase
1: Needs assessment and a training for staff (n = 140) tested in a pre-experimental study with a pre/post-design.
Phase 2: Assessment of communication training for patients and their social support providers (n = 423) in a
randomized controlled study. Phase 3: Assessment of an app supporting the communication between staff,
patients, and their social support providers (n = 423) in a case-control study. The primary outcome is improvement
of communication competencies. A range of other implementation outcomes will also be assessed (i.e. pAEs,
patient/treatment satisfaction, work satisfaction, safety culture, training-related outcomes).
Discussion: This is the first large intervention study on communication and patient safety in gynecology and
obstetrics integrating two theoretical models that have not been applied to this setting. It is expected that the
interventions, including the app, will improve communication practice which is linked to a lower probability of
pAEs. The app will offer an effective and inexpensive way to promote effective communication independent of
users’ motivation. Insights gained from this study can inform other patient safety interventions and health policy
developments.
Trial registration: ClinicalTrials.gov Identifier: NCT03855735; date of registration: February 27, 2019.
Keywords: Preventable adverse events, Patient safety, Communication competences, Midwifery models of care,
HAPA, Participatory intervention development, Digitization, App, eHealth, Health services research
© The Author(s). 2019 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.
* Correspondence: s.lippke@jacobs-university.de
1Jacobs University Bremen gGmbH, Germany Campus Ring 1, 28759 Bremen,
Germany
Full list of author information is available at the end of the article
Lippke et al. BMC Health Services Research          (2019) 19:908 
https://doi.org/10.1186/s12913-019-4579-y

Background
Patient safety is a key target in public health, health ser-
vices, and medicine [1, 2]. In addition to medical skills
and knowledge, communication has been shown to be a
major contributor to patient safety, both within the
healthcare team and between healthcare professionals
and patients [3–5]. Communication, not only between
different professionals, but also between staff members
and patients or relatives, is a significant part in clinical
routine each day. Important information may be lost be-
cause of the use of medical terms and may result in re-
duced patient safety, especially when medical terms are
used with patients and their partners and relatives [3–5].
Different communication errors and barriers to effective
communication have been identified in parts of the clinical
team. Errors, such as the omission of important information,
describe the kind of suboptimal communication behaviors,
whereas barriers are obstructions to engaging in effective
communication behaviors and include organizational and
(inter-) personal factors such as rapidly changing healthcare
teams, work overload, lack of mutual respect, not feeling
part of the team, lack of self-confidence, and lack of training
[6]. In a review [7] it was summarized that “effective clinical
communication is respectful, clear, direct, and explicit. Con-
sistent execution of successful communication requires ex-
cellent listening skills, superb administrative support, and
collective commitment to move past traditional hierarchy
and professional stereotyping.”
Studies have shown that in clinical settings, poor
communication may be responsible for up to 80% of
all preventable adverse events (pAEs; e.g. [4]), which
are events affecting patient safety that are caused by
unsafe healthcare processes, rather than by the med-
ical condition of the patient [2]. PAEs can occur in
all clinical specialties, including gynecology and obstet-
rics [9, 18]. Besides communication between health-
care providers, many studies have demonstrated that
suboptimal doctor-patient communication is related to
pAEs, including medical errors [35]. Not only is it
important to communicate or disclose medical errors
to patients appropriately [10] but also to communi-
cate (more) safely and effectively in general [11]. In
obstetrics, clinical routine is challenging due to high
workload and risks of emergency calls (e.g., due to
emergency caesarean section) as well as because med-
ical staff is always responsible for both the mother
and the fetus/newborn.
A typical example of a pAE in gynecology and obstet-
rics is the confusion of maternal and infant pulse rates
during childbirth, which could result in life-long damage
to the fetus due to asphyxia during childbirth (damage
case analyses by [12]). This pAE may be caused by the
ineffective use of available resources due to poor com-
munication between the different partners (staff, patients
and their accompanying persons/ social support pro-
viders, [13]). PAEs in gynecology and obstetrics include
any physical or mental injury to the pregnant woman,
fetus, or newborn due to poor communication, which
may lead to incorrect medical decisions causing still-
births, perinatal, neonatal or maternal mortality, un-
planned caesarean sections, neonatal morbidity, blood
loss, and hemorrhage [8].
With regard to the prevalence of pAEs, an observation
study conducted in obstetrics and gynecology by November
et al. in Boston, USA, identified forty-one pAEs within a
time frame of 12-weeks [14]. In a recent international meta-
analysis by Tanaka, Eriksson and Obermair, the incidence of
adverse events in gynecological hospital admissions was
10.8% [15]. Of these adverse events, 52.5% could have been
prevented and 1.2% resulted in death. The authors note that
“preventability can only be assessed from available docu-
mentation and can be influenced by study personnel experi-
ence, and knowledge [ …] amendments [ …] need to take
place to improve healthcare delivery in gynecology” (p.
198f). Improved communication is also likely to result in
better healthcare provider and patient outcomes. For in-
stance, a recent study has discussed the importance of com-
munication between healthcare professionals and physician
well-being. Physician burnout was associated with an in-
creased risk for unsafe care, unprofessional behaviors, and
low patient satisfaction [16–18]. This is especially true when
under time constraints [6, 19, 20].
Patient satisfaction is an important patient-centric out-
come for a gynecological clinic and its staff. Giving birth can
be a positive experience but it can also be painful. The more
pain a mother experiences and the longer her convalescence
lasts, the more it affects her satisfaction. Despite healthcare
providers’ awareness of this relationship, there is still room
for improvement in pain treatment during labor [21]. Effect-
ive communication is one key in pain management, espe-
cially under high stress and demands. Accordingly, this
needs to be improved based on empirical evidence. Empir-
ical evidence on the effectiveness of communication training
is ambiguous. Several studies show that communication er-
rors and barriers can be reduced by efficient training pro-
grams that help individuals to identify, prevent or manage
such errors and barriers. For instance, one study demon-
strated that a standardized team-training program for
healthcare professionals in obstetric units, based on an ana-
lysis of common causes for adverse events, was found to
successfully raise professionals’ confidence in dealing with
complex emergency situations [12]. Perceived ownership of
staff has been demonstrated to be the key moderator of the
effectiveness of such trainings [22]. However, a recent sys-
tematic review concluded that “Current evidence is inad-
equate to inform content of training or practice“[9]. Thus,
communication between professionals and with patients
should be structured [23, 24] specifically to the specific
Lippke et al. BMC Health Services Research          (2019) 19:908 
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context. The primary aim of our project, which is theoretic-
ally grounded in models of health-related communication
[11] and behavioral change (HAPA) [25], is to improve com-
munication behaviors in gynecology and obstetrics. The sec-
ond aim is to reduce pAEs and increase healthcare provider
and patient satisfaction.
Communication
A multitude of models of communication in healthcare
exists. Accurate, clear communication is central to all of
them. For instance, communication is one of four cen-
tral aspects in the TeamStepps framework of teamwork
in healthcare, which has been validated in many clinical
settings, including obstetrics [26–28]. The communica-
tion dimension of this framework utilizes different tools
to facilitate communication between healthcare pro-
viders, particularly in critical situations like emergencies
or handovers. These tools include check-back (or closed-
loop communication) to ensure the recipient has under-
stood the sender’s information correctly, callout, which
is used to convey critical information to a larger group
of people efficiently, SBAR (an acronym standing for
situation, background, assessment and recommendation),
which can be used when requesting help in emergency
situations, and a checklist for handovers [29]. The im-
portance of sufficient, accurate and clear conveyance of
information is also represented in the SACCIA model by
Hannawa [11]. The acronym "SACCIA" stands for five
core competencies that constitute safe communication
in
healthcare:
"Sufficiency",
"Accuracy",
"Clarity",
"Contextualization" and "Interpersonal Adaptation". The
model has been used to classify communication causes
of critical incidents, and it explains how communication
errors put patient safety at risks [30].
According to the SACCIA model, focusing on trans-
porting factual information is necessary for effective com-
munication, but not sufficient, especially in obstetrics.
Communication, and interpersonal/relational dimensions
in particular, have also been identified as one of four di-
mensions in midwifery models of care. In obstetrics, the
biomedical
or
pathogenic
approach
to
patient
care
adopted by physicians may clash with nurses’ or midwives’
salutogenetic approaches [31]. These models consider that
– unlike most other reasons to visit a hospital – birth is a
natural process in most cases and a joyful moment for the
parents, but it can also cause uncertainty or fear. Thus,
consideration of interpersonal or relational aspects of
communication with the expectant mother – such as be-
ing respectful of and taking her emotions into account –
is essential to transport important information to and
from the mother and accompanying persons. Moreover,
focusing on interpersonal communication with other team
members is likely to improve team functioning [32] and
thus increase team members’ motivation to engage in
more technical communication.
In addition, the model of relational coordination (com-
munication between healthcare providers) and relational
coproduction (communication between healthcare pro-
vider and patient, [33]) is defined as ‘a mutually reinfor-
cing process of communicating and relating for the
purpose of task integration’ ([34], p. 301). It combines
the technical dimensions of communication (frequent,
timely, accurate, and problem-solving) with interper-
sonal communication goals (shared goals, shared know-
ledge, and mutual respect [35]). The relational aspect of
this model has been adapted to the communicative
process of decision-making between midwives and ex-
pectant mothers as a response to the critique that in-
formed choice or shared decision models rely too much
on factual information without taking the context or
conversation partner into account [36].
If the communication competencies are practiced
adequately, the quality of healthcare communication is
increased and, as a result, risk of pAEs is reduced.
[11]. This objective can be achieved through training
sessions,
and
digitization
(telehealth,
eHealth,
mHealth) [37] opens new avenues, especially in times
of work concentration due to efficiency increasing,
skills shortage due to few experts on the labor market,
and multi-tasking as a societal trend [2, 16, 17]. There
are multiple advantages to digital training, such as
adaptability to the user’s needs [38], just-in-time-in-
terventions [37] and a high number of potential users
who are motivated to participate due to technological
interests instead of the content, making it easier to
reach rather unmotivated individuals [39, 40].
Behavioral change
While the models described above [33, 36] provide theor-
etical frameworks describing communication, they do not
explain how effective communication behaviors can be
implemented into daily practice. For instance, the incon-
sistency between knowledge about pain management and
actual pain management described above begs the ques-
tion why mothers are not treated more adequately if pro-
fessionals know about the relationship between pain and
patient satisfaction. The Health Action Process Approach
(HAPA) [25] model describes how to translate the
intention/motivation to adopt a new behavior into actually
adopting the behavior, and specifically takes the role of
motivation and awareness of a situation into account. The
HAPA model has been found useful to describe, explain
and successfully improve behaviors in a variety of settings,
particularly in healthcare and preventive settings [38–42].
Modules for trainings and interventions can be developed
and structured based on the HAPA model (Fig. 1).
Lippke et al. BMC Health Services Research          (2019) 19:908 
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The HAPA model suggests a distinction between the
(a) motivational phase that leads to a behavioral goal
intention/motivation,
followed
by
the
(b)
volitional
phase that leads to the actual health behavior [41].
Within the two phases, different patterns of social-
cognitive predictors may emerge (see Fig. 1). In the ini-
tial motivation phase (a), a person develops an intention
to act. In this phase, risk perception is seen as a distal
antecedent (e.g., “I am at risk for poor communication”).
Risk perception in itself is insufficient to enable a person
to form an intention. Rather, it sets the stage for a con-
templation process and further elaboration of thoughts
about consequences and competences. Similarly, positive
outcome expectancies (e.g., “If I communicate effectively,
I will reduce my risk for adverse events and being unsat-
isfied”) are most relevant in the motivation phase when
a person evaluates the pros and cons of certain behav-
ioral outcomes. One needs to believe in their capability
to perform a desired action, which is conceptualized as
perceived self-efficacy (e.g., “I am capable to communi-
cate effectively in spite of the high time pressure or diffi-
cult communication partners”). Perceived self-efficacy
operates in concert with positive outcome expectancies,
both of which substantially contribute to forming an
intention. Both beliefs are needed for forming intentions
to adopt difficult behaviors, such as effective communi-
cation. After forming an intention, the volitional phase
(b) is entered.
When a person is inclined to adopt a particular
health behavior, the ‘good intention’ has to be trans-
formed into detailed (self-)instructions on how to per-
form the desired action by means of planning [43].
Once an action has been initiated, it has to be main-
tained. This is not achieved through a single act of will
but involves ongoing use of self-regulatory skills and
strategies. Thus, the volitional phase should be further
broken down into more proximal factors, such as
planning, self-efficacy, and social support. Social sup-
port is one factor reflecting the barriers and resources
as part of the HAPA model: Support is a resource, and
the lack of it can be a barrier to adopt or maintain
health behaviors [42]. Instrumental, emotional, and in-
formational social support can enable the adoption
and continuation of behaviors. Social support can be
addressed by means of directly integrating important
network partners. For patients in gynecology and ob-
stetrics, this network does not only include the profes-
sional at the clinic but also their social support
providers such as the spouse or partner, key family
members, friends, or the attending midwife who might
not be employed with the hospital [9, 20]. Therefore, a
dyadic perspective focusing on both the patient and
their social support providers should be taken. For
healthcare professionals, an intervention that uses a
structured and applicable approach to enhance com-
munication might help them to communicate effect-
ively under a heavy workload. On the one hand,
negative effects of impaired physician well-being on
communication might be avoided; on the other hand,
it is possible that communication becomes less chal-
lenging, which relieves stress. This has been shown in
the context of nursing homes [44]. We therefore aim
to include stress management in the HAPA model for
healthcare professionals as a training-related outcome.
Multiple studies explain the usefulness of the HAPA
model to describe and promote behavior and behavior
change (e.g., [45] including compliance [42], hand hy-
giene [46, 47] and vaccination [48]).
Research questions and hypotheses
The interventions in this study will integrate the HAPA
model and SACCIA-inspired communication competen-
cies into an advanced training delivered face-to-face in
groups of clinical staff, patients and their social support
Fig. 1 Components of the HAPA model and planned training modules for improving communication competences and adopting the behavior
“effective communication”
Lippke et al. BMC Health Services Research          (2019) 19:908 
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providers. In addition to this, a state-of-the art interven-
tion will make use of digital options by translating the
training material into an app [39, 40]. Previous research
has shown that patient coaching can be an intervention
to improve communication [49–51], and professionals
can also significantly benefit [52, 53].
The research questions of this project are the following:
what is the effect of a communication training delivered
face-to-face and via a digital app on effective communication
behaviors? To what extent can patient and healthcare pro-
vider satisfaction be improved and pAEs be reduced by im-
proving
effective
communication
behaviors?
“Effective
communication” is defined and operationalized in this pro-
ject within the "SACCIA" framework [10, 17]. Beside these
main outcomes, personal (e.g., perceived stress, coping) and
training-related outcomes (e.g., goal intentions, action plan-
ning) will be assessed (see Table 1).
This will be scientifically evaluated using a three-phase
study, in which phases are built sequentially on each other
and described in detail in the method section: Phase 1, imple-
mentation phase (including needs assessment, retrospective
cohort study of pAEs) and pre-experimental study with a
group and pre−/post-test testing the effect of a training for
professionals; Phase 2, quasi-experimental efficacy study with
a randomized controlled trial study design (RCT) testing the
effect of a training addressing patients and their social sup-
port providers; Phase 3, implementation of the app, aimed at
staff, patients, and their social support providers, which will
test the effect in a case-control study. Efficacy indicators are
outlined in Table 1.
The hypotheses are the following: for Phase 1, it is ex-
pected that as a result of the training (1.) the communica-
tion competences of healthcare providers will measurably
improve. As a result, (2.) healthcare providers will be more
satisfied (3.) and the number and severity of pAEs should be
significantly reduced for short and medium term (i.e. over
the period of the intervention study and beyond). In Phase
2, it is expected that patients and their social support pro-
viders in the intervention group will develop significantly
(4.) higher competences in communication with staff as well
as (5.) higher satisfaction after the intervention compared to
patients and their social support providers in the control
group. It is also expected that (6.) the number and severity
of pAEs in the intervention group will be significantly re-
duced compared to the number and severity of pAEs in the
control group. For Phase 3, we hypothesize that the inter-
vention group using the app compared to the intervention
group without the app will show (7.) higher patient and
healthcare provider communication competences and (8.)
satisfaction as well as (9.) a significant reduction in the num-
ber and severity of pAEs. The effects of the training on com-
munication competences may be (10.) mediated by training-
related
and
personal
outcomes
and
moderated
by
organizational factors (11.). All interventions in all phases
will improve organizational outcomes if communication
competences are improved successfully. Thus, the hypoth-
eses will be tested in this project.
There are three aspects that make this project particu-
larly unique. At first, previous studies have not combined
the underlying theories of communication and HAPA, and
tailored the intervention to the healthcare context. Sec-
ondly, the utilization of a digital app is expected to
increase participation and training effectiveness. Thirdly,
the project addresses healthcare providers, patients and
their social support providers, regarding all people involved
in developing effective communication and public health.
Methods/design
The project will apply a step-wise study design with three
study phases in two level one perinatal maternity clinics:
Implementation phase and pre-experimental study (Phase
1), a quasi-experimental efficacy study (Phase 2), and a
case control study (Phase 3; Fig. 2).
For the study flow of enrollment and interventions for
each phase, see the Appendix. All study participants are
professionals, patients and social support providers in
two
participating
gynecology
and
obstetrics
clinics,
Table 1 Overview of the addressed concepts and hypotheses (numbers in brackets represent the hypotheses as described in text below)
Phase 1
Phase 2
Phase 3
Communication competences (1., 4., 7.)
↑
↑
↑
Preventable adverse events (pAEs) (3., 6., 9.)
↓
↓
↓
Healthcare provider satisfaction (2., 8.)
↑
↑
↑
Patient satisfaction (5., 8.)
–
↑
↑
Training-related outcomes1 (outcome expectancies,
goals and intention, action planning, coping planning,
behavior, self-efficacy) (10.)
↑
↑
–
Personal outcomes (stress, coping, subjective
safety culture) (10.)
↑
↑
↑
Organizational outcomes (adherence to safety
culture) (11.)
↑
↑
↑
Note: 1As described in the HAPA model; ↓= Hypotheses that criteria decreases due to the training; ↑= Hypotheses that criteria increase; −= no evaluation planned
Lippke et al. BMC Health Services Research          (2019) 19:908 
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therefore, they receive the regular treatment as patients
in terms of healthcare or as staff with human resource
(HR) management. Table 2 provides a summary of
outcome variables across the study phases.
Phase 1: implementation phase and pre-experimental study
Overview of research questions and methods
For Phase 1, we conduct a needs assessment with regard
to overall patient safety, based on the approach proposed
by van Sluisveld et al., which aimed to improve the safety
of patient transfers in intensive care units [63]. In the
current
project,
this
approach
will
be
applied
to
gynecology and obstetrics clinics with their staff, patients
(expecting mothers/women who are about to deliver or
who gave birth recently), and social support providers
(e.g., spouse/partner, relatives, close friends¸ Fig. 2). The
approach differentiates into stages A to E (see Table 3),
which will be conducted accordingly in the current study.
Observations for the ethnographic analyses will be re-
corded using a standardized observation protocol [30]. The
qualitative data will be analyzed in terms of inductive con-
tent analysis and will be used to develop the training. The
details of this approach are described in Sluisveld et al.
(2013) [63]. Focus groups and interviews will be conducted
with partially standardized guidelines with at least one
person from each occupational group in order to gain an
impression of potential resources and barriers as compre-
hensive as possible (as found by previous research, e.g. [6])
for the implementation of the intervention [22]. Immigra-
tion background will be considered during data collection
and testing as well as during app development (i.e. it will be
ensured that patients and social support providers with an
immigration background will also be included in the
development as cultural background was found to influence
communication behaviors [9, 61, 62, 64]).
This approach will lead to a comprehensive under-
standing of factors that facilitate and inhibit effective
communication and pAE’s. Additionally, it will identify
possibilities and potential benefits for the implementa-
tion of the intervention in the field, e.g., how communi-
cation competences can be integrated into clinical
practice beyond the training. Possible options include
daily communication logs, regular e-mails with tips on
practical application etc.
The results will be used to develop the training for
professionals (physicians, nursing staff, training assis-
tants, psychologists, midwives), which will be imple-
mented in Stage E of Phase 1 in this project (pre-
Fig. 2 Study flow with project phases and stages, study participants and outcome (Study Flowcharts for all three Phases are in the Appendix).
Note. The phases consist of different stages (see Table 3). Stages A to C (see Table 3) will be addressed in Phase 1. Stages D and E will be
addressed in Phase 1 and 3
Lippke et al. BMC Health Services Research          (2019) 19:908 
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experimental study; see Fig. 4 in the Appendix). The re-
sults will also be used to develop the training for patients
and their social support providers in a quasi-experimen-
tal efficacy study in Phase 2 (see Fig. 5 in the Appendix).
An equivalent procedure applying and testing a training
program was successfully performed in a recent study
[12]. However, only staff members were addressed and
no communication competences or HAPA variables
were targeted. In the current study, due to theoretical,
ethical
and
methodological
reasons,
all
individuals
should get the benefit of the training. All professionals
will be assigned to the intervention group and the evalu-
ation will be done by a pre/post comparison.
Translation of the HAPA model into practice – development
of the training
The design of the communication training will be informed
by theory and previous empirically tested trainings. Exhibit-
ing effective communication will be the desired behavioral
outcome as specified in the HAPA model (Fig. 1). Perform-
ance modeling, performance desensitization (stemming
from work on fears and anxiety disorders), performance ex-
posure
and
self-instructed
performance
are
all
good
methods for designing treatments that target enactive
mastery experience [37, 38], or maintain the desired behav-
ior in the HAPA model. An example would be to instruct
persons to monitor and record how many times a day they
have performed effective communication in face of time
pressure and to track this on paper (Phase 1 and 2), or in
the app (Phase 3). All of the above elements will be inte-
grated into the trainings for professionals (in Phase 1, see
Table 4) and for patients and their social support providers
(in Phase 2, see Table 5).
Training for professionals will take place during work
hours and will last approximately 4 hours. Training for pa-
tients will last approximately 8 hours. The concrete devel-
opment of the intervention content and procedure, in
addition to the above description, is an important step to-
wards employing participatory intervention development
within this first study phase. The subsequent publications
on the actual intervention contents and procedures will
contribute to the current paper and allow for the replica-
tion of this study, including the interventions.
Procedure, sample, and data collection
Training for professionals at the clinics will integrate the
communication competences and will be designed based
on the HAPA model. A short manual will be provided to
support the participants in implementing the lessons they
Table 2 Overview over the outcome variables and covariates considered in the different study phases
Phase 1
Phase 2
Phase 3
T1
T2
T1
T2
T1
T2
Primary outcomes
Communication competences1
X
X
X
X
X
X
Preventable adverse events (pAEs)2
X
X
X
X
X
X
Secondary outcomes
Healthcare provider satisfaction3
X
X
X
X
X
X
Patient/treatment satisfaction3
(patients/social support providers)
X
X
X
X
Training-related outcomes4
X
X
X
X
X
X
Personal outcomes5
X
X
X
X
X
X
Organizational outcomes
Adherence safety culture6
X
X
X
X
X
X
Subjective safety culture7
X
X
X
X
Covariates
Socio-demographic variables
including migration status8
X
X
X
Note: Examples for the measurements are:
1 Self-developed questionnaire
2 Operationalized via trigger events (such as unavailable staff, equipment failure, readmissions, length of stay, communication error) as defined by [54, 55]
3 Nurses’ job satisfaction scale [56]
4 HAPA questionnaire including outcome expectancies, goals and intentions/motivation, action planning and coping planning, behavior, self-efficacy, perceived
stress see [25, 42, 45–48]
5 Emotional exhaustion, depersonalization, perceived social support [4, 57]
6 The Hygiene Inventory - 23 items (HI-23) [58]
7 Measures equivalent to the ones used in [59, 60]
8 Age, gender, education, professional experience, depressive symptoms, anxiety and migration [61, 62]
Lippke et al. BMC Health Services Research          (2019) 19:908 
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learn into their working practice. Written documentation
of the training will also be provided to avoid failure of im-
plementation. The training will be offered to all profes-
sionals at both intervention sites. Its effectiveness will be
tested in the pre-experimental study, which aims to inves-
tigate the association between training participation and
the reduction/occurrence of pAEs, to observe the mecha-
nisms that make the training successful with regard to
supporting professionals in their work and understanding
how patient training can be implemented in Phase 2.
The study (Stage E of Phase 1) has a one-group,
pre−/post-design (see Fig. 4 in Appendix). It includes
all professionals (e.g., doctors, nursing staff, midwives/
obstetricians, training assistants, psychologists) at all
locations and intends to recruit a total of N = 140
participants without any participant exclusion criteria.
Professionals
will
be
trained
in
interdisciplinary
groups of 10 to 12 participants. Recruitment will take
place via the hospitals involving line managers, works
Table 3 Implementation phase: Research questions, methods, study participants and target criteria with regards to patient safety
Stage Research questions
Methods
Target group/data source
Outcome measures
A
What is the status of communication
competences?
Questionnaire (self-
developed)
Healthcare providers
Communication competences as
described by the SACCIA framework
What is the prevalence of pAEs?
Routine data
Mixed Methods study,
Analysis of birth protocols
(observations), staff
questionnaire
Anonymous routine data of
the hospital from the last year
(2018), birth protocols and
patient records, subjective
prevalence
Quality indicators: pAEs such as
unavailable staff, equipment failure,
readmissions, length of stay,
communication errors
B
What are effective interventions
to improve safety and communication
in everyday hospital life?
Scoping review
Pubmed, PsychInfo, Cochrane
Database
Web of Science Core
Collection database1
Overview of effective interventions
and effect sizes
C
What is the adherence for current
patient safety measures (e.g., hand
hygiene)?
Questionnaire, e.g., HI-23
All professionals at both
intervention sites
Adherence to patient safety
measures; relationships between
adherence and quality indicators incl.
patients’ satisfaction with their
treatment and professionals work
satisfaction
D
What are the resources and barriers
for the implementation of an
intervention in order to optimize
communication in everyday hospital
life?
Ethnographic observation;
Individual semi-structured
and focus group interviews
Physicians, nursing staff,
training assistants,
psychologists, midwives
Resources and barriers classified
according to: (1.) intervention
characteristics; (2.) societal context,
(3.) implementation characteristics,
(4.) institutional characteristics, (5.)
social context, (6.) professional
characteristics, and (7.) patient
characteristics.
E
What is an appropriate strategy to
implement effective interventions to
optimize communication?
Intervention mapping with
the method of Bartholomew
and Kok (2011), triangulation
of results from previous
stages
Matching of data from
interviews, focus groups and
questionnaires with evidence
from the literature
Implementation strategy tailored to
the found resources and barriers to
the implementation of effective
interventions to increase patient
safety
Note: pAEs = preventable adverse events; the content of this table is based on Table 2 in [63]
1The literature search for this paper used the following search term combinations:
Communication Training/Intervention AND Resource AND Implementation AND Health Experts
Communication Training/Intervention AND Barrier AND Implementation AND Professionals/Patients
Communication Training/Intervention AND Resource/Barrier AND Outcome Expectancies
We always maintained “Communication, Training, Intervention, Resource, Barrier” as search terms and will refine the larger searches with the following terms:
Intention, plan, behavior, social-cognitive
Table 4 Contents and planned structure of the training for
professionals (in Phase 1)
1st part
2nd part
Introduction and warming up;
preview learning goals
and reflection on expectations
Case studies and analyses
with practical exercises
and discussion
Training Part 1:
Introduction in communication
and patient safety
Module 2:
Improvement of self-efficacy
Training Part 2:
Previous experiences with
communications skills/challenges
Training Part 3:
Further work on communication
competences
Module 1:
Improvements of outcome
expectancies
and goal setting
Module 3:
Development and reality check
of action and coping plans
Transfer, reflections and feedback
Closing meeting with rounding
up, further transfer exercise
Active break with networking and
social support
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councils, quality management departments, and HR
departments. They will be involved to ensure adequate
participant enrollment to reach target sample size. Partici-
pants will be included in the analysis only if they provide
informed consent, which will be collected by project man-
agers working at the hospitals. Data will be analyzed ac-
cording
to
intention
to
treat.
If study
participants
withdraw their consent to be contacted for follow-up mea-
surements at any point, their contact details will be re-
moved from the database. If they indicate that they do not
want their data included in the analyses, their data will
also be removed. Otherwise, they will be considered as
study dropout. All target criteria are shown in Table 2.
Statistical analyses
Training effects will be tested by evaluating differences
between the measurement times using linear and general
mixed models. Baseline values of the first measurement
time point will be considered as covariates. Clinics are
modeled as fixed effect. Key demographic variables such
as age, gender and occupation will be used to calculate
selectivity in dropout rates. Missing data per measure-
ment point, but also over time, will be treated by ad-
vanced methods to handle missing data such as the full
information maximum likelihood method (FIML; this
will be the same in all other phases, too).
Phase 2: quasi-experimental efficacy study
Aim/overview of research questions and methods
In Phase 2 (see Fig. 2 and Fig. 5 in Appendix), the effect-
iveness of the communication competences intervention
for the target group of patients and their social support
providers will be tested using the gold standard, i.e. a ran-
domized control trial (RCT). This intervention will be
based on all stages of Phase 1 of this project, and thus will
be developed in a participatory approach with patients
and professionals working in the clinics [63]. The inter-
vention will enable patients and social support providers
to gain knowledge about the prevalence of pAEs and com-
munication problems as well as expectations of action re-
sults. Moreover, it will allow participants to practice
communication competences and develop their self-
efficacy. Furthermore, the intervention will utilize the pro-
vided theoretical input in order to integrate theory into
everyday hospital life by means of action and coping plans.
To implement the acquired competences as effectively as
possible, the following three components will be addressed
in the intervention [65]:
1. the motivation or intention to communicate
effectively and confidently with each other,
2. the knowledge of what is crucial for effective
communication,
3. the ability to communicate effectively.
The intervention is based on the HAPA model as a
social-cognitive model for behavioral change [25] and
communication competences (see description of the
training above in Phase 1). Participants will be trained in
groups by specialized instructors over the course of one
and a half days in facilities of the participating clinics
(see Table 5, and Fig. 5 in Appendix).
Procedure
In each hospital, four professionals will be taught in a train-
the-trainer seminar to train patients and their social support
providers based on the short manual developed to teach
communication competences. Recruitment will take place
via the doctors, nurses and midwives in the hospitals (Fig. 5
in Appendix). The quality management departments will be
involved to ensure adequate enrollment in order to reach
the target sample size of N = 423 participants. Informed
consent will be collected by on-site project managers. When
an expectant mother is admitted to the clinic and agrees to
participate in the study, she will be randomly assigned to a
training group (IG) or a control group (CG). If she is ac-
companied by a partner, relative, or close friend, they will be
assigned to the same group. All patients and social support
providers randomly assigned to the intervention group will
receive the same training content over the course of this
Table 5 Contents and planned structure of the training for
patients and their social support providers (in Phase 2)
1st day1
2nd day
Introduction and warming up;
preview learning goals and
reflection on expectations
Introduction and warming
up
Training Part 1: Introduction in communication
and patient safety
Module 2: Improvement
of self-efficacy
Active break for networking
and social support
Active morning break
Training Part 2: Previous experiences with
communications skills/challenges
Training Part 3:
Further work on
communication
competences
Module 1: Improvements of
outcome expectancies and
goal setting
Active break for networking
and social support
Active break for networking
and social support mobilization
Case studies and -analyses
with practical exercises and
discussion
Module 3: Development
+ reality-check of
action and coping plans
Transfer, reflections and feedback
Closing meeting with
rounding up further
transfer exercise
Note: 1Patients and their social support providers receive the training
during two mornings. If participants are interested in an advanced
training, another session will be provided
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study. In contrast, the control group will receive the hospital
care-as-usual (see Fig. 5 in Appendix).
Randomization will be done per site and day (block
randomization). The central project coordinator will
generate the allocation sequence. Depending on this
sequence, all patients admitted to the hospital on that
day will be allocated to either the IG or to the CG.
Patients and staff will not be informed beforehand on
which days allocation to the IG or the CG takes place
to prevent biases. Instead, the on-site project manager
at each hospital will receive a sealed envelope each
day containing this information, enabling them to in-
form other staff involved as well as enroll and assign
participants to the CG or IG treatment. This process
allows trial participants, general care providers, out-
come assessors and data analysts to remain blinded
throughout the allocation sequence. Trial participants
and general care providers will be unblinded in case
they ask for more information about the training. Re-
vealing a participant’s allocated intervention during
the trial can be performed after completion of the IG
treatment to disclose the content of the intervention.
A flyer will be provided containing this information,
which will be also used after the study to disseminate
findings and tools. Inclusion and exclusion criteria are
outlined in Table 6.
According to a power analysis, a sample of N = 352
is necessary (alpha error = 0.05, power = 80%, to be
analyzed IG
analysis: N = 176; CG
analysis: N = 176) in
order to detect an effect size of d = 0.3. With an as-
sumed drop-out rate of 20%, N = 423 participants (IG
recruited: N = 212; CG recruited: N = 211) have to be re-
cruited in the study. The pAEs will be collected on
an individual basis (anonymized) and coded according
to the communication competences (see Fig. 5 in
Appendix).
Statistical analyses
The target criteria (see Tables 1 and 2) will be evaluated
statistically and clinically, as in Phase 1, with linear and
general mixed models and with superiority trial tests to
investigate whether the intervention is better than the
standard care. As expecting mothers and their social
support providers participate in the intervention, dyadic
data will be assessed and analyzed. Additional analyses
will test whether subgroups of patients with psycho-
logical risk factors (e.g., depressive symptoms, anxiety)
and low motivation benefit from the intervention to the
same extent as study participants without such risk fac-
tors. Furthermore, adjusted analyses will be performed
in terms of ANCOVAs considering factors related to so-
cial inequality, such as education, anxiety, and immigra-
tion status (see also Table 2).
Phase 3: implementation of the app and case-control study
Functions of the app
A digital app will be developed to help users communicate
well. The app will be developed in a participatory and
theory-driven way from all findings and conclusions ob-
tained in Phases 1 and 2 (Fig. 2) [66]. Stages D and E of
Phase 1 will be repeated with professionals, expecting
mothers/patients, and social support providers to update
the evidence and answer questions that may have arisen
during Phase 2. The aim of Phase 3 is to determine exactly
how the app can support communication between profes-
sionals, patients, and their social support providers in their
daily work/hospital experience and thereby lead to a reduc-
tion in pAEs. As app users will have completed the face-to-
face training, they can use the app at their convenience to
monitor their behavior and experiences (see Fig. 3) and
deepen their skills and knowledge. To achieve this aim,
there will be two functions of the app.
Firstly, the app will be designed to provide guidance on
how to cope with specific (future) communication problems
including communication initiated by a) the patient, b) the
professional and c) between professionals. The following
scenarios illustrate how the app may improve communica-
tion. Regarding a), if a woman prepares for a conversation
with a professional in a labor ward, she may worry about
how to express the wish for peridural anesthesia or more
anesthesia if the pain escalates (cf. [21]). The app explains/
provides suggestions to her (and her social support pro-
viders) how to communicate this wish in a clear and con-
structive way [43, 51] (Fig. 3). This may enable shared
decision making in terms of understanding risks and disad-
vantages. Furthermore, she is supported to ask the right
questions or maybe even audio record her questions and the
Table 6 Summary of the inclusion and exclusion criteria
Inclusion criteria
Exclusion criteria
Expectant mother or patient in
gynecology and obstetrics or
social support providers
(spouse/partner, relative,
close friend) to be recipient
of the training
Professional in a gynecology
and obstetrics hospital to be
trainer of the patients and the
social support providers
Not proficient in the
German language and/or does not have the
capability of writing
Severe cognitive deficits
(unable to read/write/
answer questions) and
impairments due to
diagnosed brain injuries,
neurological disorders, etc.
Insufficient corrected
eyesight (patients must be
able to read on the cell
phone)
Participation in another
research study or
intervention trial conducted
in the clinic
Aged 18 years and above
Younger than 18 years
Healthy volunteers
High risk, emergency case
Declaration of consent
for participation in the study
Withdraw of consent for
participation in the study
at any point in time
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answers from professionals, as it has been done in previous
research [49]. Regarding b), a doctor may be unsure how to
handle the expectant mother’s fear of childbirth and post-
partum posttraumatic stress disorder (cf. [67]). Typical prob-
lems include sharing bad news and dealing with difficult
emotions [24, 68, 69]. The app would help the doctor to
communicate accurate information in a way that still ad-
dresses the fear that may come along with bad news. This
may prevent complications due to insufficient information.
Professionals will be asked to analyze and solve scenarios
that involve both patients and their social support providers.
The app will then explain the communication compe-
tences again and give concrete suggestions how to use
them for solving the case. Depending on demands, the
app will give suggestions such as “Speak slowly”, “Try not
to use acronyms or abbreviations”, “Try to refrain from
using scientific terms”, “Make use of visualizations”, “Be
sensitive to verbal and non-verbal cues that may indicate
lack of understanding”, “Stress the most important aspects
that the patient must keep in mind”, and “Make use of the
teach-back method” [19]. Regarding c), one team member
of the delivery ward knows that a high-risk patient in labor
needs
prophylactic
negative-pressure
wound
therapy
(NPWT) after cesarean delivery, but they do not know
how to communicate this to colleagues under time pres-
sure [20]. The app helps to overcome time pressure by
providing a message on the display for the colleagues
which can be copied to a piece of paper, and thus support
communication [70]. All of the above cases will be pro-
vided to colleagues, who will be asked to analyze and solve
them. Communication competences will be explained
with regard to communication between colleagues. De-
pending on demands, specific suggestions such as com-
munication tools (daily goal sheet, bedside whiteboard, or
door communication card), trust building, mindfulness,
and reflective exercises will be given [71].
Secondly, the app will assist in monitoring typical or re-
cent communication with focus on (1.) one’s own role, (2.)
the role of the communication partner and (3.) resonance
(a feeling of mutual understanding), thus supporting the
development of general communication competences.
These aspects will be evaluated with regard to the com-
munication competences (see Tables 1 and 2).
Learning from the communication of all participants is en-
sured by collecting dyadic self-reported data and the partners
reported data. Concretely, target-group specific tasks that
train general communication competences seldom aid to
overcoming specific obstacles, so reminders of resources and
application/transfer options will be provided in the app, too.
Procedure, sample and data collection
Patients will be recruited via doctors and midwives in the
hospitals; recruitment of staff and collection of informed
consent of both patients and staff will be conducted by the
on-site project managers. Quality management departments
will be involved to ensure adequate participant enrollment
to reach the target sample size. The target criteria of the pa-
tient sample will be evaluated statistically and clinically as in
Phase 1 and 2 (see Table 2). Group differences will be tested
with linear and general mixed models and with superiority
Fig. 3 Example of the monitoring and guidance functions of the app
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trial tests that investigate whether the intervention is helping
more than the standard care in Phase 2.
Statistical analyses
To test the effectiveness of the digital app, a case-control
study will be performed (see Fig. 6 in Appendix). Cases
are newly recruited individuals that fulfil the inclusion cri-
teria outlined in Table 6. Comparators/controls are the
participants in one of the two intervention arms of the
previously conducted RCT study in Phase 2 (i.e. patients;
historical control groups; No-Treatment CG analysis: N =
176;
No-Treatment
CG
recruited:
N = 212;
Previously
Treated/Active CG analysis: N = 176 (called IG1 in Fig. 6 in
Appendix); Previously Treated/Active CG
recruited: N =
212, see in section Phase 2). N = 176 participants need to
be analyzed for the intervention group (IG2 analysis). As-
suming a drop-out of 20%, N = 212 participants have to be
recruited for the intervention group (IG2 recruited) in Phase
3 (see Fig. 6 in Appendix). The intervention will also be
provided to the professionals in the clinic. Adoption and
acceptance of the intervention will be evaluated in all
groups by means of observational data and self-report.
Target criteria are specified in Tables 1 and 2.
At the end of Phase 3, the results from all three
phases will be disseminated using a white paper with
recommendations for practice. Further plans to com-
municate trial results to participants, healthcare profes-
sionals, the public, and other relevant groups via
publication, presentations and press releases will be de-
veloped using a participatory approach, with the restric-
tion that anonymity is ensured at all times.
Discussion
This project investigates interpersonal communication
based on communication competences and the Health Ac-
tion Process Approach (HAPA) to better understand where
and how problems may occur and how to overcome these
problems with interventions in everyday clinical life. Cur-
rently, there is no study that has done so in everyday clin-
ical practice and has demonstrated the effectiveness of
corresponding interventions based on the two theories as
theoretical backdrop for designing the intervention.
The overall aim of the project is to support communi-
cation based on the communication competences model
and the HAPA, and to overcome difficulties in everyday
hospital life. The project is characterized by three in-
novative aspects. The first innovative aspect is the theor-
etical
background
and
its
application to
maternity
clinics. The communication competences model has been
specifically designed to address communication in the
healthcare context, whereas the HAPA model has been
shown to bridge the gap between intention and behavior
[25]. The combination of both HAPA and communication
competences will aid in the design of an intervention
specifically tailored to the healthcare context, which in-
creases its potential effectiveness.
The second innovation of this project lies in its digital
focus, and thus, a focus on innovation policy. The question
is, to what extent can digital support of interpersonal
communication actually support effective communication
and which evidence-based recommendations can be
given? Although there is some evidence, which we have
reviewed in the beginning of this paper, this new project
has a clear innovative potential to set the stage for future
research in public health and prevention.
The third innovative aspect of this project lies in its sys-
tematic empirical investigation of including professionals,
patients and their social support providers as active part-
ners for patient safety. This adds to the value of this pro-
ject by assessing dyadic data and is currently also regarded
by the WHO as a central issue in patient safety [72].
Despite the need for developing healthcare profes-
sionals’ and patients’ communication skills, (ongoing)
face-to-face training is rather time-consuming and may
not be achievable given the overall need for increasing
hospital efficiency [73]. Digital communication training
offers a solution to this dilemma as it reduces costs and
organization resources. Moreover, users can participate
in the training according to their own schedules, thus
potentially increasing their motivation and the training’s
effectiveness, but only if the digital trainings are suffi-
ciently implemented and monitored [74].
Two studies included in a previous review evaluated the
effectiveness of training interventions to improve communi-
cation [9]. The training package targeting communication
skills for doctors was not associated with higher satisfaction
with work scores recorded by women, although they re-
ported high satisfaction with training workshops [75]. While
Crofts et al. reported that improvements in all their test
variables in the three clinical scenarios were statistically sig-
nificant after the training, this was based on a pre- and post-
intervention analysis with no comparison groups [76].
Perceptions of safety and communication significantly im-
proved after training with patient-actors, compared to
training using mannequins for postpartum hemorrhage sce-
narios, but it is unclear why no statistically significant im-
provements were found. Furthermore, the authors revealed
no benefits of additional teamwork training on patient-actor
perceptions of care related to safety, communication, and re-
spect [76]. Due to the innovative aspects outlined above, our
own evaluation is expected to outperform these previous ef-
fects in order to support communication. This study will also
provide valuable information on the effectiveness, user-
acceptability, and feasibility of the intervention. It addresses
the need to investigate new approaches to improve commu-
nication, which can relieve health systems from the growing
demands caused by challenges with communication around
the world and in all areas of medicine and public health.
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Appendix
Fig. 4 Trial design for Phase 1. Step 1: Participants (clinical staff members) are initially identified, informed and invited to take part in the training. Step 2:
Participants give informed consent while baseline variables that can be measured independently are assessed. All participants in this phase receive the
training so that there is no allocation to either treatment or control group but only to similar treatment groups. Step 3: Pre-tests2. Step 4: Participants
complete the communication training. Step 5: Post-tests3. Step 6: Follow-up after 3 months. Note: 1 Baseline data includes baseline assessments of pAE
prevalence and costs, adherence safety culture and job description. 2 Pre-test assessment includes demographic data, competences, training-related
outcomes and work satisfaction. 3 Post-test assessments include competences and training-related outcomes. 4 At three months post-intervention, job
stress and satisfaction, competences, behavior change as training-related outcomes and adherence safety culture will be assessed.
Lippke et al. BMC Health Services Research          (2019) 19:908 
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Fig. 5 Trial design for Phase 2. Step 1: Participants (mothers-to-be/patients and their social support providers) are initially identified and screened
for eligibility. Step 2: If eligible, participants are invited to take part in the study, give informed consent and are allocated to either the
intervention group (IG, Communication training) or the control group (CG). Step 3: Pre-tests. Step 4: Participants in the intervention group
complete the communication training. Step 5: Post-tests. Step 6: pAEs are assessed after the patient gave birth. Note: 1 For inclusion and exclusion
criteria, see Table 6. 2 Baseline data includes baseline assessments of pAE prevalence and costs. 3 Pre-test assessment includes demographic data,
perceived social support, competences, training-related outcomes, subjective safety culture and treatment satisfaction.4 Post-test assessments in-
clude perceived social support, competences and training-related outcomes. 5 At three months post-intervention, perceived social support, com-
petences, behavior change as training-related outcome, subjective safety culture and treatment satisfaction will be assessed
Lippke et al. BMC Health Services Research          (2019) 19:908 
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Abbreviations
BCT: Behavior change techniques; CG: Control group; HAPA: Health Action
Process Approach; IG: Intervention group; N/n: Number of study participants;
NPWT: Negative-pressure wound therapy; pAEs: Preventable adverse events;
RCT: Randomized controlled trial; SACCIA: “Sufficiency”, “Accuracy”, “Clarity”,
“Contextualization”, and “Interpersonal Adaptation”; SBAR: “Situation”,
“Background”, “Assessment”, and “Recommendation”; WHO: World Health
Organization
Acknowledgements
The authors wish to thank Emma Siefring and Nara Skipper for language
editing the manuscript and Simon Keller for format editing. The authors wish
to thank Kureva Matuku for helping with the literature search.
Authors’ contributions
SL, JW, HM, FL, CS and AH have contributed to the development of this
protocol. FMK and CD are PhD students and LK is a research student
supervised by SL. SL, JW, HM, FL, CS and AH have contributed developing
the analytical strategy and overall methodology. SL, JW, FMK, CD, AW, LK,
HM, FL, CS and AH have worked on developing the intervention. SL wrote
the first and final draft of the protocol. SL, JW, FMK, CD, AW, LK, KHG, MW,
KE, KK, and CS have contributed to the drafting process. All authors have
read and approved the final manuscript.
Authors’ information
Name and contact information for the trial sponsor: Prof. Dr. Sonia Lippke;
Professor of Health Psychology and Behavioral Medicine; Jacobs University
Fig. 6 Trial design for Phase 3. Step 1: Participants (mothers-to-be/patients and their social support providers) are initially identified and screened
for eligibility. All staff members are eligible for phase 3. Step 2: If eligible, participants give informed consent. Step 3: Pre-tests4. Step 4: Participants
are provided with the Effective Communication App. Step 5: Post-tests5. Step 6: 3-months follow-up; person-specific pAEs are assessed after the
patient gave birth. Possible reasons for participant drop-out have already been presented in Fig. 4/5. Note: 1 The comparator groups do not
complete any tests again. Data acquisition in this group will be finished during Phase 2. 2 For inclusion/exclusion criteria, see Table 6. 3 Baseline
data includes baseline assessments of pAE prevalence and costs. 4 Pre-test assessment includes demographic data, perceived social support,
competences, training-related outcomes, subjective safety culture and treatment satisfaction. 5 Post-test assessments include perceived social
support, competences and training-related outcomes. 6 At three months post-intervention, perceived social support, competences, behavior
change as training-related outcome, subjective safety culture and treatment satisfaction will be assessed.
Lippke et al. BMC Health Services Research          (2019) 19:908 
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Bremen gGmbH; Campus Ring 1; 28759 Bremen; Germany; Phone: + 49 421
200–4730 | Fax + 49 421 200–49-4730; s.lippke@jacobs-university.de
The role of study sponsor in the study design, data collection, management,
analysis, and interpretation of data, writing of the report, and the decision to
submit the report for publication is defined as consortium leader. The funder
receives all reports but has no ultimate authority over any of these activities
because of good scientific practice and independency of the researchers.
Funding
The study is funded by the Innovation Fund (Project No. 01VSF18023) of the
The Federal Joint Committee (G-BA, the highest decision-making body of
the joint self-government of physicians, dentists, psychotherapists, hospitals,
and health insurance funds in Germany; see https://www.g-ba.de/down-
loads/17-98-2804/2018-12-04_G-BA_Flyer_Der_Gemeinsame_Bunde-
sausschuss_EN_bf.pdf) with SL as consortium leader. The funding body only
observes whether the study is carried out as proposed and approved in
terms of study design. The funding body has no influence on the collection,
analysis, and interpretation of data. The funding body is not involved in writ-
ing the manuscripts but will be informed about the authors' activities.
Availability of data and materials
The full protocol including data security protocol (in German) and
publication guidelines will be available from the corresponding author on
reasonable request. Data sharing is not applicable to this article as no
datasets were generated or analyzed so far.
Ethics approval and consent to participate
The research received ethics approval from the University Hospital of Ulm
Human Research Ethics Committee (Number 114/19), the University Hospital
of Frankfurt Medical Research Ethics Committee (Number 19-292) and the
Ethics Committee at Jacobs University (dated September 17, 2019). All study
participants have to consent in a written form to participate in the study.
Consent for publication
The paper is not published or under consideration elsewhere. All authors
consent the publication of this manuscript.
Competing interests
When submitting the grant application and receiving the funding statement,
JW was working at Die Techniker, but left Die Techniker to join Jacobs
University Bremen gGmbH before the project started. The authors declare
that they have no further competing interests.
Author details
1Jacobs University Bremen gGmbH, Germany Campus Ring 1, 28759 Bremen,
Germany. 2Die Techniker; Unternehmenszentrale, Fachbereich
Versorgungsmanagement, Bramfelder Str. 140, 22305 Hamburg, Germany.
3Aktionsbündnis Patientensicherheit, Am Zirkus 2, 10117 Berlin, Germany.
4Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Frankfurt
Goethe-Universität, Theodor-Stern-Kai 7, 60596 Frankfurt am Main, Germany.
5Universitätsklinikum Ulm, Prittwitzstr. 43, 89075 Ulm, Germany.
6Universitätsklinikum Ulm, Albert-Einstein-Allee 23, 89070 Ulm, Germany.
7Center for the Advancement of Healthcare Quality and Patient Safety
(CAHQS), Faculty of CommunicationSciences, Università della Svizzera
Italiana, Lugano, Switzerland.
Received: 6 August 2019 Accepted: 9 October 2019
References
1.
Pronovost PJ, Holzmueller CG, Ennen CS, Fox HE. Overview of progress in
patient safety. Am J Obstet Gynecol. 2011;204(1):5–10.
2.
Schrappe M. APS-Weißbuch Patientensicherheit. In: Sicherheit in der
Gesundheitsversorgung: neu denken, gezielt verbessern [APS Report on
Patient safety]. 1st ed. Berlin: Medizinisch Wissenschaftliche
Verlagsgesellschaft; 2018.
3.
Bartlett G, Blais R, Tamblyn R, Clermont RJ, MacGibbon B. Impact of patient
communication problems on the risk of preventable adverse events in
acute care settings. CMAJ. 2008;178(12):1555–62.
4.
Leonard M, Graham S, Bonacum D. The human factor: the critical
importance of effective teamwork and communication in providing safe
care. Qual Saf Health Care. 2004;13(Suppl 1):85.
5.
Hickson GB, Clayton EW, Githens PB, Sloan FA. Factors that prompted
families to file medical malpractice claims following perinatal injuries. JAMA.
1992;267(10):1359–63.
6.
Olde Bekkink M, Farrell SE, Takayesu JK. Interprofessional communication in
the emergency department: residents' perceptions and implications for
medical education. Int J Med Educ. 2018;9:262–70.
7.
Lyndon A, Zlatnik MG, Wachter RM. Effective physician-nurse
communication: a patient safety essential for labor and delivery. Am J
Obstet Gynecol. 2011;205(2):91–6.
8.
Antony J, Zarin W, Pham B, Nincic V, Cardoso R, Ivory JD, et al. Patient safety
initiatives in obstetrics: a rapid review. BMJ Open. 2018;8(7):e020170.
9.
Chang Y, Coxon K, Portela AG, Furuta M, Bick D. Interventions to
support effective communication between maternity care staff and
women in labour: a mixed-methods systematic review. Midwifery.
2018;59:4–16.
10.
Hannawa AF. Disclosing medical errors to patients: effects of nonverbal
involvement. Patient Educ Couns. 2014;94(3):310–3.
11.
Hannawa A, Wendt A, Day L. New horizons in patient safety: safe
communication: evidence-based core competencies with case studies from
nursing practice. Berlin: Walter de Gruyter GmbH & Co KG; 2017.
12.
Zech A, Gross B, Jasper-Birzele C, Jeschke K, Kieber T, Lauterberg J, et al.
Evaluation of simparteam - a needs-orientated team training format for
obstetrics and neonatology. J Perinat Med. 2017;45(3):333–41.
13.
Berg CJ, Harper MA, Atkinson SM, Bell EA, Brown HL, Hage ML, et al.
Preventability of pregnancy-related deaths: results of a state-wide review.
Obstet Gynecol. 2005;106(6):1228–34.
14.
November M, Chie L, Weingart SN. Physician-reported adverse events and
medical errors in obstetrics and gynecology. In: Henriksen K, Battles JB,
Keyes MA, Grady ML, editors. Advances in patient safety: new directions
and alternative approaches. Rockville (MD): Agency for Healthcare
Research and Quality; 2008.
15.
Tanaka K, Eriksson L, Asher R, Obermair A. Incidence of adverse events,
preventability and mortality in gynaecological hospital admissions: a systematic
review and meta-analysis. Aust N Z J Obstet Gynaecol. 2019;59(2):195–200.
16.
Panagioti M, Geraghty K, Johnson J, Zhou A, Panagopoulou E, Chew-
Graham C, et al. Association between physician burnout and patient safety,
professionalism, and patient satisfaction: a systematic review and meta-
analysis. JAMA Intern Med. 2018;178(10):1317–30.
17.
Welp A, Meier LL, Manser T. Emotional exhaustion and workload predict
clinician-rated and objective patient safety. Front Psychol. 2014;5:1573.
18.
Welp A, Meier LL, Manser T. The interplay between teamwork, clinicians'
emotional exhaustion, and clinician-rated patient safety: a longitudinal
study. Crit Care. 2016;20(1):110.
19.
Morony S, Weir K, Duncan G, Biggs J, Nutbeam D, Mccaffery KJ. Enhancing
communication skills for telehealth: development and implementation of a
teach-Back intervention for a national maternal and child health helpline in
Australia. BMC Health Serv Res. 2018;18(1):162.
20.
Avula R, Menon P, Saha KK, Bhuiyan MI, Chowdhury AS, Siraj S, et al. A program
impact pathway analysis identifies critical steps in the implementation and
utilization of a behavior change communication intervention promoting infant
and child feeding practices in Bangladesh. J Nutr. 2013;143(12):2029–37.
21.
Tan DJA, Sultana R, Han NLR, Sia ATH, Sng BL. Investigating determinants
for patient satisfaction in women receiving epidural analgesia for labour
pain: a retrospective cohort study. BMC Anesthesiol. 2018;18(1):50.
22.
Weis J, Zoffmann V, Egerod I. Improved nurse-parent communication in
neonatal intensive care unit: evaluation and adjustment of an
implementation strategy. J Clin Nurs. 2014;23(23–24):3478–89.
23.
Bolognesi M, Nigg CR, Massarini M, Lippke S. Reducing obesity indicators
through brief physical activity counseling (PACE) in Italian primary care
settings. Ann Behav Med. 2006;31(2):179–85.
24.
Omura M, Maguire J, Levett-Jones T, Stone TE. The effectiveness of
assertiveness communication training programs for healthcare professionals
and students: a systematic review. Int J Nurs Stud. 2017;76:120–8.
25.
Schwarzer R. Modeling health behavior change: how to predict and
modify the adoption and maintenance of health behaviors. Appl
Psychol. 2008;57(1):1–29.
26.
Clancy CM, Tornberg DN. TeamSTEPPS: Assuring Optimal Teamwork in
Clinical Settings. Am J Med Qual. 2016;22(3):214–7.
Lippke et al. BMC Health Services Research          (2019) 19:908 
Page 16 of 18

27.
Haller G, Garnerin P, Morales M, Pfister R, Berner M, Irion O, et al. Effect of
crew resource management training in a multidisciplinary obstetrical
setting. Int J Qual Health Care. 2008;20(4):254–63.
28.
Nielsen PE, Goldman MB, Mann S, Shapiro DE, Marcus RG, Pratt SD,
et al. Effects of teamwork training on adverse outcomes and process of
care in labor and delivery: a randomized controlled trial. Obstet
Gynecol. 2007;109(1):48–55.
29.
Liaw SY, Zhou WT, Lau TC, Siau C, Chan SW. An interprofessional
communication training using simulation to enhance safe care for a
deteriorating patient. Nurse Educ Today. 2014;34(2):259–64.
30.
Hannawa AF, Roter DL. TRACEing the roots: a diagnostic “tool for retrospective
analysis of critical events”. Patient Educ Couns. 2013;93(2):230–8.
31.
Baldwin A, Harvey C, Willis E, Ferguson B, Capper T. Transitioning across
professional boundaries in midwifery models of care: a literature review.
Women Birth. 2019;32(3):195–203.
32.
McEwan D, Ruissen GR, Eys MA, Zumbo BD, Beauchamp MR. The effectiveness of
teamwork training on teamwork behaviors and team performance: a systematic
review and meta-analysis of controlled interventions. PLoS One. 2017;12(1):e0169604.
33.
Gittell JH. Relational coordination. In: Cooper CL, Flood PC, Freeney Y, editors. Wiley
encyclopedia of management. Atlanta: American Cancer Society; 2015. p. 1–6.
34.
Gittell JH, Fairfield KM, Bierbaum B, Head W, Jackson R, Kelly M, et al. Impact
of relational coordination on quality of care, postoperative pain and
functioning, and length of stay: a nine-hospital study of surgical patients.
Med Care. 2000;38(8):807–19.
35.
Gittell JH. Relationships between service providers and their impact on
customers. J Serv Res. 2002;4(4):299–311.
36.
Noseworthy DA, Phibbs SR, Benn CA. Towards a relational model of
decision-making in midwifery care. Midwifery. 2013;29(7):e48.
37.
Haug S, Meyer C, Dymalski A, Lippke S, John U. Efficacy of a text messaging (SMS)
based smoking cessation intervention for adolescents and young adults: study
protocol of a cluster randomised controlled trial. BMC Public Health. 2012;12:51.
38.
Lippke S, Fleig L, Wiedemann AU, Schwarzer R. A computerized lifestyle
application to promote multiple health behaviors at the workplace: testing its
behavioral and psychological effects. J Med Internet Res. 2015;17(10):e225.
39.
Duan YP, Liang W, Guo L, Wienert J, Si GY, Lippke S. Evaluation of a web-based
intervention for multiple health behavior changes in patients with coronary
heart disease in home-based rehabilitation: pilot randomized controlled trial. J
Med Internet Res. 2018;20(11):e12052.
40.
Storm V, Dörenkämper J, Reinwand DA, Wienert J, De Vries H, Lippke S.
Effectiveness of a web-based computer-tailored multiple-lifestyle
intervention for people interested in reducing their cardiovascular risk: a
randomized controlled trial. J Med Internet Res. 2016;18(4):e78.
41.
Lippke S, Schwarzer R, Ziegelmann JP, Scholz U, Schüz B. Testing stage-specific
effects of a stage-matched intervention: a randomized controlled trial targeting
physical exercise and its predictors. Health Educ Behav. 2010;37(4):533–46.
42.
Lippke S, Plotnikoff RC. Testing two principles of the health action process
approach in individuals with type 2 diabetes. Health Psychol. 2014;33(1):77–84.
43.
Lippke S, Corbet JM, Lange D, Parschau L, Schwarzer R. Intervention
engagement moderates the dose-response relationships in a dietary
intervention. Dose-Response. 2016;14(1):1559325816637515.
44.
Sprangers S, Dijkstra K, Romijn-Luijten A. Communication skills training in a
nursing home: effects of a brief intervention on residents and nursing aides.
Clin Interv Aging. 2015;10:311–9.
45.
Zhang C, Zhang R, Schwarzer R, Hagger MS. A meta-analysis of the health
action process approach. Health Psychol. 2019;38(7):623–37.
46.
Reyes Fernández B, Lippke S, Knoll N, Blanca Moya E, Schwarzer R.
Promoting action control and coping planning to improve hand hygiene.
BMC Public Health. 2015;15:964.
47.
Lhakhang P, Lippke S, Knoll N, Schwarzer R. Evaluating brief motivational
and self-regulatory hand hygiene interventions: a cross-over longitudinal
design. BMC Public Health. 2015;15:79.
48.
Ernsting A, Gellert P, Schneider M, Lippke S. A mediator model to predict
workplace influenza vaccination behaviour--an application of the health
action process approach. Psychol Health. 2013;28(5):579–92.
49.
Alders I, Smits C, Brand P, van Dulmen S. Does patient coaching
make a difference in patient-physician communication during
specialist consultations? A systematic review. Patient Educ Couns.
2017;100(5):882–96.
50.
Belkora J, Volz S, Loth M, Teng A, Zarin-Pass M, Moore D, et al. Coaching
patients in the use of decision and communication aids: RE-AIM evaluation
of a patient support program. BMC Health Serv Res. 2015;15:209.
51.
Dykes PC, Rozenblum R, Dalal A, Massaro A, Chang F, Clements M, et al.
Prospective evaluation of a multifaceted intervention to improve outcomes
in intensive care: the promoting respect and ongoing safety through
patient engagement communication and technology study. Crit Care Med.
2017;45(8):e813.
52.
Ammentorp J, Graugaard LT, Lau ME, Andersen TP, Waidtløw K, Kofoed P.
Mandatory communication training of all employees with patient contact.
Patient Educ Couns. 2014;95(3):429–32.
53.
Emani SS, Allan CK, Forster T, Fisk AC, Lagrasta C, Zheleva B, et al. Simulation
training improves team dynamics and performance in a low-resource
cardiac intensive care unit. Ann Pediatr Cardiol. 2018;11(2):130–6.
54.
Forster AJ, Fung I, Caughey S, Oppenheimer L, Beach C, Shojania KG, et al.
Adverse events detected by clinical surveillance on an obstetric service.
Obstet Gynecol. 2006;108(5):1073–83.
55.
Pettker CM. Systematic approaches to adverse events in obstetrics, part I:
event identification and classification. Semin Perinatol. 2017;41(3):151–5.
56.
Ellenbecker CH, Byleckie JJ. Home healthcare Nurses’ job satisfaction scale:
refinement and psychometric testing. J Adv Nurs. 2005;52(1):70–8.
57.
Büssing A, Perrar K. Die Messung von Burnout. Untersuchung einer deutschen
Fassung des Maslach Burnout Inventory (MBI-D). Diagnostica. 1992;38(4):328–53.
58.
Stevenson RJ, Case TI, Hodgson D, Porzig-Drummond R, Barouei J, Oaten
MJ. A scale for measuring hygiene behavior: development, reliability and
validity. Am J Infect Control. 2009;37(7):557–64.
59.
Hellings J, Schrooten W, Klazinga N, Vleugels A. Challenging patient safety
culture: survey results. Int J Health Care Qual Assur. 2007;20(7):620–32.
60.
Nabhan A, Ahmed-Tawfik MS. Understanding and attitudes towards patient
safety concepts in obstetrics. Int J Gynaecol Obstet. 2007;98(3):212–6.
61.
Whittal A, Lippke S. Investigating patients with an immigration background
in Canada: relationships between individual immigrant attitudes, the doctor-
patient relationship, and health outcomes. BMC Public Health. 2016;16:23.
62.
Whittal A, Hanke K, Lippke S. Investigating acculturation orientations of
patients with an immigration background and doctors in Canada: implications
for medical advice adherence. Qual Life Res. 2017;26(5):1223–32.
63.
van Sluisveld N, Zegers M, Westert G, van der Hoeven JG, Wollersheim H. A
strategy to enhance the safety and efficiency of handovers of ICU patients:
study protocol of the pICUp study. Implement Sci. 2013;8:67.
64.
Teunissen E, Gravenhorst K, Dowrick C, Van Weel-Baumgarten E, Van den
Driessen Mareeuw F, de Brún T, et al. Implementing guidelines and training
initiatives to improve cross-cultural communication in primary care consultations:
a qualitative participatory European study. Int J Equity Health. 2017;16(1):32.
65.
Spitzberg BH, Cupach WR. Disentangling the dark side of interpersonal
communication. Mahwah: Lawrence Erlbaum; 2007.
66.
Meeks DW, Smith MW, Taylor L, Sittig DF, Scott JM, Singh H. An analysis of
electronic health record-related patient safety concerns. J Am Med Inform
Assoc. 2014;21(6):1053–9.
67.
van Dinter-Douma EE, de Vries NE, Aarts-Greven M, Stramrood CAI, van
Pampus MG. Screening for trauma and anxiety recognition: knowledge,
management and attitudes amongst gynecologists regarding women with
fear of childbirth and postpartum posttraumatic stress disorder. J Matern
Fetal Neonatal Med. 2018;18:1–281.
68.
Taylor LJ, Adkins S, Hoel AW, Hauser J, Suwanabol P, Wood G, et al. Using
implementation science to adapt a training program to assist surgeons with
high-stakes communication. J Surg Educ. 2019;76(1):165–73.
69.
Karger A, Geiser F, Vitinius F, Sonntag B, Schultheis U, Hey B, et al.
Communication skills trainings: subjective appraisal of physicians from five
Cancer Centres in North Rhine. Germany Oncol Res Treat. 2017;40(9):496–501.
70.
Yu L, Kronen RJ, Simon LE, Stoll CRT, Colditz GA, Tuuli MG. Prophylactic
negative-pressure wound therapy after cesarean is associated with reduced
risk of surgical site infection: a systematic review and meta-analysis. Am J
Obstet Gynecol. 2018;218(2):210–e1.
71.
Wang Y, Wan Q, Lin F, Zhou W, Shang S. Interventions to improve
communication between nurses and physicians in the intensive care unit:
an integrative literature review. Int J Nurs Sci. 2018;5(1):81–8.
72.
Service Delivery and Safety Department, World Health Organization and The
Gordon and Betty Moore Foundation. Global Expert Consultation on the WHO
Framework on Patient and Family Engagement. WHO, vol. 2014; 2015. p. 27–8.
73.
Nigam A, Huising R, Golden BR. Improving hospital efficiency. Med Care Res
Rev. 2014;71(1):21–42.
74.
Wienert J. Understanding health information technologies as complex
interventions with the need for thorough implementation and monitoring
to sustain patient safety. Front ICT. 2019;6:9.
Lippke et al. BMC Health Services Research          (2019) 19:908 
Page 17 of 18

75.
Bashour HN, Kanaan M, Kharouf MH, Abdulsalam AA, Tabbaa MA,
Cheikha SA. The effect of training doctors in communication skills on
women's satisfaction with doctor-woman relationship during labour and
delivery: a stepped wedge cluster randomised trial in Damascus. BMJ
Open. 2013;3(8):e002674.
76.
Crofts JF, Bartlett C, Ellis D, Winter C, Donald F, Hunt LP, et al. Patient-actor
perception of care: a comparison of obstetric emergency training using
manikins and patient-actors. Qual Saf Health Care. 2008;17(1):20–4.
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