To test if the *analogue patient paradigm* is a suitable methodology to assess effects of communication on patient outcomes. More specifically we aim to test if watching a video of a simulated consultation on a common medical problem leads to…
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Brief title
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- Other condition
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Health condition
Het onderzoek heeft geen betrekkinig op een specifieke aandoening. Het onderwerp van de simulatie is menstruatiepijn, maar het onderzoek heeft betrekking op de methodologie.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study's primary parameters are affective, physiological and cognitive
responses measured as state anxiety, psycho-physiological arousal as measured
with skin conductance responses and outcome expectations about the the
simulated illness in the interview. The study endpoint is the concordance of
these measures between 1) subjects participating in the interview and subjects
re-viewing their own interview and 2) between subjects participating in an
interview and other participants (not participating in any interview) viewing
interviews of others.
Secondary outcome
Secondary study parameters are heart rate, positive and negative affect and
illness perceptions about the simulated illness in the interview. Demographic
variables, health status, trust in healthcare, communication preferences and
empathic ability will be measured as control variables.
Background summary
Research shows that communication is an important element of medical care with
regard to patient outcomes. To assess causal relationships between specified
elements in communication and outcomes, strictly controlled experiments are
needed. Manipulating communication in real consultations can be ethically
unsound, because of burdening patients with research procedures during their
care or by exposing patients to unpleasant or possible iatrogenic
communication. Furthermore, the interaction between physicians and patients is
hard to control, due to its dynamic nature. This complicates studying the
effects of specified communicative behaviors. This can be bypassed by not
assessing the effects of communication in subjects directly, but by showing a
video of a standardized consultation to subjects instead. This is called the
*analogue patient paradigm* in which the viewer is the analogue patient. While
there is substantive evidence that watching situations (on pictures or in
films) evokes the same type of empathic reactions in viewers as participating
in those situations, it is not clear if the comparability is large enough to
warrant replacing subjects participating in interaction by *analogue subjects*
watching a video of that interaction when testing the effects of different
types of communication styles. If the validity of the analogue patient
methodology proves warranted in healthy subjects, it offers a design with
ethical and methodological advantages for researching the effects of medical
communication on patient outcomes.
Study objective
To test if the *analogue patient paradigm* is a suitable methodology to assess
effects of communication on patient outcomes. More specifically we aim to test
if watching a video of a simulated consultation on a common medical problem
leads to comparable affective, cogntive and physiological responses in subjects
as when they are really participating in this role-played consultation. The
objective of Phase II is to test whether this so-called 'analogue patient
paradigm' is a reliable and valid method to test the effects of different types
of communication on subjects' outcome measures.
Study design
A two-phase partly observational, partly experimental study with a mixed
within- and between subjects design. In phase I, 30 healthy subjects will
participate in a role-played interaction with an interviewer to simulate a
medical consultation and subsequently watch their own conversation on video. In
phase II, four videos from Phase I will be slected which differ in physician's
communication style (showing affect and raising expectations). In a 2x2
experimental design, 320 subjects will watch randomly one out of the four video
consultations. In both phases before and after the video-viewing several
psychological and pysiological (phase I only) will be taken.
Study burden and risks
Participants have to fill in a questionnaire at home (half hour) and either
role-play a medical consultation and watch this consultation on video (phase I)
and subjects (not participating in a role-played interview) will view one out
of the four video consultations selected from Phase I (phase II) and fill in
some questionnaires (half hour). Throughout Phase I, skin conductance and heart
rate are non-invasively measured (three hours). There are no risks associated
with participation. Patients receive no medical treatment.
Otterstraat 118-124
Utrecht 3513 CR
NL
Otterstraat 118-124
Utrecht 3513 CR
NL
Listed location countries
Age
Inclusion criteria
Participants have to be women with an age between 18 and 45.
Exclusion criteria
Inability to have an unaided conversation in Dutch
Knowing the interviewer who performs the simulated medical consultation
No experience at all with menstrual pain
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24672.041.08 |