Department of Psychiatry and Neuropsychology, European Graduate School of Neuroscience, Maastricht University, The Netherlands and Division of Psychological Medicine, Institute of Psychiatry, UK
Università degli Studi di Milano, Milan, Italy;
Department of MedicinePsychiatry, Universidad de Oviedo, Oviedo, Spain
Research Institute of Biological Psychiatry, St Hans Hospital, Roskilde, Denmark
Trafford General Hospital, Manchester, UK
University Hospital for Psychiatry, Vienna, Austria
Klinik für Psychiatrie und Psychotherapie der Universität Hamburg, Hamburg, Germany
Centre Mémoire, Clinique de Psychiatrie et de Psychologie Médicale, Hôpital Pasteur, Nice, France
Correspondence: Professor Dr Jim van Os, Department of Psychiatry and Neuropsychiatry, South Limburg Mental Health Research Network, Maastricht University, PO Box 616 (DRT10), 6200 MD Maastricht,The Netherlands.Tel: 43 3875443; fax: 43 3875444; e-mail: j.vanos{at}sp.unimaas.nl
Funding detailed in Acknowledgement.
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ABSTRACT |
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Aims To examine whether providing patients with an opportunity to identify and discuss their needs would improve communication and induce changes in care.
Method Patients with schizophrenia (n=134) were randomly allocated to either standard care or use of the Two-Way Communication Checklist (2-COM). Before seeing their clinician for a routine follow-up, participants in the active intervention group were given 2-COM, a list of 20 common needs, and told to indicate those areas they wanted to discuss with their doctor.Outcomes were assessed immediately and again after 6 weeks.
Results Using 2-COM induced a stable improvement of patient-reported quality of patientdoctor communication (B=0.33, P=0.031), and induced changes in management immediately after the intervention (OR=3.7, P=0.009; number needed to treat, 6). Treatment change was more likely inpatients with more reported needs, and needs most likely to induce treatment change displayed stronger associations with non-medication than with medication changes.
Conclusions A simple intervention to aid people in discussion of their needs results in improved communication and changes in management.
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INTRODUCTION |
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The Two-Way Communication Checklist (2-COM) is a simple communication tool developed with the aim of improving communication between patient and professional carer in everyday clinical practice. In a previous observational study of 243 patients who completed 2-COM prior to routine appointments, both doctors and patients found the checklist useful in revealing new information. In addition, patients (but not clinicians) considered that the checklist had resulted in a change in treatment. The results indicated that 2-COM was most highly regarded by patients with the greatest number of care needs (van Os et al, 2002). However, although encouraging, these results do not in themselves demonstrate that 2-COM changes the behaviour of professional carers, as reflected in changes of treatment and attitude. We therefore set out to examine, in a randomised controlled trial, whether the use of 2-COM as an intervention would result in identifiable changes in clinician behaviour and improved patientclinician communication, in particular in patients with more severe illness and more need for care.
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METHOD |
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Patients were excluded if they:
The great majority of professional carers who participated in the study were clinicians routinely involved in the day-to-day care of patients with schizophrenia.
Power and randomisation
Patients were randomised centrally by an independent, non-investigator
agency using a predetermined random sequence. In the power calculation, it was
assumed that the intervention would double the probability of any change in
management given a 25% baseline chance of treatment change. This required a
minimum of 65 patients in each study group.
2-COM
The 2-COM is a simple list of 20 common problems, or areas of perceived
need, that might be experienced by patients with severe mental illness. The
list includes problems with housing, relationships, money, lack of activities,
psychological distress, sexuality, symptoms and treatment side-effects. The
basic psychometric properties of the instrument have been described previously
(van Os et al, 2002;
see also
http://www.2coms.homestead.com).
In summary, 2-COM has shown adequate testretest reliability and is well
accepted by patients as a valued aid to communication with their doctor.
Patients are provided with the 2-COM prior to seeing their clinician and given
simple instructions to facilitate its completion, guiding patients to indicate
which of the 20 problems apply to them and to highlight any that they wish to
discuss with their clinician during the subsequent clinic appointment. Field
work to date indicates that using a completed checklist to guide discussion
during the clinical interview extends the duration of the appointment by an
average of 13 min (van Os et al,
2002).
Procedures and assessments
The intervention and assessment took place over three out-patient clinic
visits. At visit 1, patients gave informed consent and the clinician recorded
a list of all current interventions, including medication and non-medical
treatments, together with demographic information and an assessment of current
level of functioning, using the Global Assessment of Functioning scale (GAF;
Frances et al, 1994).
Within 314 days of the baseline assessment, the patient attended the
clinic for a second clinical interview. Prior to the second visit, patients
were randomised to receive either 2-COM (to be completed by the patient
immediately before the clinical interview and used as the basis for discussion
during the interview), or standard carea routine
appointment without 2-COM. Immediately after the interview, all patients,
whether they had completed 2-COM or not, completed a confidential
questionnaire (sealed by the patients themselves) in which they could indicate
the perceived quality of communication with their clinician, current views on
their relationship with their clinician, and attitudes to their illness and
care. Similarly, clinicians completed a repeat of the list of all current
interventions, together with an assessment of any changes to the treatment
plan implemented after the interview with the patient. Changes in treatment
plan were categorised in the questionnaire as:
Four to six weeks after clinic visit 2, patients attended the clinic for a third, routine clinical interview. Both patients and clinicians then completed the same set of post-interview assessments as at visit 2.
Outcomes
The two main outcomes were quality of patientclinician communication
as reported by the patient, and change in clinician behaviour, indicated by
any change in management, as reported by the clinician. This dual set of
outcomes had been chosen to allow perceived change in communication, as
reported by the patient, to be validated alongside changes in behaviour as
reported by the clinician. The first outcome of patientclinician
communication was scored by the patient on a four-point scale (higher score
indicated better communication), answering the following question: How
easy did you find it to discuss the problems and worries you have with your
doctor at todays clinic appointment? A single dichotomous
variable reflecting whether or not clinicians had changed their treatment was
calculated for each patient at both visit 2 and visit 3.
Analyses
For each patient, one overall effect size was calculated for the two
outcomeschange in treatment, and patientdoctor communication.
This statistic incorporated data from the two separate post-intervention study
observations (visit 2 and visit 3). In addition, in order to assess the
pattern of response over time, effects were calculated separately for visit 2
and visit 3. The data were analysed using regression procedures in STATA
version 8 (StataCorp, 2002).
For the continuous variable relating to perceived patientdoctor
communication, multiple regression analysis was used, whereas for the
dichotomous variable relating to doctors treatment change, logistic
regression was applied. To facilitate interpretation of effect sizes,
regression coefficients from the multiple regression analyses were expressed
as standard deviations of the response variable. For the dichotomous outcome,
effect sizes were expressed in terms of odds ratios and numbers needed to
treat (NNT).
As observations at visit 2 and visit 3 were clustered within individuals,
the CLUSTER and ROBUST options were used in the STATA regression analyses.
This allows for the use of observations that are not wholly independent within
clusters (in this case, within individuals) and obtains the HuberWhite
sandwich estimator of variance instead of the traditional variance estimator.
All analyses were adjusted for centre and also for diagnosis, as the
randomisation had not been successful for this latter variable
(Table 1). Values of P
were two-sided with set at 5%.
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Illness severity effect modification
Interactions with illness severity were explored by introducing a term for
the interaction of continuous baseline GAF score and the 2-COM intervention in
the models of the outcomes.
Relating 2-COM needs to change in treatment
The likelihood of treatment change and the quality of patientdoctor
communication within the intervention group were analysed as a function of
total number of needs scored on 2-COM by the patient. In addition, in order to
be able to describe the needs that were most associated with treatment change,
post hoc analytic and descriptive analyses were carried out using
individual needs as predictors of treatment change. For needs that were most
strongly associated with treatment change, the odds of non-medication
treatment changes v. the odds of medication treatment changes
associated with these needs were numerically compared.
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RESULTS |
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Outcomes
Patients using 2-COM rated communication with their doctor as significantly
better than patients on standard care (2-COM group mean score
3.4, standard care group mean score 3.2; adjusted B 0.33, P=0.031).
This effect size was approximately similar for the second visit (adjusted B
0.29, P=0.10) and the third visit (adjusted B 0.37,
P=0.046). There was no interaction between scores on quality of
patientdoctor communication and baseline illness severity, as measured
by the continuous GAF score (adjusted B interaction 0.014,
P=0.253). Similarly, within the intervention group, there was no
interaction between ratings for quality of communication and the number of
needs identified by the patient (adjusted B 0.021,
P=0.25).
Patients in the 2-COM group were more likely to have had their treatment changed, as reported by the doctor, than were those in the standard care group (2-COM 74%, standard care 61%; adjusted OR=2.2, 95% CI 1.024.7; NNT=8). This effect size was much larger for the second visit (adjusted OR=3.7, 95% CI 1.49.6, P=0.009; NNT=6) than for the third visit (adjusted OR=1.5, 95% CI 0.63.3, P=0.39; NNT=15). No interaction with severity of illness as expressed by continuous GAF score was apparent (adjusted OR interaction 0.98, P=0.59). However, within the intervention group, the larger the number of needs reported, the greater was the likelihood of treatment change (adjusted OR per increase in need 1.16, 95% CI 1.071.25, P<0.0001).
Analyses at level of individual needs
Within the 2-COM intervention group, some needs were more likely than
others to induce changes in treatment at the second visit
(Table 2). Reported needs
associated with the strongest likelihood of treatment change at the second
visit were problems with sleep, not being able to enjoy oneself, feeling
tense, being easily upset, having unpleasant thoughts, problems with
medication, problems with family or other persons, problems with money,
problems finding things to do, problems going out, and wanting more
information about illness and treatment. Of these, the perceived need for
information about illness and treatment had by far the greatest effect size.
For all these items, the odds for non-medication changes in treatment were
numerically greater than the odds for a change in medication, even when the
provision of information as a treatment change was excluded (data not
shown).
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DISCUSSION |
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Limitations
Studies involving patientdoctor communication pose particular
challenges with regard to masking. There is the possibility that the behaviour
of clinicians changed because they wanted to show that 2-COM worked, and that
patients, for similar reasons, reported positive experiences about their
interactions with the clinician. However, none of the participating clinicians
had previously been involved in the development of 2-COM. Moreover, our
previous work indicated that clinicians tend to be only moderately positive
about 2-COM in terms of its perceived impact on their practice and their
appreciation of patient needs. Interestingly, despite the views expressed by
clinicians in the earlier 2-COM evaluation, the results of this study indicate
that 2-COM does indeed have an impact on clinicians management of
patients.
Interpretation of findings
The positive experiences of patients in this study accord with the findings
of our earlier observational study, and have face validity given the fact that
2-COM actually lengthens the visit to the clinician
(van Os et al, 2002).
Treatment change was more likely in patients with higher levels of reported
needs, but not in patients with lower GAF scores as rated by the clinician.
However, although the interactions with GAF score were not significant, both
were suggestive of a greater effect for patients with lower GAF scores (i.e.
patients with more impairments). Therefore, it is likely to be the patients
with more perceived needs and greater levels of impairment who benefit most
from 2-COM. This replicates our previous finding that 2-COM is considered most
useful by patients with the greatest level of need
(van Os et al, 2002).
There are a number of possible explanations for this relationship. Patients
with fewer problems might experience less difficulty in unaided communication
with their clinician; an alternative explanation would be that those with more
problems might have insufficient time during the routine visit to discuss all
their needs. Another explanation is that patients with schizophrenia, in
particular those with more severe illness, might have difficulties initiating
the goal-directed actions that are necessary to expose, discuss and resolve
issues that make up care needs (Frith,
1987). The results suggest that providing patients with an
opportunity to set the agenda for the visit actually engenders and facilitates
a discussion about care needs, resulting in real changes in management that
might otherwise not have occurred. As these changes occurred in the context of
discussion of patients needs, it is tempting to speculate that these,
in turn, might positively influence patient outcomes. However, the goal of
this study was to assess whether 2-COM would result in any actual change of
behaviour, rather than to investigate the extent to which these behaviours
might eventually produce better patient outcomes, other than patient
perception of quality of communication. Longer follow-up would be required to
assess the effects on longer-term clinical outcomes. It is likely, however,
that in order for 2-COM to influence clinical outcome, constant reinforcement
and continued patient participation would be required
(Anthony, 2000).
Implications for practice
Although further work needs to be conducted, the results of this simple
randomised, controlled trial confirm that not just the implementation of the
treatment plan, but also the communication leading up to decisions on
treatment and care, should be specific focuses of attention. Use of 2-COM
prolongs the clinical interview by approximately 13 min on average. The
instrument is well regarded by patients; the improvement in communication
brought about by its use may have considerable benefits in the treatment of
schizophrenia. Helping the patient to become vocal in the decision process may
be highly rewarding for clinical practice.
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Clinical Implications and Limitations |
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LIMITATIONS
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ACKNOWLEDGMENTS |
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Received for publication June 9, 2003. Revision received August 27, 2003. Accepted for publication September 5, 2003.