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Effectiveness of a cognitive behavioural workbook for changing beliefs about antipsychotic polypharmacy: analysis from a cluster randomized controlled trial Andrew Thompson MD MRCPsych, 1,2 Sarah Sullivan Msc Bsc, 3 Maddi Barley Msc Bsc, 4 Laurence Moore PhD, 5 Paul Rogers PhD, 6 Attila Sipos MD MRCPsych 7 and Glynn Harrison MD FRCPsych 8 1 Consultant Psychiatrist, 3 Research Associate, 4 Research Associate, 7 Consultant Psychiatrist and Honorary Senior Lecturer, 8 Professor, Academic Unit of Psychiatry, University of Bristol, Bristol, UK 2 Honorary Senior Fellow, ORYGEN Research Centre, Department of Psychiatry, University of Melbourne, Melbourne, Australia 5 Professor, School of Social Sciences, Cardiff University, Cardiff, UK 6 Professor, School of Care Sciences, University of Glamorgan, Pontypridd, UK Keywords antipsychotic agents, education, evidence-based medicine, polypharmacy Correspondence Ms Sarah Sullivan Academic Unit of Psychiatry University of Bristol Bristol BS6 6JL UK E-mail [email protected] The study took place in Academic Unit of Psychiatry, University of Bristol, Bristol, UK. Accepted for publication: Accepted 5 November 2008 doi:10.1111/j.1365-2753.2009.01153.x Abstract Rationale, aims and objectives Educational workbooks have been used in psychiatry to influence patient but not clinician behaviour. Targeted education interventions to change prescribing practice in other areas of medicine have only looked at changes in prescribing and not attitudes or beliefs related to the prescribing. We aimed to examine whether clinicians’ beliefs about a common prescribing issue in psychiatry (antipsychotic polyp- harmacy prescription) changed alongside behaviour as a result of a complex intervention. Method Medical and nursing staff were recruited from 19 general adult psychiatry units in the south-west of the UK as part of a cluster randomized controlled trial. A questionnaire was used to assess beliefs on the prescribing of antipsychotic polypharmacy as a secondary outcome before and after completion of a cognitive behavioural ‘self-help’ style workbook (one part of a complex intervention). A factor analysis suggested three dimensions of the questionnaire that corresponded to predetermined themes. The data were analysed using a random-effects regression model (adjusting for clustering) controlling for possible confounders. Results There was a significant change in beliefs on both of the factors: antipsychotic polypharmacy (coefficient =-0.89, P < 0.01) and rapid tranquilization (coefficient = -0.68, P = 0.01) specifically targeted by the workbook. There was a modest but stati- stically significant change in antipsychotic polypharmacy prescribing (odds ratio 0.43, 95% confidence intervals 0.21–0.90). Conclusions The workbook appeared to change staff beliefs about antipsychotic polyp- harmacy, but achieving substantial changes in clinician behaviour may require further exploration of other factors important in complex prescribing issues. Introduction Antipsychotic polypharmacy remains a common prescribing prac- tice for psychiatrists in most countries despite a number of practice guidelines advising against it [1,2]. These practice guidelines also highlight the lack of research evidence in favour of such prescrib- ing for schizophrenia [3,4]. Indeed, high rates of antipsychotic polypharmacy have been cited for a number of years and may actually have increased in some countries recently [5,6,7]. Clini- cians (including those in the field of psychiatry) regularly concur that guidelines are helpful tools that should be followed [8,9]. Therefore, an important question is why guidelines are not always adhered to. ‘Self-help’ style workbooks are available in a number of clinical areas: smoking cessation, medication compliance and asthma control. These are often based on cognitive behavioural principles [10]. The use of cognitive behavioural workbooks is well estab- lished in the psychiatric treatment of a number of disorders with an increasingly robust evidence base [11,12]. ‘Educational’ work- books have also been used as a teaching aid in a number of studies to improve doctors’, nurses’ and other staff members’ performance. They have been shown to improve outcomes in several areas of Journal of Evaluation in Clinical Practice ISSN 1356-1294 © 2010 The Authors. Journal compilation © 2010 Blackwell Publishing Ltd, Journal of Evaluation in Clinical Practice 16 (2010) 520–528 520

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Page 1: Effectiveness of a cognitive behavioural workbook for changing beliefs about antipsychotic polypharmacy: analysis from a cluster randomized controlled trial

Effectiveness of a cognitive behavioural workbook forchanging beliefs about antipsychotic polypharmacy: analysisfrom a cluster randomized controlled trialAndrew Thompson MD MRCPsych,1,2 Sarah Sullivan Msc Bsc,3 Maddi Barley Msc Bsc,4

Laurence Moore PhD,5 Paul Rogers PhD,6 Attila Sipos MD MRCPsych7 andGlynn Harrison MD FRCPsych8

1Consultant Psychiatrist, 3Research Associate, 4Research Associate, 7Consultant Psychiatrist and Honorary Senior Lecturer, 8Professor, AcademicUnit of Psychiatry, University of Bristol, Bristol, UK2Honorary Senior Fellow, ORYGEN Research Centre, Department of Psychiatry, University of Melbourne, Melbourne, Australia5Professor, School of Social Sciences, Cardiff University, Cardiff, UK6Professor, School of Care Sciences, University of Glamorgan, Pontypridd, UK

Keywords

antipsychotic agents, education,evidence-based medicine, polypharmacy

Correspondence

Ms Sarah SullivanAcademic Unit of PsychiatryUniversity of BristolBristol BS6 6JLUKE-mail [email protected]

The study took place in Academic Unit ofPsychiatry, University of Bristol, Bristol, UK.

Accepted for publication:Accepted 5 November 2008

doi:10.1111/j.1365-2753.2009.01153.x

AbstractRationale, aims and objectives Educational workbooks have been used in psychiatry toinfluence patient but not clinician behaviour. Targeted education interventions to changeprescribing practice in other areas of medicine have only looked at changes in prescribingand not attitudes or beliefs related to the prescribing. We aimed to examine whetherclinicians’ beliefs about a common prescribing issue in psychiatry (antipsychotic polyp-harmacy prescription) changed alongside behaviour as a result of a complex intervention.Method Medical and nursing staff were recruited from 19 general adult psychiatry units inthe south-west of the UK as part of a cluster randomized controlled trial. A questionnairewas used to assess beliefs on the prescribing of antipsychotic polypharmacy as a secondaryoutcome before and after completion of a cognitive behavioural ‘self-help’ style workbook(one part of a complex intervention). A factor analysis suggested three dimensions of thequestionnaire that corresponded to predetermined themes. The data were analysed usinga random-effects regression model (adjusting for clustering) controlling for possibleconfounders.Results There was a significant change in beliefs on both of the factors: antipsychoticpolypharmacy (coefficient = -0.89, P < 0.01) and rapid tranquilization (coefficient =-0.68, P = 0.01) specifically targeted by the workbook. There was a modest but stati-stically significant change in antipsychotic polypharmacy prescribing (odds ratio 0.43, 95%confidence intervals 0.21–0.90).Conclusions The workbook appeared to change staff beliefs about antipsychotic polyp-harmacy, but achieving substantial changes in clinician behaviour may require furtherexploration of other factors important in complex prescribing issues.

IntroductionAntipsychotic polypharmacy remains a common prescribing prac-tice for psychiatrists in most countries despite a number of practiceguidelines advising against it [1,2]. These practice guidelines alsohighlight the lack of research evidence in favour of such prescrib-ing for schizophrenia [3,4]. Indeed, high rates of antipsychoticpolypharmacy have been cited for a number of years and mayactually have increased in some countries recently [5,6,7]. Clini-cians (including those in the field of psychiatry) regularly concurthat guidelines are helpful tools that should be followed [8,9].

Therefore, an important question is why guidelines are not alwaysadhered to.

‘Self-help’ style workbooks are available in a number of clinicalareas: smoking cessation, medication compliance and asthmacontrol. These are often based on cognitive behavioural principles[10]. The use of cognitive behavioural workbooks is well estab-lished in the psychiatric treatment of a number of disorders with anincreasingly robust evidence base [11,12]. ‘Educational’ work-books have also been used as a teaching aid in a number of studiesto improve doctors’, nurses’ and other staff members’ performance.They have been shown to improve outcomes in several areas of

Journal of Evaluation in Clinical Practice ISSN 1356-1294

© 2010 The Authors. Journal compilation © 2010 Blackwell Publishing Ltd, Journal of Evaluation in Clinical Practice 16 (2010) 520–528520

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practice such as junior doctors’ inpatient management of diabetes[13], physician breast cancer screening practices and counsell-ing skills [14], nurses medication dose calculation skills [15] andthe assessment and management of depression in general medicalcare [16]. There have been a number of studies that have usededucational materials to try to change doctors’ prescribing behav-iour with variable success [17]. The use of cognitive behaviouralstyle workbooks, which attempt to directly target unhelpful cogni-tions in order to change prescribing practice, has been limited.

The influential ‘transtheoretical model’ [18] has improvedunderstanding of the process of behaviour change in patientgroups, particularly in the area of substance misuse. Recently,authors have suggested that psychological models could be helpfulnot only in understanding and structuring interventions forpatients’ health behaviour change but also for clinician behaviourchange [19]. Most trials of complex interventions to implementguidelines or evidence have focused on changes in observablebehaviour such as prescribing.

A number of the more influential models of behaviour changesuch as the theory of planned behaviour [20] and the health beliefmodel [21] have highlighted the importance of attitudes (describedin the theory of planned behaviour as beliefs about the outcomecombined with evaluation of the outcome) and perceptions aboutthe outcome of the behaviour (perceived benefit/efficacy and sus-ceptibility and severity of consequences) along with social orsubjective norms and perceived behavioural control. In areas of‘entrenched’ behaviours (such as the prescribing of antipsychoticpolypharmacy), an understanding of the beliefs behind the behav-iour may provide pointers about the best methods of changingthese behaviours.

In a recent cluster randomized controlled trial of a complexintervention targeting ward staff, we demonstrated a small butsignificant reduction in the prescription of antipsychotic polyphar-macy [22]. We wanted to explore further the relationship betweenthis behaviour change (prescribing) and cognitions relating to pre-scribing (expressed as beliefs). We were interested in whether beliefchange corresponded with behaviour change. If this was not thecase, it seemed unlikely that behaviour change was contingent onbelief change and that another mechanism was important. Part ofour complex intervention was a cognitive behavioural workbookaimed specifically at changing particular, pre-identified, beliefsabout the prescribing of antipsychotic medication. We were there-fore interested in the role of the workbook in changing these beliefs.

Aims of the study

This study aims to evaluate the effect of part of a complex inter-vention (a Cognitive Behavioural Therapy style workbook) onthe beliefs staff hold regarding antipsychotic polypharmacy. Wehypothesized that the workbook would change individual staffs’beliefs towards a number of predefined themes relating to antip-sychotic polypharmacy as measured by the Strength of BeliefsQuestionnaire.

Material and methods

The DEBIT trial

The DEBIT (Developing Evidence Based Implementation Trial)trial [22] was a cluster randomized controlled trial involving four

different mental health trusts (public mental health care serviceprovider organizations) in the south-west of England. The clusterswere adult psychiatric units (comprising one or more wards). Theclusters (units) were stratified into size (number of beds) and trustto which they belonged (based on the results of a previous pre-scribing survey) [23] and then randomized within these strata.Control units received a guideline regarding antipsychotic poly-pharmacy distributed through the normal channels for each orga-nization. The intervention units received this guideline plus amultifaceted intervention delivered over a 6-month period. Thisintervention comprised of three parts: (1) a ‘prompt system’ usinga reminder sticker placed on drug charts by ward pharmacistswhere patients were prescribed antipsychotic polypharmacy; (2)an interactive educational visit to individual consultants by atrained pharmacist based on the principles of ‘academic detailing’[24]; and (3) a workbook for all ward staff (nurses and doctors)with an educational component and a cognitive behaviour-basedmodel with suggestions for change. The primary outcome measurefor the trial was polypharmacy prescription rates as measured by a1-day survey at baseline and 6 months later (post-intervention).The secondary outcome measure was a pre-designed questionnairebased on previous qualitative interviews with consultant psychia-trists to assess strength of the beliefs about polypharmacy.

Cognitive behavioural workbook

This 47-page workbook taking approximately 1 hour to complete(copy available on request), utilized themes that emerged fromprevious qualitative work with consultant psychiatrists and non-participant observation on two psychiatric wards [25]. This fol-lowed the UK Medical Research Council guidance on thedevelopment of complex intervention trials [26] and correspondedto the modelling phase where barriers and facilitators to changewere explored.

We adapted a cognitive behaviour framework used with offend-ers [27] based on the principles of ‘rule breaking’. ‘Rule breaking’behaviour was defined as failure to follow the antipsychotic polyp-harmacy prescribing guidance. Using this approach, we were ableto provide an understandable ‘pathway to polypharmacy’, the endresult being the prescription or administration of antipsychoticpolypharmacy. We then provided suggestions for reflection onpractice, ideas for change and behavioural experiments for clini-cians to undertake in order to redress ‘rule breaking’. Thisapproach also uses the concept of ‘cognitive dissonance’ [28] andthe need to provide explanations, in terms of attitudes towardspolypharmacy, for a behaviour that most clinicians felt was notevidence-based [25]. Quotes and examples from the qualitativework were included within the workbook to provide real-lifeexamples and solutions and to address current concerns in ‘realworld’ practice [25]. The message was consistent with that pub-lished by the National Institute for Clinical Excellence [3,29] anda well-respected prescribing guideline [1]. We also provided an‘educational’ literature review of the current issues in antipsy-chotic polypharmacy prescribing, both in the body of the work-book and in a more detailed fashion as an appendix. Box 1 showsan excerpt from the workbook.

The workbook was piloted by both doctors and nurses on aforensic psychiatry ward to examine time to complete, ease ofunderstanding (flesch reading ease readability statistics of 41.6 for

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the main body of the workbook) and relevance to practice. It wasadapted appropriately. In line with cognitive behavioural treat-ments, a ‘booster’ follow-up four-page booklet providing anexecutive summary, a review of progress and suggestions formaintaining or instigating change in practice was distributeddirectly to staff 8 weeks after the distribution of the workbook.

Strength of Belief Questionnaire

It is common practice with cognitive behavioural techniques tosample cognitions about a subject before and after an interventionor a period of therapy. One way of accessing a person’s cognitionsis to assess beliefs. Beliefs represent the knowledge and informa-tion we have about the world (although they may be inaccurate orincomplete) and are non-evaluative, unlike attitudes that have a‘value’ ingredient added [30]. The key beliefs and themes involvedin antipsychotic polypharmacy prescribing were identified fromprevious qualitative work investigating consultant and nursingstaff views on antipsychotic polypharmacy [25]. We identifiedthree separate themes: (1) beliefs about polypharmacy in general;(2) beliefs about guidelines and evidence; and (3) beliefs aboutrapid tranquilization. All the belief statements, except those aboutevidence and guidelines, were either directly or indirectly chal-lenged in the workbook, through provision of information or self-learning. Some of these beliefs may have been challenged in theacademic detailing part of the intervention although in much lessdirect and consistent manner.

Structure of the questionnaire

Strength of belief was measured using 18 individual statements.The statements were taken directly from or were adapted from the

views of consultant psychiatrists or nursing staff towards antipsy-chotic polypharmacy. Each statement had a visual analogueresponse scale of between 1 and 100 (1 is strongly disagree/do notbelieve in and 100 is strongly agree/believe in). The preferredresponses to the questions (disagree or agree) were varied to reducethe possibility of a response set. The questionnaire was piloted onmedical and nursing staff from a forensic inpatient unit andamended appropriately. An example question from the question-naire is: ‘it is acceptable practice to use atypical antipsychoticmedication and typical anti-psychotic medication at the same time’.The questionnaire is available from the authors on request. It wascompleted at baseline and 6 months later following the intervention.

A factor analysis was performed on the results of the question-naire at baseline using STATA 8.0 for Windows [31]. This revealedthree main factors, which corresponded with the three predefinedthemes proposed a priori for the questionnaire: (1) beliefs onpolypharmacy; (2) beliefs on rapid tranquillization; and (3) beliefson evidence and guidelines. These accounted for 100% of the totalvariance (range of eigenvalues: 0.83 to 4.01). Items that loaded�0.50 on the factor matrix were retained. A total of 14 of the 18questions were utilized for the three factors.

The questionnaire was subjected to test–retest reliability at theend of the study. Using the method described by Streiner [32], weidentified that we would need 130 subjects in order to obtain areliability coefficient of 0.70 (standard reasonable intraclass cor-relations) with adequate power. Clinicians who returned their post-intervention questionnaires (258 subjects) were asked to return afurther questionnaire within 2 weeks. Repeat questionnaires werereceived from 65.9% (170/258) of post-intervention respondents.The three factors had intraclass correlations of 0.84, 0.68 and 0.82respectively. This indicates ‘good’ or ‘above average’ reliability, asa intraclass correlation ranges between 0 and 1, with a value of 1corresponding to complete reliability and no measurement error[33].

All doctors and nurses in the participating units (control andintervention) were sent a questionnaire, a trial information sheetand a prepaid envelope 4 weeks prior to the start of the trial. Areminder letter was sent to those who had not returned their ques-tionnaires after 2 weeks. Questionnaires received after the start ofthe trial were not included. Repeat questionnaires were sent to thesame staff 2 weeks after the end of the 5-month intervention period(unless the staff list indicated that they were no longer working onthe ward in question). A reminder was sent 2 weeks after this tonon-responders.

Measures of intervention uptake

An indication of the number of participants completing the work-book was obtained through completion and return of a feedbackform located at the back of the workbook. There was also aquestion in the post-intervention questionnaire asking about work-book completion. Measures for uptake of the educational visit(academic detailing) and pharmacy prompt reminder system werealso recorded.

Sample sizes

The sample size calculations for the prescribing outcome measureare outlined in the paper by Thompson et al. [22]. As the ques-

Box 1 An excerpt from the workbook outlining the Cognitive Behav-ioural Therapy approach

The ‘SOMETHING’ that happens

The ‘something’ can be viewed as the ‘trigger’. This trigger invari-ably acts as a catalyst and begins a sequence of events. It does notalways result in polypharmacy but often does. Without this triggerpolypharmacy is less likely to occur.

The ‘INTERPRETATION’

The interpretation of the ‘something’ is crucial. The interpretation willoften determine whether the next stage of the polypharmacypathway is reached. Clinicians can interpret the same occurrencesdifferently. Often these interpretations are ‘personal’ in their content.

The ‘PERMISSION GIVING THOUGHTS’

Giving ourselves permission is crucial in the chain of events leadingto polypharmacy. Giving ourselves permission is a way of overcom-ing the fact that we are breaking a ‘general rule’. In this case, thegeneral rule is that we should not give two antipsychotics at thesame time. Giving ourselves permission allows us to justify toothers and ourselves the course of action that we plan to take.In this case, the action that we plan to take is antipsychoticpolypharmacy.

The ‘ACTION’

The action is the prescribing and administration of more than oneantipsychotic medication (except for the three exceptions), even iffor just 1 day.

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tionnaire was novel, power for this outcome was calculated byassuming the instrument that had a standard deviation of 1 and anormal distribution. To achieve a change of 0.4 standard devia-tions, a sample size of 200 would be needed (assuming comparingtwo groups of 100) at a power of 0.8 and a significance level of0.05 (two-sided).

Statistical analysis

Analysis of the three factors derived from the questionnaire wasperformed using random-effects regression, using individual leveldata, with the psychiatric unit as the random effect and adjustingfor stratifying variables (size of unit and trust of origin) and base-line data. We also performed an adjusted analysis of the secondaryoutcome including unit-level values for the primary outcome (pro-portion of prescribed polypharmacy for each unit or cluster)at baseline. The primary outcome (proportion of antipsychoticpolypharmacy prescribing) was analysed using a unit-levelweighted regression analysis. This is further detailed in Thompsonet al. [22]. All analyses were a priori defined and undertaken usingSTATA version 8.0 [31].

Results

Intervention participants

All 19 psychiatric units from the four mental health care truststook part in the study. There were 10 units randomized to theintervention group and nine units randomized to the control group.There were more specialist beds in the intervention units, butotherwise the groups were reasonably balanced between the trialarms. The characteristics of these units are shown in detail else-where [22]. A total of 193 doctors and 474 nurses were identifiedthrough ward managers as working on these 19 units. Of these 667,555 (83.2%) were still working in the units at the end of thetrial. Therefore, only 555 questionnaires were sent out at post-intervention, as we were only interested in belief changes in indi-vidual members of staff. A total of 112 members of staff (16.8%)had left their original ward post-intervention, 47 from the controlgroup and 65 from the intervention, 24 doctors and 88 nurses(see Fig. 1). This group was not significantly different from thoseremaining in the trial in terms of their baseline belief factor scores.

Prescribing outcome measure

The results of the primary outcome measure are reported in fullelsewhere [22]. The overall rate of polypharmacy was reduced inthe intervention arm and increased in the control arm. The regres-sion model for antipsychotic prescribing showed that the complexintervention led to a significant reduction in prescribing of polyp-harmacy in the intervention units (odds ratio 0.43, 95% confidenceintervals 021–0.90, P = 0.03), but this was mainly due to theplanned (a priori) adjustment for baseline differences in prescrib-ing [22]. There was considerable between unit variation in pre-scribing change in the intervention units (range -26 to +7%).

Beliefs outcome measure

The overall response rate for the questionnaire at baseline was45.6% (304/667) and 46.5% (258/555) post-intervention

(calculated using those who remained working on the wards as thedenominator). There were differentially more questionnairereplies from the intervention group than the control group both atbaseline (48.0% compared with 42.6%) and at post-intervention(48.4% compared with 44.2%). Of the individuals who wereworking on the ward at both sampling time points, 33.9% (188/555) replied to both the questionnaires at both time points, with allquestions answered, and were subject to the a priori regressionanalysis.

Baseline beliefs

Table 1 shows the characteristics of the responders to the ques-tionnaire at baseline. There were proportionately more responsesby females and doctors in the intervention group, but they hadfewer years of experience. Otherwise, the two groups were rela-tively well matched.

Of the non-responders, proportionately more at baseline were inthe intervention units (53.2% as opposed to 46.8%). There wereproportionately more doctor non-responders in the control groupthan in the intervention (43.6% of all doctors compared with31.3% of all doctors). The proportion of nurse non-responders wassimilar (63.9% in the control compared with 59.6% of all nurses inthe intervention). Of the non-responders at baseline, proportion-ately more of these were nurses than doctors; this was similar inboth control and intervention groups.

Belief factors scores

The baseline and post-intervention questionnaire mean scores forthe three identified factors for individuals in the control and inter-vention groups are shown in Table 2. Both the beliefs about polyp-harmacy and the beliefs about rapid tranquilization factors havesmaller scores at post-intervention in the intervention group, but thebelief about evidence and guidelines factor scores are slightlyhigher. Questionnaire wording meant that we would expect reducedscores in beliefs about polypharmacy and rapid tranquilization if thebeliefs have changed in the preferred direction. The beliefs aboutevidence and guidelines were not directly challenged in the inter-vention, but a change on these beliefs would result in increasedscores. There were limited changes pre- and post-intervention in thecontrol group. Factor scores were similar for all those individualswho replied to both questionnaires and those who were sub-sequently included in the regression model below.

Regression model for the beliefs outcome

Table 3 shows the results of the random-effects regression modeladjusting for predefined confounders. The results show that thepredicted negative changes for the beliefs about polypharmacy andthe beliefs about rapid tranquilization factors produced significantresults, whereas the positive change in the beliefs about guidelinesfactor was not significant. The regression models were repeated asa post hoc analysis by clinician type but with reduced numbers andconsequent wider confidence intervals. For both doctors andnurses, the hypothesized changes in beliefs about polypharmacyremained significant at the 0.05 level; for beliefs about rapid tran-quilization, the changes were only significant for the doctors withthe P-value for the nurses being at a trend level (P = 0.08).

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Enrolment

Allocation

Baseline

Recruitment

Participation

Post-intervention

Recruitment

Participation

Assessed for eligibility – four trusts with 19 units (clusters) [noneexcluded or refused to take part]

Randomized units (n=19)

Allocated to intervention(n=10 )

Allocated to control(n=9)

Units n=10Relevant staff n=371 (nurses=272;doctors=99)Questionnaires sent n=371

Participants leavingthe units n=65Nurses=54Doctors=11

Participants leavingthe units n=47Nurses=34Doctors=13

Units n=9Relevant staff n=296 (nurses=202;doctors=94)Questionnaires sent n=296

Units n=10Participants n=371Questionnaires returned n=178(nurses=110; doctors=68)

Units n=9Participants n=296Questionnaires returned n=126(nurses=73; doctors=53)

Units n=10Relevant staff n=306(nurses=218; doctors=88)Questionnaires sent n=306

Units n=10Participants n= 306Questionnaires returned n=148(nurses=94; doctors=54)

Units n=9Relevant staff n=249 (nurses=168;doctors=81)Questionnaires sent n=249

Units n=9Participants n=249Questionnaires returned n=110(nurses=62; doctors=48)

Figure 1 Flow of inpatient units and staff (doctors and nurses working on the wards) recruited and numbers of staff sent and returning questionnairesthroughout the trial.

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Sensitivity analysis

A sensitivity analysis was performed where the baseline proportionof polypharmacy for each unit was included as a covariate in theanalysis. The results of the regression models are shown in Table 3

for each factor. The effects for both the beliefs about polypharmacyand rapid tranquilization factors are strengthened; the belief aboutevidence and guidelines factor remains non-significant.

Intervention uptake

Returned workbook feedback forms gave an estimate of howmany people completed it. A total of 50% participants returned aform, consisting of proportionately more nurses than doctors(52% of all doctors compared with 45% of all nurses). Between67.9% and 69.8% of the sample analysed (those who replied toboth questionnaires) reported in their post-intervention question-naire that they had completed the workbook. This was a similarpercentage range (67.1% to 68.1%) to that reported for all repliespost-intervention, some of which had not completed the baselinequestionnaire. The educational visit (academic detailing) had aninitial uptake of 92.7% (first visit) and 43.6% (follow-up visit);the medication chart prompt system had 61% coverage on arandom check.

DiscussionCompared with a control group, our complex intervention whichincluded a cognitive behavioural style workbook significantlychanged beliefs as measured by two predefined factors corre-sponding to particular themes about antipsychotic polypharmacy.This change became more pronounced when the baseline propor-tion of polypharmacy for each individual psychiatric unit wascontrolled for. The complex intervention also changed prescribingbehaviour, as shown by the primary outcome results, although thiseffect could best be described as a modest change.

Table 1 Characteristics of questionnaire respondents at baseline in thecontrol and intervention groups

Control unitsn/N (%)

Intervention unitsn/N (%)

Responders 126/296 (42.6) 178/371 (48.0)Age (years)

16–24 1/119 (0.8) 4/174 (2.3)25–34 33/119 (27.7) 47/174 (27.0)35–44 44/119 (37.0) 70/174 (40.2)45–54 34/119 (28.6) 44/174 (25.3)55–64 6/119 (5.0) 7/174 (4.0)>64 1/119 (0.8) 2/174 (1.1)

SexMale 61/123 (49.6) 74/176 (42.0)Female 62/123 (50.4) 101/176 (57.4)

Years since qualified0–4 25/119 (21.0) 42/170 (24.7)5–9 25/119 (21.0) 30/170 (17.6)10–15 10/119 (8.4) 33/170 (19.4)>15 59/119 (49.6) 65/170 (38.2)

ProfessionNurse 73/126 (57.9) 110/178 (61.8)Doctor 53/126 (42.1) 68/178 (38.2)Of all nurses recruited 73/202 (36.1) 110/272 (40.4)Of all doctors recruited 53/94 (56.4) 68/99 (68.7)

Table 2 Baseline and post-intervention scores, number of observations and standard deviations for the three factors (beliefs about antipsychoticpolypharmacy, evidence and guidelines and rapid tranquilization respectively) from the questionnaire in the control and intervention groups for allreturned questionnaires and for those analysed (when both baseline and post-intervention are returned by an individual)

NumberBaselinescores

Standarddeviation Number

Post-interventionscores

Standarddeviation

All returned questionnairesIntervention

Antipsychotic polypharmacy factor 174 4.15 1.66 144 3.26 1.71Evidence and guidelines factor 177 1.74 2.02 149 1.9 1.86Rapid tranquilization factor 175 4.5 1.92 144 3.58 1.83

ControlAntipsychotic polypharmacy factor 121 3.8 1.66 106 4.11 1.8Evidence and guidelines factor 124 1.51 1.97 108 1.45 2Rapid tranquilization factor 123 4.28 1.99 107 4.34 1.88

All analysed questionnairesIntervention

Antipsychotic polypharmacy factor 106 4.17 1.63 106 3.28 1.76Evidence and guidelines factor 110 1.62 2.04 110 1.74 1.88Rapid tranquilization factor 106 4.46 1.89 106 3.51 1.85

ControlAntipsychotic polypharmacy factor 74 3.88 1.65 74 3.98 1.8Evidence and guidelines factor 78 1.24 2.04 78 1.36 2.09Rapid tranquilization factor 77 4.29 2 77 4.09 1.99

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Study design

Multifaceted or complex interventions, especially those address-ing specific barriers to change, appear to be the most effectivemethod of improving professional practice [34]. This trial addsto the literature but also examines other aspects associated withbehaviour change. It has been suggested that a more targetedpsychological approach that takes into account the literature onbehaviour change should be used when designing such trials[19]. We believe our workbook represents such a targeted psy-chological approach involving predefined barriers to change anda specific model to attempt to change behaviours. The workbookappeared to influence specific beliefs involved in ‘rule breaking’which correspond with potential barriers to behavioural change.The use of similar cognitive behavioural style workbooks withclinical staff is relatively novel and we know of no similarapproaches in the implementation literature either in psychiatryor in other specialities.

However, although we appeared to achieve a relatively largechange in beliefs in the trial, the strength of the change in behav-iour, although statistically significant, could be best described asmodest. It is therefore important to examine why such a change inbeliefs does not correspond to a larger change in behaviour.

The relationship between behaviour and beliefs is complex,with changes in beliefs and attitudes often described without acorresponding change in behaviour and vice versa [30]. Theoriesof behaviour change such as the theory of planned behaviourhave emphasized the importance of perceived behaviouralcontrol, additional to attitudes and subjective norms that mayhave been positively influenced by the intervention. From ourpreparatory work, we were aware that a number of the barriers tobehaviour change were not specifically related to the individualclinician but to the systems and culture of the psychiatric unititself. This may be an explanation for why some units changedtheir practice overall and other did not. For example, psychiatricunits with a high staff turnover and high levels of disturbanceappeared to be those in which behaviour change was difficult toachieve. This may be due to the perceived lack of control of theclinicians themselves over external factors. Baker et al. [35] havesuggested that a novel approach that either specifically targets allaspects involved in particular models of behaviour change (suchas self-efficacy, beliefs and social norms in the theory of plannedbehaviour) or even identifies which of these elements are most

important for a particular individual in order to facilitate achange in their behaviour.

From our preparatory qualitative work, attitudes towards antip-sychotic prescribing were elicited and knowledge of the process ofprescribing on wards obtained [25]. The role played by nurses inthe prescribing process was appreciated. Psychiatry is a specialityin which the expertise of the nursing staff in monitoring mentalstate to guide prescribing behaviour is important, especially in aninpatient setting. There are a number of other medical specialitieswhere prescribing decisions are heavily influenced by nursingexpertise. This may become even more important given recentinitiatives that have advocated nurse prescribing in a number ofspecialities. Despite this, the approach of aiming such interven-tions at both nurses and doctors is not common in psychiatric orother health service research. Only two trials in psychiatry ofacademic detailing to reduce prescribing of antipsychotic drugs innursing homes have addressed this issue. In their first trial aimedpurely at doctors, Ray and colleagues showed no effect of theintervention, citing other factors within the nursing home as apotential reason for this [36]. They identified the effect of both thenursing home and the staff in influencing prescribing and sug-gested that a more intensive approach that did not solely target theprescribing physicians may be appropriate. In a further controlledtrial of a more comprehensive intervention, they targeted multipleprescribers and determinants of medication use such as physi-cians, nurse’s aides and families. They were able to demonstrate amarked reduction in antipsychotic use, with no increase in behav-iour problems or substitute benzodiazepine prescribing [37].Avorn et al. [38] used educational materials and audit and feed-back to reduce the prescription of ‘psychoactive drugs’ in a similarnursing home population. They used a clinical pharmacist toconduct three individual visits to targeted clinicians and also usedfour training sessions with nurses and aides. We were able todemonstrate a change in beliefs both with nursing staff and withdoctors using the workbook.

Comparison with previous studies

Literature reviews in this area have cited many studies that useeducational materials to change prescribing behaviour withvarying degrees of success [17]; however, few have used a work-book approach. Workbooks have been used in trials to influenceprescribing practice in primary care. Braybrook and Walker [39]

Table 3 Results of the adjusted random-effects regression model (adjusting for unit size, trust and baseline factor score) and the same modeladditionally adjusting for the baseline polypharmacy proportions (shown are number subject to analysis, the coefficient, 95% confidence intervals andthe P-value for each of the three factors)

Numberanalysed

Adjusted regression modelModel additionally adjustedfor baseline polypharmacy

Coefficient95% confidenceintervals P Coefficient

95% confidenceintervals P

Antipsychotic polypharmacyfactor

180 -0.89 -1.38 to -0.40 <0.01 -1.23 -1.83 to -0.63 <0.01

Evidence and guidelinesfactor

188 0.19 -0.33 to 0.71 0.47 0.37 -0.28 to 1.02 0.27

Rapid tranquilization factor 183 -0.68 -1.17 to -0.19 <0.01 -1.17 -1.72 to -0.62 <0.01

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compared the effect of a ‘pharmaceutical prescribing advisor’ anda practice-specific prescribing analysis workbook with treatmentas usual. They observed some improvements in targeted prescrib-ing practices with the workbook but a stronger effect for theprescribing advisor. The use of workbooks with a particular cog-nitive behavioural approach is limited other than for patient behav-iour change. We know of no similar implementation trial inpsychiatry that has investigated belief change as well as behaviourchange.

Limitations

There was variable uptake of parts of the intervention in someunits, and only 50% of the staff in the intervention group sent backan evaluation form, suggesting that they completed this part of theintervention. However, this is likely to be an underestimate assome will have completed the workbook but not returned theirfeedback form. The additional finding that around 70% of thosecompleting the post-intervention questionnaire responded thatthey had completed the workbook increases the support for this.We acknowledge that persuading staff to participate in this part ofthe intervention was difficult given the time commitment involved.

Although we managed to analyse 188 responders, we appreciatethat this is a small percentage (33%) of the original sample andmay represent a biased population. It does appear that theseresponders were more likely than the non-responders to have com-pleted the workbooks. We have no detailed data on non-responders. The decision was taken to only include those whoreturned both questionnaires in the analysis, as the aim of theworkbook was to assess individual’s beliefs pre- and post-intervention. However, a post hoc analysis of the data withoutcontrolling for baseline beliefs, with a larger sample (254 indi-viduals), showed similar results. This was also the case for analysisof the responders sub-divided by profession (doctors or nurses).

The questionnaire design aimed to avoid a response set in thequestionnaire, but we cannot be sure that this was successful.Neither can we be sure that responses were not made in a sociallyacceptable manner, although anonymity makes this less likely. Wehave attempted to show that our questionnaire has a degree ofreliability by performing a test–retest exercise. Its validity is alsostrengthened by the fact that it draws directly from previous quali-tative work by our research group on prescribing views with con-sultant psychiatrists. We accept that such a bespoke instrument hasno concurrent validity, but we believe that it accurately reflectsstaff beliefs in this area. Further validation of this questionnairewould be welcomed in different populations.

It could be argued that as the trial was multifaceted the changein beliefs could be associated with other parts of the intervention(such as the academic detailing) and not specifically to the work-book. While this is possible and some of the themes of the work-book may have been discussed in the academic detailing visitswith the consultant, we believe that as the questionnaire was spe-cifically designed to test the themes of the workbook this wouldaccount for most of the variance in belief change. Neither of theother interventions directly challenged the beliefs sampled by thequestionnaire to the same extent as the workbook. As the beliefchange was evident in both the doctors (some of whom weresubject to the academic detailing part of the intervention as well asthe workbook) and the nurses (who just received the workbook),

we would argue that workbook was responsible for the majority ofthe belief change. Given the cross-sectional nature of this measureof beliefs, we are not able to demonstrate in this study that theeffect of this change is sustained over time.

Conclusions

We were able to demonstrate a change in both behaviour andbeliefs regarding a common problematic prescribing issue withinpsychiatry using a novel approach to change clinicians’ prescrib-ing behaviour. However, the relatively large changes in beliefswere not related to large changes in behaviour, and we concludethat other factors important in the process of prescribing such asthe role of the hospital system itself may be equally important.Therefore, trials attempting to change complex practices shouldconsider the role of the system as well as the individual in theirdesign.

AcknowledgementsThe authors would like to thank Tim Peters for his help in dataanalysis, Glyn Lewis for his helpful comments on the study and allthe participating clinicians. We would also like to thank NicolaHovey, Graham Parton, Liz Davenport and James Marriot forproviding liaison between the appropriate trusts, medical directorsand nursing directors. We acknowledge Eli Lilly for their help inproviding marketing selling training for the intervention.

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