Family Practice Advance Access published online on June 25, 2008
Family Practice, doi:10.1093/fampra/cmn032
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Interactive workshops increase chlamydia testing in primary care—a controlled study
a Health Protection Agency Primary Care Unit, Microbiology Department, Gloucestershire Royal Hospital, Great Western Road, Gloucester GL1 3NN
b Gloucestershire Primary Care Trust, Bell Lane Surgery, Minchinhampton Gloucestershire GL6 9JF
c Gloucestershire Primary Care Trust, The Surgery, Whitminster Lane, Frampton on Severn, Gloucestershire GL2 7HU
d Statistics, Modelling and Bioinformatics, Health Protection Agency , Centre for Infections, 61 Colindale Avenue, London NW9 5EQ
e Gloucester Research and Development Support Unit, Great Western Road, Gloucester GL1 3NN
f Consultant Microbiologist, Pathology Laboratory, County Durham and Darlington Acute Hospitals NHS Trust, Darlington Memorial Hospital, Hollyhurst Road, Darlington DL3 6HX
g Clinical Biochemist, Clinical Laboratory, County Durham and Darlington Acute Hospitals NHS Trust, General Hospital, Bishop Auckland DL14 6AD, UK
Correspondence to Dr Cliodna McNulty, Health Protection Agency Primary Care Unit, Microbiology Department, Gloucestershire Royal Hospital, Great Western Road, Gloucester GL1 3NN, UK; Email: cliodna.mcnulty{at}hpa.org.uk
Received 21 August 2007; Accepted 22 May 2008.
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Abstract |
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Background. Primary care clinicians suggest that staff education is needed to increase chlamydia testing appropriately.
Objectives. To determine if interactive workshops and modified laboratory request forms could increase testing and case detection.
Methods. Study design: Prospective cluster randomized controlled study, using modified Zelen's design, examining the effect of workshops and modified request forms on primary care clinicians' chlamydia specimen submission and case positivity rate. Study population: 82 general practices in six geographical clusters within five primary care trusts (PCTs) in Gloucestershire and County Durham and Darlington. Intervention: Practices within geographical clusters were randomly assigned to workshops on chlamydia or a control consisting of comparable workshops on the management of urinary symptoms, held in PCT-protected learning time. Half the practices were randomized to receive modified laboratory request forms. Staff were unaware that they were part of a study.
Results. Interactive workshops increased chlamydia testing in 16- to 24-year-old women by 33% in intervention practices compared to controls with effect persisting at 10 months (P = 0.003). No associated rise in the number of chlamydia infections was detected (P = 0.91), suggesting that increased testing may have occurred in a lower risk population. Modified forms did not change test submission (P = 0.75).
Conclusions. Interactive workshops for general practices can be used to successfully increase chlamydia-testing rates. Chlamydia detection rates will need to be monitored as this type of educational programme may not increase absolute numbers of chlamydia infections detected, if patients at lower risk of infection are inappropriately tested. Other interventions may need to be combined with the workshops, to reach sufficiently high chlamydia screening rates to significantly reduce prevalence of chlamydial infection.
Keywords. Chlamydia, education, screening, primary care, RCT.
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Introduction |
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Increasing trends in the diagnoses of Chlamydia trachomatis across Europe since the mid-1990s highlight the major public health implications of this infection, especially in young women.1,2 Studies indicate that efforts aimed at primary care to increase chlamydia testing should be accompanied by clear guidance and education to increase understanding about the value of chlamydia screening and overcome barriers of discussing sexual health.3–5
Guidance recommends that clinicians should consider a chlamydia swab in at-risk groups when examining the cervix or taking high vaginal swabs (HVSs).6,7 However, laboratory audit showed only 40%–50% of HVS from 16- to 25-year-old women in Gloucestershire and Herefordshire also had a specific swab for C. trachomatis, with a 40-fold variation in general practice submission per 1000 population.8
Cochrane reviews show that multifaceted interventions including interactive workshops are more effective than didactic lectures in changing practice.9,10 We aimed to determine if interactive workshops with primary care staff could increase chlamydia testing in the at-risk age group of 16- to 24-year olds. To reinforce the message, we also developed modified laboratory request forms, which contained the key message to always consider a chlamydia swab in sexually active women under 25 years. So that practice staff behavior would not be influenced by the knowledge that they were part of a trial, all participants were unaware that they were part of a trial. This modified Zelen design is particularly applicable to trials of educational interventions.11,12
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Methods |
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Study design
Prospective cluster randomized controlled study, with modified Zelen design, examining the effect of workshops and modified request forms on primary care clinicians’ microbiology laboratory specimen submission.
Study population
General practices served by the microbiology departments of Gloucestershire Hospitals NHS Foundation Trust and County Durham and Darlington Acute Hospitals NHS Trust, which are 200 miles apart. The County Durham and Darlington area had 3 primary care trusts (PCTs), 33 general practices and a population of 284 800. The 49 Gloucestershire practices fall into three distinct geographical clusters within two PCTs, with a population of 324 300.
Ethics
The study was approved by the Gloucester Local Research Ethics Committee (LREC) (Ref. number 02/52G) and Durham LREC (061/Sept02) and approved by the PCT clinical governance leads. We used a modified Zelen design,12 i.e. participating practice clinicians and managers did not know that they were part of an educational study.
Intervention allocation
The six geographical clusters were randomly assigned by the flick of a coin by CAMM and MT to receive either chlamydia or urine workshops. Clusters given urine workshops were the control group. Within these groups, half the practices were randomized by JB, using random number tables, to receive modified laboratory request forms (Fig. 1).
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Outcomes
Primary outcome: Effect of workshops and modified request forms on the rate of laboratory chlamydia specimen submissions.
Secondary outcome: Effect of workshops and modified request forms on the rate of positive chlamydia results per thousand populations diagnosed in general practice.
Workshops
All staff were invited to a standardized interactive outreach workshop during March 2003 on the clinical and laboratory diagnosis of genital chlamydia infection or urinary symptoms. Workshops were held in continuing professional development sessions funded by the PCTs. A clinical microbiologist (a well-respected Gloucestershire opinion leader) gave the workshops in all areas. Workshops were based on the Scottish Intercollegiate Guidelines Network and Health Protection Agency (HPA) Web site guidance.6,7,13 The workshops were designed with two Gloucestershire GPs (MT and CB), two nurses, a clinical microbiologist and a consultant in genitourinary medicine.
To allow clinicians to compare their testing rates with other practices, the workshops included a poster session presenting practice chlamydia-testing and positivity rates per 1000 population. Each workshop posed questions to participants covering the key messages (Box 1). Participants discussed these with their neighbors, and then the evidence underpinning the answers and guidance was presented. Pairs of participants listed barriers to increasing chlamydia testing, then possible ways of overcoming these barriers were discussed with the whole group (Box 1).
BOX 1 Chlamydia workshop key messages.
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A copy of key messages, HPA guidance and local chlamydia-testing and positivity rates of practices in the cluster were given to participants at the workshop and also distributed 1 month later to all intervention practices.
Modified forms
Modified laboratory forms containing the main key messages were distributed 2 months after the workshops in Gloucester and 6 months after the workshops in Durham/Darlington to the randomly selected practices (Fig. 1). Requestors were asked to tick a clinical management strategy box (Box 2). A similar biochemistry scheme has been trialled successfully.14
Six months after the workshops, practice managers in all areas were sent a letter to remind clinical staff of the key messages. The correspondence also asked if the practice had discussed testing at a practice meeting, had undertaken any audits on testing and if testing behavior had changed. Reponses in the two workshop groups were compared by chi-square or Fisher's exact test.
Laboratory test submissions
Both laboratories throughout this study recommended endocervical swabs for the diagnosis of chlamydia in women. The Gloucester laboratory used enzyme immunoassays (EIAs) (Syva MicroTrak II Chlamydia EIA; Dade Behring, Kanato, Ontario, Canada) and confirmed positives with direct immunoflourescence (MicrotrakII, Dako, Ely, Cambridge, UK); Durham/Darlington used the Becton Dickinson ligase chain reaction (LCR) system (Becton Dickinson, Oxford, UK) and repeated all positives. Laboratory data and general practice population data were collected for the 9 months before the intervention in all areas from April 1, 2002, to December 30, 2002 (preintervention data), and from April 2003 to 9 months after the modified forms were issued (February 04 in Gloucestershire and June 30, 2004, in Durham). Data were used to determine the chlamydia- and HVS-testing rate and the positivity rate per 1000 patients. Four practices were excluded from the analysis as they piloted the modified forms and practice staff had participated in recent chlamydia research which included focus group discussions with researchers to explore their chlamydia-testing behavior and barriers to chlamydia screening.
Sample size determination
The size of the study was fixed by the number of GP practices within the six geographical clusters. However, assuming that a 20% increase in chlamydia submissions could be considered as clinically important and there being around 25 submissions per 1000 patients per year, a total sample size of 44 practices would be required to ensure 90% power to detect this increase.
Data analysis
Chlamydia submission and positivity rate per 1000 population in women were compared in the age groups 16–24 years and 25 years and over between active and control groups. We also compared the percentage of patients under 25 years who had a chlamydia swab taken at the time of an HVS. The effect of using the modified forms on both submission and chlamydia incidence rates was similarly assessed.
Statistical modeling was undertaken with the practice chlamydia submission and positivity rates in 3-month periods as the dependent variables. The natural logarithm of the practice capitation was incorporated as a covariate in the model. The Durham/Darlington practices submitted significantly more chlamydia specimens than Gloucestershire practices before the intervention (for 16- to 24-year olds, median 32.0/1000, interquartile range (IQR) 26.3–47.9/1000 versus median 23.7/1000 IQR 14.3–35.5/1000, P < 0.001 and for 25+ year olds median 19.7/1000, IQR 13.1–47.9/1000 versus median 22.2/1000, IQR 9.4–29.5/1000, P < 0.001); therefore, the aggregate baseline number of submissions and positive tests were included as covariates. A multilevel model was used to allow for cluster randomization. The outcome variable was assumed to have a Poisson distribution and a logarithmic link function was used to obtain direct estimates of the rate ratios. The models were implemented in Stata version 8.2. The unit of analysis was the GP practice. The two interventions, outreach workshop and modified form, and their interaction were treated as fixed effects, as was the region (Gloucestershire or Durham/Darlington). Time since the workshop was also included in the model to enable determination of any effect modification with time.
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Results |
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Out of the 82 practices within the PCTs (total population 609 100), 42 practices were randomized to attend chlamydia workshops and 40 to attend the control urine workshops (Fig. 1). One practice closed during the study period and was excluded from the analysis. Two pairs of practices merged; each pair was treated as a single practice throughout the analysis. In 66% of practices randomized to attend a chlamydia workshop, at least one staff member attended (59% were doctors, 40% were nurses and 1% were administrators).
After the intervention practices in the chlamydia, workshop areas submitted 33% more chlamydia specimens from 16- to 24-year-old females compared to the controls [ratio 1.33, confidence interval (CI) 1.10–1.60]. The increased submission rate did not change with time. Specimen submissions from females 25 years and over did not change significantly (ratio 1.08, CI 0.88–1.32) (Table 1). In Gloucestershire, within the 16- to 24-age group, there was no significant change in the age of patients sampled by workshop practices after the intervention (21.1 years before, 21.2 years after, P = 0.27). We do not have ages for the Durham/Darlington patients.
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The number of chlamydial infections detected per 1000 population in the workshop areas was not significantly greater than controls in either age group (Table 1, 16–24 years female ratio 0.98, CI 0.69–1.40; females
25 years 1.03, CI 0.67–1.60) and did not change with time. Specimen positivity for chlamydia fell from 9.5% to 7.6% in workshop areas and from 9.9% to 9.2% in control areas. The modified forms had no effect on submission or positives per 1000 population and had no additional effect when given with the workshops, or with time.
Submission of chlamydia specimens with HVS
Overall, workshops had no effect on submission of chlamydia specimens with HVS (P = 0.55). In Gloucestershire where workshop and control practices had similar preintervention submissions, there was a 14% increase. However, the Durham/Darlington workshop practices already submitted chlamydia specimens with 83% of HVS preintervention compared to 45% in the controls, so there was much less scope for improvement (Table 2).
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Six-month questionnaire
Sixty-six of the 82 (80%) practices completed the 6-month questionnaire. In all, 64% (27/42) of practices in the workshop area reported that they had discussed chlamydia at a practice meeting and 57% (24/42) that they had changed their testing or protocols, compared to 32.5% (13/40, P = 0.004) and 18% (7/40, P < 0.001) in the control areas. Audits had been undertaken by 14% (6/42) of practices in the workshop areas compared to none in the control group (Fishers exact test P = 0.03).
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Discussion |
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Key findings
Interactive workshops held with general practice staff led to a sustained 33% increase in chlamydia testing in the target age group of 16- to 24-year-old women. There was, however, no associated rise in the number of chlamydia infections detected per 1000 population, suggesting that the extra patients tested were at lower risk of chlamydia infection. Modified forms made no difference to submission of chlamydia tests.
Study strengths
This is the first randomized controlled trial (RCT) examining the effect of workshops and modified forms on microbiology specimen submission or submission of chlamydia tests. The study was a prospective, multicenter RCT, and participants were unaware that they were part of a study. We used a modified Zelen design, which recognizes that as knowledge of the trial by the control group in trials of educational interventions may influence results, blinding to the trial may be the optimum solution.11,12 This design is difficult if data collection is intrusive; however, we were analysing routinely collected data. Data were analysed for the whole general practice population base, not just for the clinicians who attended the workshops. These factors make the findings more generalizable than many other educational intervention trials.9,10 In Gloucestershire, 91% of workshop participants were doctors compared to only 27% in Durham/Darlington. This difference in staff attendance may suggest that more nurses were involved in chlamydia testing in Durham than in Gloucestershire. However, despite this possible difference in staff approach and attendance, there was no geographical difference in the increase in chlamydia testing, suggesting that this workshop approach is equally effective with nurses or doctors.
Study weaknesses
For ease of workshop organization and blinding of clinicians, the study was randomized by area rather than practice. As clinicians did not know they were part of a study, they were free to discuss the workshops with control practices. However, we believe that exchange of information between intervention and control practice staff about the workshops was unlikely as they were in geographically distinct areas, half 240 miles apart, with no work-related contact between practice staff at educational meetings or during on-call rotas. If discussions did occur, the differences between intervention and controls may be underestimated.
The chlamydia-testing workshops aimed to increase submissions, and urine workshops aimed to reduce them: this may have had unintended implications for the use of one type of workshop as the control group for the other. For example, those attending the chlamydia workshop may have taken on board the message to increase all laboratory submissions, and submitted more urine samples, therefore reducing the difference between control and intervention groups. The before and after submission data do not support this proposition. Furthermore, the contents of the workshop were very condition specific and did not include general advice on sampling policy.
Our impression was that no particular age or sex of staff was more likely to participate in the chlamydia workshops. However, due to the pragmatic design and blinding of practice staff to the study, we were not able to collect this information and, therefore, cannot determine how this would have influenced workshop outcome. The aim of our study was to determine the effect of workshops across the whole of a typical PCT, staff attendance are likely to be similar in other PCTs. We had intended to distribute modified request forms at the same time interval after the workshops; however, the microbiologist in Durham had to serve in the Iraq war for several months and distribution in Durham was delayed. However, the timing of the form distribution made no difference to outcomes and there was no temporary effect after distribution at any of the PCTs. The EIA detection method used in Gloucester is known to have lower sensitivity than the LCR method used in Durham/Darlington and nucleic acid detection methods now used in the National Chlamydia Screening Programme.15 There is also some evidence that sensitivity of EIA may be lower in specimens from asymptomatic younger patients.16 There was no evidence to suggest that the effect of workshop on positivity differed by geographical area, so this difference in test used should not influence interpretation of the results. The number of chlamydia specimens submitted with HVS increased significantly in Gloucestershire. In contrast, in Durham/Darlington, the controls significantly increased their percentage submissions compared to workshop practices, but nearly twice as many patients had a chlamydia specimen sent with an HVS in the Durham/Darlington workshop area (83%) prior to the intervention than in controls (45%), so there was little scope for improvement. Although none of the geographical areas were registered with the National Chlamydia Screening Programme, there may have been a general increased awareness among general practice staff, irrespective of the workshops, of the importance of chlamydia and the need to test at-risk patients for chlamydia when taking a vaginal swab for the investigation of genitourinary symptoms. One-third of control practices had discussed chlamydia testing at a practice meeting. This awareness in control practice staff may have reduced the differences in chlamydia test submissions overall and with HVS’ from workshop practices versus controls.
Other work in this area
Cochrane reviews have shown that multifaceted interventions are the most effective way to change behavior, although none have included microbiology tests.9,10 Several educational methods have been used to improve opportunistic chlamydia-testing rates, including nurse self-audit and reflection,17 video package to improve communication skills,18 multicomponent internet education19 and a multifaceted intervention (including clinic-based training, newsletters and testing audits).20 All these studies were in self-selected clinicians who are likely to be more motivated. As our study clinicians were not self-selected, and staff did not know their testing rates were being monitored, our findings are more likely to reflect the true effects of workshops given to boost chlamydia testing. Oxman et al.21 indicated that a local opinion leader is needed to facilitate change in practice. In our study, one individual gave the workshops, and the effect was similar in each geographical location.
Interpretation of results
Interestingly, despite the 33% rise in test submission in 16- to 24-year olds, we found no associated rise in the observed number of chlamydia infections detected. However, the CI around the observed percentage change in detected chlamydia infections in the 16- to 24-year olds was wide (–31% to 40%), making it possible that the observed lack of increase could be due to chance. It is possible that the testing methods used failed to detect infection. The outcomes did not vary by geographical location despite Darlington/Durham using the more sensitive test; therefore, it is unlikely to be due to the diagnostic test used. After the intervention, practice staff may have tested patients at lower risk of infection. Certainly, a systematic review of chlamydial infection prevalence in the UK found the most important determinants of chlamydia positivity in women, aged 16–19 years, and health care setting.22 The mean age of patients tested did not change after our intervention. At our workshops, we encouraged clinicians to undertake opportunistic testing of sexually active women less than 25 years, at cervical screens, when they took HVS or when they examined the cervix. This may have included a greater proportion of patients at lower risk of infection and more asymptomatic patients after the intervention. This is likely as the percentage of tests positive for chlamydia fell by almost 2% (from 9.5% to 7.6%) in the workshop practices with no fall in the controls. We cannot confirm this as we did not have ethical approval to prospectively collect clinical details from patient's notes, and this may have highlighted to practice staff our particular interest in their chlamydia-testing behavior. This data collection would be useful in any future prospective study.
Implications
Interactive workshops are successful and many practices can participate simultaneously. Workshops may be used to increase chlamydia screening within National programmes. The 33% increase in chlamydia testing attained by workshops may be insufficient in isolation to attain the chlamydia screening rates that have been calculated in mathematical modeling to be required to significantly reduce the prevalence of chlamydia.23 Therefore, workshops will need to be combined with other interventions as suggested by Oxman et al.21 Chlamydia screening coordinators have suggested that this should include screening targets and raising the profile of the screening programme among professionals and public through advertising and practice information.24 Monitoring of case detection rates is needed to ensure that increased testing rates are having a useful effect, as if increased testing does not increase the absolute numbers of chlamydia infections detected, workshops may not be an effective use of resources.
The modified forms had no effect in this scenario. This may be explained by the relative lack of exposure to the forms compared to biochemistry tests, where asking requesters to specify their clinical management strategy has been shown to significantly change requests.12 We would not advise use of hard copy-modified forms where there is low throughput of a test. As the transfer to electronic requesting occurs, this may allow prompts to remind GPs to consider chlamydia when sending an HVS.
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Declaration |
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Ethical approval: The study was approved by the Gloucester LREC (Ref. number 02/52G), Durham LREC (061/Sept02) and the PCT clinical governance leads.
Conflicts of interest: CAMM writes the Health Protection Agency quick reference guide for primary care covering chlamydia.
Funding: none, financed by core Health Protection Agency funding.
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Acknowledgments |
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We wish to thank practice staff who attended the workshops; Dr Sulaiman, Jill Whiting, HPA medical illustration and all the PCT professional development teams for their input in the design and help at the workshops and Wally Palmer in Gloucester and Kate McGill in Durham for collecting the laboratory data.
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Notes |
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McNulty CAM, Thomas M, Bowen J, Buckley C, Charlett A, Gelb D, Foy C, Sloss J and Smellie S. Interactive workshops increase chlamydia testing in primary care—a controlled study. Family Practice 2008; Pages 1–8 of 8.
1 Present address: Health and Safety Laboratory, Harpur Hill, Buxton, Derbyshire SK17 9JN, UK. 
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References |
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