Implementing referral guidelines: lessons from a negative outcome cluster randomised factorial trial in general practice

Moyez Jiwa 2 Paul Skinner 1 Akinoso Olujimi Coker 0 Lindsey Shaw 3 Michael J Campbell 3 Joanne Thompson 3 0 Doncaster Royal Infirmary , Doncaster , UK 1 Northern General Hospital , Sheffield , UK 2 Professor of Primary Care, Curtin University of Technology , GPO Box U1987, Perth, WA 6845 , Australia 3 Institute of General Practice, University of Sheffield , Sheffield , UK Background: Few patients with lower bowel symptoms who consult their general practitioner need a specialist opinion. However data from referred patients suggest that those who are referred would benefit from detailed assessment before referral. Methods: A cluster randomised factorial trial. 44 general practices in North Trent, UK. Practices were offered either an electronic interactive referral pro forma, an educational outreach visit by a local colorectal surgeon, both or neither. The main outcome measure was the proportion of cases with severe diverticular disease, cancer or precancerous lesions and inflammatory bowel disease in those referred by each group. A secondary outcome was a referral letter quality score. Semistructured interviews were conducted to identify key themes relating to the use of the software Results: From 150 invitations, 44 practices were recruited with a total list size of 265,707. There were 716 consecutive referrals recorded over a six-month period, for which a diagnosis was available for 514. In the combined software arms 14% (37/261) had significant pathology, compared with 19% (49/253) in the non-software arms, relative risk 0.73 (95% CI: 0.46 to 1.15). In the combined educational outreach arms 15% (38/258) had significant pathology compared with 19% (48/256) in the non-educational arms, relative risk 0.79 (95% CI: 0.50 to 1.24). Pro forma practices documented better assessment of patients at referral. Conclusion: There was a lack of evidence that either intervention increased the proportion of patients with organic pathology among those referred. The interactive software did improve the amount of information relayed in referral letters although we were unable to confirm if this made a significant difference to patients or their health care providers. The potential value of either intervention may have been diminished by their limited uptake within the context of a cluster randomised clinical trial. A number of lessons were learned in this trial of novel innovations. - Background Few patients with diarrhoea or rectal bleeding consult a general practitioner and fewer still need referral for specialist advice [1]. In the UK guidelines describe patients who need to be referred urgently [2]. Here general practitioners are audited on their efforts to identify such cases with reference to guidelines published by the Department of Health [3]. It has been reported that over ninety percent of patients with colorectal cancer satisfy the published criteria for urgent referral and yet most patients who merit an urgent referral do not have cancer [4]. It has also been suggested that delayed diagnosis may result in part for a failure to elicit the relevant history or perform the pertinent examination of symptomatic patients [5]. Therefore the detailed assessment of patients with colorectal symptoms is considered to be vital when choosing which patients to refer in order to achieve a timely diagnosis. We report a trial in which an electronic interactive referral pro forma prompting the assessment of patients with lower bowel symptoms was introduced in general practice as part of the workflow. It was anticipated that practitioners would learn which signs and symptoms were important and which patients required urgent referral. Adult learning theories predict that when practitioners are offered guidance at the time of making a decision, 'learning' or a 'relatively permanent change to the frequency of actions brought about by instruction or reinforced practice' will take place [6,7]. Empirical evidence from Patel and Kaufman indicate that the integration of software systems into clinical settings fundamentally change not only how physicians view their daily work practice but also the very process of medical reasoning itself [8]. Mugford and colleagues identified 36 published studies of interventions of feedback of information, concluding that information feedback was most likely to influence clinical practice if the information was presented close to the time of decision-making and the clinicians had previously agreed to review their practice [9]. Data from the US suggests that in-office education of primary care physicians may be effective in improving awareness of significant clinical features [10]. Similarly a Cochrane review concluded that educational outreach visits, may be a promising approach to modifying health professional behaviour [11]. Presentations by invited clinical experts are often feature in educational events aimed at general practitioners. Thus we also included a visit by a colorectal surgeon as part of an educational outreach programme as a second intervention. The research question is whether the introduction of an electronic interactive referral pro forma or educational outreach visits by a colorectal surgeon to general practice can alter the case mix of patients referred to lower bowel specialists. Methods Recruitment Practices were recruited from Doncaster and Sheffield. Ethical review was by the North Sheffield Research Ethics Committee. Referrals to colorectal surgeons in this region were not required on any existing pro forma. A total of 150 practices were offered the opportunity to participate and 44 practices were recruited (29%) from August to December 2003 (see Additional File 1). Development of software intervention We developed and piloted an interactive electronic pro forma for processing referrals to colorectal surgeons (General Practice Referral Assessment Facilitator or G-RAF). The interactive pro forma requested information on drop down menus for fifteen clinical signs and symptoms previously identified by GPs and colorectal surgeons as those of significant colorectal disease [12]. Once the clinical data were entered on the pro forma the interactive software offered the practitioner guidance on which cases needed urgent referral with reference to current UK Department of Health guidelines [3]. Once clinical data were entered a referral letter was automatically produced seeking an appropriate appointment at a hospital clinic. (See screen grabs in Figure 1, 2, 3, 4). It was not possible to merge GRAF with the practice software, as there were a plethora of different clinical software systems deployed at local practices. A member of the project team who offered technical support throughout the project trained GPs in the use of G-RAF on a one-to-one basis at their practice. The software was installed in the relevant practices by March 2004 and was available for the duration of the project. Educational outreach (EO) A colorectal surgeon delive (...truncated)