Pragmatic randomised controlled trial to evaluate guidelines for the management of infertility across the primary care-secondary care interface

Objective To investigate the effect of clinical guidelines on the managemen t of infertility across the primary care-secondary care interface. Design Cluster randomised controlled trial. Setting General practices and NHS hospitals accepting referrals for inferti lity in the Greater Glasgow Health Board area. Participants All 221 general practices in Glasgow; 214 completed the trial. Intervention General practices in the intervention arm received clinical gu idelines developed locally. Control practices received them one year later. Dissemination of the guidelines included educational meetings. Main outcome measures The time from presentation to referral, investigation s completed in general practice, the number and content of visits as a hosp ital outpatient, the time to reach a management plan, and costs for referra ls from the two groups. Results Data on 689 referrals were collected. No significant difference was found in referral rates for infertility. Fewer than 1% of couples were ref erred inappropriately early. Referrals from intervention practices were sig nificantly more likely to have all relevant investigations carried out (odd s ratio 1.32, 95% confidence interval 1.00 to 1.75, P = 0.025). 70% of meas urements of serum progesterone concentrations during the midluteal phase an d 34% of semen analyses were repeated at least once in hospital, despite ha ving been recorded as normal when checked in general practice. No differenc e was found in the proportion of referrals in which a management plan was r eached within one year in the mean duration between first appointment and d ate of management plan. NHS costs were not significantly affected. Conclusions Dissemination of infertility guidelines by commonly used method s results in a modest increase in referrals having recommended investigatio ns completed in general practice, but ther are no detectable differences in outcome for patients or reduction in costs. Clinicians in secondary care t ended to fail to respond to changes in referral practice by doctors. Guidel ines that aim to improved the referral process need to be disseminated and implemented so as to lead to changes in both primary care and secondary car e.