Future Health Today and patients at risk of undiagnosed cancer: a pragmatic cluster randomised trial of quality- improvement activities in general practice

Abstract

Background: Diagnosing cancer in general practice is complex, given the non-specific nature of many presenting symptoms and the overlap of potential diagnoses.

Aim: This trial aimed to evaluate the effectiveness of Future Health Today (FHT) - a technology that provides clinical decision support, auditing, and quality-improvement monitoring - on the appropriate follow-up of patients at risk of undiagnosed cancer.

Design and setting: Pragmatic, cluster randomised trial undertaken in general practices in Victoria and Tasmania, Australia.

Method: Practices were randomly assigned to receive recommendations for follow-up investigations for cancer (FHT cancer module) or the active control. Algorithms were applied to the electronic medical record, and used demographic information and abnormal test results that are associated with a risk of undiagnosed cancer (that is, anaemia/iron deficiency, thrombocytosis, and raised prostate-specific antigen) to identify patients requiring further investigation and provide recommendations for care. The intervention consisted of the FHT cancer module, a case-based learning series, and ongoing practice support. Using the intention-to-treat approach, the between-arm difference in the proportion of patients with abnormal test results who were followed up according to guidelines was determined at 12 months.

Results: In total, 7555 patients were identified as at risk of undiagnosed cancer. At 12 months post-randomisation, 76.0% of patients in the intervention arm had received recommended follow-up (21 practices, n = 2820/3709), compared with 70.0% in the control arm (19 practices, n = 2693/3846; estimated between-arm difference = 2.6% [95% confidence interval (CI)] = -2.8% to 7.9%; odds ratio = 1.15 [95% CI = 0.87 to 1.53]; P = 0.332).

Conclusion: The FHT cancer module intervention did not increase the proportion of patients receiving guideline-concordant care. The proportion of patients receiving recommended follow-up was high, suggesting a possible ceiling effect for the intervention.

Keywords: cancer; clinical decision support; diagnosis; general practice; primary care.

Figure 1.

CONSORT flow diagram. ^aFrequent inclusion criteria that were not met included practice size, willingness to install GRHANITE, and incompatible practice software. ^bOther reasons for exclusion included recruitment targets being met in the trial and practices being lost to follow-up/non-responsive.

Figure 2.

Forest plot showing estimated intervention effects (absolute differences), including planned sensitivity analyses for the primary outcome. ^a Difference in the proportion of patients followed up according to guidelines at 12 months between the intervention and the control arms. ^bSensitivity analysis adjusted for the practice participation in formalised quality improvement programme, patient’s age in years, cohort type, and patient’s sex. ^cSensitivity analysis without symptoms. N = number of investigations and n = number or participants.