Clinical outcomes of an integrated primary–secondary model of care for individuals with complex type 2 diabetes: a non-inferiority randomised controlled trial

Abstract

Aims/hypothesis The aim of the study was to determine if a Beacon model of integrated care utilising general practitioners (GPs) with special interests could achieve similar clinical outcomes to a hospital-based specialist diabetes outpatient clinic. Methods This pragmatic non-inferiority multisite randomised controlled trial assigned individuals with complex type 2 diabetes to care delivered by a Beacon clinic or to usual care delivered by a hospital outpatient department, in a 3:1 ratio. Owing to the nature of the study, researchers were only blinded during the allocation process. Eligible participants were aged 18 or over, had been referred by their usual GP to the hospital central referral hub with type 2 diabetes and had been triaged to be seen within 30 or 90 days. The intervention consisted of diabetes management in primary care by GPs with a special interest who had been upskilled in complex diabetes under the supervision of an endocrinologist. The primary outcome was HbA 1c at 12 months postrecruitment. The non-inferiority margin was 4.4 mmol/mol (0.4%). Both per-protocol and intention-to-treat analyses are reported. Results Between 27 November 2012 and 14 July 2015, 352 individuals were recruited and 305 comprised the intention-to-treat sample (71 in usual care group and 234 in the Beacon model group). The Beacon model was non-inferior to usual care for both the per-protocol (difference −0.38 mmol/mol [95% CI −4.72, 3.96]; −0.03% [95% CI −0.43, 0.36]) and the intention-to-treat (difference −1.28 mmol/mol [95% CI −5.96, 3.40]; −0.12% [95% CI −0.55, 0.31]) analyses. Non-inferiority was sustained in a sensitivity analysis at 12 months. There were no statistically or clinically significant differences in the secondary outcomes of BP, lipids or quality of life as measured by the 12 item short-form health survey (SF-12v2) and the diabetes-related quality of life (DQoL-Brief) survey. Safety indicators did not differ between groups. Participant satisfaction on the eight-item client satisfaction questionnaire (CSQ-8) was good in both groups, but scores were significantly higher in the Beacon model group than the usual care group (mean [SD] 28.4 [4.9] vs 25.6 [4.9], respectively, p < 0.001). Conclusions/interpretation In individuals with type 2 diabetes, a model of integrated care delivered in the community by GPs with a special interest can safely achieve clinical outcomes that are not inferior to those achieved with gold-standard hospitalbased specialist outpatient clinics. Individuals receiving care in the community had greater satisfaction. Further studies will determine the cost of delivering this model of care.

Community‐based management of complex type 2 diabetes: adaptation of an integrated model of care in a general practice setting

“…Although we used simple pragmatic questionnaires to assess participant satisfaction, there were marked increases in the proportions of participants moderately or very satisfied with key aspects of diabetes management as a result of DCCC involvement. This finding parallels that in the Beacon randomised trial in which scores on a validated client satisfaction questionnaire were higher in participants in the Beacon programme compared to those in usual outpatient clinic care 7 . It is possible that the relatively high satisfaction rate in the DCCC was a major factor underlying the low non‐attendance rate for scheduled appointments.…”

“…In the two Brisbane Beacon studies reported to date, there were similar average falls in HbA 1c of 1.1% 6 and 1.3% 7 (12 and 14 mmol/mol respectively) at 6 months, and 0.8% 6 and 1.1% 7 (10 and 12 mmol/mol respectively) at 12 months, from a similar baseline HbA 1c (8.6% 6 and 9.4%, 7 or 70 and 79 mmol/mol, respectively, compared to 9.4% or 79 mmol/mol in the present study). Although we did not have a comparator group, the most recent Beacon trial included a usual hospital outpatient care arm and the Beacon model proved non‐inferior for glycaemic efficacy 7 . This suggests that DCCC participants were not disadvantaged by utilising integrated care in the community rather than specialist clinics.…”

“…It is possible that the relatively high satisfaction rate in the DCCC was a major factor underlying the low non‐attendance rate for scheduled appointments. This was <10% in the DCCC and also in the Beacon randomised trial, 7 compared to up to 39% in previous reports for usual outpatient care including from Australia 15 …”

“…In this model, the management of patients with complex type 2 diabetes is delivered in a community‐based general practice by upskilled GP with a special interest in diabetes working on site with an endocrinologist and diabetes nurse educator (DNE). In a recent randomised trial, the Beacon model proved non‐inferior to hospital‐based specialist outpatient clinics in improving glycaemia and non‐glycaemic cardiovascular risk factors while providing better patient satisfaction 7 …”

“…Before the Beacon model can be applied more widely, it needs to be assessed in other contexts. The studies involving this model that have been performed to date have involved recruitment of patients to unblinded research studies 6,7 with the possibility of a Hawthorne effect influencing the magnitude of benefit 8 . Although the Beacon model included prompt communication of a management plan to the participant's GP, there was periodic research‐associated contact with the patients until at least nine months after the initial consultation which was in addition to, and may have influenced, usual care.…”