Survivors of Intensive Care With Type 2 Diabetes and the Effect of Shared-Care Follow-Up Clinics: The SWEET-AS Randomized Controlled Pilot Study.

ABSTRACT

BACKGROUND: Follow-up clinics after ICU admission have demonstrated limited benefit. However, existing trials have evaluated heterogeneous cohorts and used physicians who had limited training in outpatient care. RESEARCH QUESTION What are the effects of a "shared-care" intensivist-endocrinologist clinic for ICU survivors with type 2 diabetes on process measures and clinical outcomes 6 months after hospital discharge, and is it feasible to conduct a larger trial? STUDY DESIGN AND METHODS: This was a prospective, randomized, single-center pilot study with blinded outcome assessment. Patients with type 2 diabetes, who required ≥ 5 days of ICU care (mixed medical-surgical ICU) and survived to ICU discharge, were eligible. Participants were randomized to attendance at the shared-care clinic 1 month after hospital discharge or usual care. Six months after hospital discharge, participants were assessed for outcomes including glycated hemoglobin, neuropathy, nephropathy, quality of life, return to employment, frailty, and health-care use. The primary outcome was participant recruitment and retention. RESULTS: During an 18-month period, 42 of 82 eligible patients (51%) were recruited. Four participants (10%) withdrew before assessment at 6 months and 11 (26%) died. At 6 months, only 18 of 38 participants who did not withdraw (47%) were living independently without support, and 24 (63%) required at least one subsequent hospital admission. In the intervention group (n = 21), 16 (76%) attended the clinic. Point estimates did not indicate that the intervention improved glycated hemoglobin (+5.6 mmol/mol; 95% CI, -6.3 to 17; P = .36) or quality of life (36-Item Short Form Survey physical summary score, 32 [9] vs. 32 [7]; P = 1.0). INTERPRETATION: Outcomes for ICU survivors with type 2 diabetes are poor. Because of low participation and high mortality, a larger trial of a shared-care follow-up clinic in this cohort, using the present design, does not appear feasible. TRIAL REGISTRY Australian New Zealand Clinical Trials Registry (ANZCTR); No. ACTRN12616000206426; URL www.anzctr.org.au.