title: Supporting insulin initiation in type 2 diabetes in primary care: results of the Stepping Up pragmatic cluster randomised controlled clinical trial.
abstract: ObjectiveTo compare the effectiveness of a novel model of care ("Stepping Up") with usual primary care in normalising insulin initiation for type 2 diabetes, leading to improved glycated haemoglobin (HbA1c) levels.DesignCluster randomised controlled trial.SettingPrimary care practices in Victoria, Australia, with a practice nurse and at least one consenting eligible patient (HbA1c ≥7.5% with maximal oral treatment).Participants266 patients with type 2 diabetes and 74 practices (mean cluster size 4 (range 1-8) patients), followed up for 12 months.InterventionThe Stepping Up model of care intervention involved theory based change in practice systems and reorientation of the roles of health professionals in the primary care diabetes team. The core components were an enhanced role for the practice nurse in leading insulin initiation and mentoring by a registered nurse with diabetes educator credentials.Main outcome measuresThe primary endpoint was change in HbA1c. Secondary endpoints included the proportion of participants who transitioned to insulin, proportion who achieved target HbA1c, and a change in depressive symptoms (patient health questionnaire, PHQ-9), diabetes specific distress (problem areas in diabetes scale, PAID), and generic health status (assessment of quality of life instrument, AQoL-8D).ResultsHbA1c improved in both arms, with a clinically significant between arm difference (mean difference -0.6%, 95% confidence interval -0.9% to -0.3%), favouring the intervention. At 12 months, in intervention practices, 105/151 (70%) of participants had started insulin, compared with 25/115 (22%) in control practices (odds ratio 8.3, 95% confidence interval 4.5 to 15.4, P<0.001). Target HbA1c (≤7% (53 mmol/mol)) was achieved by 54 (36%) intervention participants and 22 (19%) control participants (odds ratio 2.2, 1.2 to 4.3, P=0.02). Depressive symptoms did not worsen at 12 months (PHQ-9: -1.1 (3.5)v-0.1 (2.9), P=0.05). A statistically significant difference was found between arms in the mean change in mental health (AQoL mental component summary: 0.04 (SD 0.16)v-0.002 (0.13), mean difference 0.04 (95% confidence interval 0.002 to 0.08), P=0.04), favouring the intervention, but no significant difference in physical health (AQoL physical component summary: 0.03 (0.15)v0.02 (0.13)) nor diabetes specific distress (5.6 (15.5)v-2.4 (15.4)). No severe hypoglycaemia events were reported.ConclusionsThe Stepping Up model of care was associated with increased insulin initiation rates in primary care, and improvements in glycated haemoglobin without worsening emotional wellbeing.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12612001028897.
authors.affiliation: Department of General Practice, University of Melbourne, Carlton, Melbourne, VIC, 3053, Australia j.furler@unimelb.edu.au.
authors.forename: John
authors.initials: J
authors.lastname: Furler
authors.affiliation: Department of Medicine, St Vincent's Hospital, University of Melbourne, Melbourne, Australia.
authors.forename: David
authors.initials: D
authors.lastname: O'Neal
authors.affiliation: School of Psychology, Deakin University, Victoria, Australia.|The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Victoria, Australia.|AHP Research, United Kingdom.
authors.forename: Jane
authors.initials: J
authors.lastname: Speight
authors.affiliation: Department of General Practice, University of Melbourne, Carlton, Melbourne, VIC, 3053, Australia.
authors.forename: Jo-Anne
authors.initials: JA
authors.lastname: Manski-Nankervis
authors.affiliation: Melbourne EpiCentre, the University of Melbourne, Melbourne, Australia.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Gorelik
authors.affiliation: School of Psychology, Deakin University, Victoria, Australia.|The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Victoria, Australia.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Holmes-Truscott
authors.affiliation: School of Psychology, Deakin University, Victoria, Australia.
authors.forename: Louise
authors.initials: L
authors.lastname: Ginnivan
authors.affiliation: Department of General Practice, University of Melbourne, Carlton, Melbourne, VIC, 3053, Australia.|Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.
authors.forename: Doris
authors.initials: D
authors.lastname: Young
authors.affiliation: Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore.
authors.forename: James
authors.initials: J
authors.lastname: Best
authors.affiliation: School of Nursing, University of Melbourne, Australia.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Patterson
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Australia.
authors.forename: Danny
authors.initials: D
authors.lastname: Liew
authors.affiliation: Health Economics and Social Policy Group, Division of Health Sciences, University of South Australia, Adelaide, Australia.
authors.forename: Leonie
authors.initials: L
authors.lastname: Segal
authors.affiliation: Faculty of Health Sciences, University of Southampton, Southampton, UK.
authors.forename: Carl
authors.initials: C
authors.lastname: May
authors.affiliation: John Richards Initiative, Australian Institute for Primary Care and Ageing, College of Science, Health and Engineering, La Trobe University, Melbourne, Australia.
authors.forename: Irene
authors.initials: I
authors.lastname: Blackberry
mesh_terms: D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010348:Patient Care Team; D011320:Primary Health Care / Q000379:methods*; D016896:Treatment Outcome; D014739:Victoria
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin