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Supporting insulin initiation in type 2 diabetes in primary care: results of the Stepping Up pragmatic cluster randomised controlled clinical trial

Furler, John, O'Neal, David, Speight, Jane, Manski-Nankervis, Jo-Anne, Gorelik, Alexandra, Holmes-Truscott, Elizabeth, Ginnivan, Louise, Young, Doris, Best, James, Patterson, Elizabeth, Liew, Danny, Segal, Leonie, May, Carl and Blackberry, Irene 2017, Supporting insulin initiation in type 2 diabetes in primary care: results of the Stepping Up pragmatic cluster randomised controlled clinical trial, BMJ, vol. 356, pp. 1-10, doi: 10.1136/bmj.j783.

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Title Supporting insulin initiation in type 2 diabetes in primary care: results of the Stepping Up pragmatic cluster randomised controlled clinical trial
Author(s) Furler, John
O'Neal, David
Speight, JaneORCID iD for Speight, Jane orcid.org/0000-0002-1204-6896
Manski-Nankervis, Jo-Anne
Gorelik, Alexandra
Holmes-Truscott, ElizabethORCID iD for Holmes-Truscott, Elizabeth orcid.org/0000-0001-9139-4663
Ginnivan, Louise
Young, Doris
Best, James
Patterson, Elizabeth
Liew, Danny
Segal, Leonie
May, Carl
Blackberry, Irene
Journal name BMJ
Volume number 356
Article ID j783
Start page 1
End page 10
Total pages 10
Publisher BMJ Group
Place of publication London, Eng.
Publication date 2017-03-08
ISSN 0959-535X
1756-1833
Keyword(s) Diabetes Mellitus, Type 2
Female
Follow-Up Studies
Humans
Hypoglycemic Agents
Insulin
Male
Middle Aged
Patient Care Team
Primary Health Care
Treatment Outcome
Victoria
Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
GLYCEMIC CONTROL
MANAGEMENT
THERAPY
INERTIA
QUALITY
INTENSIFICATION
HYPERGLYCEMIA
HYPOGLYCEMIA
INTEGRATION
PHYSICIANS
Summary Objective To 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.

Design Cluster randomised controlled trial.

Setting Primary care practices in Victoria, Australia, with a practice nurse and at least one consenting eligible patient (HbA1c ≥7.5% with maximal oral treatment).

Participants 266 patients with type 2 diabetes and 74 practices (mean cluster size 4 (range 1-8) patients), followed up for 12 months.

Intervention The 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 measures The 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).

Results HbA1c 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) v 0.02 (0.13)) nor diabetes specific distress (5.6 (15.5) v −2.4 (15.4)). No severe hypoglycaemia events were reported.

Conclusions The Stepping Up model of care was associated with increased insulin initiation rates in primary care, and improvements in glycated haemoglobin without worsening emotional wellbeing.
Language eng
DOI 10.1136/bmj.j783
Field of Research 170106 Health, Clinical and Counselling Psychology
1117 Public Health And Health Services
Socio Economic Objective 920401 Behaviour and Health
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2017, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution non-commercial licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30092125

Document type: Journal Article
Collections: Faculty of Health
School of Psychology
Open Access Collection
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.