Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: The stepping up to insulin cluster randomized controlled trial protocol

John S. Furler, Doris Young, James Best, Elizabeth Patterson, David O'Neal, Danny Liew, Jane Speight, Leonie Segal, Carl May, Jo Anne Manski-Nankervis, Elizabeth Holmes-Truscott, Louise Ginnivan, Irene D. Blackberry

    Research output: Contribution to journalArticle

    10 Citations (Scopus)

    Abstract

    Background: Type 2 diabetes (T2D) brings significant human and healthcare costs. Its progressive nature means achieving normoglycaemia is increasingly difficult, yet critical to avoiding long term vascular complications. Nearly one-half of people with T2D have glycaemic levels out of target. Insulin is effective in achieving glycaemic targets, yet initiation of insulin is often delayed, particularly in primary care. Given limited access to specialist resources and the size of the diabetes epidemic, primary care is where insulin initiation must become part of routine practice. This would also support integrated holistic care for people with diabetes. Our Stepping Up Program is based on a general practitioner (GP) and practice nurse (PN) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses. Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care.Methods: This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D. 224 patients between the ages of 18 and 80 years with T2D, on two or more oral hypoglycaemic agents and with an HbA1c ≥7.5% in the last six months will be recruited from 74 general practices. The unit of randomization is the practice.Primary outcome is change in glycated haemoglobin HbA1c (measured as a continuous variable). We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5% lower than control group at 12 months follow up. Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of <7.0%. We will also collect data on patient psychosocial outcomes and healthcare utilization and costs.Discussion: The study is a pragmatic translational study with important potential implications for people with T2D, healthcare professionals and funders of healthcare though making better use of scarce healthcare resources, improving timely access to therapy that can improve disease outcomes.Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12612001028897.

    LanguageEnglish
    Article number20
    JournalImplementation Science
    Volume9
    Issue number1
    DOIs
    Publication statusPublished - 14 Feb 2014

    Keywords

    • Australia
    • Health services research
    • Implementation
    • Insulin
    • Nursing
    • Primary care
    • Randomized trial
    • Type 2 diabetes

    ASJC Scopus subject areas

    • Health Policy
    • Health Informatics
    • Public Health, Environmental and Occupational Health

    Cite this

    Furler, John S. ; Young, Doris ; Best, James ; Patterson, Elizabeth ; O'Neal, David ; Liew, Danny ; Speight, Jane ; Segal, Leonie ; May, Carl ; Manski-Nankervis, Jo Anne ; Holmes-Truscott, Elizabeth ; Ginnivan, Louise ; Blackberry, Irene D. / Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes : The stepping up to insulin cluster randomized controlled trial protocol. In: Implementation Science. 2014 ; Vol. 9, No. 1.
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    abstract = "Background: Type 2 diabetes (T2D) brings significant human and healthcare costs. Its progressive nature means achieving normoglycaemia is increasingly difficult, yet critical to avoiding long term vascular complications. Nearly one-half of people with T2D have glycaemic levels out of target. Insulin is effective in achieving glycaemic targets, yet initiation of insulin is often delayed, particularly in primary care. Given limited access to specialist resources and the size of the diabetes epidemic, primary care is where insulin initiation must become part of routine practice. This would also support integrated holistic care for people with diabetes. Our Stepping Up Program is based on a general practitioner (GP) and practice nurse (PN) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses. Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care.Methods: This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D. 224 patients between the ages of 18 and 80 years with T2D, on two or more oral hypoglycaemic agents and with an HbA1c ≥7.5{\%} in the last six months will be recruited from 74 general practices. The unit of randomization is the practice.Primary outcome is change in glycated haemoglobin HbA1c (measured as a continuous variable). We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5{\%} lower than control group at 12 months follow up. Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of <7.0{\%}. We will also collect data on patient psychosocial outcomes and healthcare utilization and costs.Discussion: The study is a pragmatic translational study with important potential implications for people with T2D, healthcare professionals and funders of healthcare though making better use of scarce healthcare resources, improving timely access to therapy that can improve disease outcomes.Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12612001028897.",
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    author = "Furler, {John S.} and Doris Young and James Best and Elizabeth Patterson and David O'Neal and Danny Liew and Jane Speight and Leonie Segal and Carl May and Manski-Nankervis, {Jo Anne} and Elizabeth Holmes-Truscott and Louise Ginnivan and Blackberry, {Irene D.}",
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    Furler, JS, Young, D, Best, J, Patterson, E, O'Neal, D, Liew, D, Speight, J, Segal, L, May, C, Manski-Nankervis, JA, Holmes-Truscott, E, Ginnivan, L & Blackberry, ID 2014, 'Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: The stepping up to insulin cluster randomized controlled trial protocol', Implementation Science, vol. 9, no. 1, 20. https://doi.org/10.1186/1748-5908-9-20

    Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes : The stepping up to insulin cluster randomized controlled trial protocol. / Furler, John S.; Young, Doris; Best, James; Patterson, Elizabeth; O'Neal, David; Liew, Danny; Speight, Jane; Segal, Leonie; May, Carl; Manski-Nankervis, Jo Anne; Holmes-Truscott, Elizabeth; Ginnivan, Louise; Blackberry, Irene D.

    In: Implementation Science, Vol. 9, No. 1, 20, 14.02.2014.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes

    T2 - Implementation Science

    AU - Furler, John S.

    AU - Young, Doris

    AU - Best, James

    AU - Patterson, Elizabeth

    AU - O'Neal, David

    AU - Liew, Danny

    AU - Speight, Jane

    AU - Segal, Leonie

    AU - May, Carl

    AU - Manski-Nankervis, Jo Anne

    AU - Holmes-Truscott, Elizabeth

    AU - Ginnivan, Louise

    AU - Blackberry, Irene D.

    PY - 2014/2/14

    Y1 - 2014/2/14

    N2 - Background: Type 2 diabetes (T2D) brings significant human and healthcare costs. Its progressive nature means achieving normoglycaemia is increasingly difficult, yet critical to avoiding long term vascular complications. Nearly one-half of people with T2D have glycaemic levels out of target. Insulin is effective in achieving glycaemic targets, yet initiation of insulin is often delayed, particularly in primary care. Given limited access to specialist resources and the size of the diabetes epidemic, primary care is where insulin initiation must become part of routine practice. This would also support integrated holistic care for people with diabetes. Our Stepping Up Program is based on a general practitioner (GP) and practice nurse (PN) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses. Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care.Methods: This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D. 224 patients between the ages of 18 and 80 years with T2D, on two or more oral hypoglycaemic agents and with an HbA1c ≥7.5% in the last six months will be recruited from 74 general practices. The unit of randomization is the practice.Primary outcome is change in glycated haemoglobin HbA1c (measured as a continuous variable). We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5% lower than control group at 12 months follow up. Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of <7.0%. We will also collect data on patient psychosocial outcomes and healthcare utilization and costs.Discussion: The study is a pragmatic translational study with important potential implications for people with T2D, healthcare professionals and funders of healthcare though making better use of scarce healthcare resources, improving timely access to therapy that can improve disease outcomes.Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12612001028897.

    AB - Background: Type 2 diabetes (T2D) brings significant human and healthcare costs. Its progressive nature means achieving normoglycaemia is increasingly difficult, yet critical to avoiding long term vascular complications. Nearly one-half of people with T2D have glycaemic levels out of target. Insulin is effective in achieving glycaemic targets, yet initiation of insulin is often delayed, particularly in primary care. Given limited access to specialist resources and the size of the diabetes epidemic, primary care is where insulin initiation must become part of routine practice. This would also support integrated holistic care for people with diabetes. Our Stepping Up Program is based on a general practitioner (GP) and practice nurse (PN) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses. Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care.Methods: This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D. 224 patients between the ages of 18 and 80 years with T2D, on two or more oral hypoglycaemic agents and with an HbA1c ≥7.5% in the last six months will be recruited from 74 general practices. The unit of randomization is the practice.Primary outcome is change in glycated haemoglobin HbA1c (measured as a continuous variable). We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5% lower than control group at 12 months follow up. Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of <7.0%. We will also collect data on patient psychosocial outcomes and healthcare utilization and costs.Discussion: The study is a pragmatic translational study with important potential implications for people with T2D, healthcare professionals and funders of healthcare though making better use of scarce healthcare resources, improving timely access to therapy that can improve disease outcomes.Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12612001028897.

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    KW - Insulin

    KW - Nursing

    KW - Primary care

    KW - Randomized trial

    KW - Type 2 diabetes

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