Timothy Kenealy, MD, PhD; Nicolette Sheridan, RN, PhD, MPH
Can management of patients with type 2 diabetes mellitus safely be transferred to practice nurses in primary care?
Pragmatic randomized controlled trial.
A primary care group practice with 5 general practitioners (GPs) in the Netherlands.
230 patients with type 2 diabetes (mean age 68 y, 52% women of 206 patients completing the study), who were taking medication for diabetes and had hemoglobin (Hb) A1c levels measured in the past 3 years. Exclusion criteria included diabetes treatment in a non–primary care setting, inability to participate due to old age or comorbidity (determined by GP), and unwillingness to return for follow-up.
Protocol-based nurse (PBN) management (n = 116) or standard care by practice GPs (n = 114). PBN management was delivered by 2 practice nurses who received 1 week of training on the protocol, which was based on Dutch practice guidelines and focused on optimizing glucose levels, blood pressure (BP), lipid profiles, and eye and foot care. For the purposes of the trial, the nurses were permitted to prescribe 14 drugs (excluding insulin), make dose changes for another 30 drugs (including insulin), and order laboratory tests. Patients in either group requiring initiation of insulin were referred to an internist.
Primary outcome was mean change in HbA1c levels. Secondary outcomes included changes in BP, cholesterol levels, and ratio of cholesterol to high-density lipoprotein (HDL), and proportion of patients reaching target values for HbA1c, BP, and lipid profiles. 216 patients were required to detect a 0.5%-point difference in mean HbA1c level at follow-up with a power of 80% (α = 0.05) and an assumed standard deviation of 1.3.
Mean paired differences for change in HbA1c, BP, and lipid profiles did not differ between groups. Groups did not differ for patients reaching HbA1c, BP, or lipid targets (Table).
Protocol-based nurse management of patients with type 2 diabetes mellitus did not differ from usual care by a general practitioner for HbA1c levels, blood pressure, or lipid profiles.
Protocol-based nurse (PBN) management vs usual general practitioner care of type 2 diabetes†
†BP = blood pressure; Hb = hemoglobin; RBR = relative benefit reduction; other abbreviations defined in Glossary. RBR, RBI, and CI calculated from data in article.
‡Individual target values based on Dutch guidelines; target for cholesterol level during treatment was < 5 mmol/L.
Kenealy T, Sheridan N. Protocol-based nurse management of type 2 diabetes did not differ from usual GP care for HbA1c levels. Ann Intern Med. 2011;155:JC3–7. doi: 10.7326/0003-4819-155-6-201109200-02007
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Published: Ann Intern Med. 2011;155(6):JC3-7.
Cardiology, Coronary Risk Factors, Diabetes, Endocrine and Metabolism.
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