Long-term effects of intensive multifactorial therapy in individuals with screen-detected type 2 diabetes in primary care: 10-year follow-up of the ADDITION-Europe cluster-randomised trial

Background: Tight, targeted control of modifiable cardiovascular risk factors can reduce cardiovascular complications and mortality in individuals with type 2 diabetes (T2DM) and microalbuminuria. The effects of using an electronic “Prompt” with a treatment algorithm to support a treat-to-target approach has not been tested in primary care. Methods: A multi-centre, cluster-randomised trial among primary care practices across Leicestershire, UK. Primary outcome was proportion of individuals achieving systolic and diastolic blood pressure (<130 and <80mmHg, respectively) and total cholesterol (<3.5mmol/l) targets at 24 months. Secondary outcomes included proportion of individuals with HbA1c<58 mmol/mol (<7.5%), changes in prescribing, change in albumin-creatinine ratio, major adverse cardiovascular events, cardiovascular mortality and coding accuracy. Results: 2721 individuals from 22 practices, mean age 63 years, 41% female, 62% from Black and Minority Ethnic groups, completed two years follow-up. There were no significant differences in the proportion of individuals achieving the composite primary outcome, although the proportion of individuals achieving the pre-specified outcome of total cholesterol <4.0 mmol (Odds Ratio 1.24(1.05,1.47),p=0.01) increased with intensive intervention compared to control. Coding for microalbuminuria increased relative to control (Odds Ratio 2.05 (1.29, 3.25), p< 0.01]). Conclusions: Greater improvements in composite cardiovascular risk factor control with this intervention compared to standard care were not achieved in this cohort of high-risk individuals with T2DM. However, improvements in lipid profile and coding can benefit patients with diabetes to alter the high risk of atherosclerotic cardiovascular events. Future studies should consider comprehensive strategies including patient education and healthcare professional engagement, in the management of T2DM.

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Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial

The Lancet Diabetes & Endocrinology ◽

10.1016/s2213-8587(19)30068-3 ◽

2019 ◽

Vol 7 (5) ◽

pp. 344-355 ◽

Cited By ~ 129

Author(s):

Michael E J Lean ◽

Wilma S Leslie ◽

Alison C Barnes ◽

Naomi Brosnahan ◽

George Thom ◽

...

Keyword(s):

Type 2 Diabetes ◽

Primary Care ◽

Weight Management ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Open Label ◽

Management Intervention ◽

Cluster Randomised ◽

Weight Management Intervention

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Effects of an electronic software ‘prompt’ with healthcare professional training on cardiovascular and renal complications in a multi-ethnic population with Type 2 Diabetes and Microalbuminuria (The GP Prompt study): results of a pragmatic cluster randomised trial.

10.2337/figshare.12114174.v1 ◽

2020 ◽

Author(s):

Andrew Willis ◽

Winston Crasto ◽

Laura J Gray ◽

Helen Dallosso ◽

Ghazala Waheed ◽

...

Keyword(s):

Type 2 Diabetes ◽

Primary Care ◽

Cardiovascular Risk ◽

Odds Ratio ◽

Cardiovascular Events ◽

Primary Outcome ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Cluster Randomised

Background: Tight, targeted control of modifiable cardiovascular risk factors can reduce cardiovascular complications and mortality in individuals with type 2 diabetes (T2DM) and microalbuminuria. The effects of using an electronic “Prompt” with a treatment algorithm to support a treat-to-target approach has not been tested in primary care. Methods: A multi-centre, cluster-randomised trial among primary care practices across Leicestershire, UK. Primary outcome was proportion of individuals achieving systolic and diastolic blood pressure (<130 and <80mmHg, respectively) and total cholesterol (<3.5mmol/l) targets at 24 months. Secondary outcomes included proportion of individuals with HbA1c<58 mmol/mol (<7.5%), changes in prescribing, change in albumin-creatinine ratio, major adverse cardiovascular events, cardiovascular mortality and coding accuracy. Results: 2721 individuals from 22 practices, mean age 63 years, 41% female, 62% from Black and Minority Ethnic groups, completed two years follow-up. There were no significant differences in the proportion of individuals achieving the composite primary outcome, although the proportion of individuals achieving the pre-specified outcome of total cholesterol <4.0 mmol (Odds Ratio 1.24(1.05,1.47),p=0.01) increased with intensive intervention compared to control. Coding for microalbuminuria increased relative to control (Odds Ratio 2.05 (1.29, 3.25), p< 0.01]). Conclusions: Greater improvements in composite cardiovascular risk factor control with this intervention compared to standard care were not achieved in this cohort of high-risk individuals with T2DM. However, improvements in lipid profile and coding can benefit patients with diabetes to alter the high risk of atherosclerotic cardiovascular events. Future studies should consider comprehensive strategies including patient education and healthcare professional engagement, in the management of T2DM.

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Faculty Opinions recommendation of Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.735249351.793571209 ◽

2020 ◽

Author(s):

Luigi Fontana

Keyword(s):

Type 2 Diabetes ◽

Primary Care ◽

Weight Management ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Open Label ◽

Management Intervention ◽

Cluster Randomised ◽

Weight Management Intervention

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Long-term effects of advice to consume a high-protein, low-fat diet, rather than a conventional weight-loss diet, in obese adults with Type 2 diabetes: one-year follow-up of a randomised trial

Diabetologia ◽

10.1007/s00125-004-1511-7 ◽

2004 ◽

Vol 47 (10) ◽

pp. 1677-1686 ◽

Cited By ~ 115

Author(s):

G. D. Brinkworth ◽

M. Noakes ◽

B. Parker ◽

P. Foster ◽

P. M. Clifton

Keyword(s):

Type 2 Diabetes ◽

Weight Loss ◽

Randomised Trial ◽

Long Term Effects ◽

Obese Adults ◽

Low Fat Diet ◽

One Year

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Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial

The Lancet ◽

10.1016/s0140-6736(17)33102-1 ◽

2018 ◽

Vol 391 (10120) ◽

pp. 541-551 ◽

Cited By ~ 443

Author(s):

Michael EJ Lean ◽

Wilma S Leslie ◽

Alison C Barnes ◽

Naomi Brosnahan ◽

George Thom ◽

...

Keyword(s):

Type 2 Diabetes ◽

Primary Care ◽

Weight Management ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Open Label ◽

Cluster Randomised

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Use of the Diabetes Medication Choice Decision Aid in patients with type 2 diabetes in Greece: a cluster randomised trial

BMJ Open ◽

10.1136/bmjopen-2016-012185 ◽

2016 ◽

Vol 6 (11) ◽

pp. e012185 ◽

Cited By ~ 9

Author(s):

Thomas Karagiannis ◽

Aris Liakos ◽

Megan E Branda ◽

Eleni Athanasiadou ◽

Maria Mainou ◽

...

Keyword(s):

Type 2 Diabetes ◽

Decision Aid ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Diabetes Medication ◽

Cluster Randomised ◽

Choice Decision ◽

Medication Choice

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Precommitting to choose wisely about low-value services: a stepped wedge cluster randomised trial

BMJ Quality & Safety ◽

10.1136/bmjqs-2017-006699 ◽

2017 ◽

Vol 27 (5) ◽

pp. 355-364 ◽

Cited By ~ 14

Author(s):

Jeffrey Todd Kullgren ◽

Erin Krupka ◽

Abigail Schachter ◽

Ariel Linden ◽

Jacquelyn Miller ◽

...

Keyword(s):

Primary Care ◽

Low Back Pain ◽

Randomised Trial ◽

Choosing Wisely ◽

Cluster Randomised Trial ◽

Low Back ◽

Stepped Wedge ◽

Intervention Period ◽

Cluster Randomised

BackgroundLittle is known about how to discourage clinicians from ordering low-value services. Our objective was to test whether clinicians committing their future selves (ie, precommitting) to follow Choosing Wisely recommendations with decision supports could decrease potentially low-value orders.MethodsWe conducted a 12-month stepped wedge cluster randomised trial among 45 primary care physicians and advanced practice providers in six adult primary care clinics of a US community group practice.Clinicians were invited to precommit to Choosing Wisely recommendations against imaging for uncomplicated low back pain, imaging for uncomplicated headaches and unnecessary antibiotics for acute sinusitis. Clinicians who precommitted received 1–6 months of point-of-care precommitment reminders as well as patient education handouts and weekly emails with resources to support communication about low-value services.The primary outcome was the difference between control and intervention period percentages of visits with potentially low-value orders. Secondary outcomes were differences between control and intervention period percentages of visits with possible alternate orders, and differences between control and 3-month postintervention follow-up period percentages of visits with potentially low-value orders.ResultsThe intervention was not associated with a change in the percentage of visits with potentially low-value orders overall, for headaches or for acute sinusitis, but was associated with a 1.7% overall increase in alternate orders (p=0.01). For low back pain, the intervention was associated with a 1.2% decrease in the percentage of visits with potentially low-value orders (p=0.001) and a 1.9% increase in the percentage of visits with alternate orders (p=0.007). No changes were sustained in follow-up.ConclusionClinician precommitment to follow Choosing Wisely recommendations was associated with a small, unsustained decrease in potentially low-value orders for only one of three targeted conditions and may have increased alternate orders.Trial registration numberNCT02247050; Pre-results.

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