Does Training and Support of General Practitioners in Intensive Treatment of People with Screen-Detected Diabetes Improve Medication, Morbidity and Mortality in People with Clinically-Diagnosed Diabetes? Investigation of a Spill-Over Effect in a Cluster RCT.
BACKGROUND
Very few studies have examined the potential spill-over effect of a trial intervention in general practice. We investigated whether training and support of general practitioners in the intensive treatment of people with screen-detected diabetes improved rates of redeemed medication, morbidity and mortality in people with clinically-diagnosed diabetes.


METHODS
This is a secondary, post-hoc, register-based analysis linked to a cluster randomised trial. In the ADDITION-Denmark trial, 175 general practices were cluster randomised (i) to routine care, or (ii) to receive training and support in intensive multifactorial treatment of individuals with screen-detected diabetes (2001 to 2009). Using national registers we identified all individuals who were diagnosed with clinically incident diabetes in the same practices over the same time period. (Patients participating in the ADDITION trial were excluded). We compared rates of redeemed medication, a cardiovascular composite endpoint, and all-cause mortality between the routine care and intensive treatment groups.


RESULTS
In total, 4,107 individuals were diagnosed with clinically incident diabetes in ADDITION-Denmark practices between 2001 and 2009 (2,051 in the routine care group and 2,056 in the intensive treatment group). There were large and significant increases in the proportion of patients redeeming cardio-protective medication in both treatment groups during follow-up. After a median of seven years of follow-up, there was no difference in the incidence of a composite cardiovascular endpoint (HR 1.15, 95% CI 0.95 to 1.38) or all-cause mortality between the two groups (HR 1.08, 95% CI 0.94 to 1.23).


CONCLUSIONS
There was no evidence of a spill-over effect from an intervention promoting intensive treatment of people with screen-detected diabetes to those with clinically-diagnosed diabetes. Overall, the proportion of patients redeeming cardio-protective medication during follow-up was similar in both groups.


BACKGROUND
ClinicalTrials.gov NCT00237549.
Department of Public Health, Section of General Practice, Aarhus University, Denmark.
Morten
http://orcid.org/0000-0003-0327-9564
M
Charles
Department of Public Health, Section of Epidemiology, Aarhus University, Denmark.
Mette V
MV
Skriver
Primary Care Unit, Institute of Public Health, University of Cambridge, Cambridge, United Kingdom.|MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.
Simon J
SJ
Griffin
Department of Public Health, Section of General Practice, Aarhus University, Denmark.|MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.|Danish Diabetes Academy, Odense University Hospital, Odense, Denmark.|Aarhus Institute of Advanced Studies, Høegh-Guldbergs Gade 6B, Aarhus C, Denmark.
Rebecca K
RK
Simmons
Department of Public Health, Section of Epidemiology, Aarhus University, Denmark.|Danish Diabetes Academy, Odense University Hospital, Odense, Denmark.
Daniel R
DR
Witte
Department of Public Health, Section of General Practice, Aarhus University, Denmark.
Else-Marie
EM
Dalsgaard
Department of Public Health, Section of General Practice, Aarhus University, Denmark.
Torsten
T
Lauritzen
Department of Public Health, Section of General Practice, Aarhus University, Denmark.
Annelli
A
Sandbæk
D000328:Adult; D000368:Aged; D003718:Denmark; D003920:Diabetes Mellitus / Q000175:diagnosis* / Q000628:therapy*; D005260:Female; D058006:General Practice; D058005:General Practitioners; D006801:Humans; D033162:Incidental Findings; D008297:Male; D008403:Mass Screening; D008875:Middle Aged