Implementing a guideline for the treatment of type 2 diabetics: results of a cluster-randomized controlled trial (C-RCT).
BACKGROUND
In Italy many diabetics still lack adequate care in general practice. We assessed the effectiveness of different strategies for the implementation of an evidence-based guideline for the management of non-complicated type 2 diabetes among General Practitioners (GPs) of Lazio region.


METHODS
Three-arm cluster-randomised controlled trial with GPs as units of randomisation (clusters). 252 GPs were randomised either to an active strategy (training module with administration of the guideline), or to a passive dissemination (administration of the guideline only), or to usual care (control). Data on prescriptions of tests and drugs were collected by existing information systems, whereas patients' data came from GPs' databases. Process outcomes were measured at the cluster level one year after the intervention. Primary outcomes concerned the measurement of glycosilated haemoglobin and the commissioning of micro- and macrovascular complications assessment tests. In order to assess the physicians' drug prescribing behaviour secondary outcomes were also calculated.


RESULTS
GPs identified 6395 uncomplicated type 2 patients with a high prevalence of cardiovascular risk factors. Data on GPs baseline performance show low proportions of glycosilated haemoglobin assessments. Results of the C-RCT analysis indicate that the active implementation strategy was ineffective relating to all primary outcomes (respectively, OR 1.06 [95% IC: 0.76-1.46]; OR 1.07 [95% IC: 0.80-1.43]; OR 1.4 [95% IC:0.91-2.16]. Similarly, passive dissemination of the guideline showed no effect.


CONCLUSIONS
In our region compliance of GPs with guidelines was not enhanced by a structured learning programme. Implementation through organizational measures appears to be essential to induce behavioural changes.


BACKGROUND
ISRCTN80116232.
Perria
Carla
C
Community Health Unit, Lazio Region Public Health Agency, Rome, Italy. perria@asplazio.it
Mandolini
Donatella
D
Guerrera
Carmelina
C
Jefferson
Tom
T
Billi
Paolo
P
Calzini
Virgilio
V
Fiorillo
Alfonso
A
Grasso
Giuseppe
G
Leotta
Sergio
S
Marrocco
Walter
W
Suraci
Concetta
C
Pasquarella
Amina
A
D016000:Cluster Analysis; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004363:Drug Utilization / Q000592:standards; D019317:Evidence-Based Medicine; D005194:Family Practice / Q000592:standards* / Q000639:trends; D005260:Female; D019983:Guideline Adherence; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007558:Italy; D008297:Male; D010818:Practice Patterns, Physicians' / Q000592:standards / Q000639:trends
D007004:Hypoglycemic Agents