Effectiveness of an implementation strategy for a breastfeeding guideline in Primary Care: cluster randomised trial.
BACKGROUND
The protection and promotion of breastfeeding is considered a priority in Europe where only 22% of infants less than 6 months old are exclusively breastfed. In Spain this percentage reaches 24.8% but in our city it falls to 18.26%. Various studies emphasise that the improvement of these results should be based upon the training of health professionals. Following the recommendations of a breastfeeding guide can modify the practice of health professionals and improve results with respect to exclusively or predominatly breastfed children at 6 months of age.


METHODS
This study involves a community based cluster randomized trial in primary healthcare centres in Leganés (Madrid, Spain). The project aims to determine whether the use of an implementation strategy (including training session, information distribution, opinion leader) of a breastfeeding guideline in primary care is more effective than usual diffusion. The number of patients required will be 240 (120 in each arm). It will be included all the mothers of infants born during the study period (6 months) who come to the health centre on the first visit of the child care programme and who give their consent to participate. The main outcome variable is the exclusive o predominant breastfeeding at 6 moths of age..Main effectiveness will be analyzed by comparing the percentage of infants with exclusive or predominant breastfeeding at 6 months between the intervention group and the control group. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.


CONCLUSIONS
Strategies need to be found which facilitate the giving of effective advice on breastfeeding by professionals and which provide support to women during the breastfeeding period. By applying the guide's recommendations, clinical variability can be reduced and the care received by patients can be improved.


BACKGROUND
The trial was registered with ClinicalTrials.gov, number NCT01474096.
Dirección Asistencial Sur Atención Primaria, Servicio Madrileño de Salud, Avenida Juan de la Cierva, s/n, Getafe, 28902, Spain. smartin.gapm09@salud.madrid.org
Susana
S
Martín-Iglesias
Isabel
I
del-Cura-González
Teresa
T
Sanz-Cuesta
Celina
C
Arana-Cañedo Argüelles
Mercedes
M
Rumayor-Zarzuelo
Marta
M
Alvarez-de la Riva
Ana M
AM
Lloret-Sáez Bravo
Rosa M
RM
Férnandez-Arroyo
José L
JL
Aréjula-Torres
Óscar
Ó
Aguado-Arroyo
Francisco
F
Góngora-Maldonado
Manuela
M
García-Corraliza
Nazareth
N
Sandoval-Encinas
Margarita
M
Tomico-delRío
Ana M
AM
Cornejo-Gutiérrez
D000328:Adult; D001942:Breast Feeding / Q000379:methods / Q000523:psychology / Q000706:statistics & numerical data; D003153:Community Health Services; D003376:Counseling; D005260:Female; D017408:Guidelines as Topic / Q000592:standards; D006282:Health Personnel / Q000193:education / Q000592:standards; D006284:Health Plan Implementation; D006801:Humans; D007231:Infant, Newborn; D008430:Maternal-Child Health Centers; D015233:Models, Statistical; D009035:Mothers / Q000523:psychology / Q000706:statistics & numerical data; D017063:Outcome Assessment, Health Care; D011320:Primary Health Care / Q000458:organization & administration*; D024382:Professional Role; D011369:Professional-Patient Relations; D012959:Socioeconomic Factors; D013030:Spain