Effectiveness of a Group Educational Intervention – Prolact - In Primary Care to Promote Exclusive Breastfeeding. A Cluster Randomized Clinical Trial.

Abstract Background: The rates of exclusive breastfeeding at 6 months in Spain are far from the target recommended by the World Health Organization, which is 50% by 2025. Evidence of the effectiveness of group interventions in late postpartum is limited. The objective of this study was to evaluate the effectiveness of the PROLACT group educational intervention for increasing the proportion of mother-child dyads with exclusive breastfeeding at 6 months compared to the usual practice in primary care.Method: Multicentre cluster randomized clinical trial. A total of 434 mother-child dyads (215 in the control group and 219 in the intervention group) who breastfed exclusively in the first 4 weeks of the infant's life and agreed to participate were included. The main outcome variable was exclusive breastfeeding at 6 months. Secondary variables were the type of breastfeeding, reasons for abandonment, degree of adherence and satisfaction with the intervention. To study the effectiveness, the difference in the proportions of dyads with exclusive breastfeeding at 6 months was calculated, and the relative risk (RR) and number needed to treat (NNT) were calculated with their 95% CIs. To study the factors associated with the maintenance of exclusive breastfeeding at 6 months, a multilevel logistic regression model was fitted. All analyses were performed according to intention to treat.Results: The percentage of dyads with exclusive breastfeeding at 6 months was 22.4% in the intervention group and 8.8% in the control group. The PROLACT intervention obtained an RR of 2.53 (95% CI 1.54-4.15) and an NNT of 7 (95% CI 5-14). The factors associated with exclusive breastfeeding at 6 months were the PROLACT intervention, OR 3.51 (95% CI 1.55-7.93); age > 39 years, OR 2.79 (95% CI 1.02-7.6); previous breastfeeding experience, OR 2.61 (95% CI 1.29-5.29); monthly income/person > 833.33 €, OR 2.15 (95% CI: 0.996-4.65); planning to start work before the infant was 6 months old, OR 0.35 (0.19-0.63); and use of a pacifier, OR 0.58 (95% CI 0.30-1.11).Conclusions: The PROLACT group educational intervention in primary care is more effective than the usual practice for maintaining exclusive breastfeeding at 6 months.Trial registration: The trial was registered with ClinicalTrials.gov under code number NCT01869920 (03/06/2013).

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Effectiveness of electronic point-of-care reminders versus monthly feedback to improve adherence to 10 clinical recommendations in primary care: a cluster randomized clinical trial

BMC Medical Informatics and Decision Making ◽

10.1186/s12911-019-0976-8 ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 4

Author(s):

Ermengol Coma ◽

Manuel Medina ◽

Leonardo Méndez ◽

Eduardo Hermosilla ◽

Manuel Iglesias ◽

...

Keyword(s):

Primary Care ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Point Of Care ◽

Intervention Group ◽

Control Group ◽

Electronic Reminder ◽

Clinical Recommendations ◽

Cluster Randomized ◽

Clinical Conditions

Abstract Background Numerous studies have analyzed the effectiveness of electronic reminder interventions to improve different clinical conditions, and most have reported a small to moderate effect. Few studies, however, have analyzed reminder systems targeting multiple conditions, and fewer still have compared electronic point-of-care reminders systems with other forms of feedback designed to improve delivery of care. Methods We performed an unblinded cluster randomized clinical trial to compare the effectiveness of an electronic point-of-care reminder system with that of a well-established system providing monthly feedback on adherence to clinical recommendations. The control group received monthly feedback only while the intervention group received monthly feedback in addition to on-screen point-of-care reminders for 10 clinical conditions. The study targeted all physicians and nurses at the 283 primary care centers managed by the Institut Català de la Salut (approximately 6600 professionals). Results Following exclusions and randomization, 132 primary care centers (328,728 patients with reminders) were assigned to the intervention group while 137 centers (317,117 patients with reminders) were randomized to the control group. A 20.6% improvement (OR 1.29, 95% CI: 1.25–1.34) in reminder resolution rates was observed in the intervention group. Results varied according to the clinical condition. The most effective reminder was screening for diabetic retinopathy (OR 1.51, 95% CI:1.46–1.57) while the least effective reminders were measurement of glycated hemoglobin (OR: 1.10, 95% CI: 1.07–1.13) and smoking cessation encouragement (OR 1.12, 95% CI: 1.09–1.16). Conclusions Electronic point-of-care reminders were more effective than the existing monthly feedback system at resolving the 10 clinical situations. However, more studies are needed to investigate the variations of the effect observed. Trial registration Current Controlled Trials ISRCTN42391639, 08/10/2012. Retrospectively registered.

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Educational intervention with serial album about pregnant women positioning for spinal anesthesia: randomized clinical trial

Revista Brasileira de Enfermagem ◽

10.1590/0034-7167-2019-0878 ◽

2020 ◽

Vol 73 (suppl 4) ◽

Author(s):

Sarah de Lima Pinto ◽

Larissa Alves Sampaio ◽

Nelson Miguel Galindo Neto ◽

Paulo César de Almeida ◽

Mirna Fontenele de Oliveira ◽

...

Keyword(s):

Clinical Trial ◽

Pregnant Women ◽

Spinal Anesthesia ◽

Randomized Clinical Trial ◽

Educational Intervention ◽

Intervention Group ◽

Maternity Hospital ◽

Control Group ◽

Chi Square ◽

Exact Test

ABSTRACT Objective: To evaluate effectiveness of using educational intervention serial album to positioning pregnant women for spinal anesthesia. Method: Randomized clinical trial with 90 women casually assigned to control (CG) and intervention group (IG), in a maternity hospital located in Northeast region of Brazil. The primary endpoint was “achieve correct positioning to perform spinal anesthesia”; and secondary, “how number of spinal cord puncture attempts”. Effectiveness was verified using the chi-square test, Fisher’s exact test and likelihood ratio. Results: The positioning was correct in 37 women in each group. There was an association between women in control group remaining still, relaxing shoulders and flexing the spine; and women in intervention group should remain still and relax the shoulders; furthermore there was a statistical association achieved by correct positioning and the number of attempts to access the lumbar puncture. Conclusion: Educational intervention with serial album was effective and contributed to immobility and positioning of pregnant women. Brazilian Registry of Clinical Trials (RBR-3Z7SRD).

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Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial

Journal of Telemedicine and Telecare ◽

10.1177/1357633x211009640 ◽

2021 ◽

pp. 1357633X2110096

Author(s):

Maria KEF Feijó ◽

Karen Brasil Ruschel ◽

Daniela Bernardes ◽

Eduarda B Ferro ◽

Luis E Rohde ◽

...

Keyword(s):

Clinical Trial ◽

Emergency Department ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Heart Association ◽

Functional Class ◽

Emergency Department Visits ◽

Control Group ◽

Point Change ◽

Clinical Instability

Introduction The aim of this study was to evaluate the effectiveness of a diuretic adjustment algorithm (DAA) in maintaining clinical stability and reducing HF readmissions using telemonitoring Technologies. Methods Randomized clinical trial of patients with an indication for furosemide dose adjustment during routine outpatient visits. In the intervention group (IG), the diuretic dose was adjusted according to the DAA and the patients received telephone calls for 30 days. In the control group (CG), the diuretic dose was adjusted by a physician at baseline only. Co-primary outcomes were hospital readmission and/or emergency department visits due to decompensated HF within 90 days, and a 2-point change in the Clinical Congestion Score and/or a deterioration in New York Heart Association functional class within 30 days. Results A total of 206 patients were included. Most patients were male ( n=119; 58%), with a mean age of 62 (SD 13) years. Four patients (2%) in the IG and 14 (7%) in the CG were hospitalized for HF (odds ratio (OR) 0.31 (0.10–0.91); p=0.04). Multivariate analysis showed a reduction of 67% in readmissions and/or emergency department visits due to decompensated HF in the IG compared with the CG (95% CI 0.13–0.88; p=0.027). Regarding the combined outcome of HF readmission and/or emergency department visits or clinical instability, the IG had 20% fewer events than the CG within 30 days (IG: n=48 (23%), CG: n=70 (34%); OR 0.80 (0.63–0.93); p=0.03). Discussion Using DAA improved the combined outcome in these outpatients, with favorable and significant results that included a reduction in HF admissions and in clinical instability. (NCT02068937)

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Effect of a breastfeeding educational intervention: a randomized controlled trial

Revista Latino-Americana de Enfermagem ◽

10.1590/1518-8345.3081.3335 ◽

2020 ◽

Vol 28 ◽

Author(s):

Erdnaxela Fernandes do Carmo Souza ◽

Alfredo Almeida Pina-Oliveira ◽

Antonieta Keiko Kakuda Shimo

Keyword(s):

Randomized Controlled Trial ◽

Educational Intervention ◽

Exclusive Breastfeeding ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

P Value ◽

Postpartum Women ◽

Significance Level ◽

Randomized Controlled

Objective: to assess the effect of a breastfeeding educational intervention on the counseling provided to postpartum women. Method: this is a randomized controlled trial including 104 postpartum women (intervention group = 52 and control group = 52) from a private hospital, whose educational intervention was based on the pragmatic theory and on the use of a soft-hard technology called Breastfeeding Educational Kit (Kit Educativo para Aleitamento Materno, KEAM). Women were followed-up for up to 60 days after childbirth. Chi-Squared Test, Fischer’s Exact Test, and Generalized Estimating Equation were used, with a significance level of 5% (p-value <0.05). The analyses were performed using the Statistical Package for the Social Sciences, version 24. Results: the postpartum women in the intervention group had fewer breastfeeding difficulties and a higher percentage of exclusive breastfeeding at all time points compared with those in the control group. Conclusion: the educational intervention based on active methodologies and stimulating instructional resources was effective in developing greater practical mastery among postpartum women with regard to adherence and maintenance of exclusive breastfeeding. Registry REBEC RBR – 8p9v7v.

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Effectiveness of a primary care-based group educational intervention in the management of patients with migraine: a randomized controlled trial

Primary Health Care Research & Development ◽

10.1017/s1463423619000720 ◽

2019 ◽

Vol 20 ◽

Cited By ~ 1

Author(s):

Iñaki Aguirrezabal ◽

Maria Soledad Pérez de San Román ◽

Raquel Cobos-Campos ◽

Estibalitz Orruño ◽

Arturo Goicoechea ◽

...

Keyword(s):

Primary Care ◽

Educational Intervention ◽

Controlled Trial ◽

Basque Country ◽

Intervention Group ◽

Cost Effective ◽

Response To Treatment ◽

Secondary Outcome ◽

Control Group ◽

Randomised Controlled

Abstract Aim: The aim of this study was to assess the effectiveness of a primary care-based group educational intervention about concepts of pain neuroscience for the management of migraine compared to the routine medical care delivered to patients with this condition. Background: The way pain is understood has been radically changed in recent decades, thanks to developments in the field of neuroscience. Thus, migraine may develop as a result of an exaggerated perception of threat that activates the pain neuromatrix, which might be modifiable, from a learning perspective, by adjusting the beliefs and behaviours that favour the onset of an attack. Methods: A randomised controlled trial was carried out in five primary care health centres of Vitoria-Gasteiz (Basque Country, Spain). The follow-up period was 12 months. The main outcome measure was the reduction in days lost due to migraine-related disability according to the Migraine Disability Assessment Test (MIDAS) score. Secondary outcome measures included the intensity and frequency of the pain and the number of analgesic drugs taken in the previous three months. A positive response to treatment was considered when the MIDAS score decreased by at least 50% from baseline. Findings: Days lost due to migraine-related disability decreased by at least 50% in 68.9% (n = 37) of patients in the intervention group and 34.6% of patients in the control group (n = 18) (P < 0.001). The intensity of the headache [odds ratio (OR) 9.116; P = 0.005] and the medication intake (OR 13.267; P < 0.001) were also significantly reduced with the intervention. Conclusions: The provision of suitable information through a group educational intervention delivered in primary care appears to be effective in preventing migraine attacks. Moreover, the intervention could offer a new cost-effective management alternative that seems to reduce the need for pharmacological treatment in patients with migraine.

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The CLUES study: a cluster randomized clinical trial for the evaluation of cardiovascular guideline implementation in primary care

BMC Health Services Research ◽

10.1186/1472-6963-13-438 ◽

2013 ◽

Vol 13 (1) ◽

Cited By ~ 24

Author(s):

Arritxu Etxeberria ◽

Itziar Pérez ◽

Idoia Alcorta ◽

Jose Ignacio Emparanza ◽

Elena Ruiz de Velasco ◽

...

Keyword(s):

Primary Care ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Guideline Implementation ◽

Cluster Randomized

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Effect of prenatal recommendations of Traditional Persian Medicine on obstetric outcomes: a randomized clinical trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2017-0085 ◽

2018 ◽

Vol 15 (3) ◽

Author(s):

Mansoor Keshavarz ◽

Maryam Kashanian ◽

Soodabeh Bioos ◽

Yasaman Vazani

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Active Phase ◽

Obstetric Outcomes ◽

Control Group ◽

Control Groups ◽

Persian Medicine ◽

Traditional Persian Medicine ◽

And Control

Abstract Background Traditional Persian Medicine (TPM) is an ancient medical system that provides suggestions to improve the health of mothers and children during pregnancy and labor. Persian physicians believed that these instructions made labor easier, safer, and less painful. Methods The present randomized clinical trial was conducted among women at 33–38 weeks of pregnancy in Tehran, Iran. TPM instructions consisted of diet, bathing, and application of oil from the 38th week of pregnancy to the onset of labor. The primary outcome was the duration of the active phase of labor. Results The mean duration of the active phase was 331.60 ± 151.48 min for the intervention group and 344.40 ± 271.46 min for the control groups, but it was not statistically significant. The active phase was significantly shorter in women who had better compliance (p=0.03). The need for oxytocin augmentation was 53.3% in the control group and 38.5% in the intervention group (p=0.17). The rate of perineal infection was 13% in the control group and 0% in the intervention group (p=0.11). Conclusions The active phase was not different in the intervention and control groups, but it was shorter in compliant women. It is possible that prolonged use of these recommendations in combination with a sitz baths and a larger sample size could result in more significant outcomes.

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The Effect of Support Surfaces on the Incidence of Pressure Injuries in Critically Ill Patients: A Randomized Clinical Trial

Critical Care Research and Practice ◽

10.1155/2018/3712067 ◽

2018 ◽

Vol 2018 ◽

pp. 1-6 ◽

Cited By ~ 1

Author(s):

Wesley Henrique Bueno de Camargo ◽

Rita de Cassia Pereira ◽

Marcos T. Tanita ◽

Lidiane Heko ◽

Isadora C Grion ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Critically Ill ◽

Critically Ill Patients ◽

Intervention Group ◽

Control Group ◽

Support Surface ◽

Intention To Treat ◽

Support Surfaces ◽

Effect Of Support

Purpose. To analyze whether a viscoelastic mattress support surface can reduce the incidence of stage 2 pressure injuries compared to a standard hospital mattress with pyramidal overlay in critically ill patients. Method. A randomized clinical trial with intention-to-treat analysis was carried out recruiting patients with Braden scale ≤14 on intensive care unit admission from April 2016 to April 2017. Patients were allocated into two groups: intervention group (viscoelastic mattress) and control group (standard mattress with pyramidal overlay). The level of significance adopted was 5%. Results. A total of 62 patients were included in the study. There was a predominance of males (53%) and the mean age was 67.9 (SD 18.8) years. There were no differences in clinical or severity characteristics between the patients in the control group and the intervention group. Pressure injuries occurred in 35 patients, with a median time of 7 days (ITQ 4–10) from admission. The frequency of pressure injuries was higher in the control group (80.6%) compared to the intervention group (32.2%; p<0.001). Conclusions. Viscoelastic support surfaces reduced the incidence of pressure injuries in moderate or higher risk critically ill patients when compared to pyramidal support surfaces.

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