How to Improve Healthcare for Patients with Multimorbidity and Polypharmacy in Primary Care: A Pragmatic Cluster-Randomized Clinical Trial of the Multipap Intervention

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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Cluster randomized clinical trial (ISRCTN23732000) to evaluate the effectiveness of a diagnosis recognition and treatment guide for depressive disorders in primary care

Journal of Evaluation in Clinical Practice ◽

10.1111/j.1365-2753.2008.00978.x ◽

2009 ◽

Vol 15 (1) ◽

pp. 222-225 ◽

Cited By ~ 3

Author(s):

Selma R. Tsuji ◽

Alvaro N. Atallah ◽

Fernando C. Aranha ◽

Antonio P. Tonhom ◽

Antonio C. Siqueira ◽

...

Keyword(s):

Primary Care ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Depressive Disorders ◽

Cluster Randomized

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Durability of Benefits of Behavioral Interventions on Inappropriate Antibiotic Prescribing in Primary Care: Follow-up From a Cluster Randomized Clinical Trial

Open Forum Infectious Diseases ◽

10.1093/ofid/ofw194.10 ◽

2016 ◽

Vol 3 (suppl_1) ◽

Author(s):

Jeffrey Linder ◽

Daniella Meeker ◽

Craig Fox ◽

Mark Friedberg ◽

Stephen Persell ◽

...

Keyword(s):

Primary Care ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Behavioral Interventions ◽

Antibiotic Prescribing ◽

Cluster Randomized

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Does Medication Sampling Improve Compliance with Brief Advice? Results from a Pragmatic Randomized Clinical Trial

The Journal of Smoking Cessation ◽

10.1155/2021/6638872 ◽

2021 ◽

Vol 2021 ◽

pp. 1-4

Author(s):

Nathaniel J. Silvestri ◽

Jennifer Dahne ◽

Amy E. Wahlquist ◽

Benjamin Toll ◽

Matthew J. Carpenter

Keyword(s):

Primary Care ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Standard Care ◽

Secondary Data ◽

Tobacco Treatment ◽

Improve Compliance ◽

Cluster Randomized ◽

Brief Advice ◽

The Impact

Introduction. The 5As model is a standard component of most guidelines for tobacco treatment. Unfortunately, provider adherence to this model is modest. Aims. Providing physicians with adjunctive tools to adhere to 5As guidelines may serve as a catalyst for brief advice delivery. Methods. This was a secondary data analysis of a cluster randomized clinical trial assessing the uptake and impact of free nicotine replacement therapy (NRT) sampling versus standard care in primary care. Patients reported receipt of separate elements of the 5As model, assessed one month following a baseline visit. Analyses compared patients who recalled receipt of brief advice among those who received NRT vs. standard care. Additional analyses examined demographic predictors of receiving brief advice. Results/Findings. Medication sampling did not improve compliance with ask, advise, or assess. Receipt of “assistance” was significantly higher among NRT recipients (70%) ( p ≤ 0.0001 ). The NRT sampling group was more likely to have received all components ( p = 0.004 ). As age increased, being asked ( p = 0.006 ), advised ( p = 0.05 ), and assessed ( p = 0.003 ) decreased. Non-Whites reported higher rates of assessment ( p = 0.02 ). Conclusions. Provision of NRT sampling increased provider compliance with some elements of the brief advice model, thus enhancing the impact of cessation advice within primary care. Trial Registration. This trial is registered with ClinicalTrials.gov NCT02096029.

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