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

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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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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Effectiveness of motivational interviewing to improve therapeutic adherence in patients over 65 years old with chronic diseases: A cluster randomized clinical trial in primary care

Patient Education and Counseling ◽

10.1016/j.pec.2015.03.008 ◽

2015 ◽

Vol 98 (8) ◽

pp. 977-983 ◽

Cited By ~ 24

Author(s):

Roger Ruiz Moral ◽

Luis Angel Pérula de Torres ◽

Laura Pulido Ortega ◽

Margarita Criado Larumbe ◽

Ana Roldán Villalobos ◽

...

Keyword(s):

Primary Care ◽

Clinical Trial ◽

Motivational Interviewing ◽

Randomized Clinical Trial ◽

Chronic Diseases ◽

Therapeutic Adherence ◽

Cluster Randomized

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Effectiveness of a stepped primary care smoking cessation intervention: cluster randomized clinical trial (ISTAPS study)

Addiction ◽

10.1111/j.1360-0443.2011.03491.x ◽

2011 ◽

Vol 106 (9) ◽

pp. 1696-1706 ◽

Cited By ~ 28

Author(s):

Carmen Cabezas ◽

Mamta Advani ◽

Diana Puente ◽

Teresa Rodriguez-Blanco ◽

Carlos Martin ◽

...

Keyword(s):

Primary Care ◽

Clinical Trial ◽

Smoking Cessation ◽

Randomized Clinical Trial ◽

Smoking Cessation Intervention ◽

Intervention Cluster ◽

Cessation Intervention ◽

Cluster Randomized

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Mass Drug Administration With High-Dose Ivermectin and Dihydroartemisinin-Piperaquine for Malaria Elimination in an Area of Low Transmission With High Coverage of Malaria Control Interventions: Protocol for the MASSIV Cluster Randomized Clinical Trial

JMIR Research Protocols ◽

10.2196/20904 ◽

2020 ◽

Vol 9 (11) ◽

pp. e20904

Author(s):

Edgard Diniba Dabira ◽

Harouna M Soumare ◽

Steven W Lindsay ◽

Bakary Conteh ◽

Fatima Ceesay ◽

...

Keyword(s):

Clinical Trial ◽

Malaria Transmission ◽

Randomized Clinical Trial ◽

Drug Administration ◽

Malaria Control ◽

Mass Drug Administration ◽

High Coverage ◽

River Region ◽

Cluster Randomized ◽

The Impact

Background With a decline in malaria burden, innovative interventions and tools are required to reduce malaria transmission further. Mass drug administration (MDA) of artemisinin-based combination therapy (ACT) has been identified as a potential tool to further reduce malaria transmission, where coverage of vector control interventions is already high. However, the impact is limited in time. Combining an ACT with an endectocide treatment that is able to reduce vector survival, such as ivermectin (IVM), could increase the impact of MDA and offer a new tool to reduce malaria transmission. Objective The study objective is to evaluate the impact of MDA with IVM plus dihydroartemisinin-piperaquine (DP) on malaria transmission in an area with high coverage of malaria control interventions. Methods The study is a cluster randomized trial in the Upper River Region of The Gambia and included 32 villages (16 control and 16 intervention). A buffer zone of ~2 km was created around all intervention clusters. MDA with IVM plus DP was implemented in all intervention villages and the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program plans. Results The MDA campaigns were carried out from August to October 2018 for the first year and from July to September 2019 for the second year. Statistical analysis will commence once the database is completed, cleaned, and locked. Conclusions This is the first cluster randomized clinical trial of MDA with IVM plus DP. The results will provide evidence on the impact of MDA with IVM plus DP on malaria transmission. Trial Registration ClinicalTrials.gov NCT03576313; https://clinicaltrials.gov/ct2/show/NCT03576313 International Registered Report Identifier (IRRID) DERR1-10.2196/20904

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Mass Drug Administration With High-Dose Ivermectin and Dihydroartemisinin-Piperaquine for Malaria Elimination in an Area of Low Transmission With High Coverage of Malaria Control Interventions: Protocol for the MASSIV Cluster Randomized Clinical Trial (Preprint)

10.2196/preprints.20904 ◽

2020 ◽

Author(s):

Edgard Diniba Dabira ◽

Harouna M Soumare ◽

Steven W Lindsay ◽

Bakary Conteh ◽

Fatima Ceesay ◽

...

Keyword(s):

Clinical Trial ◽

Malaria Transmission ◽

Randomized Clinical Trial ◽

Drug Administration ◽

Malaria Control ◽

Mass Drug Administration ◽

High Coverage ◽

River Region ◽

Cluster Randomized ◽

The Impact

BACKGROUND With a decline in malaria burden, innovative interventions and tools are required to reduce malaria transmission further. Mass drug administration (MDA) of artemisinin-based combination therapy (ACT) has been identified as a potential tool to further reduce malaria transmission, where coverage of vector control interventions is already high. However, the impact is limited in time. Combining an ACT with an endectocide treatment that is able to reduce vector survival, such as ivermectin (IVM), could increase the impact of MDA and offer a new tool to reduce malaria transmission. OBJECTIVE The study objective is to evaluate the impact of MDA with IVM plus dihydroartemisinin-piperaquine (DP) on malaria transmission in an area with high coverage of malaria control interventions. METHODS The study is a cluster randomized trial in the Upper River Region of The Gambia and included 32 villages (16 control and 16 intervention). A buffer zone of ~2 km was created around all intervention clusters. MDA with IVM plus DP was implemented in all intervention villages and the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program plans. RESULTS The MDA campaigns were carried out from August to October 2018 for the first year and from July to September 2019 for the second year. Statistical analysis will commence once the database is completed, cleaned, and locked. CONCLUSIONS This is the first cluster randomized clinical trial of MDA with IVM plus DP. The results will provide evidence on the impact of MDA with IVM plus DP on malaria transmission. CLINICALTRIAL ClinicalTrials.gov NCT03576313; https://clinicaltrials.gov/ct2/show/NCT03576313 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/20904

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

10.21203/rs.3.rs-209646/v1 ◽

2021 ◽

Author(s):

María Jesús Santamaría-Martín ◽

Susana Martín Iglesias ◽

Christine Schwarz ◽

Milagros Rico-Blázquez ◽

Julián Alexander Portocarrero-Nuñez ◽

...

Keyword(s):

Primary Care ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Educational Intervention ◽

Exclusive Breastfeeding ◽

Intervention Group ◽

Control Group ◽

Usual Practice ◽

Factors Associated ◽

Cluster Randomized

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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