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Effectiveness of a brief motivational intervention in the management of risky alcohol use in primary care: ALCO-AP20 study protocol

BACKGROUND: Motivational interviewing (MI) could be a method for minimizing alcohol-related harm. The study aims to assess the effectiveness of a brief intervention, based on a MI, in patients with risky alcohol use attended in Primary Care (PC). MATERIALS AND METHODS: A cluster-randomized, two-arm...

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Autores principales: Romero-Rodríguez, Esperanza, Pérula-Jiménez, Celia, Fernández-López, Sara, Cabello-Gracia, Gregorio, Fernández-García, José Ángel, Pérula-de Torres, Luis Ángel, Roldán-Villalobos, Ana, Leiva-Cepas, Fernando, Fernández-Márquez, Rodrigo, Parras-Rejano, Juan Manuel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9880185/
https://www.ncbi.nlm.nih.gov/pubmed/36714106
http://dx.doi.org/10.3389/fmed.2022.1008832
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author Romero-Rodríguez, Esperanza
Pérula-Jiménez, Celia
Fernández-López, Sara
Cabello-Gracia, Gregorio
Fernández-García, José Ángel
Pérula-de Torres, Luis Ángel
Roldán-Villalobos, Ana
Leiva-Cepas, Fernando
Fernández-Márquez, Rodrigo
Parras-Rejano, Juan Manuel
author_facet Romero-Rodríguez, Esperanza
Pérula-Jiménez, Celia
Fernández-López, Sara
Cabello-Gracia, Gregorio
Fernández-García, José Ángel
Pérula-de Torres, Luis Ángel
Roldán-Villalobos, Ana
Leiva-Cepas, Fernando
Fernández-Márquez, Rodrigo
Parras-Rejano, Juan Manuel
author_sort Romero-Rodríguez, Esperanza
collection PubMed
description BACKGROUND: Motivational interviewing (MI) could be a method for minimizing alcohol-related harm. The study aims to assess the effectiveness of a brief intervention, based on a MI, in patients with risky alcohol use attended in Primary Care (PC). MATERIALS AND METHODS: A cluster-randomized, two-arm parallel, multicenter, open-label, controlled clinical trial. Fifty PC healthcare professionals from the province of Córdoba (Spain) will be randomized to one of the two study groups: (1) Experimental Group (EG): MI-based approach; (2) Control Group (CG): Usual care based on health advice. EG intervention: Professionals will receive a training program focused on MI, consisting of a training workshop and the use of pre- and post-workshop questionnaires to measure knowledge and skills acquired, as well as the degree of empathy, with a videotape of the health professionals with standardized patients, before and after the workshop, and subsequent training feedback. CG intervention: Workshop on the management of risky alcohol use based on health advice; participants will also complete the pre-and post-workshop questionnaires and be videotaped. Study population: Patients ≥ 14 years old with risky alcohol consumption (28 Standard Drink Units-SDU-/week in men and 17 SDU/week in women) or excessive alcohol use (≥ 6 SDU in men or ≥ 4 SDU in women, in less than 2 h). It would be necessary to include 110 subjects/group to find a difference of 20% between the percentage of patients in abstinence between EG (37%) and CG (20%), alpha error of 5%, and statistical power of 80%. Assuming a loss rate of 5% and the cluster design effect, the number of subjects to be recruited is estimated at 197/group. The follow-up period will be 12 months. The primary outcome variables will be the self-reported alcohol use level and the Alcohol Use Disorders Identification Test (AUDIT) questionnaire score. DISCUSSION: The study aims to demonstrate the effectiveness of the motivational approach in the comprehensive treatment of the patient with risky alcohol use, improving the empathy of the healthcare professionals and strengthening the healthcare professional-patient relationship to achieve the behavioral change of the patients with this problem in primary care consultations. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov.
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spelling pubmed-98801852023-01-28 Effectiveness of a brief motivational intervention in the management of risky alcohol use in primary care: ALCO-AP20 study protocol Romero-Rodríguez, Esperanza Pérula-Jiménez, Celia Fernández-López, Sara Cabello-Gracia, Gregorio Fernández-García, José Ángel Pérula-de Torres, Luis Ángel Roldán-Villalobos, Ana Leiva-Cepas, Fernando Fernández-Márquez, Rodrigo Parras-Rejano, Juan Manuel Front Med (Lausanne) Medicine BACKGROUND: Motivational interviewing (MI) could be a method for minimizing alcohol-related harm. The study aims to assess the effectiveness of a brief intervention, based on a MI, in patients with risky alcohol use attended in Primary Care (PC). MATERIALS AND METHODS: A cluster-randomized, two-arm parallel, multicenter, open-label, controlled clinical trial. Fifty PC healthcare professionals from the province of Córdoba (Spain) will be randomized to one of the two study groups: (1) Experimental Group (EG): MI-based approach; (2) Control Group (CG): Usual care based on health advice. EG intervention: Professionals will receive a training program focused on MI, consisting of a training workshop and the use of pre- and post-workshop questionnaires to measure knowledge and skills acquired, as well as the degree of empathy, with a videotape of the health professionals with standardized patients, before and after the workshop, and subsequent training feedback. CG intervention: Workshop on the management of risky alcohol use based on health advice; participants will also complete the pre-and post-workshop questionnaires and be videotaped. Study population: Patients ≥ 14 years old with risky alcohol consumption (28 Standard Drink Units-SDU-/week in men and 17 SDU/week in women) or excessive alcohol use (≥ 6 SDU in men or ≥ 4 SDU in women, in less than 2 h). It would be necessary to include 110 subjects/group to find a difference of 20% between the percentage of patients in abstinence between EG (37%) and CG (20%), alpha error of 5%, and statistical power of 80%. Assuming a loss rate of 5% and the cluster design effect, the number of subjects to be recruited is estimated at 197/group. The follow-up period will be 12 months. The primary outcome variables will be the self-reported alcohol use level and the Alcohol Use Disorders Identification Test (AUDIT) questionnaire score. DISCUSSION: The study aims to demonstrate the effectiveness of the motivational approach in the comprehensive treatment of the patient with risky alcohol use, improving the empathy of the healthcare professionals and strengthening the healthcare professional-patient relationship to achieve the behavioral change of the patients with this problem in primary care consultations. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov. Frontiers Media S.A. 2023-01-13 /pmc/articles/PMC9880185/ /pubmed/36714106 http://dx.doi.org/10.3389/fmed.2022.1008832 Text en Copyright © 2023 Romero-Rodríguez, Pérula-Jiménez, Fernández-López, Cabello-Gracia, Fernández-García, Pérula-de Torres, Roldán-Villalobos, Leiva-Cepas, Fernández-Márquez, Parras-Rejano and ALCO-AP-20 Collaborative Study Group. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medicine
Romero-Rodríguez, Esperanza
Pérula-Jiménez, Celia
Fernández-López, Sara
Cabello-Gracia, Gregorio
Fernández-García, José Ángel
Pérula-de Torres, Luis Ángel
Roldán-Villalobos, Ana
Leiva-Cepas, Fernando
Fernández-Márquez, Rodrigo
Parras-Rejano, Juan Manuel
Effectiveness of a brief motivational intervention in the management of risky alcohol use in primary care: ALCO-AP20 study protocol
title Effectiveness of a brief motivational intervention in the management of risky alcohol use in primary care: ALCO-AP20 study protocol
title_full Effectiveness of a brief motivational intervention in the management of risky alcohol use in primary care: ALCO-AP20 study protocol
title_fullStr Effectiveness of a brief motivational intervention in the management of risky alcohol use in primary care: ALCO-AP20 study protocol
title_full_unstemmed Effectiveness of a brief motivational intervention in the management of risky alcohol use in primary care: ALCO-AP20 study protocol
title_short Effectiveness of a brief motivational intervention in the management of risky alcohol use in primary care: ALCO-AP20 study protocol
title_sort effectiveness of a brief motivational intervention in the management of risky alcohol use in primary care: alco-ap20 study protocol
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9880185/
https://www.ncbi.nlm.nih.gov/pubmed/36714106
http://dx.doi.org/10.3389/fmed.2022.1008832
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