A randomized controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR Spain)

Autor: Elsa Caballeria, Hugo López-Pelayo, Lidia Segura, Paul Wallace, Clara Oliveras, Estela Díaz, Jakob Manthey, Begoña Baena, Joan Colom, Antoni Gual, Antonia Leiva Pintado, Elena Campanera Samitier, Fernando Ferrer Keysers, Rosa Freixedas Casaponsa, Marta Poch i Mora, Rosaura Figueras Camós, Silvia Duran Alcobet, Sonia Martínez Lainez, Susana Sostres Francás, Olga Bohera Gracia, José Francisco Doz Mora, Elena Casajuana Andres, Esther Bracero Alonso, Eulalia Duran Bellido, Eva Casajuana Andres, Almudena Alvarez, Nuria Garcia Moron, Juan Arenas Vidal, Rosa Pla Martínez, Cristina Ligero, Mercè Ribot Igualada, Angels Vicente Zamorano, Carmen Garcia Corominas, Elena Navarro Pou, Gloria Ribas Miquel, Josep Maria Gifre Hipolit, María del Carmen Martí Martínez, Rosa María González Cabezas, Davinia Vazquez Gonzalez, Cristina Bonaventura Sans, Gemma Castillo Tirado, Ana Morillo Ortega, Joana Hernandez Millan, Dolors Ylla Murillo, Judit Alsina Massana, Carme Codorniu Junqué, Cleofé Mellado Rodríguez, Nora Yanovksy Martí, Beatriz Fernandez Najar, Angel Garcia Vilaubí, Francisco Cortés Hurtado, Gemma Capdevila Rodriguez, Teresa Sayrol Clols, Francisco Javier Avila Rivera, Josep Ramon López Olivares, M. Isabel López Castelló, Pilar Flores Figueres, Alicia Gómez Arroyo, Elisenda Garcia Puig, Carme Danta Gómez, M. de la Serra Comas i Antich, Manel Vila Vergaz, Marta R. Solé Dalfó, Montserrat Espuga García, Silvia Crivillé Mauricio, Anna Santeugini Bosch, Andrea Carolina Berengue Gonzalez, Eva María Ramírez Moreno, Gemma Comas Arnau, Monica Mestres Massa, Montserrat Navarro Gilo, Rosa Blanca Muñoz Muñoz, Xavier Cantano Navarro, María Concepción Lasmarías Ugarte, Carme Anglada Arisa, Clara Calvó Blancafort, Carme Comino Cereto, MªCarme Parareda Plana, Natalia Sabat Vila, Olga Navarro Martinez, Renée Vink Schoenholzer, María del Mar Sánchez Hernández, Maria de las Nieves Vizcay Cruchaga, Elvira Pou Rovira, Remedios Miralles Bacete, Pere Sors i Cuffi, M. Isabel Matilla Mont, Roser Urpinas Vilà, Marta Beltran Vilella, Montse Mendez Ribas, Pau Montoya Roldan, Mireia Bernat Casals, Iris Alarcón Belmonte, Maite Fernandez Orriols, Elena Mañes López, M. Montserrat Melé Baena, M. Carmen Sánchez Herrero, Meritxell Ferrer Pujol, Esther Boix Roqueta, Juan Manuel Mendive Arbeloa, Marta Mas Regàs, Núria Plana Closa
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Internet Interventions, Vol 26, Iss , Pp 100446- (2021)
Druh dokumentu: article
ISSN: 2214-7829
DOI: 10.1016/j.invent.2021.100446
Popis: Background: Brief interventions (BI) for risky drinkers in primary healthcare have been demonstrated to be cost-effective but they are still poorly implemented. Digital BI seems to be a complementary strategy to overcome some barriers to implementation but there is a scarcity of studies in clinical environments. We present the results of a randomized controlled non-inferiority trial which tests the non-inferiority of facilitated access to a digital intervention (experimental condition) for risky drinkers against a face-to-face BI (control condition) provided by primary healthcare professionals. Method: In a non-inferiority randomized controlled trial, unselected primary healthcare patients (≥ 18 years old) were given a brief introduction and asked to log on to the study website to fill in the 3-item version of the Alcohol Use Disorders Identification Test. Positively screened patients (4+ for women and 5+ for men) received further online assessment (AUDIT, socio-demographic characteristics and EQ-5D-5L) and were automatically randomized to either face-to-face or digital BI (1:1). The primary outcome was the proportion of patients classified as risky drinkers by the digitally administered AUDIT at month 3. A multiple imputation approach for the missing data was performed. Results: Of the 4499 patients approached by 115 healthcare professionals, 1521 completed the AUDIT-C. Of the 368 positively screened patients, 320 agreed to participate and were randomized to either intervention. At month 3, there were more risky drinkers in the experimental group (59.8%) than in the control group (52%), which was similar to the distribution at baseline and less than the pre-specified margin of 10%. The difference was not significant when accounting for possible confounders. Conclusion: Digital BI was not inferior to face-to-face BI, in line with previous findings and the a priori hypothesis. However, the low power of the final sample, due to the low recruitment and loss to follow-up, limits the interpretation of the findings. New approaches in this field are required to ensure the effective implementation of digital interventions in actual practice.
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