학술논문
A randomized controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR Spain)
Document Type
article
Author
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
Source
Internet Interventions, Vol 26, Iss , Pp 100446- (2021)
Subject
Language
English
ISSN
2214-7829
Abstract
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.