Internet Interventions (Dec 2021)

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

  • 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

Journal volume & issue
Vol. 26
p. 100446

Abstract

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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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