Comparative efficacy of two primary care interventions to assist withdrawal from long term benzodiazepine use: A protocol for a clustered, randomized clinical trial
Background: Although benzodiazepines are effective, long-term use is not recommended because of potential adverse effects; the risks of tolerance and dependence; and an increased risk of hip fractures, motor vehicle accidents, and memory impairment. The estimated prevalence of long-term benzodiazepi...
| Autores: | , , , , , , , , , , , , , , , , , , , |
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| Formato: | artículo |
| Fecha de publicación: | 2011 |
| País: | España |
| Recursos: | Conselleria de Salut i Consum del Govern de les Illes Balears |
| Repositorio: | Docusalut |
| Idioma: | inglés |
| OAI Identifier: | oai:docusalut.com:20.500.13003/13341 |
| Acesso em linha: | https://hdl.handle.net/20.500.13003/13341 |
| Access Level: | acceso abierto |
| Palavra-chave: | Young Adult Adult Interviews as Topic Humans Depression Adolescent Middle Aged Research Design Substance-Related Disorders Substance Withdrawal Syndrome Primary Health Care Patient Education as Topic Single-Blind Method Anxiety Aged, 80 and over Benzodiazepines Aged Adulto Síndrome de Abstinencia a Sustancias Método Simple Ciego Trastornos Relacionados con Sustancias Adolescente Entrevistas como Asunto Humanos Persona de Mediana Edad Proyectos de Investigación Adulto Joven Depresión Anciano Ansiedad Anciano de 80 o más Años Educación del Paciente como Asunto Benzodiazepinas Atención Primaria de Salud |
| Resumo: | Background: Although benzodiazepines are effective, long-term use is not recommended because of potential adverse effects; the risks of tolerance and dependence; and an increased risk of hip fractures, motor vehicle accidents, and memory impairment. The estimated prevalence of long-term benzodiazepine use in the general population is about 2,2 to 2,6%, is higher in women and increases steadily with age. Interventions performed by General Practitioners may help patients to discontinue long-term benzodiazepine use. We have designed a trial to evaluate the effectiveness and safety of two brief general practitioner-provided interventions, based on gradual dose reduction, and will compare the effectiveness of these interventions with that of routine clinical practice. Methods/Design: In a three-arm cluster randomized controlled trial, general practitioners will be randomly allocated to: a) a group in which the first patient visit will feature a structured interview, followed by visits every 2-3 weeks to the end of dose reduction; b) a group in which the first patient visit will feature a structured interview plus delivery of written instructions to self-reduce benzodiazepine dose, or c) routine care. Using a computerized pharmaceutical prescription database, 495 patients, aged 18-80 years, taking benzodiazepine for at least 6 months, will be recruited in primary care health districts of three regions of Spain (the Balearic Islands, Catalonia, and Valencia). The primary outcome will be benzodiazepine use at 12 months. The secondary outcomes will include measurements of anxiety and depression symptoms, benzodiazepine dependence, quality of sleep, and alcohol consumption. Discussion: Although some interventions have been shown to be effective in reducing benzodiazepine consumption by long-term users, the clinical relevance of such interventions is limited by their complexity. This randomized trial will compare the effectiveness and safety of two complex stepped care interventions with that of routine care in a study with sufficient statistical power to detect clinically relevant differences. |
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