Evaluation of a multicomponent intervention consisting of education and feedback to reduce benzodiazepine prescriptions by general practitioners: The BENZORED hybrid type 1 cluster randomized controlled trial.

BACKGROUND: Current benzodiazepine (BZD) prescription guidelines recommend short-term use to minimize the risk of dependence, cognitive impairment, and falls and fractures. However, many clinicians overprescribe BZDs and chronic use by patients is common. There is limited evidence on the effectiveness of interventions delivered by general practitioners (GPs) on reducing prescriptions and long-term use of BZDs. We aimed to evaluate the effectiveness of a multicomponent intervention for GPs that seeks to reduce BZD prescriptions and the prevalence of long-term users. METHODS AND FINDINGS: We conducted a multicenter two-arm, cluster randomized controlled trial in 3 health districts in Spain (primary health centers [PHCs] in Balearic Islands, Catalonia, and Valencian Community) from September 2016 to May 2018. The 81 PHCs were randomly allocated to the intervention group (n = 41; 372 GPs) or the control group (n = 40; 377 GPs). GPs were not blinded to the allocation; however, pharmacists, researchers, and trial statisticians were blinded to the allocation arm. The intervention consisted of a workshop about the appropriate prescribing of BZDs and tapering-off long-term BZD use using a tailored stepped dose reduction with monthly BZD prescription feedback and access to a support web page. The primary outcome, based on 700 GPs (351 in the control group and 349 in the intervention group), compared changes in BZD prescriptions in defined daily doses (DDDs) per 1,000 inhabitants per day after 12 months. The 2 secondary outcomes were the proportion of long-term users (≥6 months) and the proportion of long-term users over age 65 years. Intention-to-treat (ITT) analysis was used to assess all clinical outcomes. Forty-nine GPs (21 intervention group and 28 control group) were lost to follow-up. However, all GPs were included in the ITT analysis. After 12 months, there were a statistically significant decline in total BZD prescription in the intervention group compared to the control group (mean difference: -3.24 DDDs per 1,000 inhabitants per day, 95% confidence interval (CI): -4.96, -1.53, p < 0.001). The intervention group also had a smaller number of long-term users. The adjusted absolute difference overall was -0.36 (95% CI: -0.55, -0.16, p > 0.001), and the adjusted absolute difference in long-term users over age 65 years was -0.87 (95% CI: -1.44, -0.30, p = 0.003). A key limitation of this clustered design clinical trial is the imbalance of some baseline characteristics. The control groups have a higher rate of baseline BZD prescription, and more GPs in the intervention group were women, GPs with a doctorate degree, and trainers of GP residents. CONCLUSIONS: A multicomponent intervention that targeted GPs and included educational meeting, feedback about BZD prescriptions, and a support web page led to a statistically significant reduction of BZD prescriptions and fewer long-term users. Although the effect size was small, the high prevalence of BZD use in the general population suggests that large-scale implementation of this intervention could have positive effects on the health of many patients. TRIAL REGISTRATION: ISRCTN ISRCTN28272199.

Evaluating the Implementation of a Multicomponent Intervention Consisting of Education and Feedback on Reducing Benzodiazepine Prescriptions by General Practitioners: BENZORED Hybrid Type I Cluster Randomized Controlled Trial.

BACKGROUND: General practitioners (GPs) in developed countries widely prescribe benzodiazepines (BZDs) for their anxiolytic, hypnotic, and muscle-relaxant effects. Treatment duration, however, is rarely limited, and this results in a significant number of chronic users. Long-term BZD use is associated with cognitive impairment, falls with hip fractures, traffic accidents, and increased mortality. The BENZORED IV trial was a hybrid type-1 trial conducted to evaluate the effectiveness and implementation of an intervention to reduce BZD prescription in primary care. The purpose of this qualitative study was to analyze the facilitators and barriers regarding the implementation of the intervention in primary care settings. METHODS: A qualitative interview study with 40 GPs from three Spanish health districts. Focus group meetings with GPs from the intervention arm of the BENZORED IV trial were held at primary healthcare centers in the three districts. For sampling purposes, the GPs were classified as high or low implementers according to the success of the intervention measured at 12 months. The Consolidated Framework for Implementation Research (CFIR) was used to conduct the meetings and to code, rate, and analyze the data. RESULTS: Three of the 41 CFIR constructs strongly distinguished between high and low implementers: the complexity of the intervention, the individual Stage of Change, and the key stakeholder's engagement. Seven constructs weakly discriminated between the two groups: adaptability in the intervention, external policy and incentives, implementation climate, relative priority, self-efficacy, compatibility, and engaging a formally appointed implementation leader. Fourteen constructs did not discriminate between the two groups, six had insufficient data for evaluation, and eleven had no data for evaluation. CONCLUSIONS: We identified constructs that could explain differences in the efficacy in implementation of the intervention. This information is relevant for the design of successful strategies for implementation of the intervention.

[Evaluation of a protocol to monitor cardiovascular risk factors in diabetic patients attended in primary care]. / Evaluación de un protocolo de control de factores de riesgo cardiovascular en pacientes diabéticos atendidos en atención primaria.

OBJECTIVE: To evaluate a primary care protocol for intensive monitoring of cardiovascular risk (CVR) factors in type-2 diabetes patients versus usual care. DESIGN: Randomised trial with clusters. SETTING: Primary care clinics. PARTICIPANTS: Sixty family physicians. INTERVENTIONS: Participants were randomised between following a protocol of intensive monitoring of CVR factors and maintaining their habitual practice with DM2 patients. Follow-up lasted 12 months. Data on HbA1C, CVR factors and CVR were collected at the start of the study and at 12 months. RESULTS: In all, 188 patients (94 intervention group and 94 control group) were included. At baseline measurement, CVR in control group (CG) was 36.3% (95% CI, 33.9%-38.6%); and in intervention group (IG), 35.9% (95% CI, 33.5%-38.4%), with no significant differences between groups. At one year, CVR in CG was 33.1% (95% CI, 30%-36.1%) and in IG 30.5% (95% CI, 27.8%-33.2%). The CVR difference between baseline and 1-year measurements was 2.9% (95% CI, 0.2%-5.7%) in CG and 5.4% (95% CI, 2.8%-7.1%) in IG. CONCLUSIONS: Although improvement of CVR is greater in the IG, the difference between the two groups is not significant. The characteristics of the doctors chosen may have meant that the patients of the two groups received similar treatment.

Evaluación de un protocolo de control de factores de riesgo cardiovascular en pacientes diabéticos atendidos en atención primaria / Evaluation of a protocol to monitor cardiovascular risk factors in diabetic patients attended in primary care

Objetivo. Valorar un protocolo de control intensivo de factores de riesgo cardiovascular (FRCV) frente al control habitual en pacientes con diabetes mellitus tipo 2 (DM2) en atención primaria. Diseño. Estudio aleatorizado de grupos. Emplazamiento. Consultas de atención primaria. Participantes. En total participaron 60 médicos de familia. Intervenciones. Los participantes fueron aleatorizados a seguir un protocolo de tratamiento intensivo de FRCV o a mantener su práctica habitual en pacientes con DM2. El seguimiento fue de 12 meses. Se recogieron datos acerca de la hemoglobina glucosilada, los FRCV y el riesgo cardiovascular al inicio del estudio y a los 12 meses. Resultados. Se incluyó a 188 pacientes (94 en el grupo de intervención y 94 en el grupo control). El riesgo cardiovascular basal en el grupo control (GC) fue del 36,3% (intervalo de confianza [IC] del 95%, 33,9-38,6%) y en el grupo de intervención (GI), del 35,9% (IC del 95%, 33,5-38,4%), sin diferencias significativas entre grupos. El riesgo cardiovascular a los 12 meses en el GC fue del 33,1% (IC del 95%, 30,0-36,1%) y en el GI del 30,5% (IC del 95%, 27,8-33,2%). La diferencia de riesgo cardiovascular a los 12 meses fue del ­2,9% (IC del 95%, 0,2-5,7%) en el GC y del ­5,4% (IC del 95%, 2,8-7,1%) en el GI. Conclusiones. Aunque se observa una disminución mayor del riesgo cardiovascular en el GI, la diferencia entre los grupos no es significativa. Las características de los médicos seleccionados pueden haber condicionado que los pacientes de ambos grupos hayan recibido un tratamiento similar

Objective. To evaluate a primary care protocol for intensive monitoring of cardiovascular risk (CVR) factors in type-2 diabetes patients versus usual care. Design. Randomised trial with clusters. Setting. Primary care clinics. Participants. Sixty family physicians. Interventions. Participants were randomised between following a protocol of intensive monitoring of CVR factors and maintaining their habitual practice with DM2 patients. Follow-up lasted 12 months. Data on HbA1C, CVR factors and CVR were collected at the start of the study and at 12 months. Results. In all, 188 patients (94 intervention group and 94 control group) were included. At baseline measurement, CVR in control group (CG) was 36.3% (95% CI, 33.9%-38.6%); and in intervention group (IG), 35.9% (95% CI, 33.5%-38.4%), with no significant differences between groups. At one year, CVR in CG was 33.1% (95% CI, 30%-36.1%) and in IG 30.5% (95% CI, 27.8%-33.2%). The CVR difference between baseline and 1-year measurements was 2.9% (95% CI, 0.2%-5.7%) in CG and 5.4% (95% CI, 2.8%-7.1%) in IG. Conclusions. Although improvement of CVR is greater in the IG, the difference between the two groups is not significant. The characteristics of the doctors chosen may have meant that the patients of the two groups received similar treatment