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result(s) for
"Sempere, Ermengol"
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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
by
Alegret, Santiago
,
Rodríguez-Rincón, Raquel María
,
Socias, Isabel
in
Aged
,
Audits
,
Benzodiazepines
2022
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.
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.
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.
ISRCTN ISRCTN28272199.
Journal Article
Comparative efficacy of two interventions to discontinue long-term benzodiazepine use: cluster randomised controlled trial in primary care
2014
Benzodiazepines are extensively used in primary care, but their long-term use is associated with adverse health outcomes and dependence.
To analyse the efficacy of two structured interventions in primary care to enable patients to discontinue long-term benzodiazepine use.
A multicentre three-arm cluster randomised controlled trial was conducted, with randomisation at general practitioner level (trial registration ISRCTN13024375). A total of 532 patients taking benzodiazepines for at least 6 months participated. After all patients were included, general practitioners were randomly allocated (1:1:1) to usual care, a structured intervention with follow-up visits (SIF) or a structured intervention with written instructions (SIW). The primary end-point was the last month self-declared benzodiazepine discontinuation confirmed by prescription claims at 12 months.
At 12 months, 76 of 168 (45%) patients in the SIW group and 86 of 191 (45%) in the SIF group had discontinued benzodiazepine use compared with 26 of 173 (15%) in the control group. After adjusting by cluster, the relative risks for benzodiazepine discontinuation were 3.01 (95% CI 2.03-4.46, P<0.0001) in the SIW and 3.00 (95% CI 2.04-4.40, P<0.0001) in the SIF group. The most frequently reported withdrawal symptoms were insomnia, anxiety and irritability.
Both interventions led to significant reductions in long-term benzodiazepine use in patients without severe comorbidity. A structured intervention with a written individualised stepped-dose reduction is less time-consuming and as effective in primary care as a more complex intervention involving follow-up visits.
Journal Article
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
by
Alegret, Santiago
,
Rodríguez-Rincón, Raquel María
,
Socias, Isabel
in
Benzodiazepines
,
Clinical medicine
,
Consumption
2021
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.
Journal Article
Drug Prescription Profiles in Patients with Polypharmacy in Spain: A Large-Scale Pharmacoepidemiologic Study Using Real-World Data
by
Palop-Larrea, Vicente
,
Orueta-Sánchez, Ramón
,
Sempere-Manuel, Mara
in
Age groups
,
Antidepressants
,
Calendars
2021
We aimed to identify and compare medication profiles in populations with polypharmacy between 2005 and 2015. We conducted a cross-sectional study using information from the Computerized Database for Pharmacoepidemiologic Studies in Primary Care (BIFAP, Spain). We estimated the prevalence of therapeutic subgroups in all individuals 15 years of age and older with polypharmacy (≥5 drugs during ≥6 months) using the Anatomical Therapeutic Chemical classification system level 4, by sex and age group, for both calendar years. The most prescribed drugs were proton-pump inhibitors (PPIs), statins, antiplatelet agents, benzodiazepine derivatives, and angiotensin-converting enzyme inhibitors. The greatest increases between 2005 and 2015 were observed in PPIs, statins, other antidepressants, and β-blockers, while the prevalence of antiepileptics was almost tripled. We observed increases in psychotropic drugs in women and cardiovascular medications in men. By patient´s age groups, there were notable increases in antipsychotics, antidepressants, and antiepileptics (15–44 years); antidepressants, PPIs, and selective β-blockers (45–64 years); selective β-blockers, biguanides, PPIs, and statins (65–79 years); and in statins, selective β-blockers, and PPIs (80 years and older). Our results revealed important increases in the use of specific therapeutic subgroups, like PPIs, statins, and psychotropic drugs, highlighting opportunities to design and implement strategies to analyze such prescriptions’ appropriateness.
Journal Article
Intervention to reduce benzodiazepine prescriptions in primary care, study protocol of a hybrid type 1 cluster randomised controlled trial: the BENZORED study
by
Alegret, Santiago
,
Rodríguez-Rincón, Raquel María
,
Socias, Isabel
in
Benzodiazepines
,
Benzodiazepines - therapeutic use
,
Clinical trials
2019
IntroductionBenzodiazepines (BZDs) are mainly used to treat anxiety and sleep disorders, and are often prescribed for long durations, even though prescription guidelines recommend short-term use due to the risk of dependence, cognitive impairment, and falls and fractures. Education of general practitioners (GPs) regarding the prescription of BZDs may reduce the overuse and of these drugs.The aims of this study are to analyse the effectiveness of an intervention targeted to GPs to reduce BZD prescription and evaluate the implementation process.Methods and analysisThe healthcare centres in three regions of Spain (Balearic Islands, Catalonia and Community of Valencia) will be randomly allocated to receive a multifactorial intervention or usual care (control). GPs in the intervention group will receive a 2-hour workshop about best-practice regarding BZD prescription and BZD deprescribing, monthly feedback about their BZD prescribing practices and access to a support web page. Outcome measures for each GP are the defined daily dosage per 1000 inhabitants per day and the proportion of long-term BZD users at 12 months. Data will be collected from the electronic prescription database of the public health system, and will be subjected to intention-to-treat analysis. Implementation will be evaluated by mixed methods following the five domains of the Consolidated Framework For Implementation Research.Ethics and disseminationThis study was approved by the Balearic Islands Ethical Committee of Clinical Research (IB3065/15), l’IDIAP Jordi Gol Ethical Committee of Clinical Research (PI 15/0148) and Valencia Primary Care Ethical Committee of Clinical Research (P16/024). The results will be submitted for publication in peer-reviewed journals.Trial registration number ISRCTN28272199.
Journal Article
\Doctor, I Just Can't Go On\
by
Sempere-Verdú, Ermengol
,
Salazar-Fraile, José
,
Page, J. Bryan
in
Antidepressant drugs
,
Antidepressants
,
Depression
2010
Primary-care physicians in the Spanish system of public health care may find that they do not have either the means or the time to base their treatment of depression on diagnostic criteria. They proceed to the prescription of antidepressants even if patients are not clinically depressed, as a response to patients' reports of emotional suffering and assertions that their conditions require medical treatment in the form of antidepressant medication. In this system, encounters between physicians and patients become processes of negotiating explanatory models, such as when patients expect to receive medication because they believe that any severe emotional suffering and absence of energy that continues to limit their daily functioning is a medical problem. Directly observed interactions between patients and primary care physicians and open-ended follow-up interviews elucidate processes of interaction between their respective explanatory models.
Journal Article