De-imFAR phase II project: a study protocol for a cluster randomised implementation trial to evaluate the effectiveness of de-implementation strategies to reduce low-value statin prescribing in the primary prevention of cardiovascular disease.

INTRODUCTION: This study aims to reduce potentially inappropriate prescribing (PIP) of statins and foster healthy lifestyle promotion in cardiovascular disease (CVD) primary prevention in low-risk patients. To this end, we will compare the effectiveness and feasibility of several de-implementation strategies developed following the structured design process of the Behaviour Change Wheel targeting key determinants of the clinical decision-making process in CVD prevention. METHODS AND ANALYSIS: A cluster randomised implementation trial, with an additional control group, will be launched, involving family physicians (FPs) from 13 Integrated Healthcare Organisations (IHOs) of Osakidetza-Basque Health Service with non-zero incidence rates of PIP of statins in 2021. All FPs will be exposed to a non-reflective decision assistance strategy based on reminders and decision support tools. Additionally, FPs from two of the IHOs will be randomly assigned to one of two increasingly intensive de-implementation strategies: adding a decision information strategy based on knowledge dissemination and a reflective decision structure strategy through audit/feedback. The target population comprises women aged 45-74 years and men aged 40-74 years with moderately elevated cholesterol levels but no diagnosed CVD and low cardiovascular risk (REGICOR<7.5%), who attend at least one appointment with any of the participating FPs (May 2022-May 2023), and will be followed until May 2024. We use the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to evaluate outcomes. The main outcome will be the change in the incidence rate of PIP of statins and healthy lifestyle counselling in the study population 12 and 24 months after FPs' exposure to the strategies. Moreover, FPs' perception of their feasibility and acceptability, and patient experience regarding the quality of care received will be evaluated. ETHICS AND DISSEMINATION: The study was approved by the Basque Country Clinical Research Ethics Committee and was registered in ClinicalTrials.gov (NCT04022850). Results will be disseminated in scientific peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04022850.

A communication procedure between community pharmacists and primary care professionals resolves medication errors and other administrative issues.

OBJECTIVES: The aim of this study was to implement a communication procedure, with agreed-upon protocols, to resolve daily medication errors and other administrative issues that require communication between community pharmacists (CPs) and primary healthcare professionals (PHCPs). METHODS: A 6-month pilot study followed by a year-length principal study was carried out in the Donostialdea Integrated Healthcare Organisation (IHO). Afterwards, the project was extended to other IHOs. The CPs identified medication errors or other administrative issues that required communication with PHCPs, contacting the customer service staff by telephone for urgent problems and by email for non-urgent problems. KEY FINDINGS: In total, 49 community pharmacies participated in the study. A total of 1179 medication errors and other administrative issues were detected, and over 90% of problems were solved in less than 24 h (n = 1079, 91.5%). Email was the more frequently used communication method (n = 874, 74.1%), and the most prevalent problems were due to absent (n = 766, 65.0%) and expired (n = 226, 19.2%) electronic prescriptions. Most of the participants were satisfied with the programme. CONCLUSION: The present communication procedure between CPs and PHCPs is an efficient tool to resolve a variety of challenges that occur in community pharmacies.

Evaluación de una intervención formativa con revisión estructurada de la medicación en pacientes mayores polimedicados en Atención Primaria / Evaluation of an educational intervention and a structured review of polypharmacy in elderly patients in Primary Care

Antecedentes y objetivo: Diversas intervenciones han demostrado que reducen la polimedicación y la prescripción potencialmente inapropiada (PPI). El objetivo del estudio fue evaluar el número de fármacos y PPI antes y después de una intervención educativa sobre el médico de atención primaria (MAP), con identificación electrónica de la PPI y revisión estructurada de la medicación, en ancianos con polimedicación excesiva (≥10 fármacos). Material y métodos: Estudio de intervención antes-después, en la Comarca Guipúzcoa (Osakidetza), en una muestra aleatoria de mayores de 80 años con ≥10 fármacos, cuyos MAP recibieron formación. Variables principales: cambio en el número de fármacos y PPI, evaluados por historia clínica. Variables secundarias: descripción del balance beneficio-riesgo evaluado por el MAP, problemas de seguridad y decisión terapéutica. Resultados: De los 591 pacientes elegibles, se excluyó a 88 (41: sus MAP no asistieron a la formación, 47: fallecimiento/traslado/ingreso) y se incluyó a 503, con una edad media de 84,9 años; el 67,7% eran mujeres. El número medio de fármacos y de PPI por paciente disminuyó significativamente: −0,88 (IC 95%: −1,04 a −0,72) y −0,19 (IC 95%: −0,29 a −0,09), respectivamente (p<0,0001), con una reducción del 25,8% en el número de pacientes con polimedicación excesiva. Variables secundarias: se emplearon hojas de recogida de datos de 365 pacientes y de 4.168 prescripciones. El balance beneficio-riesgo fue favorable para el 75% de las prescripciones y la decisión terapéutica mayoritaria fue mantenerlas (83%). Se mantuvieron el 47,3% de las 911 prescripciones con balance desfavorable/incierto. Conclusiones: La intervención se asocia con una reducción en la polimedicación excesiva y de la PPI en condiciones de práctica clínica habitual

Background and objective: Several interventions have been shown to reduce polypharmacy and potentially inappropriate prescription (PIP). The objective of the study was to evaluate the number of drugs and PIP before and after an educational intervention with the Primary Care physician (PCP), with electronic identification of PIP and structured medication review, in elderly patients with excessive polypharmacy (≥10 drugs). Material and methods: A before-after intervention study was conducted in the Gipuzkoa district of Osakidetza (Basque Country Health System), in a random sample of patients older than 80 years taking ≥ 10 drugs, and whose PCP attended training sessions. Primary outcomes: change in the number of drugs and PIP, registered in computerised health records. Secondary outcomes: benefit/risk ratio assessed by the PCP, safety problems, and therapeutic decision. Results: Of the 591 eligible patients, 88 were excluded (41: PCP did not attend training sessions, 47: death/transfer/admission), including a total of 503 patients with mean age of 84.9 years, with 67.7% women. The mean number of drugs and PIP per patient decreased significantly, −0.88 (95% CI: −1.04 to −0.72) and −0.19 (95% CI: −0.29 to −0.09), respectively (p<.0001), with a 25.8% reduction in the number of patients with excessive polypharmacy. Secondary outcomes: data collection sheets of 365 patients and 4,168 prescriptions were collected. The benefit-risk ratio was favourable for 75% of the prescriptions, with the most frequent decision being to maintain them (83%). Among the 911 prescriptions with an unfavourable/uncertain benefit/risk ratio, 47.3% were maintained. Conclusions: The intervention is associated with a reduction in excessive polypharmacy and PPI under real-world conditions

[Evaluation of an educational intervention and a structured review of polypharmacy in elderly patients in Primary Care]. / Evaluación de una intervención formativa con revisión estructurada de la medicación en pacientes mayores polimedicados en Atención Primaria.

BACKGROUND AND OBJECTIVE: Several interventions have been shown to reduce polypharmacy and potentially inappropriate prescription (PIP). The objective of the study was to evaluate the number of drugs and PIP before and after an educational intervention with the Primary Care physician (PCP), with electronic identification of PIP and structured medication review, in elderly patients with excessive polypharmacy (≥10 drugs). MATERIAL AND METHODS: A before-after intervention study was conducted in the Gipuzkoa district of Osakidetza (Basque Country Health System), in a random sample of patients older than 80 years taking ≥ 10 drugs, and whose PCP attended training sessions. Primary outcomes: change in the number of drugs and PIP, registered in computerised health records. SECONDARY OUTCOMES: benefit/risk ratio assessed by the PCP, safety problems, and therapeutic decision. RESULTS: Of the 591 eligible patients, 88 were excluded (41: PCP did not attend training sessions, 47: death/transfer/admission), including a total of 503 patients with mean age of 84.9 years, with 67.7% women. The mean number of drugs and PIP per patient decreased significantly, -0.88 (95% CI: -1.04 to -0.72) and -0.19 (95% CI: -0.29 to -0.09), respectively (p<.0001), with a 25.8% reduction in the number of patients with excessive polypharmacy. SECONDARY OUTCOMES: data collection sheets of 365 patients and 4,168 prescriptions were collected. The benefit-risk ratio was favourable for 75% of the prescriptions, with the most frequent decision being to maintain them (83%). Among the 911 prescriptions with an unfavourable/uncertain benefit/risk ratio, 47.3% were maintained. CONCLUSIONS: The intervention is associated with a reduction in excessive polypharmacy and PPI under real-world conditions.

Results from the CLUES study: a cluster randomized trial for the evaluation of cardiovascular guideline implementation in primary care in Spain.

BACKGROUND: The implementation of evidence-based clinical practice guidelines (CPG) can improve patients care. To date, the impact of implementation strategies has not been evaluated in our context. This study is aimed to evaluate the effectiveness of a multifaceted tailored intervention targeting clinician education for the implementation of three cardiovascular risk-related CPGs (type 2 diabetes, hypertension and dyslipidemia) in primary care at the Basque Health Service compared with usual implementation. METHODS: We conducted a cluster randomized controlled trial in two urban districts with 43 primary care units (PCU). Data from all patients diagnosed with diabetes, hypertension and all those eligible for coronary risk (CR) assessment were included. In the control group, guidelines were introduced in the usual way (by email, intranet and clinical meetings). In the intervention group, the implementation also included a specific website and workshops. Primary endpoints were annual HbA1c testing (diabetes), annual general laboratory testing (hypertension) and annual CR assessment (dyslipidemia). Secondary endpoints were process, prescription and clinical endpoints related with guideline recommendations. Analysis was performed at a PCU level weighted by cluster size. RESULTS: Significant differences between groups were observed in primary outcomes in the dyslipidemia CPG: increased CR assessment for both women and men (weighted mean difference, WMD, 13.58 and 12.91%). No significant differences were observed in diabetes and hypertension CPGs primary outcomes. Regarding secondary endpoints, annual CR assessment was significantly higher in both diabetic and hypertensive patients in the intervention group (WMD 28.16 and 27.55%). Rates of CR assessment before starting new statin treatments also increased (WMD 23.09%), resulting in a lower rate of statin prescribing in low risk women. Diuretic prescribing was higher in the intervention group (WMD 20.59%). Clinical outcomes (HbA1c and blood pressure control) did not differ between groups. CONCLUSIONS: The multifaceted implementation proved to be effective to increase the CR assessment and to improve prescription, but ineffective to improve diabetes and hypertension related outcomes. In order to obtain real improvements when cardiovascular issues are tackled, perhaps other or additional interventions need to be implemented besides education of professionals. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN 88876909 (retrospectively registered on January 13, 2009).

Desprescripción de tratamientos de larga duración con bisfosfonatos para la osteoporosis en atención primaria en el País Vasco / Deprescribing long-term treatments with bisphosphonates for osteoporosis in primary care in the Basque Country (Spain)

Objetivo: Evaluar el impacto de una intervención multifactorial para promover la desprescripción de tratamientos con bisfosfonatos de duración superior a 5 años (BF5a) en la Comarca Gipuzkoa y compararlo con la intervención estándar en el resto de las organizaciones de servicios (OS) de Osakidetza. Métodos: Estudio de evaluación del impacto de dos intervenciones con medida de resultados antes y después, con un seguimiento de 8 meses. Se incluyeron todos los pacientes de Osakidetza que en julio de 2013 tenían un tratamiento activo con BF5a (prescripción electrónica). La intervención estándar (9 OS) consistió en el envío de un documento de consenso sobre desprescripción de BF5a y en facilitar los identificadores de pacientes con BF5a para su revisión por el médico de atención primaria. La intervención multifactorial (Comarca Gipuzkoa) incluyó, además, un consenso local con los especialistas de referencia y sesiones de formación en los centros de salud. Resultados: Se incluyeron 18.725 pacientes, el 94,7% mujeres. Con la intervención estándar, los porcentajes de desprescripción oscilaron entre el 26,4% (C. Bilbao) y el 49,4% (C. Araba), siendo del 37,2% en su conjunto. Con la intervención multifactorial la desprescripción fue del 44,6%, un 7,4% superior a la estándar (p <0,0001; intervalo de confianza del 95% [IC95%]: 5,4-9,4). Los desplazamientos a otros tratamientos fueron menos frecuentes con la intervención multifactorial, con una diferencia del 3,7% (p <0.0001; IC95%: −2,2 a −5,2). Conclusiones: Las intervenciones estándar y multifactorial son muy efectivas para disminuir los tratamientos innecesarios con bisfosfonatos. La intervención multifactorial es más efectiva que la estándar, aunque más compleja de llevar a cabo (AU)

Objective: To evaluate the impact of a multifactorial intervention to promote bisphosphonate deprescription after over 5 years of use (BF5y) in a health care organisation (HCO) in Gipuzkoa (Spain) and to compare it with the standard intervention in other HCOs in the Basque Health Service-Osakidetza. Methods: An 8-month follow-up study (results from before and after) to assess the impact of two interventions. All patients from Osakidetza receiving BF5y treatment (electronic prescription) in July 2013 were included. The standard intervention (9 HCOs) consisted of mailing a consensus statement on BF5y deprescribing and facilitating patient identifiers with BF5y prescription for review by the primary care physician. The multifactorial intervention (Gipuzkoa) also included a local consensus with leading specialists and training sessions in health centres. Results: 18,725 patients were included; 94.7% were women. Standard intervention deprescribing rates ranged from 26.4% (Bilbao) to 49.4% (Araba), being 37.2% overall. The multifactorial intervention deprescribing rate was 44.6%, 7.4% (p <0.0001; 95% confidence interval [95%CI]: 5.4-9.4) higher than standard intervention. Changes to other treatments were less common with the multifactorial intervention, with a difference of 3.7% (p <0.0001; 95%CI: −2.2 to −5.2). Conclusions: Standard and multifactorial interventions are very effective in reducing unnecessary treatments with bisphosphonates. The multifactorial intervention is more effective than the standard one, although more complex to implement (AU)

[Deprescribing long-term treatments with bisphosphonates for osteoporosis in primary care in the Basque Country (Spain)]. / Desprescripción de tratamientos de larga duración con bisfosfonatos para la osteoporosis en atención primaria en el País Vasco.

OBJECTIVE: To evaluate the impact of a multifactorial intervention to promote bisphosphonate deprescription after over 5 years of use (BF5y) in a health care organisation (HCO) in Gipuzkoa (Spain) and to compare it with the standard intervention in other HCOs in the Basque Health Service-Osakidetza. METHODS: An 8-month follow-up study (results from before and after) to assess the impact of two interventions. All patients from Osakidetza receiving BF5y treatment (electronic prescription) in July 2013 were included. The standard intervention (9 HCOs) consisted of mailing a consensus statement on BF5y deprescribing and facilitating patient identifiers with BF5y prescription for review by the primary care physician. The multifactorial intervention (Gipuzkoa) also included a local consensus with leading specialists and training sessions in health centres. RESULTS: 18,725 patients were included; 94.7% were women. Standard intervention deprescribing rates ranged from 26.4% (Bilbao) to 49.4% (Araba), being 37.2% overall. The multifactorial intervention deprescribing rate was 44.6%, 7.4% (p <0.0001; 95% confidence interval [95%CI]: 5.4-9.4) higher than standard intervention. Changes to other treatments were less common with the multifactorial intervention, with a difference of 3.7% (p <0.0001; 95%CI: -2.2 to -5.2). CONCLUSIONS: Standard and multifactorial interventions are very effective in reducing unnecessary treatments with bisphosphonates. The multifactorial intervention is more effective than the standard one, although more complex to implement.

The CLUES study: a cluster randomized clinical trial for the evaluation of cardiovascular guideline implementation in primary care.

BACKGROUND: The appropriate care for people with cardiovascular risk factors can reduce morbidity and mortality. One strategy for improving the care for these patients involves the implementation of evidence-based guidelines. To date, little research concerning the impact of such implementation strategies in our setting has been published. Aims. To evaluate the effectiveness of a multifaceted tailored intervention in the implementation of three cardiovascular risk-related guidelines (hypertension, type 2 diabetes and dyslipidemia) in primary care in the Basque Health Service compared with usual implementation. METHODS/DESIGN: A two-year cluster randomized clinical trial in primary care in two districts in the Basque Health Service. All primary care units are randomized. Data from all patients with diabetes, hypertension and those susceptible to coronary risk screening will be analyzed.Interventions. The control group will receive standard implementation. The experimental group will receive a multifaceted tailored implementation strategy, including a specific web page and workshops for family physicians and nurses.Endpoints. Primary endpoints: annual request for glycosylated hemoglobin, basic laboratory tests for hypertension, cardiovascular risk screening (women between 45-74 and men between 40-74 years old). Secondary endpoints: other process and clinical guideline indicators. ANALYSIS: Data will be extracted from centralized computerized medical records. ANALYSIS will be performed at a primary care unit level weighted by cluster size. DISCUSSION: The main contribution of our study is that it seeks to identify an effective strategy for cardiovascular guideline implementation in primary care in our setting. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN88876909.