REVISTA CIENTÍFICA Ars Pharmaceutica Ars Pharm. 2011; 52(4) FACULTAD DE FARMACIA. UNIVERSIDAD DE GRANADA. ESPAÑA Editorial Martínez-Martínez F, Faus MJ, Ruiz-López MD. Originales Educación sanitaria en

Please download to get full document.

View again

of 11
All materials on our website are shared by users. If you have any questions about copyright issues, please report us to resolve them. We are always happy to assist you.


Publish on:

Views: 9 | Pages: 11

Extension: PDF | Download: 0

REVISTA CIENTÍFICA Ars Pharmaceutica Ars Pharm. 2011; 52(4) FACULTAD DE FARMACIA. UNIVERSIDAD DE GRANADA. ESPAÑA Editorial Martínez-Martínez F, Faus MJ, Ruiz-López MD. Originales Educación sanitaria en la farmacia comunitaria: estudio controlado en la provincia de Castellón. Castillo-García ML, Martínez-Raga J, López-Castellano AC, Castillo-García E. Perfil antigénico celular de cepas aisladas de Leptospira en León y Chinandega, Nicaragua. Batista N, Arencibia DF, Rosario LA, Jirón W, Duttman Ch. Calidad del sueño y consumo de alcohol en una muestra de estudiantes de 18 a 30 años. Bernabé Muñoz C, García-Corpas JP. Impacto de los cambios realizados en la etapa de multiplicación celular durante la obtención de la Sustancia Sensibilizante de Eritrocitos utilizada en el diagnóstico serológico de la Leptospirosis. Arencibia DF, Batista N, Fernández K, Rosario LA, Parra C, Blaín K, García L. Especial Effect of pharmaceutical intervention on medication adherence and blood pressure control in treated hypertensive patients: Rationale, design and methods of the AFenPA pilot study. Fikri-Benbrahim N, Sabater-Hernández D, Fikri-Benbrahim O, Faus MJ, Martínez-Martínez F, González-Segura Alsina D. Ars Pharmaceutica Effect of pharmaceutical intervention on medication adherence and blood pressure control in treated hypertensive patients: Rationale, design and methods of the AFenPA pilot study. Fikri-Benbrahim N 1, Sabater-Hernández D 1, Fikri-Benbrahim O 2, Faus MJ 1, Martínez-Martínez F 1, González-Segura Alsina D Pharmaceutical Care Research Group of University of Granada (Spain); 2. Nephrology Department. Mancha Centro Hospital Complex. Alcázar de San Juan (Ciudad Real, Spain); 3. Medical Department, Almirall S.A., (Barcelona, Spain). Special Paper Artículo Especial Correspondence: Narjis Fikri Benbrahim. Pharmaceutical Care Research Group. Faculty of Pharmacy. University of Granada. Campus Cartuja s/n Granada Received: Accepted: Competing interests: The authors declare that they have no competing interests. Fundings: The project was partially funded by Almirall S.A. and Roche Diagnostics, S.L. Financial support was provided by Almirall S.A. in the form of an unrestricted grant for a project researcher, Narjis Fikri Benbrahim. Financial support was provided by Roche Diagnostics Laboratories, S.L. through the supply at no cost of half of the blood pressure monitors used in the study and funding of the statistical analysis of the data. ABSTRACT Objective: To assess the effect of a protocol-based pharmacist intervention on blood pressure control and medication adherence among treated hypertensive patients who are users of community pharmacies. Methods: A quasi experimental study design with control group has been designed to compare the effect of pharmaceutical intervention (intervention group) versus the standard healthcare procedure (control group) on blood pressure and medication adherence among hypertensive patients receiving drug therapy in community pharmacies. The patients will be allocated evenly between the two groups (ncontrol = nintervention), with a 6-month follow-up. The pharmaceutical intervention program will comprise three main parts: 1) patient education / information on issues relating to hypertension and medication adherence; 2) self-monitoring of blood pressure; and 3) interaction with the physician through personalized reports when the mean blood pressure values recorded at home exceed the treatment goal according to the clinical condition of the patient. In order to evaluate the effect of the pharmaceutical intervention upon medication adherence and blood pressure, blood pressure recordings will be made in the pharmacy, while percent medication adherence will be established based on pill count in both groups at the start and end of the study. Discussion: To our knowledge, this is the first study in the community pharmacy setting in Spain to evaluate the effectiveness of pharmaceutical intervention in combination with home blood pressure monitoring on blood pressure control. In addition, the pharmaceutical intervention has been designed for inclusion as standard practice in the context of Pharmaceutical Care. KEY WORDS. Hypertension, adherence, community pharmacy services, intervention, home blood pressure monitoring. RESUMEN Objetivo: Evaluar el efecto de una intervención farmacéutica protocolizada sobre el control de la presión arterial y la adherencia al tratamiento farmacológico en pacientes usuarios de farmacias comunitarias. Material y métodos: Estudio cuasi-experimental con grupo control en el que se comparará el efecto de una intervención farmacéutica (grupo intervención) con el proceso de atención habitual (grupo control), sobre la presión arterial y la adherencia al tratamiento de pacientes hipertensos tratados farmacológicamente en farmacias comunitarias. Los pacientes serán distribuidos de 29 Fikri-Benbrahim N, Sabater-Hernández D, Fikri-Benbrahim O, Faus MJ, Martínez-Martínez F, González-Segura Alsina D. forma equitativa en ambos grupos (n control = n intervención) y serán seguido durante 6 meses. El programa de la intervención farmacéutica constará de tres partes fundamentales: 1) educación/ información al paciente sobre aspectos relacionados con la hipertensión y adherencia al tratamiento farmacológico, 2) automonitorización de la presión arterial y, 3) interacción con el médico mediante informes personalizados cuando la media de las cifras de presión arterial realizadas en el domicilio superen el objetivo terapéutico acorde con la situación clínica del paciente. Para evaluar el efecto de la intervención farmacéutica sobre la adherencia terapéutica y la presión arterial se obtendrán medidas de presión arterial en la farmacia y porcentaje de cumplimiento terapéutico mediante recuento de comprimidos en ambos grupos al principio y al final del estudio. Discusión: Según nuestros conocimientos, éste es el primer estudio que se realiza en farmacia comunitaria en España para probar la efectividad de una intervención farmacéutica conjuntamente con la automedida de la presión arterial sobre el control de la presión arterial. Además, la intervención farmacéutica se ha diseñado de forma que pueda integrase como práctica habitual enmarcada dentro de la Atención Farmacéutica. PALABRAS CLAVE: Hipertensión, adherencia, servicios farmacéuticos, intervención, automedida domiciliaria de la presión arterial. BACKGROUND Hypertension is a major public health problem. Its prevention and control are therefore a key objectives for the healthcare system 1, 2. In Spain, the prevalence of hypertension in the general population is estimated to be 35%, affecting a total of 10 million people throughout the country. Specifically, 40% of these patients are middle aged, and 60% are over 60 years old 3. Drug treatment for lowering blood pressure (BP) has been shown to significantly reduce the risk of ischemic stroke by 31-45%, and the risk of myocardial infarction by 8-23% 4. However, despite the availability of effective antihypertensive drugs, the control of high BP is far from optimum in this country, since less than 50% of all hypertensive patients are controlled 3. Difficulties in accessing the healthcare services, nonadherence, inadequate practice organization and physician practice patterns are some of the causes related to the lack of BP control 5, 6. In order to solve these problems, the World Health Organization, the International Society of Hypertension and other societies (American Society of Hypertension, European Society of Hypertension, and Canadian Hypertension Society) recommend the development of strategies involving the implication and participation of all those healthcare professionals that attend such patients 7-9. Community pharmacists are the most accessible healthcare professionals in Spain. In addition, as a result of their specific training, they are the ideal professionals for advising patients on proper drug use. These reasons justify the integration of community pharmacists in the multidisciplinary healthcare team setting, where they should play an active role in the follow-up of hypertensive patients with a view to enhancing compliance, reducing adverse events and improving blood pressure control 10. In this regard, the healthcare activities inherent to pharmacists, set within the concept of Pharmaceutical Care 11-13, could be a good option to be taken into account for improving BP control and medication adherence. Specifically, a number of studies have shown that BP control can be improved when the pharmacist is involved in monitoring patient s BP, offers advice on home blood pressure monitoring (HBPM), provides information on the disease, promotes changes in lifestyle and habits, encourages medication adherence and/or provides recommendations on the pharmacotherapeutic adjustments considered appropriate, in collaboration with the physician 5, In a recent systematic review of interventions used to improve control of BP in hypertensive patients 25, the authors discussed the need to implement protocols for hypertensive patient follow-up, and advocated for the promotion of HBPM and for appointment reminders as part of the strategy to improve BP control. Moreover, the authors concluded that pharmacist-led care requires further evaluation. Three systematic reviews recently published, whose objective were to evaluate the impact of pharmacists interventions in the management of hypertensive patients 14-16, highlighted that the studies carried out in a community pharmacy setting are scarce and have limitations that should be solved. Firstly, only one study 17 used a reliable method to measure antihypertensive medication adherence. Secondly, only two studies 6,26 integrated HBPM as a part of 30 Effect of pharmaceutical intervention on medication adherence and blood pressure control in treated hypertensive patients the community pharmacist intervention. Moreover, these studies presented a number of limitations such as: shorttime period of follow-up (3 months), lack of a control group or didn t show the proportion of patients with controlled hypertension at the end of the study. As it is well known, HBPM may increase patients involvement in their care, also increasing medication adherence and improving blood pressure control Furthermore, community pharmacists can play an important role in the implementation of HBPM in daily practice 29, Therefore new studies are needed in a community pharmacy setting to draw conclusive data on the benefits of pharmacist intervention in the control of BP and antihypertensive medication adherence. With the purpose of improving the quality of the research published to date, this study protocol is aimed at providing detailed information on the development of the AFenPA pilot study, specifically, as regards: study design, calculation of the sample size, operational definition of the variables, and operating procedures with a detailed definition of the pharmaceutical intervention or statistical data analysis, amongst others. Hypothesis: Pharmacist intervention together with HBPM can improve BP control and medication adherence as compared to routine practice in the pharmacy. Study aims and objectives: To assess the effect of a protocol-based pharmacist intervention on: 1) the control of hypertension; 2) reduction of systolic and/or diastolic BP; and 3) medication adherence among treated hypertensive patients who are users of community pharmacies. METHODS Study design. A quasi experimental study design with control group has been designed to compare the effect of pharmaceutical intervention (intervention group) versus the usual care procedure in community pharmacies (control group) upon BP and medication adherence. Each patient will be followed for 6 months. Study Setting. Community pharmacies of the provinces of Jaén and Granada (Spain). Community pharmacists eligibility criteria. Community pharmacists that meet all the following criteria will be eligible to participate in the AFenPA study: Pharmacists with previous research experience. Pharmacists whose pharmacies have a private counselling area where patients will be shielded from the public eye and ear, and Pharmacists able to carry out a follow-up phase for patients during at least six months. Recruitment of community pharmacists. Community pharmacists will be identified through the local professional pharmacy associations of Jaén and Granada, which will contact pharmacists of their provinces to inform them about the project. Pharmacists who agree to participate will sign the appropriate commitment document and will be instructed on hypertension, medication adherence and the development of the project. In order to minimize the risk of contamination between the intervention and the control group, trainers will emphasize that patients included in the control group should only receive usual care. Subjects. The study population will include hypertensive patients receiving drug therapy. Patient inclusion criteria. Patients of either sex, aged years who visit the pharmacy with a personal prescription for any antihypertensive drug. Patient exclusion criteria. Patients living with other subjects who are taking the same antihypertensive drug(s), pregnant women, patients who during the screening process at the pharmacy show a mean systolic / diastolic BP of 180/110 mmhg, subjects with difficulties for HBPM or where such monitoring is not recommended, patients lacking motivation for self-control, with secondary hypertension, recent cardiovascular events (less than 6 months), renal or liver insufficiency, patients who have started or have switched their antihypertensive treatment within less than one month, subjects already enrolled in a special hypertensive patient program, or subjects used to performing HBPM at least two days a month. Any patient who approaches and declines to participate or eventually abandons the study, will be included in a list in order to carry out a non-responder analysis of patients will regard to socio-demographic and clinical data. Sample size. Sample size determination was based on the difference in the expected percentage of subjects with controlled hypertension between the control group and the intervention group, at the end of the study. The prevalence of controlled hypertension in Spain is 50% 3. It is assumed that the prevalence of controlled hypertension in the control group at the end of the study will not change from baseline (π 1 =0.50) and an increase of 25% in the prevalence of controlled hypertensive patients in the intervention group after the 6 months of follow-up will occur (π 2 =0.75). A comparing two binomial proportion test was applied, using a statistical table for the design of clinical trials 35, considering the following assumptions: type II error 20% (ß = 0.80), 95% significance level (α = 0.05). 31 Fikri-Benbrahim N, Sabater-Hernández D, Fikri-Benbrahim O, Faus MJ, Martínez-Martínez F, González-Segura Alsina D. The contemplated sample size thus included 58 patients in each group (116 in total). To this number we added 20% (24 patients) to make up for possible losses during the study. The final total number of subjects (n=140) will be equally distributed among the 18 participating pharmacists (approximately 10 subjects per pharmacist). The decision to assign 10 patients per pharmacist was based on the experience of other authors, who suggest working with patients as a reasonable number for conducting patient healthcare activities at the pharmacy 36. Trial population and recruitment. Patient screening will be performed on a consecutive basis as the patients visit the pharmacy to receive their antihypertensive drug. Due to the existence of drugs being prescribed either for hypertension or heart failure, the pharmacist will consult the patient s medical report in order to check the therapeutic indication. This personal medical report includes information such as: reason of medical consultation, medical diagnosis, medical tests performed, pharmacological treatments applied and non-pharmacological advice. If the patient does not have a medical record, the pharmacist will contact the physician in order to inquire about therapeutic indication on the drugs prescribed. The pharmacists will identify patients consecutively until they have recruited 10 subjects. The recruitment stage will be fixed at a maximum of one month. Patient inclusion is contingent on their acceptance to participate in the study and the study s inclusion criteria. The assignment method will consist of a coin toss to determine the group assignment of the first recruited patient per pharmacist. This will be done in each pharmacy. As the aim is to divide the patients evenly between the two groups (n control = n intervention ), the assignment of the first patient will determine the group of subsequent patients into the intervention or control groups (for example, control/intervention/control/intervention, etc.). This process will be continued until there are10 subjects per pharmacist. The assignment method will only be known to the study coordinator at the beginning of the study. To minimize the risk of selection bias, after visits 1, 2 and 3 (initial phase, see figure 1) the participating pharmacist will contact the study coordinators to determine the assignment of the patient to the control or intervention group. The pharmacist will contact the coordinators as each patient is included in the study to ascertain their group assignment. The assignment details were revealed to patients as well as study pharmacists only after the completion of baseline data collection. 1.Variables related to the study objectives: primary outcome variables. BP at the pharmacy. It will be monitored in two different 32 periods: at the start and end of the study (figure 1). In each period, BP will be recorded on three visits scheduled in the same timeline of the day. The time period for the three visits to the pharmacy will cover three weeks. On each visit three BP measurements will be made spaced 2-3 minutes apart, on the control arm (the arm where BP is highest). All pharmacists will use the same clinically validated Visomat Comfort 20/40 monitor (UEBE Medical GmbH, Wertheim, Germany) 37. The pharmacists were previously instructed on how to monitor BP adequately according to international guidelines 38 : 5 minutes at rest, back supported with feet flat on the floor, proper cuff size at heart level, refrain from drinking coffee or tea, smoking or exercise at least 30 minutes prior to measurement. Depending on the objective, BP values will be used in their original form (objective 2) or BP will be transformed on a dichotomic basis: controlled / uncontrolled (objective 1). Mean BP and heart rate in the pharmacy will be calculated, rejecting the measurements obtained on the first day and the first measurement of the next two days. BP control will be defined as systolic BP under 140 mmhg and diastolic BP under 90 mmhg. Medication adherence. It will be recorded in two different periods: at the start and end of the study (figure 1), based on manual pill count of antihypertensive tablets. This method is an objective and reliable method to assess and investigate adherence to drug therapy in clinical practice A count will be made at the start and end, spaced one month apart. On occasion of the initial count, the date, total number of tablets in the possession of the patient, and number of tablets retrieved with the new prescriptions, if any, will be recorded. After days, the patient will be asked to return the drug packs with the complete blisters (consumed or otherwise), and the tablets will be counted (those missing being taken to have been consumed). From this point, calculation will be made of the total number of tablets apparently consumed by subtra
Related Search
Similar documents
View more...
We Need Your Support
Thank you for visiting our website and your interest in our free products and services. We are nonprofit website to share and download documents. To the running of this website, we need your help to support us.

Thanks to everyone for your continued support.

No, Thanks