The Impact of Comprehensive Medication Management Services on Clinical Outcomes in Patients With Cardiovascular Diseases at Primary Care Level
26 février 2021 mis à jour par: Iva Mucalo, University of Zagreb
Patients with established cardiovascular disease (CVD) often have multiple medications that increase the risk of prevalence of drug therapy problems (DTP), subsequently leading to unfavourable clinical and health outcomes.
By providing Comprehensive Medication Management (CMM) services to patients within a healthcare system, pharmacists assess patients' medication-related needs, identify and prevent DTP, develop individualized care plan for each individual patient and evaluate and monitor outcomes.
Thus, the CMM services delivered at the primary care level in collaboration with general practitioners and other healthcare providers could address this problem and by optimizing therapy improve patients' clinical outcomes and quality of life.
Studies have shown that patients with chronic diseases have the greatest benefit from the CMM services.
The aim of this study is to evaluate the impact of CMM services on clinical and humanistic outcomes in patients with established CVD.
The study will employ prospective, longitudinal, pre- and postintervention study with a 1-year patient follow-up.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
133
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Zagreb, Croatie, 10000
- Health Care Centre Zagreb - Centre
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Zagreb, Croatie, 10000
- University of Zagreb Faculty of Pharmacy and Biochemistry
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans à 80 ans (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Hypertension
- Established cardiovascular disease
Exclusion Criteria:
- Organic, including symptomatic, mental disorders
- Mental and behavioural disorders due to psychoactive substance use
- Schizophrenia, schizotypal and delusional disorders
- Behavioural syndromes associated with physiological disturbances and physical factors
- Disorders of adult personality and behaviour
- Mental retardation
- Disorders of psychological development
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Intervention group
In addition to usual care provided by general practitioner (GP) and other health care providers, a pharmacist-practitioner in collaboration with GPs from the study setting provided CMM services to patients in the intervention group.
Based on the pre-defined inclusion criteria, GPs were selecting patients and referring them to the pharmacist.
The individual consultation with the patient was held at the private counselling area where pharmacist and patient were able to talk face-to-face apart from the other patients.
The initial assessment lasted 60-90 minutes and the follow-up evaluations 30-60 minutes.
Alternatively, patients were followed-up by telephone.
Communication with GPs took place in a written (electronic consultation system Health net.
PRO; e-mail) and, if needed by face-to-face conversation.
Each patient in the intervention group needed to agree to participate in the study by signing an Informed consent form.
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Comprehensive Medication Management services (CMM services) is an evidence-based and patient-centred service which involves an assessment of patient's medications to determine that each medication is appropriate, effective for the medical condition being treated, safe for the patient in the presence of other medications and co-morbidities, and that the patient is able and willing to take the medications as intended.
As all patient care providers need a structured, rational thought process for sound clinical decision retrieval, the Pharmacotherapy Workup was developed and adopted as a systematic problem-solving process.
This process represents the cognitive work taking place in the mind of the practitioner, and is used to identify, resolve, and prevent drug therapy problems (DTP), establish therapy goals, select interventions and evaluate outcomes.
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Aucune intervention: Control group
Patients in the control group received the usual care which includes GP and other health care provider visits.
Data for the patients pertaining to the control group were provided by the 'control' GP and collected parallel with the intervention group.
'Control' GP profile corresponded to the profile of GPs included in the intervention group - the number of years of professional experience in the primary health care less than ten.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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The impact of CMM services on blood pressure in elderly patients with established CVD
Délai: 1 year
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Within- and between-treatment differences for the intervention and the control group in blood pressure.
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1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The impact of CMM services on LDL cholesterol, triglycerides, HDL cholesterol and total cholesterol in elderly patients with established CVD
Délai: 1 year
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Within- and between-treatment differences for the intervention and the control group in LDL cholesterol (mmol/L), triglycerides (mmol/L), HDL cholesterol (mmol/L) and total cholesterol (mmol/L).
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1 year
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The impact of CMM services on health care utilization in elderly patients with established CVD
Délai: 1 year
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Between-treatment difference in the number of hospital admissions, emergency department visits and unplanned GPs visits.
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1 year
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The impact of CMM services on drug therapy problems in elderly patients with established CVD
Délai: 1 year
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Number and type of drug therapy problems in the intervention group.
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1 year
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The impact of CMM services on health related quality of life in elderly patients with established CVD assessed by EQ-5D-5L instrument.
Délai: 1 year
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Change from baseline in health related quality of life assessed by EQ-5D-5L instrument in the intervention group.
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1 year
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The impact of CMM services on glycated haemoglobin in elderly patients with established CVD
Délai: 1 year
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Within- and between-treatment differences for the intervention and the control group in glycated haemoglobin.
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1 year
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Ramalho de Oliveira D, Brummel AR, Miller DB. Medication therapy management: 10 years of experience in a large integrated health care system. J Manag Care Pharm. 2010 Apr;16(3):185-95. doi: 10.18553/jmcp.2010.16.3.185.
- Strand LM, Cipolle RJ, Morley PC, Frakes MJ. The impact of pharmaceutical care practice on the practitioner and the patient in the ambulatory practice setting: twenty-five years of experience. Curr Pharm Des. 2004;10(31):3987-4001. Review.
- Brummel A, Carlson AM. Comprehensive Medication Management and Medication Adherence for Chronic Conditions. J Manag Care Spec Pharm. 2016 Jan;22(1):56-62. doi: 10.18553/jmcp.2016.22.1.56.
- Cranor CW, Bunting BA, Christensen DB. The Asheville Project: long-term clinical and economic outcomes of a community pharmacy diabetes care program. J Am Pharm Assoc (Wash). 2003 Mar-Apr;43(2):173-84. doi: 10.1331/108658003321480713.
- Bunting BA, Smith BH, Sutherland SE. The Asheville Project: clinical and economic outcomes of a community-based long-term medication therapy management program for hypertension and dyslipidemia. J Am Pharm Assoc (2003). 2008 Jan-Feb;48(1):23-31. doi: 10.1331/JAPhA.2008.07140.
- Brajković A, Mucalo I, Vidović T, Gonzaga MM, Nascimento D, Balenović A, Protrka I, De Oliveira DR. Implementation of medication management services at the primary healthcare level - a pilot study. Acta Pharm. 2019 Dec 1;69(4):585-606. doi: 10.2478/acph-2019-0055.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
8 janvier 2018
Achèvement primaire (Réel)
17 janvier 2021
Achèvement de l'étude (Réel)
17 janvier 2021
Dates d'inscription aux études
Première soumission
11 février 2021
Première soumission répondant aux critères de contrôle qualité
26 février 2021
Première publication (Réel)
3 mars 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 mars 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 février 2021
Dernière vérification
1 février 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 380-130/134-20-2
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
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produit fabriqué et exporté des États-Unis.
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