Clinical trial NCT04778891: The Impact of Comprehensive Medication Management Services on Clinical Outcomes in Patients With Cardiovascular Diseases at Primary Care Level
Official title: The Impact of Comprehensive Medication Management Services on Clinical Outcomes in Patients With Cardiovascular Diseases at Primary Care Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases in Old Age
Keywords: medication managements services, pharmaceutical care, primary care, elderly, control group, cardiovascular disease
Lead sponsor: University of Zagreb
Sponsor class: OTHER
Collaborators: name: Health Centre Zagreb - Centre (Dom zdravlja Zagreb - Centar)
First posted: 2021-03-03
Enrollment: 133
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The impact of CMM services on blood pressure in elderly patients with established CVD
timeFrame: 1 year
Secondary outcomes:
measure: The impact of CMM services on LDL cholesterol, triglycerides, HDL cholesterol and total cholesterol in elderly patients with established CVD
timeFrame: 1 year
measure: The impact of CMM services on health care utilization in elderly patients with established CVD
timeFrame: 1 year
measure: The impact of CMM services on drug therapy problems in elderly patients with established CVD
timeFrame: 1 year
measure: The impact of CMM services on health related quality of life in elderly patients with established CVD assessed by EQ-5D-5L instrument.
timeFrame: 1 year
measure: The impact of CMM services on glycated haemoglobin in elderly patients with established CVD
timeFrame: 1 year
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Health Care Centre Zagreb - Centre
city: Zagreb
country: Croatia
facility: University of Zagreb Faculty of Pharmacy and Biochemistry
Study officials:
References:
citation: 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.
citation: 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. doi: 10.2174/1381612043382576.
citation: 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.
citation: 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.
citation: 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.
citation: Brajkovic A, Mucalo I, Vidovic T, Gonzaga MM, Nascimento D, Balenovic 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.