The Impact of Comprehensive Medication Management Services on Clinical Outcomes in Patients With Cardiovascular Diseases at Primary Care Level

Cardiovascular Diseases in Old Age Clinical Trial

Official title:

The Impact of Comprehensive Medication Management Services on Clinical Outcomes in Patients With Cardiovascular Diseases at Primary Care Level

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04778891
• Other study ID #: 380-130/134-20-2
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: January 17, 2021

Study information

• Verified date: February 2021
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: January 17, 2021
• Est. primary completion date: January 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Diseases in Old Age

Intervention

Other:
• Comprehensive Medication Management services
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.

Locations

Country	Name	City	State
Croatia	Health Care Centre Zagreb - Centre	Zagreb
Croatia	University of Zagreb Faculty of Pharmacy and Biochemistry	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
University of Zagreb	Health Centre Zagreb - Centre (Dom zdravlja Zagreb - Centar)

Country where clinical trial is conducted

Croatia, 

References & Publications (6)

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-2 — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The impact of CMM services on blood pressure in elderly patients with established CVD	Within- and between-treatment differences for the intervention and the control group in blood pressure.	1 year
Secondary	The impact of CMM services on LDL cholesterol, triglycerides, HDL cholesterol and total cholesterol in elderly patients with established CVD	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).	1 year
Secondary	The impact of CMM services on health care utilization in elderly patients with established CVD	Between-treatment difference in the number of hospital admissions, emergency department visits and unplanned GPs visits.	1 year
Secondary	The impact of CMM services on drug therapy problems in elderly patients with established CVD	Number and type of drug therapy problems in the intervention group.	1 year
Secondary	The impact of CMM services on health related quality of life in elderly patients with established CVD assessed by EQ-5D-5L instrument.	Change from baseline in health related quality of life assessed by EQ-5D-5L instrument in the intervention group.	1 year
Secondary	The impact of CMM services on glycated haemoglobin in elderly patients with established CVD	Within- and between-treatment differences for the intervention and the control group in glycated haemoglobin.	1 year