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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases in Old Age
• Interventions: Other: Comprehensive Medication Management services

• Registration Number: NCT04778891
• Lead Sponsor: University of Zagreb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Primary Completion: 2021-01-17
• Study Completion: 2021-01-17
• Status Verified: 2021-02
• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-26
• Last Update Submitted: 2021-02-26
• Study First Posted: 2021-03-03
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Comprehensive Medication Management services	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.

Primary Outcome Measures

Name	Time	Method
The impact of CMM services on blood pressure in elderly patients with established CVD	1 year	Within- and between-treatment differences for the intervention and the control group in blood pressure.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Health Care Centre Zagreb - Centre; 🇭🇷 Zagreb, Croatia

University of Zagreb Faculty of Pharmacy and Biochemistry; 🇭🇷 Zagreb, Croatia