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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04778891
Enrollment
133
Registered
2021-03-03
Start date
2018-01-08
Completion date
2021-01-17
Last updated
2021-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases in Old Age

Keywords

medication managements services, pharmaceutical care, primary care, elderly, control group, cardiovascular disease

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.

Interventions

OTHERComprehensive 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.

Sponsors

Health Centre Zagreb - Centre (Dom zdravlja Zagreb - Centar)
CollaboratorUNKNOWN
University of Zagreb
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The impact of CMM services on blood pressure in elderly patients with established CVD1 yearWithin- and between-treatment differences for the intervention and the control group in blood pressure.

Secondary

MeasureTime frameDescription
The impact of CMM services on LDL cholesterol, triglycerides, HDL cholesterol and total cholesterol in elderly patients with established CVD1 yearWithin- 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 CVD1 yearBetween-treatment difference in the number of hospital admissions, emergency department visits and unplanned GPs visits.
The impact of CMM services on drug therapy problems in elderly patients with established CVD1 yearNumber and type of drug therapy problems in the intervention group.
The impact of CMM services on health related quality of life in elderly patients with established CVD assessed by EQ-5D-5L instrument.1 yearChange 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 CVD1 yearWithin- and between-treatment differences for the intervention and the control group in glycated haemoglobin.

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026