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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Diseases in Old Age

Intervention / Treatment
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* Other: Comprehensive Medication Management services


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Other: Comprehensive Medication Management services<br>* 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.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medication managements services, pharmaceutical care, primary care, elderly, control group, cardiovascular disease