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

26. februar 2021 opdateret af: Iva Mucalo, University of Zagreb
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

133

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

  • Kroatien
      • Zagreb, Kroatien, 10000
        • Health Care Centre Zagreb - Centre
      • Zagreb, Kroatien, 10000
        • University of Zagreb Faculty of Pharmacy and Biochemistry

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år til 80 år (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention group
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.
Andet: 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.
Ingen indgriben: Control group
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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The impact of CMM services on LDL cholesterol, triglycerides, HDL cholesterol and total cholesterol in elderly patients with established CVD
Tidsramme: 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).
1 year
The impact of CMM services on health care utilization in elderly patients with established CVD
Tidsramme: 1 year
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
Tidsramme: 1 year
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.
Tidsramme: 1 year
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
Tidsramme: 1 year
Within- and between-treatment differences for the intervention and the control group in glycated haemoglobin.
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Zagreb

Samarbejdspartnere

Health Centre Zagreb - Centre (Dom zdravlja Zagreb - Centar)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. januar 2018

Primær færdiggørelse (Faktiske)

17. januar 2021

Studieafslutning (Faktiske)

17. januar 2021

Datoer for studieregistrering

Først indsendt

11. februar 2021

Først indsendt, der opfyldte QC-kriterier

26. februar 2021

Først opslået (Faktiske)

3. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 380-130/134-20-2

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