The Impact of Comprehensive Medication Management Services on Clinical Outcomes in Patients With Cardiovascular Diseases at Primary Care Level
26. februar 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
133
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Zagreb, Kroatia, 10000
- Health Care Centre Zagreb - Centre
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Zagreb, Kroatia, 10000
- University of Zagreb Faculty of Pharmacy and Biochemistry
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
65 år til 80 år (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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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.
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Ingen inngripen: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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The impact of CMM services on blood pressure in elderly patients with established CVD
Tidsramme: 1 year
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Within- and between-treatment differences for the intervention and the control group in blood pressure.
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1 year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The impact of CMM services on LDL cholesterol, triglycerides, HDL cholesterol and total cholesterol in elderly patients with established CVD
Tidsramme: 1 year
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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).
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1 year
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The impact of CMM services on health care utilization in elderly patients with established CVD
Tidsramme: 1 year
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Between-treatment difference in the number of hospital admissions, emergency department visits and unplanned GPs visits.
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1 year
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The impact of CMM services on drug therapy problems in elderly patients with established CVD
Tidsramme: 1 year
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Number and type of drug therapy problems in the intervention group.
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1 year
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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
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Change from baseline in health related quality of life assessed by EQ-5D-5L instrument in the intervention group.
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1 year
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The impact of CMM services on glycated haemoglobin in elderly patients with established CVD
Tidsramme: 1 year
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Within- and between-treatment differences for the intervention and the control group in glycated haemoglobin.
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1 year
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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. doi: 10.18553/jmcp.2010.16.3.185.
- 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.
- 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.
- 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. doi: 10.1331/108658003321480713.
- 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.
- Brajković A, Mucalo I, Vidović T, Gonzaga MM, Nascimento D, Balenović 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-2019-0055.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
8. januar 2018
Primær fullføring (Faktiske)
17. januar 2021
Studiet fullført (Faktiske)
17. januar 2021
Datoer for studieregistrering
Først innsendt
11. februar 2021
Først innsendt som oppfylte QC-kriteriene
26. februar 2021
Først lagt ut (Faktiske)
3. mars 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. mars 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. februar 2021
Sist bekreftet
1. februar 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 380-130/134-20-2
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