The Impact of Comprehensive Medication Management Services on Clinical Outcomes in Patients With Cardiovascular Diseases at Primary Care Level
2021年2月26日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
133
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Zagreb、クロアチア、10000
- Health Care Centre Zagreb - Centre
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Zagreb、クロアチア、10000
- University of Zagreb Faculty of Pharmacy and Biochemistry
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
65年～80年 (高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The impact of CMM services on blood pressure in elderly patients with established CVD
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The impact of CMM services on LDL cholesterol, triglycerides, HDL cholesterol and total cholesterol in elderly patients with established CVD
時間枠：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
時間枠：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
時間枠：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.
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年1月8日
一次修了 (実際)
2021年1月17日
研究の完了 (実際)
2021年1月17日
試験登録日
最初に提出
2021年2月11日
QC基準を満たした最初の提出物
2021年2月26日
最初の投稿 (実際)
2021年3月3日
学習記録の更新
投稿された最後の更新 (実際)
2021年3月3日
QC基準を満たした最後の更新が送信されました
2021年2月26日
最終確認日
2021年2月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 380-130/134-20-2
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
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