Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure (COMPIC)
2021年12月31日 更新者：University Hospital, Montpellier
Interest of an Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure: Controlled, Randomized, Multicentric Study
This is a controlled, randomized, open-label, multicentric study evaluating the value of coordinated medico-pharmaceutical management compared to standard management in patients with heart failure.
The aim of this study is to evaluate the impact of these optimized activities on the re-hospitalization of the patient with cardiac insufficiency for a disease-related event within three months of the initial hospitalization.
調査の概要
詳細な説明
Heart failure (FH) is a public health problem with an estimated prevalence of about 1.5% in developed countries. In 2013, the number of patients hospitalized in France for heart failure amounted to 165 231 and 20% of them were re-hospitalized at least once for the same reason during this year. Several factors contribute to the occurrence of cardiac decompensation (DC) : some modifiable (age, severity of IC, etiology ...) and others modifiable, such as therapeutics. Various elements could reduce the frequency of re-hospitalizations and the mortality due to this disease :
- a better knowledge of treatments by patients and consequently a better therapeutic compliance
- a better knowledge of the factors and signs of DC (low-sodium diet, weighing...)
- a better implementation of prescribing recommendations : less than 50% of patients have optimal treatment compared to ESC recommendations
- a better communication at the transition points of the patient pathway. The creation of a binomial cardiologist-clinical pharmacist during hospitalization and the maintenance of this optimized multidisciplinary follow-up within 3 months post-hospitalization is a proposal to intervene on these factors. Indeed, the clinical pharmacist (present in the care unit) works in collaboration with the medical and paramedical teams and can improve the care of patients. In the experimental group, a specific multidisciplinary consultation is planned for one month after the end of the hospitalization. A 3-month follow-up visit will be carried out by phone call to meet the criteria for readmission, mortality, quality of life, adherence and persistence of treatments.
研究の種類
介入
入学 (予想される)
248
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。
研究連絡先
- 名前：Audrey CASTET-NICOLAS, MCU-PH, Pharm D, PhD
- 電話番号：+33 (0)467338564
- メール：audrey-castet@chu-montpellier.fr
研究連絡先のバックアップ
- 名前：Nicolas CHAPET, Pharm D, PhD
- 電話番号：(0)467338562
- メール：n-chapet@chu-montpellier.fr
研究場所
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Occitanie
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Montpellier、Occitanie、フランス、34295
- 募集
- University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals
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コンタクト：
- Audrey CASTET-NICOLAS, MCU-PH, Pharm D, PhD
- 電話番号：(0)467338564
- メール：audrey-castet@chu-montpellier.fr
-
コンタクト：
- Nicolas CHAPET, Pharm D
- 電話番号：(0)467338562
- メール：n-chapet@chu-montpellier.fr
-
-
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
18年歳以上 (大人、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:
- Patient aged more than 18 years
- Adult patient admitted in cardiology department (full hospitalisation or intensive care) for heart failure no matter the type and the stage of the disease
- Person affiliated or beneficiary of a social security system
- Collection of a free, informed, express and written consent
Exclusion Criteria:
- Non autonomous drug management patients and not disposing
- a present caregiver during hospitalisation
- Patients living in an institution
- Person participating in another clinical trial with an exclusion period still ongoing
- Person whose physical and/or psychological health is severely altered, and which, in the opinion of the investigator, may affect the participation's to the study
- Person deprived of his rights, person under tutorship or guardianship
- Refusal to sign the consent
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：他の
- 割り当て：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：Reinforced multidisciplinary follow-up
Entrance medication reconciliation performed by a pharmacist
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Reinforced multidisciplinary follow-up
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介入なし：Standard care
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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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Rehospitalisation for heart failure
時間枠：Call at 3 months after hospitalisation discharge
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At least one rehospitalisation with heart failure related cause
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Call at 3 months after hospitalisation discharge
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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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Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016
時間枠：At hospitalisation discharge (Day 0)
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Evaluated by a pharmacist
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At hospitalisation discharge (Day 0)
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Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016
時間枠：Call at 3 months after hospitalisation discharge
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Evaluated by a pharmacist
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Call at 3 months after hospitalisation discharge
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|
Compliance level
時間枠：At hospitalisation discharge (Day 0)
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Evaluated by the " Girerd medication adherence questionnaire " The " Girerd medication adherence questionnaire " contains 6 questions which answers are " yes " or " no ". The number of " yes " responses permits to evaluate the level of the patient medication adherence as following : 0 yes : good compliance 1 or 2 yes : minor non compliance 3 or more yes : non compliance |
At hospitalisation discharge (Day 0)
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Compliance level
時間枠：At 1 month after hospitalisation discharge for the experimental group only
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Evaluated by the "Girerd medication adherence questionnaire" Evaluated by the " Girerd medication adherence questionnaire " The " Girerd medication adherence questionnaire " contains 6 questions which answers are " yes " or " no ". The number of " yes " responses permits to evaluate the level of the patient medication adherence as following : 0 yes : good compliance 1 or 2 yes : minor non compliance 3 or more yes : non compliance |
At 1 month after hospitalisation discharge for the experimental group only
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Compliance level
時間枠：Call at 3 months after hospitalisation discharge
|
Evaluated by the "Girerd medication adherence questionnaire" Evaluated by the " Girerd medication adherence questionnaire " The " Girerd medication adherence questionnaire " contains 6 questions which answers are " yes " or " no ". The number of " yes " responses permits to evaluate the level of the patient medication adherence as following : 0 yes : good compliance 1 or 2 yes : minor non compliance 3 or more yes : non compliance |
Call at 3 months after hospitalisation discharge
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Treatment persistence rates
時間枠：Call at 3 months after hospitalisation discharge
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Evaluated by a pharmacist
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Call at 3 months after hospitalisation discharge
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Death rate
時間枠：Call at 3 months after hospitalisation discharge
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Evaluated by a pharmacist
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Call at 3 months after hospitalisation discharge
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Time before death
時間枠：Call at 3 months after hospitalisation discharge
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Evaluated by a pharmacist
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Call at 3 months after hospitalisation discharge
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Time of occurrence of a potential rehospitalisation related to the disease
時間枠：Call at 3 months after hospitalisation discharge
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Evaluated by a pharmacist
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Call at 3 months after hospitalisation discharge
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Quality of life score
時間枠：Call at 3 months after hospitalisation discharge
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Evaluated by the Minnesota Living with Heart Failure Questionnaire the Minnesota Living with Heart Failure Questionnaire contains 21 questions.
Each of the 21 questions ask the patients to indicate how much a possible effect of heart failure have affected their ability to live as wanted during the past month using a scale from 0 (not present or no effect), 1 (very little), 2, 3, 4, or 5 (very much).The measurement of heart failure severity is assessed by summing the responses that ranges from 0 to 105.
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Call at 3 months after hospitalisation discharge
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Satisfaction of the patient
時間枠：Call at 3 months after hospitalisation discharge
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Evaluated by Likert scale This questionnaire indicates the degree of patient satisfaction using 9 questions which explore the improvement of patient behavior concerning disease and treatment.
The measurement of satisfaction is assessed by summing the responses that range from 9 (unsatisfied) to 36 (very satisfied)
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Call at 3 months after hospitalisation discharge
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Satisfaction of health professionals
時間枠：online questionnaire at 3 months after hospitalisation discharge
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Evaluated by Likert scale (only for interventional arm) This questionnaire indicates the degree of health professional satisfaction using 6 questions which explore the improvement of transition between hospital to community and comprehension of therapeutic optimization.
The measurement of satisfaction is assessed by summing the responses that range from 6 (unsatisfied) to 24 (very satisfied)
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online questionnaire at 3 months after hospitalisation discharge
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Incremental cost-effectiveness ratio
時間枠：3 months after hospitalisation discharge
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3 months after hospitalisation discharge
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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
- Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available. Erratum In: Eur Heart J. 2016 Dec 30;:
- Jackevicius CA, de Leon NK, Lu L, Chang DS, Warner AL, Mody FV. Impact of a Multidisciplinary Heart Failure Post-hospitalization Program on Heart Failure Readmission Rates. Ann Pharmacother. 2015 Nov;49(11):1189-96. doi: 10.1177/1060028015599637. Epub 2015 Aug 10.
- Available at: https://academic.oup.com/eurheartj/article/37/27/2129/1748921/2016-ESC-Guidelines-for-the-diagnosis-and. (Accessed: 12th September 2017).
- Masters J, Morton G, Anton I, Szymanski J, Greenwood E, Grogono J, Flett AS, Cleland JG, Cowburn PJ. Specialist intervention is associated with improved patient outcomes in patients with decompensated heart failure: evaluation of the impact of a multidisciplinary inpatient heart failure team. Open Heart. 2017 Mar 8;4(1):e000547. doi: 10.1136/openhrt-2016-000547. eCollection 2017.
- Van Spall HGC, Rahman T, Mytton O, Ramasundarahettige C, Ibrahim Q, Kabali C, Coppens M, Brian Haynes R, Connolly S. Comparative effectiveness of transitional care services in patients discharged from the hospital with heart failure: a systematic review and network meta-analysis. Eur J Heart Fail. 2017 Nov;19(11):1427-1443. doi: 10.1002/ejhf.765. Epub 2017 Feb 24.
- Lopez Cabezas C, Falces Salvador C, Cubi Quadrada D, Arnau Bartes A, Ylla Bore M, Muro Perea N, Homs Peipoch E. Randomized clinical trial of a postdischarge pharmaceutical care program vs regular follow-up in patients with heart failure. Farm Hosp. 2006 Nov-Dec;30(6):328-42. doi: 10.1016/s1130-6343(06)74004-1. English, Spanish.
- Parajuli DR, Franzon J, McKinnon RA, Shakib S, Clark RA. Role of the Pharmacist for Improving Self-care and Outcomes in Heart Failure. Curr Heart Fail Rep. 2017 Apr;14(2):78-86. doi: 10.1007/s11897-017-0323-2.
- Wan TTH, Terry A, Cobb E, McKee B, Tregerman R, Barbaro SDS. Strategies to Modify the Risk of Heart Failure Readmission: A Systematic Review and Meta-Analysis. Health Serv Res Manag Epidemiol. 2017 Apr 18;4:2333392817701050. doi: 10.1177/2333392817701050. eCollection 2017 Jan-Dec.
- Buckley MS, Harinstein LM, Clark KB, Smithburger PL, Eckhardt DJ, Alexander E, Devabhakthuni S, Westley CA, David B, Kane-Gill SL. Impact of a clinical pharmacy admission medication reconciliation program on medication errors in "high-risk" patients. Ann Pharmacother. 2013 Dec;47(12):1599-610. doi: 10.1177/1060028013507428. Epub 2013 Oct 15.
- Warden BA, Freels JP, Furuno JP, Mackay J. Pharmacy-managed program for providing education and discharge instructions for patients with heart failure. Am J Health Syst Pharm. 2014 Jan 15;71(2):134-9. doi: 10.2146/ajhp130103.
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)
2019年8月2日
一次修了 (予想される)
2022年2月1日
研究の完了 (予想される)
2022年8月1日
試験登録日
最初に提出
2019年3月27日
QC基準を満たした最初の提出物
2019年4月1日
最初の投稿 (実際)
2019年4月3日
学習記録の更新
投稿された最後の更新 (実際)
2022年1月4日
QC基準を満たした最後の更新が送信されました
2021年12月31日
最終確認日
2021年12月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
心不全の臨床試験
-
Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)
Reinforced multidisciplinary follow-upの臨床試験
-
University of WashingtonNational Institute on Aging (NIA); Kaiser Permanente完了