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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.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reinforced multidisciplinary follow-up | Experimental | Entrance medication reconciliation performed by a pharmacist
|
|
| Standard care | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reinforced multidisciplinary follow-up | Other | Reinforced multidisciplinary follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rehospitalisation for heart failure | At least one rehospitalisation with heart failure related cause | Call at 3 months after hospitalisation discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016 | Evaluated by a pharmacist | At hospitalisation discharge (Day 0) |
| Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals | Montpellier | Occitanie | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26259774 | Result | 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. | |
| 27206819 | Result | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Evaluated by a pharmacist |
| Call at 3 months after hospitalisation discharge |
| Compliance level | 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) |
| Compliance level | 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 |
| Compliance level | 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 |
| Treatment persistence rates | Evaluated by a pharmacist | Call at 3 months after hospitalisation discharge |
| Death rate | Evaluated by a pharmacist | Call at 3 months after hospitalisation discharge |
| Time before death | Evaluated by a pharmacist | Call at 3 months after hospitalisation discharge |
| Time of occurrence of a potential rehospitalisation related to the disease | Evaluated by a pharmacist | Call at 3 months after hospitalisation discharge |
| Quality of life score | 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. | Call at 3 months after hospitalisation discharge |
| Satisfaction of the patient | 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) | Call at 3 months after hospitalisation discharge |
| Satisfaction of health professionals | 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) | online questionnaire at 3 months after hospitalisation discharge |
| Incremental cost-effectiveness ratio | 3 months after hospitalisation discharge |
| Result | Available at: https://academic.oup.com/eurheartj/article/37/27/2129/1748921/2016-ESC-Guidelines-for-the-diagnosis-and. (Accessed: 12th September 2017). |
| 28409010 | Result | 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. |
| 28233442 | Result | 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. |
| 17298190 | Result | 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. |
| 28233258 | Result | 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. |
| 28462286 | Result | 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. |
| 24259613 | Result | 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. |
| 24375606 | Result | 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. |