CClinicalTrials.gg
CompletedNCT03902028COMPICUpdated Apr 3, 2026

Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure

An interventional study of Reinforced multidisciplinary follow-up in Heart Failure, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
229
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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.
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Conditions studied

  • Heart Failure

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Keywords

  • Heart failure
  • pharmacist
  • multidisciplinary team
  • readmission
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In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 229 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
229 participants (actual)

Study arms

  • Experimental
    Reinforced multidisciplinary follow-up

    Entrance medication reconciliation performed by a pharmacist * Patient compliance evaluation * Patient quality of life evaluation * Pharmaceutical analysis with focus on medication optimization with a specific check-list (according to ESC 2016 recommendations) * Hospitalisation discharge medication reconciliation * Patient pharmaceutic interview at the hospitalisation discharge * Transmission of informations to the general practitioner and the pharmacist's patient * Multidisciplinary consult at 1 month after hospitalisation discharge

    Other: Reinforced multidisciplinary follow-up

  • No intervention
    Standard care

    * Drug review by a paramedic or a pharmacist * Pharmaceutical analysis * Therapeutic optimisation based on the usual practices care of the cardiologic department * Writing of the prescription given on leaving hospital based on the usual care of the department * Treatments explanations and support to the patient on the usual care * Transmission of the hospitalisation report to the patient general practitioner as the usual practice * Medical consult in usual time frames (an average of 1 month after hospitalisation discharge) at the patient location of choice

Interventions

  • OtherReinforced multidisciplinary follow-up

    Reinforced multidisciplinary follow-up

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What researchers measure

Primary outcomes

  1. Rehospitalisation for heart failure

    At least one rehospitalisation with heart failure related cause

    Time frame: Call at 3 months after hospitalisation discharge

Secondary outcomes

  1. Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016

    Evaluated by a pharmacist

    Time frame: At hospitalisation discharge (Day 0)

  2. Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016

    Evaluated by a pharmacist

    Time frame: Call at 3 months after hospitalisation discharge

  3. 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

    Time frame: At hospitalisation discharge (Day 0)

  4. 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

    Time frame: At 1 month after hospitalisation discharge for the experimental group only

  5. 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

    Time frame: Call at 3 months after hospitalisation discharge

  6. Treatment persistence rates

    Evaluated by a pharmacist

    Time frame: Call at 3 months after hospitalisation discharge

  7. Death rate

    Evaluated by a pharmacist

    Time frame: Call at 3 months after hospitalisation discharge

  8. Time before death

    Evaluated by a pharmacist

    Time frame: Call at 3 months after hospitalisation discharge

  9. Time of occurrence of a potential rehospitalisation related to the disease

    Evaluated by a pharmacist

    Time frame: Call at 3 months after hospitalisation discharge

  10. 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.

    Time frame: Call at 3 months after hospitalisation discharge

  11. 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)

    Time frame: Call at 3 months after hospitalisation discharge

  12. 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)

    Time frame: online questionnaire at 3 months after hospitalisation discharge

  13. Incremental cost-effectiveness ratio

    Time frame: 3 months after hospitalisation discharge

07

Study locations

1 site
  • University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals
    Montpellier, Occitanie 34295, France
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References and documents

Publications

  • 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. PubMed 26259774 ↗
  • 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. PubMed 27206819 ↗
  • 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. PubMed 28409010 ↗
  • 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. PubMed 28233442 ↗
  • 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. PubMed 17298190 ↗
  • 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. PubMed 28233258 ↗
  • 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. PubMed 28462286 ↗
  • 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. PubMed 24259613 ↗
  • 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. PubMed 24375606 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03902028
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Apr 3, 2019
Start date
Aug 2, 2019
Primary completion
Jan 25, 2025
Completion
Jan 25, 2025
Last update
Apr 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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