NCT03902028

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
248

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 2, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

2.5 years

First QC Date

March 27, 2019

Last Update Submit

December 31, 2021

Conditions

Heart Failure

Keywords

Heart failurepharmacistmultidisciplinary teamreadmission

Outcome Measures

Primary Outcomes (1)

  • Rehospitalisation for heart failure

    At least one rehospitalisation with heart failure related cause

    Call at 3 months after hospitalisation discharge

Secondary Outcomes (13)

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

    At hospitalisation discharge (Day 0)

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

    Call at 3 months after hospitalisation discharge

  • Compliance level

    At hospitalisation discharge (Day 0)

  • Compliance level

    At 1 month after hospitalisation discharge for the experimental group only

  • Compliance level

    Call at 3 months after hospitalisation discharge

  • +8 more secondary outcomes

Study Arms (2)

Reinforced multidisciplinary follow-up

EXPERIMENTAL

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

Standard care

NO INTERVENTION

* 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

Reinforced multidisciplinary follow-upOTHER

Reinforced multidisciplinary follow-up

Reinforced multidisciplinary follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non autonomous drug management patients and not disposing
  • a present caregiver during hospitalisation
  • Patients living in an institution
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals

Montpellier, Occitanie, 34295, France

RECRUITING

Related Publications (10)

  • 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.

    PMID: 26259774RESULT

  • 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.

    PMID: 27206819RESULT

  • Available at: https://academic.oup.com/eurheartj/article/37/27/2129/1748921/2016-ESC-Guidelines-for-the-diagnosis-and. (Accessed: 12th September 2017).

    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.

    PMID: 28409010RESULT

  • 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.

    PMID: 28233442RESULT

  • 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.

    PMID: 17298190RESULT

  • 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.

    PMID: 28233258RESULT

  • 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.

    PMID: 28462286RESULT

  • 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.

    PMID: 24259613RESULT

  • 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.

    PMID: 24375606RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Audrey CASTET-NICOLAS, MCU-PH, Pharm D, PhD

CONTACT

(0)467338564audrey-castet@chu-montpellier.fr

Nicolas CHAPET, Pharm D, PhD

CONTACT

(0)467338562n-chapet@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2019

First Posted

April 3, 2019

Study Start

August 2, 2019

Primary Completion

February 1, 2022

Study Completion

August 1, 2022

Last Updated

January 4, 2022

Record last verified: 2021-12

Locations

FR(1)