Integral Management of Healthcare Problems Related With Drugs in Polimedicated Patients: Medication Code

NCT ID: NCT03607097

Last Updated: 2020-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

808 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-28

Study Completion Date

2020-12-31

Brief Summary

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Background:

Although Drug- related Problems (DRPs) in polimedicated patients are a major public health problem in western countries and many of them have been considered avoidable, secondary and primary prevention policies have not been systematized, beyond pharmaceutical care programs in certain settings and on specific patients.

Objectives:

The main objective of this study is to evaluate the impact of implementing the Medication Code (CM) on patients who consult the emergency department for a DRP (secondary prevention of DRP). It is also intended to draw conclusions, based on the knowledge obtained in terms of DRP that will allow the establishment of future actions to reduce its prevalence (primary prevention actions).

Method:

A single-centre clinical trial is proposed in which adult patients will be selected to consult the Hospital Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCSP) for a primary or secondary diagnosis of DRP and will be randomised with a 1:1 distribution to be included in the medication code (intervention group) or to receive usual care (control group). The intervention will be evaluated in terms of health outcomes (ED consultations and hospital readmission).

Detailed Description

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A single-centre clinical trial is proposed in which adult patients will be selected to consult the Hospital Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCSP) for a primary or secondary diagnosis of DRP and will be randomised with a 1:1 distribution to be included in the medication code (intervention group) or to receive usual care (control group). The intervention will be evaluated in terms of health outcomes (ED consultations and hospital readmission).

Conditions

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Drug Related Problems Pharmaceutical Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Secondary prevention of DRPs (medication code) (intervention)

The intervention consists of :1)Patient-centred prescription Espaulella-Panicot J model (review model that includes different strategies in a single intervention. It is performed by a multidisciplinary team, and allows them to adapt the pharmacological plan of patients with clinical complexity). 2)strategies to improve medication adherence

Group Type EXPERIMENTAL

Secondary prevention program for drug related problems

Intervention Type PROCEDURE

The interventions consists of three stages: 1) actions aimed at improving the chronic prescription of the patient, 2) actions aimed at improving the therapeutic adherence and 3) actions aimed at improving the assistance healthcare levels coordination

Usual care (control group)

The patient is reviewed according to the standard procedure, consisting only on the review of the medical prescription in the emergency department by the pharmacist assisting the unit

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Secondary prevention program for drug related problems

The interventions consists of three stages: 1) actions aimed at improving the chronic prescription of the patient, 2) actions aimed at improving the therapeutic adherence and 3) actions aimed at improving the assistance healthcare levels coordination

Intervention Type PROCEDURE

Other Intervention Names

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Medication Code

Eligibility Criteria

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Inclusion Criteria

* Age \>= 18 years
* Drug Related Problems (DRP) related to drugs from Anatomical Therapeutic Chemical (ATC) groups A, B and C

Exclusion Criteria

* DRP due to autolytic attempt or final phase of life.
* Denied informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ana M Juanes, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Sante Creu i Sant Pau, Barcelona (Spain)

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Ana M Juanes, PhD

Role: CONTACT

+34932919000 ext. 1887

Jesus Ruiz, PhD

Role: CONTACT

+34932919000 ext. 1887

Facility Contacts

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Ana Juanes

Role: primary

References

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Nivya K, Sri Sai Kiran V, Ragoo N, Jayaprakash B, Sonal Sekhar M. Systemic review on drug related hospital admissions - A pubmed based search. Saudi Pharm J. 2015 Jan;23(1):1-8. doi: 10.1016/j.jsps.2013.05.006. Epub 2013 May 30.

Reference Type BACKGROUND
PMID: 25685036 (View on PubMed)

Baena MI, Fajardo PC, Pintor-Marmol A, Faus MJ, Marin R, Zarzuelo A, Martinez-Olmos J, Martinez-Martinez F. Negative clinical outcomes of medication resulting in emergency department visits. Eur J Clin Pharmacol. 2014 Jan;70(1):79-87. doi: 10.1007/s00228-013-1562-0. Epub 2013 Oct 3.

Reference Type BACKGROUND
PMID: 24091839 (View on PubMed)

Castro I, Guardiola JM, Tuneu L, Sala ML, Faus MJ, Mangues MA. Drug-related visits to the emergency department in a Spanish university hospital. Int J Clin Pharm. 2013 Oct;35(5):727-35. doi: 10.1007/s11096-013-9795-7. Epub 2013 May 22.

Reference Type BACKGROUND
PMID: 23695594 (View on PubMed)

Patel P, Zed PJ. Drug-related visits to the emergency department: how big is the problem? Pharmacotherapy. 2002 Jul;22(7):915-23. doi: 10.1592/phco.22.11.915.33630.

Reference Type BACKGROUND
PMID: 12126224 (View on PubMed)

Queneau P, Bannwarth B, Carpentier F, Guliana JM, Bouget J, Trombert B, Leverve X, Lapostolle F, Borron SW, Adnet F; Association Pedagogique Nationale pour l'Enseignement de la Therapeutique (APNET). Emergency department visits caused by adverse drug events: results of a French survey. Drug Saf. 2007;30(1):81-8. doi: 10.2165/00002018-200730010-00008.

Reference Type BACKGROUND
PMID: 17194173 (View on PubMed)

Wei L, Yang X, Li J, Liu L, Luo H, Zheng Z, Wei Y. Effect of pharmaceutical care on medication adherence and hospital admission in patients with chronic obstructive pulmonary disease (COPD): a randomized controlled study. J Thorac Dis. 2014 Jun;6(6):656-62. doi: 10.3978/j.issn.2072-1439.2014.06.20.

Reference Type BACKGROUND
PMID: 24976987 (View on PubMed)

Obreli-Neto PR, Marusic S, Guidoni CM, Baldoni Ade O, Renovato RD, Pilger D, Cuman RK, Pereira LR. Economic evaluation of a pharmaceutical care program for elderly diabetic and hypertensive patients in primary health care: a 36-month randomized controlled clinical trial. J Manag Care Spec Pharm. 2015 Jan;21(1):66-75. doi: 10.18553/jmcp.2015.21.1.66.

Reference Type BACKGROUND
PMID: 25562774 (View on PubMed)

Koshman SL, Charrois TL, Simpson SH, McAlister FA, Tsuyuki RT. Pharmacist care of patients with heart failure: a systematic review of randomized trials. Arch Intern Med. 2008 Apr 14;168(7):687-94. doi: 10.1001/archinte.168.7.687.

Reference Type BACKGROUND
PMID: 18413550 (View on PubMed)

Ravn-Nielsen LV, Duckert ML, Lund ML, Henriksen JP, Nielsen ML, Eriksen CS, Buck TC, Pottegard A, Hansen MR, Hallas J. Effect of an In-Hospital Multifaceted Clinical Pharmacist Intervention on the Risk of Readmission: A Randomized Clinical Trial. JAMA Intern Med. 2018 Mar 1;178(3):375-382. doi: 10.1001/jamainternmed.2017.8274.

Reference Type BACKGROUND
PMID: 29379953 (View on PubMed)

Juanes A, Ruiz J, Puig M, Blazquez M, Gilabert A, Lopez L, Baena MI, Guiu JM, Antonia Mangues M. The Effect of the Drug-Related Problems Prevention Bundle on Early Readmissions in Patients From the Emergency Department: A Randomized Clinical Trial. Ann Pharmacother. 2023 Sep;57(9):1025-1035. doi: 10.1177/10600280221143237. Epub 2022 Dec 20.

Reference Type DERIVED
PMID: 36539949 (View on PubMed)

Other Identifiers

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IIBSP-COD-2018-25

Identifier Type: -

Identifier Source: org_study_id

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