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

NCT03607097 | Unknown

• 1 other identifier: IIBSP-COD-2018-25
• Study Type: interventional
• Target: 808
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Drug Related Problems; Pharmaceutical Care

Keywords

secondary prevention; pharmaceutical care; drug related problems; emergency department

Outcome Measures

Primary Outcomes (1)

• 30 day readmission

  Readmissions during the 30 days after the intervention in any hospital centre from the "Àrea Integral de Salut Barcelona Dreta" after consulting the Hospital de la Santa Creu i Sant Pau (HSCSP) emergency department.

  30 days

Secondary Outcomes (3)

• 30 day consultation

  30 days

• 30 day mortality

  30 days

• Time on Emergency Department

  72 hours

Study Arms (2)

Secondary prevention of DRPs (medication code) (intervention)

EXPERIMENTAL

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

Procedure: Secondary prevention program for drug related problems

Usual care (control group)

NO INTERVENTION

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

Interventions

Secondary prevention program for drug related problems 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

Also known as: Medication Code

Secondary prevention of DRPs (medication code) (intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• DRP due to autolytic attempt or final phase of life.
• Denied informed consent

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Related Publications (10)

• 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.

  PMID: 25685036 BACKGROUND

• 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.

  PMID: 24091839 BACKGROUND

• 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.

  PMID: 23695594 BACKGROUND

• 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.

  PMID: 12126224 BACKGROUND

• 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.

  PMID: 17194173 BACKGROUND

• 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.

  PMID: 24976987 BACKGROUND

• 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.

  PMID: 25562774 BACKGROUND

• 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.

  PMID: 18413550 BACKGROUND

• 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.

  PMID: 29379953 BACKGROUND

• 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.

  PMID: 36539949 DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana M Juanes, PhD

  Hospital Sante Creu i Sant Pau, Barcelona (Spain)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana M Juanes, PhD

CONTACT

+34932919000; ajuanes@santpau.cat

Jesus Ruiz, PhD

CONTACT

+34932919000; jrzrms@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 31, 2018
• Study Start: August 28, 2018
• Primary Completion: October 30, 2020
• Study Completion: December 31, 2020
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

ES (1)