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

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ClinicalTrials.gov Identifier: NCT03607097
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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).


Condition or disease Intervention/treatment Phase
Drug Related Problems Pharmaceutical Care Procedure: Secondary prevention program for drug related problems Not Applicable

Detailed Description:
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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 808 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Integral Management of Healthcare Problems Related With Drugs in Polimedicated Patients: Drug Code
Actual Study Start Date : August 28, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: 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
Procedure: 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
Other Name: Medication Code

No Intervention: Usual care (control group)



Primary Outcome Measures :
  1. 30 day readmission [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures :
  1. 30 day consultation [ Time Frame: 30 days ]
    Consultation 30 days after the intervention for any cause to the HSCSP

  2. 30 day mortality [ Time Frame: 30 days ]
    Any cause mortality 30 days after the intervention

  3. Time on Emergency Department [ Time Frame: 72 hours ]
    Time from patient admission to discharge from the emergency department



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607097


Contacts
Contact: Ana M Juanes, PhD +34932919000 ext 1887 ajuanes@santpau.cat
Contact: Jesus Ruiz, PhD +34932919000 ext 1887 jrzrms@gmail.com

Locations
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Ana Juanes         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications:

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03607097     History of Changes
Other Study ID Numbers: IIBSP-COD-2018-25
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
secondary prevention
pharmaceutical care
drug related problems
emergency department