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

February 12, 2020 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

808

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital de La Santa Creu i Sant Pau
        • Contact:
          • Ana Juanes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Medication Code
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 day consultation
Time Frame: 30 days
Consultation 30 days after the intervention for any cause to the HSCSP
30 days
30 day mortality
Time Frame: 30 days
Any cause mortality 30 days after the intervention
30 days
Time on Emergency Department
Time Frame: 72 hours
Time from patient admission to discharge from the emergency department
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Ana M Juanes, PhD, Hospital Sante Creu i Sant Pau, Barcelona (Spain)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2018

Primary Completion (Anticipated)

October 30, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

July 20, 2018

First Submitted That Met QC Criteria

July 30, 2018

First Posted (Actual)

July 31, 2018

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIBSP-COD-2018-25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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