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

Not Applicable

• Conditions: Pharmaceutical Care; Drug Related Problems
• Interventions: Procedure: Secondary prevention program for drug related problems

• Registration Number: NCT03607097
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-07-31
• Study Start: 2018-08-28
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-13
• Primary Completion: 2020-10-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 808

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Secondary prevention of DRPs (medication code) (intervention)	Secondary prevention program for drug related problems	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

Primary Outcome Measures

Name	Time	Method
30 day readmission	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

Name	Time	Method
Time on Emergency Department	72 hours	Time from patient admission to discharge from the emergency department
30 day consultation	30 days	Consultation 30 days after the intervention for any cause to the HSCSP
30 day mortality	30 days	Any cause mortality 30 days after the intervention

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain