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

Study Overview
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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).

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

Conditions
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Drug Related Problems, Pharmaceutical Care

Intervention / Treatment
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* Procedure: Secondary prevention program for drug related problems


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secondary prevention of DRPs (medication code) (intervention)<br>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<br>* 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<br>* Other names: Medication Code;|
| No Intervention: Usual care (control group)<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug related problems, secondary prevention, pharmaceutical care, emergency department