Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service. (MedeA)

Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service. Population Cohort [MedeA21].

An open longitudinal observational study, non-randomized, which will include the adult population, attended by the SES, in which preference will be given to those patients under treatment with drugs that can produce relevant adverse effects. It is a naturalistic study in which no pharmacological or other type of intervention will be carried out, only the information recommended in the drug data sheet (pharmacogenetic biomarkers, relevant interactions and clinical contraindications) will be provided.

Study Overview

• Status: Recruiting
• Conditions: Adverse Drug Event

• Study Type: Observational
• Enrollment (Estimated): 6445

Contacts and Locations

Study Locations

• Spain
  • Badajoz, Spain, 06080
    • Recruiting
    • Complejo Hospitalario Universitario de Badajoz
    • Contact: Adrián LLerena, Doctor; Phone Number: +34 924218040; Email: adrian.llerena@salud-juntaex.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Consecutive sampling is a widely used non-probability sampling that, if performed correctly, can be considered as random sampling. In this case, patients are selected as they come for consultation and as long as they meet the inclusion criteria.

SES patients are eligible for inclusion in the study, so that a minimum of 3000 participants are expected to be included in the study in order to ensure adequate frequency of genetic polymorphisms of pharmacogenetic relevance. During the Deployment Phase of the Prescription Support Program, it is estimated that an additional 4,000 to 8,000 patients will be included, with a target of 0.1% of the population of Extremadura.

Description

Inclusion Criteria:

Patients with a recent diagnosis and who are to be or are being treated according to usual clinical practice, who meet the criteria to participate in the study, read the corresponding information sheet, sign informed consent and agree to participate, provided they meet the following inclusion criteria:

General criteria for all patients:

• Age ≥ 18 years. In case of minors, they may be included, under the following assumptions:
• If the minor is under 12 years of age, participation will require the consent and signature of the informed consent document by both parents (or their guardian).
• If the minor is between 12 and 16 years of age, a proxy informed consent form will be provided and signed by both parents (if both parents are present at the time of the interview) or only one of them (in which case one of the following two conditions must be stated: that the other parent is not present at the time of the interview but does not object to the participation of the minor in the study or that the signatory is the sole legal guardian of the minor).
• Be registered or potentially/have been attended in the Extremadura Health Service.
• Not have language or communication barrier or present disability being totally dependent on another person.

Exclusion Criteria:

• Failure to meet any of the inclusion criteria described above.
• Refusal by the patient to be part of the cohort initially, or to continue to be part of the cohort during follow-up.
• Manifest difficulty for follow-up.

Study Plan

How is the study designed?

Number of groups / cohorts

17

Cohorts and Interventions

Group / Cohort
Lusitania; Primary health care
Celtici; Oncology
Vettonia; Mental health
Turdulia; Internal medicine
Lácara; Nephrology
Tartessos; Neurology
Cancho Roano; Emergencies
Oretania; Cardiology
Carpetania; Rheumatology
Baeturia; Transplants
Endovélico; Infectious
Sirona; Clinical pharmacology
Gaudeamus; University of extremadura
Sucellus; Urology
Mnemosyne; Neurology-Vascular
Paidos; Pediatrics
Turuñuelo; Pneumology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service.	To analyze the implementation in the clinical routine of a pharmacogenetics and personalized medicine program in SES patients, evaluating the overall impact on the health system, and at the individual level, general modifications in the clinical response and its temporal evolution.	December 2024

Collaborators and Investigators

• Sponsor: Complejo Hospitalario Universitario de Badajoz

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: MedeA21.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No