Clinical trial NCT05402254: Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing
Official title: Evaluation of the Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing on Patients and Professionals at Hospital: Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Drug Event
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 395
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: HYPOTHESIS An advanced practice nursing intervention in the area of pharmacovigilance performed on patients and professionals improves the identification and reporting of suspected adverse drug reactions (ADR) and improves the overall experience of hospitalized patients.

Detailed description: PRIMARY OBJETIVES

1. To assess whether an advanced nursing intervention improves the identification and reporting of suspected ADR.

SECONDARY OBJECTIVES

1. To determine if an advanced nursing intervention improves the experience related to the use of medications measured through the QExPac-21 patient experience questionnaire.
2. Identify which factors associated with medications increase the risk of ADRs and the characteristics of the patients.
3. Know the incidence and describe ADRs: severity, preventability, and causality using validated scales.
4. Describe the degree of nursing intervention according to the North American Nursing Diagnosis Association (NANDA) Taxonomy, and the classification of nursing interventions (NIC) Related to drug use.
5. Quantify the number of interconsultation generated by patients and professionals related to the use of drugs.
6. Determine the degree of adherence and compliance with the regimens prescribed to the patients.

STUDY DESIGN Prospective, randomized and controlled study of an intervention that compares a group of patients according to the usual practice of the nursing care process, against another on which a more intensive nursing intervention is carried out for the identification and notification of ADRs. It is carried out on a representative sample of patients admitted to a tertiary level hospital with 860 beds of the Madrid Health Service during the year 2022.

Eligibility criteria: Inclusion Criteria:

1. Patients with pharmacological treatment.
2. Patients of both sexes aged between 0 and 100 years.
3. Patients admitted to medical or surgical hospitalization units or emergency services for at least 24 hours.
4. Patients who have received the information and agreed to participate in the study.

Exclusion Criteria:

1. Patients included in other clinical trials or drug studies at the time of selection.
2. Patients with significant cognitive impairment, without adequate family support or primary caregiver.
3. Patients and/or caregivers who, once offered to participate in the study, do not give their consent
4. Impossibility of communication due to language barriers or other biopsychosocial problems.

Primary outcomes:
measure: Adverse drug event
timeFrame: Seven months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital San Carlos
Study officials:
affiliation: Hospital San Carlos
name: Natalia Rodriguez Galán
role: PRINCIPAL_INVESTIGATOR
References: