Adverse Drug EventIMPACTONCT05402254
Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing
A study testing Pharmacovigilance Program in people with Adverse Drug Event, run by Natalia Rodriguez Galan at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adverse Drug Event
- What is being tested?
- Pharmacovigilance Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with pharmacological treatment.
- Patients of both sexes aged between 0 and 100 years.
- Patients admitted to medical or surgical hospitalization units or emergency services for at least 24 hours.
- Patients who have received the information and agreed to participate in the study.
Who cannot join
- Patients included in other clinical trials or drug studies at the time of selection.
- Patients with significant cognitive impairment, without adequate family support or primary caregiver.
- Patients and/or caregivers who, once offered to participate in the study, do not give their consent
- Impossibility of communication due to language barriers or other biopsychosocial problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing on Patients and Professionals at Hospital: Intervention Study
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.
Read the detailed description
PRIMARY OBJETIVES
- To assess whether an advanced nursing intervention improves the identification and reporting of suspected ADR.
SECONDARY OBJECTIVES
- To determine if an advanced nursing intervention improves the experience related to the use of medications measured through the QExPac-21 patient experience questionnaire.
- Identify which factors associated with medications increase the risk of ADRs and the characteristics of the patients.
- Know the incidence and describe ADRs: severity, preventability, and causality using validated scales.
- 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.
- Quantify the number of interconsultation generated by patients and professionals related to the use of drugs.
- 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.
- Conditions
- Adverse Drug Event
- Being tested
- Pharmacovigilance Program
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacovigilance ProgramOther
Knowledge of the risks in the use of the drug, identification and notification of ADE
| Study group | Role | What they receive |
|---|---|---|
| Pharmacovigilance Program | Experimental | Intensive nursing intervention is carried out for the identification and notification of ADE Receives: Other: Pharmacovigilance Program |
| Control | No intervention | The Usual practice of the nursing care process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse drug event
Number of identified adverse drug event
Measured: Seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 May 2022
- Primary completion1 Nov 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Drug EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natalia Rodriguez Galan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Natalia Rodriguez Galan, Hospital San Carlos, Madrid
- Investigators
- Natalia Rodriguez Galán, Principal investigator, Hospital San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402254
- Sponsor's protocol ID
- EI-FC-2022-03
- Acronym
- IMPACTO
- Status last verified
- Oct 2024
- First submitted
- 23 May 2022
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing on Patients and Professionals at Hospital: Intervention Study
- ClinicalTrials.gov ID
- NCT05402254
- Acronym / sponsor ID
- IMPACTO / EI-FC-2022-03
- Conditions
- Adverse Drug Event
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Natalia Rodriguez GalanUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To assess whether an advanced nursing intervention improves the identification and reporting of suspected ADR.
SECONDARY OBJECTIVES
- To determine if an advanced nursing intervention improves the experience related to the use of medications measured through the QExPac-21 patient experience questionnaire.
- Identify which factors associated with medications increase the risk of ADRs and the characteristics of the patients.
- Know the incidence and describe ADRs: severity, preventability, and causality using validated scales.
- 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.
- Quantify the number of interconsultation generated by patients and professionals related to the use of drugs.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacovigilance Program | Experimental | Other: Pharmacovigilance ProgramIntensive nursing intervention is carried out for the identification and notification of ADE |
| Control | No intervention | –The Usual practice of the nursing care process |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with pharmacological treatment.
- Patients of both sexes aged between 0 and 100 years.
- Patients admitted to medical or surgical hospitalization units or emergency services for at least 24 hours.
- Patients who have received the information and agreed to participate in the study.
Key exclusion criteria (4 listed)
- Patients included in other clinical trials or drug studies at the time of selection.
- Patients with significant cognitive impairment, without adequate family support or primary caregiver.
- Patients and/or caregivers who, once offered to participate in the study, do not give their consent
- Impossibility of communication due to language barriers or other biopsychosocial problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacovigilance ProgramKnowledge of the risks in the use of the drug, identification and notification of ADE | Other | Pharmacovigilance Program |
Primary outcome
Adverse drug event
Time frame: Seven months
Number of identified adverse drug event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Rodriguez Galán principal investigator
Hospital San Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacovigilance Program in people with Adverse Drug Event, run by Natalia Rodriguez Galan at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse drug event (time frame: Seven months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.