Trial Outcomes & Findings for Educational Intervention in Pharmacovigilance for Hospital Health Professionals (NCT NCT02134587)

Results Overview

Investigators are going to verify the numbers of adverse drug events reported by health professionals which was made 12 months before educational intervention. A follow up across 12 months post-educational intervention also will be performed, in order to identify the number of adverse drug events reported by health professionals. Prevalence of ADE in both periods will be estimated and compared, in order to asses the impact of the intervention on change behavior of health professionals.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

203 participants

Primary outcome timeframe

12 months

Results posted on

2023-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects Post Educational Intervention Multifaceted educational intervention in pharmacovigilance Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance. 2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance.
Overall Study STARTED	203
Overall Study COMPLETED	173
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Subjects Post Educational Intervention Multifaceted educational intervention in pharmacovigilance Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance. 2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance.
Overall Study Did not completed all meetings	30

Baseline Characteristics

Educational Intervention in Pharmacovigilance for Hospital Health Professionals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Post Educational Intervention n=173 Participants Multifaceted educational intervention in pharmacovigilance Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance. 2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance.
Age, Continuous	30.6 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment Brazil	173 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Before educational intervention, health professionals reported only three adverse drug events, related to therapeutic failure. However, after the study, the number of reports rise 70-fold, since subjects reported 165 medication errors, 26 adverse drug reactions, 18 quality deviations, 5 therapeutic failure and one off-label use.

Investigators are going to verify the numbers of adverse drug events reported by health professionals which was made 12 months before educational intervention. A follow up across 12 months post-educational intervention also will be performed, in order to identify the number of adverse drug events reported by health professionals. Prevalence of ADE in both periods will be estimated and compared, in order to asses the impact of the intervention on change behavior of health professionals.

Outcome measures

Outcome measures
Measure	Subjects Post Educational Intervention n=173 Participants Multifaceted educational intervention in pharmacovigilance Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance. 2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance.	Subjects Prior to Educational Intervention n=173 Participants Number of health professionals who had the potential to report adverse drug reaction, before the educational intervention
Absolute Number of ADE Reporting (Change Behavior of Health Professionals)	215 absolute number of adverse drug events	3 absolute number of adverse drug events

SECONDARY outcome

Timeframe: Two days

Population: The subjects were assessed regarding pharmacovigilance´s knowledge prior to educational interventions and after as well, in order to evaluate the effectiveness of the study in aware health professionals to report adverse drug events.

Knowledge assessment will be performed by content analysis of answers obtained from questionnaire, being assigned scores from zero to ten. Definitions related to pharmacovigilance of World Health Organization will be considered gold-standard answers. Scores below five will be classified as unsatisfactory, among five and 7.5 were considered regular and above 7.6 satisfactory on the knowledge acquisition.The questionnaire will be applied in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings. Data will be compared, in order to assess the impact of educational intervention on knowledge of health professionals.

Outcome measures

Outcome measures
Measure	Subjects Post Educational Intervention n=173 Participants Multifaceted educational intervention in pharmacovigilance Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance. 2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance.	Subjects Prior to Educational Intervention n=173 Participants Number of health professionals who had the potential to report adverse drug reaction, before the educational intervention
Knowledge (Awareness) Regarding Pharmacovigilance	5.2 percentage of right answers Interval 0.9 to 9.3	2.3 percentage of right answers Interval 0.0 to 6.6

SECONDARY outcome

Timeframe: Two days

Population: The subjects were assessed regarding pharmacovigilance´s skills prior to educational interventions and after as well, in order to evaluate the effectiveness of the study in contribute on the improvement of the quality of information inserted on the form.

Skills evaluation will be carried out according to the perception of the voluntary regarding the relevance´s degree of the information to be filled in ADE form. Therefore, in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings, subjects will be asked to highlight the fields of ADE form, according to unnecessary, necessary or essential information to be reported. Minimal and desirable criteria to be filled in ADE form preconized by Pan-American Health Organization will be considered gold-standard answers. Scores from zero to ten will be assigned, according to gold-standard answers. Data will be compared, in order to estimate the impact of educational intervention on skills to fill ADE form.

Outcome measures

Outcome measures
Measure	Subjects Post Educational Intervention n=173 Participants Multifaceted educational intervention in pharmacovigilance Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance. 2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance.	Subjects Prior to Educational Intervention n=173 Participants Number of health professionals who had the potential to report adverse drug reaction, before the educational intervention
Quality of ADE Reports	5.2 percent of correctly filled forms Interval 0.0 to 9.2	3.9 percent of correctly filled forms Interval 0.0 to 8.0

Adverse Events

Subjects Post Educational Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Fabiana Rossi Varallo

School of Pharmaceutical Scientes of Universidade Estadual Paulista Júlio de Mesquita Filho, Araraquara, SP (Brazil)

Phone: 5516997629496

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place