EIPhv: Educational Intervention in Pharmacovigilance for Hospital Health Professionals

• Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho (Other)
• Overall Status: Completed
• CT.gov ID: NCT02134587
• Collaborator: (none)
• Enrollment: 203
• Location: 1
• Arm: 1
• Duration (Months): 26.9
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

Spontaneous reports by health professionals generate the signals in pharmacovigilance. However, the passive method has limitations and the most important of them are the underreporting and the poor quality of data, hindering the causality assessment of adverse drug events (ADE). Therefore, the present study aimed to validate an educational intervention (EI) in pharmacovigilance for hospital health professionals, in order to analyze the impact on the knowledge, skill and attitude in ADE reporting.

Investigators proposed a multifaceted EI which will be developed in four meetings with one hour each. The following activities will be carried out: application of a questionnaire to assess the knowledge, skill and attitude before and after EI; lecture; practical class and education material distribution. The answers of questionnaire are going to be analyzed using content analysis technique. The definitions of World Health Organization and the minimum and desired criteria to fill the ADE form, according to the Pan American Health Organization, are going to be considered gold-standard answers. The statistical test of Wilcoxon-Mann Whitney test for paired samples will be applied, in order to assess the impact of educational intervention on behavior of health professionals (ADE reporting).

With the present study, the following hypotheses will be tested:

H0= There is no difference between the numbers of ADE reported (behavior/attitudes) before and after the educational intervention.

H1= The numbers of ADE reported before and after the educational intervention are different.

Condition or Disease	Intervention/Treatment	Phase
Adverse Drug Reaction	Other: Multifaceted educational intervention	N/A

Detailed Description

A quasi-experimental study with health professionals who acted in a general and public hospital of medium complexity with 104 beds will be performed.

Investigators proposed an educational intervention, with the development of lecture and practical class, application of questionnaire before and after EI and the distribution of educational material. Activities will be developed in four meetings of one hour each one.

In the first meeting, questionnaire will be applied, in order to assess knowledge, skills and attitudes in pharmacovigilance prior to EI. The instrument was elaborated based on previous studies. Second meeting will be comprise a lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material, whose content includes the same issues of presentation. In the third meeting, a practical class will be performed to promote a discussion of a fictitious case of adverse drug reaction (ADR), in order to elucidate the correct fill of ADE form. In the fourth meeting, will be repeated the application of questionnaire, in order to assess the impact of EI. With the aim to verify change behavior of health professionals regarding pharmacovigilance activities, the number of ADE reports made prior and after intervention will be compared.

Study Design

• Study Type: Interventional
• Actual Enrollment: 203 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Implementation of a Hospital Pharmacovigilance Service and Comparison of Algorithms for Adverse Drug Reaction Causality Assessment
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Other: Subjects post educational intervention Multifaceted educational intervention in pharmacovigilance

Other: Multifaceted educational intervention; Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance. Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material Distribution of educational material Practical class to explain the correct fill of adverse drug events form Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance.

Outcome Measures

Primary Outcome Measures

1. Absolute Number of ADE Reporting (Change Behavior of Health Professionals) [12 months]

   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.

Secondary Outcome Measures

1. Knowledge (Awareness) Regarding Pharmacovigilance [Two days]

   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.

2. Quality of ADE Reports [Two days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

All health professionals (physicians, pharmacists, nurses, auxiliaries of nurses and pharmacists, as well as the multidisciplinary team - social assistants, physiotherapists, audiologists, nutritionists, psychologists, occupational therapists and administrative officers), with employment link at the hospital under study who agree to participate by signing an informed consent form are going to be enrolled.

Exclusion Criteria:

The exclusion criteria meet professionals who will be on sick leave, vacation, those who will not to be registered to carry out the intervention and those who will refuse to answer the questionnaire, despite to having shown interest in participating in the lecture and practical class.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Estadual Américo Brasiliense	Américo Brasiliense	São Paulo	Brazil	14820-000

Sponsors and Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho

Investigators

• Study Chair: Patricia C Mastroianni, PhD, School of Pharmaceutical Sciences of Unesp
• Principal Investigator: Fabiana R Varallo, Master, School of Pharmaceutical Sciences of Unesp

Study Documents (Full-Text)

None provided.

More Information

Publications

• Biagi C, Montanaro N, Buccellato E, Roberto G, Vaccheri A, Motola D. Underreporting in pharmacovigilance: an intervention for Italian GPs (Emilia-Romagna region). Eur J Clin Pharmacol. 2013 Feb;69(2):237-44. doi: 10.1007/s00228-012-1321-7. Epub 2012 Jun 17.
• Figueiras A, Herdeiro MT, Polónia J, Gestal-Otero JJ. An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial. JAMA. 2006 Sep 6;296(9):1086-93.
• Figueiras A, Tato F, Fontaiñas J, Gestal-Otero JJ. Influence of physicians' attitudes on reporting adverse drug events: a case-control study. Med Care. 1999 Aug;37(8):809-14.
• Gerritsen R, Faddegon H, Dijkers F, van Grootheest K, van Puijenbroek E. Effectiveness of pharmacovigilance training of general practitioners: a retrospective cohort study in the Netherlands comparing two methods. Drug Saf. 2011 Sep 1;34(9):755-62. doi: 10.2165/11592800-000000000-00000.
• Herdeiro MT, Figueiras A, Polónia J, Gestal-Otero JJ. Influence of pharmacists' attitudes on adverse drug reaction reporting : a case-control study in Portugal. Drug Saf. 2006;29(4):331-40.
• Herdeiro MT, Figueiras A, Polónia J, Gestal-Otero JJ. Physicians' attitudes and adverse drug reaction reporting : a case-control study in Portugal. Drug Saf. 2005;28(9):825-33.
• Herdeiro MT, Polónia J, Gestal-Otero JJ, Figueiras A. Improving the reporting of adverse drug reactions: a cluster-randomized trial among pharmacists in Portugal. Drug Saf. 2008;31(4):335-44.
• Herdeiro MT, Ribeiro-Vaz I, Ferreira M, Polónia J, Falcão A, Figueiras A. Workshop- and telephone-based interventions to improve adverse drug reaction reporting: a cluster-randomized trial in Portugal. Drug Saf. 2012 Aug 1;35(8):655-65. doi: 10.2165/11599750-000000000-00000.
• Pedrós C, Vallano A, Cereza G, Mendoza-Aran G, Agustí A, Aguilera C, Danés I, Vidal X, Arnau JM. An intervention to improve spontaneous adverse drug reaction reporting by hospital physicians: a time series analysis in Spain. Drug Saf. 2009;32(1):77-83. doi: 10.2165/00002018-200932010-00007.
• Ribeiro-Vaz I, Herdeiro MT, Polónia J, Figueiras A. Strategies to increase the sensitivity of pharmacovigilance in Portugal. Rev Saude Publica. 2011 Feb;45(1):129-35. Epub 2010 Nov 12. English, Portuguese.

• Responsible Party: Fabiana Rossi Varallo, Clinical pharmacist and PhD student, Universidade Estadual Paulista Júlio de Mesquita Filho
• ClinicalTrials.gov Identifier: NCT02134587
• Other Study ID Numbers: E015/10
• First Posted: May 9, 2014
• Last Update Posted: Aug 20, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Fabiana Rossi Varallo, Clinical pharmacist and PhD student, Universidade Estadual Paulista Júlio de Mesquita Filho: Health knowledge, attitudes, practices.; Adverse drug reaction reporting systems.; Pharmacovigilance. Product Surveillance, Postmarketing.; Drug-related side effects and adverse reactions.
• Additional relevant MeSH terms: Drug-Related Side Effects and Adverse Reactions

Study Results

Participant Flow

Arm/Group Title	Subjects Post Educational Intervention
Arm/Group Description	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.
Period Title: Overall Study
STARTED	203
COMPLETED	173
NOT COMPLETED	30

Baseline Characteristics

Arm/Group Title	Subjects Post Educational Intervention
Arm/Group Description	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 Participants	173
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	30.6 (6.5)
Sex: Female, Male (Count of Participants)
Female	150 86.7%
Male	23 13.3%
Region of Enrollment (participants) [Number]
Brazil	173 100%

Outcome Measures

1. Primary Outcome

Title	Absolute Number of ADE Reporting (Change Behavior of Health Professionals)
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Subjects Post Educational Intervention	Subjects Prior to Educational Intervention
Arm/Group Description	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.	Number of health professionals who had the potential to report adverse drug reaction, before the educational intervention
Measure Participants	173	173
Number [absolute number of adverse drug events]	215	3

2. Secondary Outcome

Title	Knowledge (Awareness) Regarding Pharmacovigilance
Description	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.
Time Frame	Two days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Subjects Post Educational Intervention	Subjects Prior to Educational Intervention
Arm/Group Description	Knowledge of health professionals after 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.	Knowledge of health professionals before the educational intervention regarding pharmacovigilance
Measure Participants	173	173
Median (Full Range) [percentage of right answers]	5.2	2.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Subjects Post Educational Intervention
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.00001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Quality of ADE Reports
Description	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.
Time Frame	Two days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Subjects Post Educational Intervention	Subjects Prior to Educational Intervention
Arm/Group Description	Skills of health professionals in fill correctly the adverse drug events form after 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.	Skills of health professionals in fill correctly the adverse drug events form before educational intervention
Measure Participants	173	173
Median (Full Range) [percent of correctly filled forms]	5.2	3.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Subjects Post Educational Intervention
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	The number of adverse drug events reported by health professionals was followed up after one year of educational intervention.
Arm/Group Title	Subjects Post Educational Intervention
Arm/Group Description	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.
All Cause Mortality
	Subjects Post Educational Intervention
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Subjects Post Educational Intervention
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Subjects Post Educational Intervention
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.