Back to resultsEvaluation of the Effectiveness of a Continuing Education Program in Community Pharmacies
Primary Purpose
Controlled Drug Dependence
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Staff pharmacy whith intervention
Sponsored by
About this trial
This is an interventional health services research trial for Controlled Drug Dependence focused on measuring Dispensation, Health Education, Pharmacovigilance, Pharmacists
Eligibility Criteria
Inclusion Criteria:
- Pharmacy staff working in Pharmacy or Drugstore, located geographically in the city of Medellín and in the Metropolitan Area
- That the owner works in the establishment
Inclusion Exclusion:
1. Pharmacy staff who do not agree to participate in the study
Sites / Locations
- Universidad de Antioquia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Staff pharmacy whith intervention
Staff pharmacy without intervention
Arm Description
Staff pharmacy who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist
Staff pharmacy who will receive only pharmacy information
Outcomes
Primary Outcome Measures
Pharmacy staff competences (Pharmacy staff knowledge, skills and attitudes. )
Pharmacy staff knowledge, skills and attitudes.
An adapted and self-designed questionnaire is used from different bibliographical references, among them, the General Level Framework (GLF), as well as the guidelines of the Colombian legislation for pharmacy staff competences. The main areas of competency (competency clusters): which are:
Delivery of patient care
Personal
Problem Solving
Management and Organisation
The assessment rating is on a 4-point scale ranging from rarely, sometimes, usually to consistently:
Rarely: Very rarely meets the standard expected. No logical thought process appears to apply (0-20 %)
Sometimes: Much more haphazard than "usually" (21-50 %)
Usually: Implies standard practice with occasional lapses (51-84 %)
Consistently: Demonstrates the expected standard of practice with very rare lapses (85-100 %)
Secondary Outcome Measures
Characterize the processes associated with the use of medications in the Pharmaceutical Establishments
Recognize basic information of the Pharmaceutical Establishments (PE), to characterize some processes related to the use of controlled drugs (CD), including compliance with the regulations, and determine the level of risk perception and the continuing education needs of the pharmacy staff. An adapted and self-designed questionnaire is used from different bibliographical references.
The assessment rating is on a 4-point scale ranging from rarely, sometimes, usually to consistently:
Rarely: Very rarely meets the standard expected. No logical thought process appears to apply (0-20 %)
Sometimes: Much more haphazard than "usually" (21-50 %)
Usually: Implies standard practice with occasional lapses (51-84 %)
Consistently: Demonstrates the expected standard of practice with very rare lapses (85-100 %)
Implementation of pharmaceutical professional services
Measure the degree of implementation of pharmaceutical professional services: Dispensation, Health Education and Pharmacovigilance services. An adapted and self-designed questionnaire is used from different bibliographical references, among them, the guidelines of the Colombian legislation for the development of pharmaceutical services.
The assessment rating is on a 4-point scale ranging from rarely, sometimes, usually to consistently:
Rarely: Very rarely meets the standard expected. No logical thought process appears to apply (0-20 %)
Sometimes: Much more haphazard than "usually" (21-50 %)
Usually: Implies standard practice with occasional lapses (51-84 %)
Consistently: Demonstrates the expected standard of practice with very rare lapses (85-100 %)
Satisfaction level pharmacy staff
Pharmacy staff satisfaction about the continuing education program. An adapted and self-designed questionnaire is used from different bibliographical references, among them, the General Level Framework (GLF), as well as the guidelines of the Colombian legislation for the development of labor competences from the pharmaceutical services.
A five points scale (5=Excellent, 4=Good, 3=Satisfactory, 2=Needs Improvement, and 1=Unacceptable) will used in the questionnaire.
Satisfaction level patients
Patients satisfaction of pharmacy professional services. An adapted and self-designed questionnaire is used from different bibliographical references.
A five points scale (5=Excellent, 4=Good, 3=Satisfactory, 2=Needs Improvement, and 1=Unacceptable) will used in the questionnaire
Full Information
NCT ID
NCT03388567
First Posted
November 28, 2017
Last Updated
April 8, 2020
Sponsor
Universidad de Antioquia
1. Study Identification
Unique Protocol Identification Number
NCT03388567
Brief Title
Evaluation of the Effectiveness of a Continuing Education Program in Community Pharmacies
Official Title
Evaluation of the Effects of a Drug With Fiscalized Substances Dispensation, Health Education and Pharmacovigilance Continuing Education Program in Community Pharmacies: Study Protocol for a Multicenter, Cluster-randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Antioquia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Preventable failures in the drug chain are related to Drugs Problems Related Use and are associated with medication errors (prescription, dispensing, administration or use by the patient or caregiver), including failures In the Medication Supply System (availability and quality).
The controlled drugs are those that contain substances regulated by international conventions on drug control. They are important in various fields of medicine, such as pain management, obstetric emergencies, mental disorders such as the treatment of substance dependence, psychiatry and neurology. It has been defined as abuse of drugs the improper use of these for non-medical purposes, and associated with the use without medical prescription, which can produce addiction or psychic or physical dependence.
Detailed Description
Experimental study with random assignment of the staff pharmacist of Pharmacies. The staff pharmacists admitted will be followed for 12 months (1 year). The study will make it possible to determine the effect of the continuing education program accompanied by Information and Communication Technologies (ICT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Controlled Drug Dependence
Keywords
Dispensation, Health Education, Pharmacovigilance, Pharmacists
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
study protocol for a multicenter, cluster-randomized controlled trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Staff pharmacy whith intervention
Arm Type
Experimental
Arm Description
Staff pharmacy who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist
Arm Title
Staff pharmacy without intervention
Arm Type
No Intervention
Arm Description
Staff pharmacy who will receive only pharmacy information
Intervention Type
Other
Intervention Name(s)
Staff pharmacy whith intervention
Intervention Description
Pharmacists who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist
Primary Outcome Measure Information:
Title
Pharmacy staff competences (Pharmacy staff knowledge, skills and attitudes. )
Description
Pharmacy staff knowledge, skills and attitudes.
An adapted and self-designed questionnaire is used from different bibliographical references, among them, the General Level Framework (GLF), as well as the guidelines of the Colombian legislation for pharmacy staff competences. The main areas of competency (competency clusters): which are:
Delivery of patient care
Personal
Problem Solving
Management and Organisation
The assessment rating is on a 4-point scale ranging from rarely, sometimes, usually to consistently:
Rarely: Very rarely meets the standard expected. No logical thought process appears to apply (0-20 %)
Sometimes: Much more haphazard than "usually" (21-50 %)
Usually: Implies standard practice with occasional lapses (51-84 %)
Consistently: Demonstrates the expected standard of practice with very rare lapses (85-100 %)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Characterize the processes associated with the use of medications in the Pharmaceutical Establishments
Description
Recognize basic information of the Pharmaceutical Establishments (PE), to characterize some processes related to the use of controlled drugs (CD), including compliance with the regulations, and determine the level of risk perception and the continuing education needs of the pharmacy staff. An adapted and self-designed questionnaire is used from different bibliographical references.
The assessment rating is on a 4-point scale ranging from rarely, sometimes, usually to consistently:
Rarely: Very rarely meets the standard expected. No logical thought process appears to apply (0-20 %)
Sometimes: Much more haphazard than "usually" (21-50 %)
Usually: Implies standard practice with occasional lapses (51-84 %)
Consistently: Demonstrates the expected standard of practice with very rare lapses (85-100 %)
Time Frame
2 months
Title
Implementation of pharmaceutical professional services
Description
Measure the degree of implementation of pharmaceutical professional services: Dispensation, Health Education and Pharmacovigilance services. An adapted and self-designed questionnaire is used from different bibliographical references, among them, the guidelines of the Colombian legislation for the development of pharmaceutical services.
The assessment rating is on a 4-point scale ranging from rarely, sometimes, usually to consistently:
Rarely: Very rarely meets the standard expected. No logical thought process appears to apply (0-20 %)
Sometimes: Much more haphazard than "usually" (21-50 %)
Usually: Implies standard practice with occasional lapses (51-84 %)
Consistently: Demonstrates the expected standard of practice with very rare lapses (85-100 %)
Time Frame
12 months
Title
Satisfaction level pharmacy staff
Description
Pharmacy staff satisfaction about the continuing education program. An adapted and self-designed questionnaire is used from different bibliographical references, among them, the General Level Framework (GLF), as well as the guidelines of the Colombian legislation for the development of labor competences from the pharmaceutical services.
A five points scale (5=Excellent, 4=Good, 3=Satisfactory, 2=Needs Improvement, and 1=Unacceptable) will used in the questionnaire.
Time Frame
12 months
Title
Satisfaction level patients
Description
Patients satisfaction of pharmacy professional services. An adapted and self-designed questionnaire is used from different bibliographical references.
A five points scale (5=Excellent, 4=Good, 3=Satisfactory, 2=Needs Improvement, and 1=Unacceptable) will used in the questionnaire
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pharmacy staff working in Pharmacy or Drugstore, located geographically in the city of Medellín and in the Metropolitan Area
That the owner works in the establishment
Inclusion Exclusion:
1. Pharmacy staff who do not agree to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Amariles, PhD
Organizational Affiliation
Universidad de Antioquia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Antioquia
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
1226
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32560735
Citation
Ceballos M, Salazar-Ospina A, Sabater-Hernandez D, Amariles P. Evaluation of the effects of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in Colombia drugstores and drugstores/pharmacies: study protocol of a multicenter, cluster-randomized controlled trial. Trials. 2020 Jun 19;21(1):545. doi: 10.1186/s13063-020-04481-1.
Results Reference
derived
Learn more about this trial
Evaluation of the Effectiveness of a Continuing Education Program in Community Pharmacies
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