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CompletedNCT03388567Updated Apr 10, 2020

Evaluation of the Effectiveness of a Continuing Education Program in Community Pharmacies

An interventional study of Staff pharmacy whith intervention in Controlled Drug Dependence, sponsored by Universidad de Antioquia. Completed at 1 site in Colombia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-10.

Sponsored by Universidad de Antioquia · Not applicable, Interventional, and Health services research

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Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Controlled Drug Dependence

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Keywords

  • Dispensation
  • Health Education
  • Pharmacovigilance
  • Pharmacists
03

In context

Health Education

483 studies on the registry are indexed under Health Education; 112 are open to participants now.

This study's enrollment of 360 is above the median of 132 across 452 interventional studies indexed under Health Education.

Browse Health Education studies →

Lead sponsor

Universidad de Antioquia is the lead sponsor of 80 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  1. Pharmacy staff working in Pharmacy or Drugstore, located geographically in the city of Medellín and in the Metropolitan Area
  2. That the owner works in the establishment

Inclusion Exclusion:

  1. Pharmacy staff who do not agree to participate in the study
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
360 participants (actual)

Study arms

  • Experimental
    Staff pharmacy whith intervention

    Staff pharmacy who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist

    Other: Staff pharmacy whith intervention

  • No intervention
    Staff pharmacy without intervention

    Staff pharmacy who will receive only pharmacy information

Interventions

  • OtherStaff pharmacy whith intervention

    Pharmacists who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist

06

What researchers measure

Primary outcomes

  1. 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 %)

    Time frame: 12 months

Secondary outcomes

  1. 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 %)

    Time frame: 2 months

  2. 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 %)

    Time frame: 12 months

  3. 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.

    Time frame: 12 months

  4. 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

    Time frame: 12 months

07

Study locations

1 site
  • Universidad de Antioquia
    Medellín, Antioquia 1226, Colombia
08

References and documents

Publications

  • 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. PubMed 32560735 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2018 to primary completion in Dec 2018, 0 months.

Of 292 non-industry interventional studies with no phase under Health Education, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 24. This study's 0 months is below that.

Counting every sponsor, half of 293 studies reached it within 11 months; a quarter within 3 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2017
First posted
Jan 3, 2018
StartActual
Dec 1, 2018
Primary completionActual
Dec 1, 2018
CompletionActual
Dec 31, 2019
Last update
Apr 10, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03388567
Lead sponsor
Universidad de Antioquia
Responsible party
Pedro Amariles (Investigador principal, Universidad de Antioquia) — Principal investigator
First posted
Jan 3, 2018
Start date
Dec 1, 2018
Primary completion
Dec 1, 2018
Completion
Dec 31, 2019
Last update
Apr 10, 2020

Study contacts

Pedro Amariles, PhD
principal investigator · Universidad de Antioquia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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