Controlled Drug DependenceNCT03388567
Evaluation of the Effectiveness of a Continuing Education Program in Community Pharmacies
A study testing Staff pharmacy whith intervention in people with Controlled Drug Dependence, run by Universidad de Antioquia at 1 site in Colombia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Controlled Drug Dependence
- What is being tested?
- Staff pharmacy whith intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteColombia
- Study dates
- 1 Dec 2018to 31 Dec 2019
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 1. Pharmacy staff who do not agree to participate in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Controlled Drug Dependence
- Being tested
- Staff pharmacy whith intervention
- Keywords
- Dispensation, Health Education, Pharmacovigilance, Pharmacists
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staff pharmacy whith interventionOther
Pharmacists who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist
| Study group | Role | What they receive |
|---|---|---|
| Staff pharmacy whith intervention | Experimental | Staff pharmacy who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist Receives: Other: Staff pharmacy whith intervention |
| Staff pharmacy without intervention | No intervention | Staff pharmacy who will receive only pharmacy information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %)
Measured: 12 months
Secondary outcomes (4)
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 %)
Measured: 2 months
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 %)
Measured: 12 months
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.
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start1 Dec 2018
- Primary completion1 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Controlled Drug DependenceStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- study protocol for a multicenter, cluster-randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Amariles, Universidad de Antioquia
- Investigators
- Pedro Amariles, PhD, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388567
- Sponsor's protocol ID
- 0017102017MC
- Status last verified
- Apr 2020
- First submitted
- 28 Nov 2017
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03388567
- Acronym / sponsor ID
- 0017102017MC
- Conditions
- Controlled Drug Dependence
- Keywords
- Dispensation, Health Education, Pharmacovigilance, Pharmacists
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 Jan 2018 (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.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- study protocol for a multicenter, cluster-randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Staff pharmacy whith intervention | Experimental | Other: Staff pharmacy whith interventionStaff pharmacy who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist |
| Staff pharmacy without intervention | No intervention | –Staff pharmacy who will receive only pharmacy information |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- 1. Pharmacy staff who do not agree to participate in the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Staff pharmacy whith interventionPharmacists 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 |
Primary outcome
Pharmacy staff competences (Pharmacy staff knowledge, skills and attitudes. )
Time frame: 12 months
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 %)
4 secondary outcomes
Characterize the processes associated with the use of medications in the Pharmaceutical Establishments
Time frame: 2 months
Implementation of pharmaceutical professional services
Time frame: 12 months
Satisfaction level pharmacy staff
Time frame: 12 months
Satisfaction level patients
Time frame: 12 months
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 10 Apr 2020.
- Derived from this study: PubMed 32560735Ceballos 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.
- 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.
Pedro Amariles, PhD principal investigator
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staff pharmacy whith intervention in people with Controlled Drug Dependence, run by Universidad de Antioquia at 1 site in Colombia.
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 3 inclusion and 0 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 10 Apr 2020. 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 Colombia. 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?
Pharmacy staff competences (Pharmacy staff knowledge, skills and attitudes. ) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388567, which also lists 1 linked publication.
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 10 Apr 2020.