Pharmaceutical ServicesEACPharModelNCT03338725
Effect and Associated Factors of the Clinical Pharmacy Model in the Incidence of Medical Errors
A study testing Clinical pharmacy model in people with Pharmaceutical Services and Medication Errors, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Medication errors are considered by WHO to be a subject that requires attention at all levels of care, in order to reduce the serious and preventable damage related to medication. These strategies are aimed at the patient's safety policy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pharmaceutical Services, Medication Errors, Drug-Related Side Effects and Adverse Reactions
- What is being tested?
- Clinical pharmacy model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteColombia
- Study dates
- 1 Feb 2018to 10 Nov 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To be hospitalized in the Hospital Pablo Tobón Uribe a minimum of 24 hours.
- Patient with at least 5 drugs in their pharmacological therapy
Who cannot join
- Patients with only surgical procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect and Associated Factors of the Clinical Pharmacy Model in the Incidence of Medical Errors in the Hospital Pablo Tobon Uribe- Colombia
Medication errors are considered by WHO to be a subject that requires attention at all levels of care, in order to reduce the serious and preventable damage related to medication.
These strategies are aimed at the patient's safety policy. In Colombia, at the regulatory level there is no standardized clinical pharmacy model where the role of the clinical pharmacist is described extensively and in detail, and in addition, data are unknown of the scope or direct effect of the incorporation of this model in the assistance in the results of health care.
The Hospital Pablo Tobón Uribe, it is a highly complex institution in Medellin (Colombia), certified by Join Comission International (JCI), which requires the continuous interaction of the pharmacist in patient care, in order to avoid medication errors and contribute to patient safety indicators. In this sense, the hospital structured and implemented a clinical pharmacy model that establishes the activities of the pharmacist incorporated into the care team in the patient attention. Today this model is applied in the institution, however, it is necessary to know the effect of its application in the solution of drug-related problems (DRPs) or a negative outcome related to medicine. The objective of this study is to know the effect on patient safety of a clinical pharmacy model in a hospital of high complexity and framed in the WHO initiative to reduce these errors of medication.
Read the detailed description
A randomized controlled clinical trial of stepped wedge will be performed. Patients will be admitted according to the inclusion criteria. Randomization will be done at the cluster level (group) and the result measured in the participants within the cluster.
- Conditions
- Pharmaceutical Services, Medication Errors, Drug-Related Side Effects and Adverse Reactions, Outcome Assessment (Health Care)
- Being tested
- Clinical pharmacy model
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical pharmacy modelOther
Patients who are being monitored by a clinical pharmacy model
| Study group | Role | What they receive |
|---|---|---|
| Patients without intervention | Active comparator | Patients without follow-up by clinical pharmacy model Receives: Other: Clinical pharmacy model |
| Patients with intervention | Experimental | Patients who are being monitored by a clinical pharmacy model Receives: Other: Clinical pharmacy model |
What is being measured
The primary outcome is the main question the study is designed to answer.
The probability of developing medication errors over a certain period of time and recommendations to avoid such errors.
Identify and analyze the types of medication errors
Measured: 2 months
Secondary outcomes (4)
Problems related with the pharmacotherapy
Identify, quantify and classify problems related with the pharmacotherapy:
If any prescription in a patient have at least on of: Incorrect dosage, Incorrect frequency, Incorrect route of administration, Incorrect duration of therapy, drug not indicated, Contraindicated drug, Lack of treatment, Drug-drug interaction, Drug-food Interaction, Therapeutic duplicity. it is considered as problem related with the pharmacotherapy
According whit the oficial FDA label of each drug.
Measured: 2 months
Factors that contribute to the occurrence of process and outcomes problems
The factors that influence the occurrence of errors will be estimated through logistic regression
Measured: 2 months
To classify according to the clinical severity the results problems detected
To classify according to the clinical severity the results problems detected:
A-Circumstances or incidents that are capable of causing error B-The error occurred but did not reach the patient C-The error reached the patient, but did not cause harm D-The error reached the patient and did not cause damage, but needed follow-up to check it E-The error contributed or caused temporary damage to the patient and required intervention F-The error contributed or caused temporary damage and specified or prolonged hospitalization G-The error contributed or caused permanent damage to the patient H-The error affected the life of the patient I-The error contributed or caused the death of the patient
Measured: 2 months
Estimate adjusted survival distribution curves determined by Cox proportional hazards method, in order to estimate the probability that a subject re-mains free of an error medication and its resolution over the time
Estimate adjusted survival distribution curves determined by Cox proportional hazards method, in order to estimate the probability that a subject re-mains free of an error medication and its resolution over the time
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start1 Feb 2018
- Primary completion30 May 2019
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pharmaceutical ServicesStudies 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
- Sequential
- Model description
- Cluster Randomized Trials and The Stepped Wedge (Cluster Analysis Mesh Terms)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Pablo Tobón Uribe
- Responsible party
- Sponsor
- Investigators
- Johann Granados, Msc, Principal investigator, Hospital Pablo Tobon Uribe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338725
- Sponsor's protocol ID
- 0016052017JG
- Acronym
- EACPharModel
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2017
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Granados J, Amariles P, Botero-Aguirre JP, Ortiz-Cano NA, Valencia-Quintero AF, Salazar-Ospina A. Effect and associated factors of a clinical pharmacy model in the incidence of medication errors in the hospital Pablo Tobon Uribe eacpharmodel study: stepped wedge randomized controlled Trial (NCT03338725). Int J Clin Pharm. 2022 Apr;44(2):439-447. doi: 10.1007/s11096-021-01361-9. Epub 2022 Jan 3.
PubMed 34977994Granados J, Salazar-Ospina A, Botero-Aguirre JP, Valencia-Quintero AF, Ortiz N, Amariles P. Effect and associated factors of a clinical pharmacy model in the incidence of medication errors (EACPharModel) in the Hospital Pablo Tobon Uribe: study protocol for a stepped wedge randomized controlled trial (NCT03338725). Trials. 2020 Jan 6;21(1):26. doi: 10.1186/s13063-019-3945-8.
PubMed 31907009
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Associated Factors of the Clinical Pharmacy Model in the Incidence of Medical Errors in the Hospital Pablo Tobon Uribe- Colombia
- ClinicalTrials.gov ID
- NCT03338725
- Acronym / sponsor ID
- EACPharModel / 0016052017JG
- Conditions
- Pharmaceutical Services, Medication Errors, Drug-Related Side Effects and Adverse Reactions, Outcome Assessment (Health Care)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Collaborators
- Hospital Pablo Tobón Uribe
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 9 Nov 2017 (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.
Medication errors are considered by WHO to be a subject that requires attention at all levels of care, in order to reduce the serious and preventable damage related to medication.
These strategies are aimed at the patient's safety policy. In Colombia, at the regulatory level there is no standardized clinical pharmacy model where the role of the clinical pharmacist is described extensively and in detail, and in addition, data are unknown of the scope or direct effect of the incorporation of this model in the assistance in the results of health care.
The Hospital Pablo Tobón Uribe, it is a highly complex institution in Medellin (Colombia), certified by Join Comission International (JCI), which requires the continuous interaction of the pharmacist in patient care, in order to avoid medication errors and contribute to patient safety indicators. In this sense, the hospital structured and implemented a clinical pharmacy model that establishes the activities of the pharmacist incorporated into the care team in the patient attention. Today this model is applied in the institution, however, it is necessary to know the effect of its application in the solution of drug-related problems (DRPs) or a negative outcome related to medicine. The objective of this study is to know the effect on patient safety of a clinical pharmacy model in a hospital of high complexity and framed in the WHO initiative to reduce these errors of medication.
Detailed description
A randomized controlled clinical trial of stepped wedge will be performed. Patients will be admitted according to the inclusion criteria. Randomization will be done at the cluster level (group) and the result measured in the participants within the cluster.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster Randomized Trials and The Stepped Wedge (Cluster Analysis Mesh Terms)
| Arm | Type | Receives |
|---|---|---|
| Patients without intervention | Active comparator | Other: Clinical pharmacy modelPatients without follow-up by clinical pharmacy model |
| Patients with intervention | Experimental | Other: Clinical pharmacy modelPatients who are being monitored by a clinical pharmacy model |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- To be hospitalized in the Hospital Pablo Tobón Uribe a minimum of 24 hours.
- Patient with at least 5 drugs in their pharmacological therapy
Key exclusion criteria (1 listed)
- Patients with only surgical procedures.
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 |
|---|---|---|
| Clinical pharmacy modelPatients who are being monitored by a clinical pharmacy model | Other | Patients with intervention, Patients without intervention |
Primary outcome
The probability of developing medication errors over a certain period of time and recommendations to avoid such errors.
Time frame: 2 months
Identify and analyze the types of medication errors
4 secondary outcomes
Problems related with the pharmacotherapy
Time frame: 2 months
Factors that contribute to the occurrence of process and outcomes problems
Time frame: 2 months
To classify according to the clinical severity the results problems detected
Time frame: 2 months
Estimate adjusted survival distribution curves determined by Cox proportional hazards method, in order to estimate the probability that a subject re-mains free of an error medication and its resolution over the time
Time frame: 14 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 12 Nov 2020.
- Derived from this study: PubMed 34977994Granados J, Amariles P, Botero-Aguirre JP, Ortiz-Cano NA, Valencia-Quintero AF, Salazar-Ospina A. Effect and associated factors of a clinical pharmacy model in the incidence of medication errors in the hospital Pablo Tobon Uribe eacpharmodel study: stepped wedge randomized controlled Trial (NCT03338725). Int J Clin Pharm. 2022 Apr;44(2):439-447. doi: 10.1007/s11096-021-01361-9. Epub 2022 Jan 3.
- Derived from this study: PubMed 31907009Granados J, Salazar-Ospina A, Botero-Aguirre JP, Valencia-Quintero AF, Ortiz N, Amariles P. Effect and associated factors of a clinical pharmacy model in the incidence of medication errors (EACPharModel) in the Hospital Pablo Tobon Uribe: study protocol for a stepped wedge randomized controlled trial (NCT03338725). Trials. 2020 Jan 6;21(1):26. doi: 10.1186/s13063-019-3945-8.
- 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.
Johann Granados, Msc principal investigator
Hospital Pablo Tobon Uribe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical pharmacy model in people with Pharmaceutical Services and Medication Errors, 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 2 inclusion and 1 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 12 Nov 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?
The probability of developing medication errors over a certain period of time and recommendations to avoid such errors. (time frame: 2 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 NCT03338725, which also lists 2 linked publications.
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 12 Nov 2020.