Evaluation of the Effect of Consensus-based Protocols for the Treatment of Minor Ailments
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient guided and followed by the pharmacist.
- Who it may be relevant to
- Registry conditions: Community Pharmacy Services. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Colombia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effect of Consensus-based Protocols for the Treatment of Minor Ailments in Drugstores and Pharmacies in Medellin and the Metropolitan Area, Colombia: A Randomized Clinical Trial.
Overview
Minor ailments are common, self-limited conditions unrelated to the patient's underlying health problems or adverse effects of their current medications. Minor ailment services are pharmacist-led interventions that provide patients with the most appropriate recommendation when unsure about the medication for a specific minor ailment. It involves advice on nonprescription drugs, non-pharmacological measures, or referral to another health care practitioner. In Colombia, evaluating and implementing this service could optimize nonprescription drugs use and improve minor ailment management in primary health care settings.
Detailed description
A 10-month parallel-group clinical trial will be conducted in drugstores and pharmacies (ambulatory retail establishments) in Medellín and the Metropolitan Area. Patients requesting nonprescription drugs for one of five predefined minor ailments (influenza-like syndrome, common cold, headache, dysmenorrhea, or sore throat) will be eligible. Establishments, randomized by cluster sampling, will be allocated to either the intervention (management using CBPs) or control (standard management + education on responsible self-medication) group. Pharmacy staff will receive training in appropriate CBP use. Eligible patients will be consecutively enrolled and followed-up by the research team on days 3, 5, 7, and 10 after the consultation in both groups. Analyses will be performed using Python, including descriptive statistics, bivariate comparisons (p \< 0.05), and multivariate Cox regression for significant variables. An intention-to-treat approach will address missing data and dropouts.
The aim of this study is to evaluate the effect of Consensus-based Protocols (CBPs) on the management and duration of some MA, and on the referral rate to General medical Practitioner (GPs) in drugstores and pharmacies. Secondary outcomes include: 1) To clinically and socio-demographically characterize the population that visits a drugstore or pharmacy requesting a nonprescription drug to manage a MA, and 2) To assess the management, duration, rate and causes of GP referrals in drugstores and pharmacies with the use of CBPs among patients requesting nonprescription drugs for the management of a potential MA.
Interventions
- Other Patient guided and followed by the pharmacist
The Study Coordinating Group will train the pharmacy Staff regarding these protocols. This training will cover both pharmacological and non-pharmacological aspects of MA management. The pharmacological component will emphasize the appropriate selection and safe use of nonprescription drugs, with a focus on identifying potential drug interactions, contraindications, and moderate and serious ADRs. Pharmacy staff will also be equipped with tools to apply proper criteria for referral to a GP when n
Primary outcome measures
- MA resolution [Time frame: 12 months]
- MA duration [Time frame: 12 months]
- Referral rate to GP [Time frame: 12 months]
Secondary outcome measures (3)
- Characterization of the patient population visiting the drugstores and pharmacies to request nonprescription drugs for the management of a MA [Time frame: 3 months]
- Identification and classification of the MA [Time frame: 12 months]
- Need for a nonprescription drug to treat the MA [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
Drugstores and drugstores/pharmacies:
- Establishments located in Medellin and Metropolitan area
- Establishments that have a Pharmacy Technician serving as the technical director.
- Establishments with electronic point-of-sale system for data collection.
- Commitment to participate for the full 10-month study period.
Participants (patients):
- Explicit consent to participate in the study.
- Are the direct consumers requesting the nonprescription drug (i.e., not requesting them on behalf of someone else).
- Present one of the five predefined potential MA that will be included in the study: influenza-like syndrome and catarrh, headache, common cold, sore throat, and menstrual pain or cramps.
- Have access to mobile phone for follow-upThe person requesting the OTC medication must be the end consumer of it.
Exclusion criteria
- Subjects who refuse to sign the informed consent
- Subjects with an evident incapacity to complete the data questionnaire
- Pregnant or breastfeeding women
- Patients whose MA result from an ADR
- Patients with symptoms lasting more than seven days
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Colombia · 1 center
- Farmacias Pasteur S.A. — Medellín
Identifiers
NCT: NCT06378099 · CBP Colombia