Evaluation of the Effect of Consensus-based Protocols for the Treatment of Minor Ailments

Universidad de Antioquia

Status: Enrolling

Conditions: Community Pharmacy Services

Treatments: Other: Patient guided and followed by the pharmacist

Study type: Interventional

Funder types: Other

Identifiers

NCT06378099

CBP Colombia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

Control Group (standard management + education on responsible self-medication)

No Intervention group

Description:

Patients will receive standard management + education on responsible self-medication. This group will have three activities: 1. Voluntary selection of OTC medication, 2. Health education on what responsible self-medication entails, 3. Monitoring for moderate and serious ADRs related to the use of selected nonprescription drugs or worsening symptoms of the MA, with referral to a GP if necessary. For each MA, the Pharmacist will request the patient's signature on Annex 1, proceed with Activity 1, fill in the instrument included in Annex 4, and continue with Activity 2. On days 3, 5, 7, and 10 after the consultation, patients will be contacted via a chatbot or a phone call to answer Annex 5. On days 5 to 6, and 10 to 12, a pharmacist of the research team will review patient responses to evaluate the need for medical referral (Activity 3), if the presence of a moderate or serious ADR or worsening of the symptom is identified (T5-T6, T10-T12).

Intervention Group (management using CBPs)

Experimental group

Description:

Patients will receive management using CBPs. This group will have four activities: 1. Identification and classification of the MA, 2.Referral to a GP if the patient's condition is not classified as an MA, 3. Patient guidance on appropriate pharmacological measures in case an OTC medication is required 4. Monitoring for moderate or serious ADRs related to the use of selected nonprescription drugs or worsening symptoms of the MA, with referral to a GP if necessary. For each MA, the Pharmacist will request the patient's Informed Consent, apply what is described in Activities 1, 2, and 3, and fill in the instrument included in Annex 4. Days 3, 5, 6, 7, 10, and 12 will be followed as described for control group.

Treatment:

Other: Patient guided and followed by the pharmacist