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

NCT06378099 | Recruiting DMC

• 1 other identifier: CBP Colombia
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Community Pharmacy Services

Keywords

Minor ailments; Minor Ailment Services; Pharmacies; Nonprescription drugs; Pharmacy Technicians; Health education; Self care; Ambulatory care; Community Health Services

Outcome Measures

Primary Outcomes (3)

• MA resolution

  MA resolution will be evaluated using five self-administered questionnaires. These will be administered at baseline (T0) before the intervention, and on days 3 (T3), 5 (T5), 7 (T7), and 10 (T10) after the consultation. MA resolution will be recorded as a binary outcome (yes/no). This outcome is clinically relevant as it will reflect the effectiveness of the intervention with CBPs.

  12 months

• MA duration

  The duration of the MA will be evaluated using five self-administered questionnaires. These will be administered at baseline (T0) before the intervention, and on days 3 (T3), 5 (T5), 7 (T7), and 10 (T10) after the consultation. MA duration will be measured in days from the intervention at the drugstore or pharmacy to complete symptom resolution or if a referral to a GP is needed. This outcome is clinically relevant as it will reflect the effectiveness of the intervention with CBPs.

  12 months

• Referral rate to GP

  Referral rate to GP, both due to symptoms worsening or occurrence of moderate or serious ADRs, will be evaluated using five self-administered questionnaires. These will be administered at baseline (T0) before the intervention, and on days 3 (T3), 5 (T5), 7 (T7), and 10 (T10) after the consultation. Based on patients' responses to follow-up questionnaires, referral to a GP will be recorded as a binary outcome (yes/no), indicating whether a referral occurred due to symptom worsening or suspected moderate or serious ADRs. This measure is relevant for evaluating patient safety and the effectiveness of the intervention with CBPs.

  12 months

Secondary Outcomes (3)

• Characterization of the patient population visiting the drugstores and pharmacies to request nonprescription drugs for the management of a MA

  3 months

• Identification and classification of the MA

  12 months

• Need for a nonprescription drug to treat the MA

  12 months

Study Arms (2)

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

NO INTERVENTION

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

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.

Other: Patient guided and followed by the pharmacist

Interventions

Patient guided and followed by the pharmacist OTHER

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 necessary. The staff will be divided into three groups, and every group will have a minimum of two sessions, each one of 4 hours. Additionally, there will be a practical component where simulations of real situations will be conducted. Throughout the 12-month follow-up and intervention period, one of the researchers will be available to receive phone calls to address doubts and concerns about the Consensus-based Protocols.

Also known as: Use of consensus-based protocols

Intervention Group (management using CBPs)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Antioquia: lead
• Farmacias Pasteur: collaborator

Study Sites (1)

Farmacias Pasteur S.A.

Medellín, Antioquia, 050001, Colombia

RECRUITING

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Andrea Salazar

CONTACT

+573017971909; asalazarospina@gmail.com

Milena Ortiz

CONTACT

+573175007349; milena.ortizr@udea.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of the participants and the pharmacists involved in the care is not possible due to the nature of the intervention.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: An exploratory, clustered randomized controlled clinical trial with a baseline period will be conducted over a 10-month period. During this time, five MA will be analyzed: influenza-like syndrome and catarrh, headache, common cold, sore throat, and menstrual pain or cramps. Drugstores and pharmacies (clusters) will be randomized in a 1:1 ratio to either the intervention group (management using CBPs) or the control group (standard management + education on responsible self-medication).

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: December 4, 2024
• Primary Completion: June 3, 2025
• Study Completion: October 1, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)