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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- MA resolution
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Blinding of the participants and the pharmacists involved in the care is not possible due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
MA resolution
时间窗: 12 months
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.
MA duration
时间窗: 12 months
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.
Referral rate to GP
时间窗: 12 months
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.
次要结局
- 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)
研究者
Pedro Amariles
Professor
Universidad de Antioquia