Implementation, Integration and Sustainability of a Minor Ailment Service in Usual Practice of Community Pharmacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20,987
- 试验地点
- 2
- 主要终点
- Implementation process of a Minor Ailment Service.
研究概览
简要总结
Self-care and self-medication are commonly the treatments of choice for the management of minor ailments. Minor ailments can be treated through community pharmacy using a Minor Ailment Service (MAS). The INDICA+PRO Impact Study, evaluated the clinical, economic and humanistic impact of a MAS, concluding that community pharmacies could greatly benefit the health system. Thus, the following objectives were defined for the INDICA+PRO implementation study.
The primary objective is to implement a standardised MAS in usual practice in community pharmacy in Spain. The secondary objectives include an evaluation of the clinical and economic outcomes and the role and impact of two different models of change agents. A pragmatic study with an effectiveness-implementation hybrid design type 3 will be undertaken using the Framework for the Implementation of Services in Pharmacy (FISpH). The study will be carried between October 2020 and December 2022. Two type of practice change facilitators FaFa and SEFaFa. Their main function, using the Observe-Plan-Do-Study-Act process, will be to facilitate the implementation through individualised continuous support to providers of the MAS. The depth and breadth of support to pharmacist providers by each type of change agents will vary.
Pharmaceutical Associations (PA) and/or Spanish Society of Community Pharmacy (SEFAC) will invite community pharmacies/pharmacists. Participating pharmacists will need to sign a commitment form. The second study population will consist of patients presenting with minor ailments or requesting a non-prescription medication. Recruitment of patients will be carried out by the pharmacist providers. The inclusion criteria will be: patients or caregivers (aged ≥18 years, or younger if they are accompanied by an adult) presenting with 31 minor ailments, grouped into five categories (respiratory, moderate pain, digestive, dermatological and other) with pre-agreed referral protocols. Other symptoms may be included at the discretion of the pharmacists. The exclusion criteria will be patients who do not provide informed consent.
The patient/pharmacist intervention will consist of a MAS protocol adapted for each symptom. The consultation will be record in an electronic data capture system (SEFAC eXPERT®-) that provides a step-by-step approach with protocols and clinical information embedded.
The FISpH model will be used to guide the implementation of MAS. Two types of change agents, FaFas and SeFaFas, previously trained for 18 hours, will be used to facilitate the implementation. During each of the stages (exploration, preparation, testing and operation, and initial sustainability), strategies will be used by FaFas and SeFaFas to moderate implementation factors. The impact of strategies will be evaluated. Data on pharmacy/pharmacist's provider performance and patient outcomes will be provided to pharmacist, change agents and PA and SEFAC. FaFas and SeFaFas will have a classification system for barriers and facilitators derived from the constructs in the Consolidated Framework for Implementation Research (CFIR). The classification system for implementation strategies consists of an adaptation of the facilitation activities listed by Dogherty et al. These will be documented in an electronic data capture system.
FaFas will train their pharmacists (max. of 25 pharmacies) for 6 hours and subsequently provide at least monthly follow-up.
The research team will provide ongoing feedback and support to the FaFas and SeFaFas through periodically, hold group meetings by video conference between the research group and all the FaFas and SeFaFas. The research group will provide formal reports on the implementation process and patient outcomes. Other forms of communication such as emails, telephone calls or WhatsApp messaging will also be available.
Implementation and patient consultation process and outcome variables will be measured such as reach, fidelity and integration. Outcome service indicators will be clinical, economic and humanistic. A patient follow up will occur at a maximum of 10 days. Continuous variables will be reported using mean and standard deviation, or median and percentiles. Categorical variables will be reported using percentages. T Student's test or the ANOVA test or Kruskal-Wallis. χ2 test, Fisher's exact test or Yate's chi-squared will also be used. To determine the relationship between the dependent and the independent variables, logistic regression models will be performed including the variables with statistical significance in the bivariate model. The level of significance will be set at p <0.05. Machine learning and big data techniques are being considered for predictive modelling.
The research team will only have access to de-identified data of pharmacists and patients. This study protocol has been approved by the Granada Research Ethics Committee on the 5th February 2020.
详细描述
INDICA+PRO Implementation Programme for the Implementation, Integration and Sustainability of a Standardised Minor Ailment Service in Usual Practice in Community Pharmacy
Background The World Health Organization (WHO) stated in 2009 that self-care is one of the essential components for achieving health objectives, as it directs and improves access to the appropriate level of healthcare system and reduces costs. Self-care and self-medication are commonly the treatments of choice for the management of minor ailments. Encouraging self-care promotes the improvement of the public's knowledge and skills to optimise decision-making related to health. Access to quality information at appropriate levels of health literacy is an essential element in the self-care process; and thus, health professionals, particularly community pharmacists, play a fundamental role.
Minor ailments are defined by Faus-Dáder et al. as "a health problem that is non-serious in nature, self-limited and of short duration, which has no relationship with the clinical manifestations of any other health problems suffered by the patient, or with the effects (desired or not) of any medication taken by the individual. Minor ailments do not require a medical diagnosis and respond to or are alleviated by symptomatic treatments".
Minor ailments can be treated through community pharmacy using a Minor Ailment Service (MAS). In Spain MAS was defined in 2019 by the "Pharmaceutical Care in Community Pharmacy Forum" (PC-CPF) as "the professional pharmaceutical service provided when a patient or caregiver visits a community pharmacy consulting a specific health problem and requesting the most appropriate remedy". PC-CPF includes a patient request for a non-prescription drug as part of a MAS. Responding to symptoms presented by patients and dealing with requests for non-prescription medication account for between 9% and 16% of the activity of community pharmacies. However, these activities are not legally classified as MAS.
A previous phase of the INDICA+PRO program, the INDICA+PRO Impact Study, evaluated for the first time in Spain the clinical, economic and humanistic impact of a MAS, concluding that community pharmacies could greatly benefit the health system through a more efficient treatment of minor ailments. In turn, increasing the accessibility of patients to the healthcare system as well as ensuring its future sustainability. Thus, the following objectives were defined for an implementation study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years or younger if they are accompanied by a responsible adult seeking care i.e. presenting symptoms or requesting a product (direct non-prescription product request) for minor ailments included.
- •Patients presenting symptoms or requesting a product for dermatological problems such as acne, bites and stings, cold sore, dermatitis, foot fungi, hyperhidrosis, minor burn, mouth ulcer, rash or soft tissue injury.
- •Patients presenting symptoms or requesting a product for gastrointestinal disturbances such as constipation, diarrhoea, flatulence, heartburn or vomiting.
- •Patients presenting symptoms or requesting a product for pain-related minor ailments such as dental pain, dysmenorrhea, headache, musculoskeletal pain or sore throat.
- •Patients presenting symptoms or requesting a product for upper respiratory tract related ailments such as cold, cough or nasal congestion. Others ailments such as dry eye, haemorrhoids, red eye, sleep problems, stress, temperature, vaginal candidiasis/thrush or varicose veins.
排除标准
- •Patients who do not give consent to participate in the study.
结局指标
主要结局
Implementation process of a Minor Ailment Service.
时间窗: Up to 26 months
Implementation phases: Exploration (number of pharmacists that wish to enrol in the study) Preparation (number of pharmacies that complete the training to provide the Service and record between 1 - 4 consultations per month per pharmacist) Testing (number of pharmacies that record 5 to 10 consultations per month per pharmacist) Implementation (number of pharmacies that perform the MAS on the full number of target patients) Initial sustainability (number of pharmacies that recruit and complete the MAS for the full number of target consultations, 11 or more consultations per month for a further 6 months).
Fidelity of the implementation process of a Minor Ailment Service
时间窗: Up to 26 months
Degree to which the critical components for the provision of the Minor Ailment Service are carried out according to how it was standardised. A fifteen-item questionnaire (fidelity questionnaire) is used by the practice change facilitator to evaluate the degree of fidelity for implementing the service for each pharmacist. Each item of the questionnaire uses a 5-item likert scale from very low fidelity to very high fidelity.
Integration of a Minor Ailment Service
时间窗: Up to 26 months
Degree of incorporation of the service into the usual practice. A self-administered questionnaire (integration questionnaire) is completed by the pharmacist. Each of the fifteen items of the questionnaire uses a 5-item likert scale from completely disagree (service not integrated in usual practice) to completely agree (service integrated in usual practice).
次要结局
- Symptom resolution(Up to 26 months)
- Reconsultation rate for the same minor ailment(Up to 26 months)
- Implementation facilitators(Up to 26 months)
- Appropriate medical referral(Up to 26 months)
- Implementation barriers(Up to 26 months)
- Interventions used during the implementation(Up to 26 months)
- Rate of modification of direct product request(Up to 26 months)
研究者
Noelia Amador Fernández
Project coordinator
Universidad de Granada