Implementation of a Minor Ailment Service in Community Pharmacy Practice

NCT05247333 | Completed DMC

• 1 other identifier: IndicaPROImp-2019-v2
• Study Type: interventional
• Target: 20,987
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne; Bites; Burns; Cold; Cold Sore Mouth; Constipation; Cough; Dental Trauma; Dermatitis; Diarrhea; Dry Eye; Dysmenorrhea; Flatulence; Foot Fungal Infection; Hemorrhoids; Headache; Heartburn; Hyperhidrosis; Mouth Ulcer; Musculoskeletal Pain; Nasal Congestion; Rash; Red Eye; Sleep Disorder; Soft Tissue Injuries; Sore Throat; Stress Disorder, Acute; Temperature Regulation Disorder; Vaginal Candidiasis; Varicose Veins; Vomiting

Keywords

Minor ailments

Outcome Measures

Primary Outcomes (3)

• Implementation process of a Minor Ailment Service.

  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).

  Up to 26 months

• Fidelity of the implementation process of a Minor Ailment Service

  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.

  Up to 26 months

• Integration of a Minor Ailment Service

  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).

  Up to 26 months

Secondary Outcomes (7)

• Appropriate medical referral

  Up to 26 months

• Rate of modification of direct product request

  Up to 26 months

• Symptom resolution

  Up to 26 months

• Reconsultation rate for the same minor ailment

  Up to 26 months

• Implementation barriers

  Up to 26 months

Study Arms (1)

Patients presenting with minor ailments or requesting a non-prescription product.

EXPERIMENTAL

Community pharmacists working with agreed protocols with primary care physicians respond to all type of patients presenting with minor ailments or requesting a non-prescription product. Following this consultation, patients are followed up after ten days.

Other: Minor ailment service

Interventions

Minor ailment service OTHER

The service had several components: agreed standard operational procedures between community pharmacists and primary care physicians for 31 minor ailments, IT based consultation protocol and training before and during the study for the pharmacists. Practice change facilitators were used to confirm the fidelity of the intervention.

Patients presenting with minor ailments or requesting a non-prescription product.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who do not give consent to participate in the study.

Sponsors & Collaborators

• Universidad de Granada: lead
• Spanish Society of Community Pharmacy: collaborator
• Pharmaceutical Association, Valencia (MICOF): collaborator
• Pharmaceutical Association, Madrid (Colegio Oficial de Farmacéuticos de Madrid): collaborator
• Pharmaceutical Association, Gipuzkoa (Colegio Oficial de Farmacéuticos de Gipuzkoa): collaborator
• Pharmaceutical Association, Málaga (Colegio Oficial de Farmacéuticos de Málaga): collaborator
• Pharmaceutical Association, Castellón (Colegio Oficial de Farmacéuticos de Castellón): collaborator
• Pharmaceutical Association of Valladolid (Colegio Oficial de Farmacéuticos de Valladolid): collaborator

Study Sites (1)

Spanish Society of Community Pharmacy

Madrid, 28045, Spain

Location

Related Publications (19)

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Related Links

• World Health Organization. Self-care in the context of primary health care report of the regional consultation. Bangkok: World Health Organization; 2009.
• Baos Vicente V, Faus Dáder MJ. Protocolos de indicación farmacéutica y criterios de derivación al médico en síntomas menores. Madrid: Fundación Abbott; 2008.
• Foro de Atención Farmacéutica-Farmacia Comunitaria (Foro AF-FC). Guía práctica para los Servicios Profesionales Farmacéuticos Asistenciales en la Farmacia Comunitaria. Madrid: Consejo General de Colegios Oficiales de Farmacéuticos; 2019.
• Real Decreto 109/. Boletín Oficial del Estado núm. 44, de 19/02/2010.
• Scottish Executive. National Health Service (Scotland) ACT 1978 Health Board additional pharmaceutical services (Minor ailment service) (Scotland) directions. Edinburgh: Scottish Executive; 2006.
• Canadian Pharmacists Association. Summary of pharmacists' expanded scope of practice across Canada. Canada: Canadian Pharmacists' Association; 2014.
• NES Pharmacy. Implementation of the minor ailment service introducing the minor ailment service section 1. Scotland: NHS Education for Scotland; 2017
• NES Pharmacy. Implementation of the minor ailment service section 5 key steps to implementation of MAS. Scotland: NHS Education for Scotland; 2017
• Mary Seacole Research Centre. The Pharmacy First Minor Ailments Scheme in Leicester \[Internet\]. Leicester: Mary Seacole Research Centre; 2011
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MeSH Terms

Conditions

Acne Vulgaris; Bites and Stings; Burns; Common Cold; Constipation; Cough; Dermatitis; Diarrhea; Dry Eye Syndromes; Dysmenorrhea; Flatulence; Hemorrhoids; Headache; Heartburn; Hyperhidrosis; Oral Ulcer; Musculoskeletal Pain; Nasal Obstruction; Exanthema; Sleep Wake Disorders; Soft Tissue Injuries; Pharyngitis; Stress Disorders, Traumatic, Acute; Candidiasis, Vulvovaginal; Varicose Veins; Vomiting

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Lacrimal Apparatus Diseases; Eye Diseases; Menstruation Disturbances; Pathologic Processes; Pelvic Pain; Pain; Neurologic Manifestations; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Sweat Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Muscular Diseases; Musculoskeletal Diseases; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Otorhinolaryngologic Diseases; Nervous System Diseases; Mental Disorders; Pharyngeal Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Officials

• Fernando Martínez-Martínez, PhD

  Pharmaceutical Care Research Group, University of Granada

  PRINCIPAL INVESTIGATOR

• Jesús C Gómez Martínez, PhD

  Spanish Society of Community Pharmacy

  STUDY CHAIR

• Shalom I Benrimoj, PhD

  Pharmaceutical Care Research Group, University of Granada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project coordinator

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: February 18, 2022
• Study Start: October 1, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: October 2020-December 2022
• Access Criteria: Contact principal investigator

Locations

ES (1)