Implementation of a Minor Ailment Service in Community Pharmacy Practice

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

Interventions

OTHER

Minor ailment service

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.

Sponsors & Collaborators

• Spanish Society of Community Pharmacy

  collaborator UNKNOWN

• Pharmaceutical Association, Valencia (MICOF)

  collaborator UNKNOWN

• Pharmaceutical Association, Madrid (Colegio Oficial de Farmacéuticos de Madrid)

  collaborator UNKNOWN

• Pharmaceutical Association, Gipuzkoa (Colegio Oficial de Farmacéuticos de Gipuzkoa)

  collaborator UNKNOWN

• Pharmaceutical Association, Málaga (Colegio Oficial de Farmacéuticos de Málaga)

  collaborator UNKNOWN

• Pharmaceutical Association, Castellón (Colegio Oficial de Farmacéuticos de Castellón)

  collaborator UNKNOWN

• Pharmaceutical Association of Valladolid (Colegio Oficial de Farmacéuticos de Valladolid)

  collaborator UNKNOWN

• Universidad de Granada

  lead OTHER

Principal Investigators

• Fernando Martínez-Martínez, PhD · Pharmaceutical Care Research Group, University of Granada

• Jesús C Gómez Martínez, PhD · Spanish Society of Community Pharmacy

• Shalom I Benrimoj, PhD · Pharmaceutical Care Research Group, University of Granada

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-01

Primary Completion

2023-09-30

Completion

2023-09-30

Countries

• Spain

Study Locations