Evaluation of a pharmaceutical service for managing minor ailments
| ISRCTN | ISRCTN17235323 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17235323 |
| Secondary identifying numbers | IndicaPRO-2016-v1 |
- Submission date
- 15/04/2021
- Registration date
- 07/05/2021
- Last edited
- 24/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
The World Health Organization (WHO) defines the pharmacy practice mission as “contributing to health improvement and helping patients with health problems to make the best use of their medicines”. Minor ailments are “self-limiting conditions which may be diagnosed and managed without a medical intervention”. Traditionally, patients present in community pharmacy for these conditions or alternatively self-select a non-prescription medication. The aim of this study is to evaluate the outcomes of a Minor Ailment Service (MAS) in community pharmacy compared with usual care.
Who can participate?
Patients aged 16 and over (or between 2 and 16 years of age if accompanied by a responsible adult), seeking care (i.e. presenting symptoms or requesting a product) for the following minor ailments: skin problems (cold sore, foot fungi), digestive disturbance (diarrhoea, flatulence, heartburn or vomiting), pain (dysmenorrhea, headache, sore throat) and upper respiratory tract (cough, cold or nasal congestion).
What does the study involve?
MAS is provided through a face-to-face encounter between the pharmacist and the patient, so individual interviews are carried out in the community pharmacy. When patients attend the pharmacy either requesting a direct product request (non-prescription medicine) or presenting symptoms covered in the study they are informed about the study. 10 days after this consultation a researcher phones them at the number provided during the consultation in the pharmacy for an interview about the minor ailment outcomes.
What are the possible benefits and risks of participating?
The benefits are managing the minor ailment consulted with the best recommendation possible for the patient's specific situation. The risks are limited because in case the health problem presented in the pharmacy was out of scope for the pharmacists, patients are referred to the appropriate health professional.
Where is the study run from?
Universidad de Granada (Spain)
When is the study starting and how long is it expected to run for?
January 2017 to June 2018
Who is funding the study?
1. Spanish Society of Community Pharmacy (Spain)
2. Pharmaceutical Association of Valencia (Spain)
Who is the main contact?
Noelia Amador Fernández
namador@sefac.org
Contact information
Scientific
Facultad de Farmacia
Universidad de Granada
Campus de Cartuja s/n
Granada
18071
Spain
 ORCID ID |
0000-0001-8247-1751 |
|---|---|
| Phone | +34 (0)609652555 |
| femartin@ugr.es |
Scientific
C/Valdeabades 13
Estepa (Sevilla)
41560
Spain
| ORCID ID |
0000-0002-6491-1984 |
|---|---|
| Phone | +34 (0)633138434 |
| namador@sefac.org |
Study information
| Study design | Cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | ISRCTN17235323_PIS.pdf |
| Scientific title | INDICA+PRO study: evaluation of a minor ailment service in community pharmacy |
| Study acronym | INDICA+PRO |
| Study hypothesis | A co-designed minor ailment service can lead to better clinical, humanistic and economic outcomes for patients than usual practice. |
| Ethics approval(s) | 1. Approved 20/07/2017, University of Granada Ethics Committee (Gran Vía de Colon 48 2 planta, 18071, Granada, Spain; +34 (0)958 243008; investigacion@ugr.es), ref: 331/CEIH/2017 2. Approved 29/07/2017, Xátiva-Ontinyent Ethics Committee “Lluís Alcanyís” (Hospital Lluís Alcanyís, ctra Xátiva-Alzira km 2, 46800 Xátiva, Spain; +34 (0)962 28 93 00; comitebioetica_dsxo@gva.es), ref: not applicable |
| Condition | Minor ailments: dermatological problems (cold sore, foot fungi), gastrointestinal disturbance (diarrhoea, flatulence, heartburn or vomiting), pain (dysmenorrhea, headache, sore throat), upper respiratory tract (cough, cold or nasal congestion) |
| Intervention | Patients requesting a non-prescription medication (direct product request) or presenting minor ailments receive the Minor Ailment Service (MAS) or usual care (UC) and are followed up by telephone 10 days after the consultation. The pharmacist-patient intervention consists of a standardised consultation on a web-based program using co-developed protocols pharmacists’ training, practice change facilitators and patients’ educational material. |
| Intervention type | Mixed |
| Primary outcome measure | Measured at the pharmacist–patient consultation, completed by the pharmacist: 1. Appropriate medical referral: patient referral by the pharmacist made in accordance with the designed protocols, calculated as the proportion of patients appropriately referred divided by the total number of patients. 2. Modification of direct product request: treatment requested by the patient modified by the pharmacist due to not approved indication of use for the minor ailment, wrong dose, dosage or formulation. The summary of product characteristics determined by the Spanish Agency was used as the standard. |
| Secondary outcome measures | 1. Symptom resolution: relief of symptoms measured using a Likert scale from 1 “not at all” to 5 “completely” at 10-day telephone follow-up with interview conducted by the research group 2. Reconsultation rate for the same minor ailment, whenever the patient had to consult again for the same ailment 3. Health-related quality of life (HRQoL) measured using EuroQol 5D-5L (EQ-VAS) and Utility at pharmacist–patient consultation and at 10-day telephone follow-up 4. Cost-effectiveness: incremental cost-effectiveness ratio (ICER) of the service measured at pharmacist–patient consultation and at 10-day telephone follow-up |
| Overall study start date | 01/01/2017 |
| Overall study end date | 10/06/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 726 |
| Total final enrolment | 808 |
| Participant inclusion criteria | 1. Patients aged ≥16 years or over 2 years of age if they are accompanied by a responsible adult 2. Seeking care i.e. presenting symptoms or requesting a product (direct product request) for minor ailments. The minor ailments considered in the study are: dermatological problems (cold sore, foot fungi), gastrointestinal disturbance (diarrhoea, flatulence, heartburn or vomiting), pain (dysmenorrhea, headache, sore throat) and upper respiratory tract (cough, cold or nasal congestion) |
| Participant exclusion criteria | 1. Patients younger than 16 years old not accompanied by a responsible adult 2. Third person different than the patient consulting in community pharmacy |
| Recruitment start date | 01/12/2017 |
| Recruitment end date | 31/05/2018 |
Locations
Countries of recruitment
- Spain
Study participating centres
46180
Spain
46117
Spain
46183
Spain
46191
Spain
46960
Spain
46360
Spain
46370
Spain
46388
Spain
46940
Spain
46930
Spain
46190
Spain
46530
Spain
46500
Spain
46890
Spain
46860
Spain
46812
Spain
46690
Spain
46830
Spain
46880
Spain
46650
Spain
46850
Spain
46891
Spain
46870
Spain
46842
Spain
46270
Spain
46800
Spain
Sponsor information
Research organisation
Paseo de las Delicias, 31 – Esc. Izq. 4º Dcha
Madrid
28045
Spain
| Phone | +34 (0)91435 48 88 |
|---|---|
| pmolina@sefac.org | |
| Website | https://www.sefac.org/ |
Research organisation
Carrer del Comte de Montornés, 7
Valencia
46003
Spain
| Phone | +34 (0)963 92 20 00 |
|---|---|
| v.colomer.000@micof.es | |
| Website | https://www.micof.es/ |
Funders
Funder type
Research organisation
No information available
No information available
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Further results publications are planned: 1. Clinical and humanistic impact of a minor ailment service in community pharmacy: a cluster randomised controlled trial 2. A cost-utility analysis alongside a cluster-randomised trial evaluating a minor ailment service compared to usual care in community pharmacy |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the main investigator Fernando Martínez Martínez (femartin@ugr.es) or Noelia Amador Fernández (namador@sefac.org). Data shared would be the information recorded at the patient's consultation (Excel file), this data is anonymised. This information is already available and it will be until 5 years after the study ended (31/05/2023). Consent was obtained from patients or responsible adults (when patients were between 2 and 16 years of age). Data was extracted already anonymised from the website used by participant pharmacists to record consultations. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/12/2019 | 04/05/2021 | Yes | No | |
| Participant information sheet | 01/06/2021 | No | Yes | ||
| Protocol file | version v1.0 | 01/01/2017 | 01/06/2021 | No | No |
| Results article | outcome measure data | 25/10/2022 | 26/10/2022 | Yes | No |
| Dataset | 24/06/2024 | No | No | ||
| Results article | Cost utility analysis | 20/11/2024 | 24/06/2024 | Yes | No |
Additional files
- ISRCTN17235323_PIS.pdf
- Uploaded 01/06/2021
- ISRCTN17235323_PROTOCOL_v1.0_01Jan2017.pdf
- Uploaded 01/06/2021
Editorial Notes
24/06/2024: The following changes were made to the trial record:
1. Publication reference added.
2. Link to dataset added.
26/10/2022: Publication reference added.
01/06/2021: The following changes have been made:
1. Uploaded protocol version 1.0, 1 January 2017 (not peer reviewed).
2. The participant information sheet has been uploaded as an additional file.
04/05/2021: Trial's existence confirmed by the University of Granada Ethics Committee and Xátiva-Ontinyent Ethics Committee “Lluís Alcanyís”.
