Impact of Pharmaceutical Intervention in Self-Medication: Focus on Pain Management in Pharmacies

NCT07867301 | Not Yet Recruiting

• 1 other identifier: RESP-IR 2023 BEDHOMME
• Study Type: interventional
• Target: 376
• Locations: 0 countries
• Sites: N/A

Brief Summary

Self-medication is an increasingly common practice that carries risks. When a patient requests self-medication, the community pharmacist intervenes in the identification, prevention and resolution of medication-related problems. Previous work led to the validation of a reporting grid for pharmaceutical interventions and to the creation of a database of several thousand pharmaceutical interventions in self-medication. Thirty per cent of these are associated with a complaint of pain. Recording these interventions and following up on their outcomes, particularly when the community pharmacist is at the limit of their advisory role and referral to another healthcare professional is required, would help promote coordinated practice among primary care professionals and could even inform public health policy. The AUTOMED'IP-DOL study will test the introduction of a liaison form and a brief pharmaceutical follow-up interview for pharmaceutical interventions arising from a spontaneous request in a context of pain and leading to the patient being referred to a consultation with a healthcare professional. The aim is to compare the value of such a practice with usual care in the pharmacy, by assessing patients' pain levels, quality of life and satisfaction.

Conditions

Self-medication for Pain; Limits on Advice From Community Pharmacists and Referral to a Primary Care Practitioner

Keywords

self-medication; pain; community pharmacists' intervention

Outcome Measures

Primary Outcomes (1)

• Change in pain levels between enrollment and five days later, measured on a numerical scale ranging from 0 to 10.

  Zero is equivalent to no pain and 10 indicates the worst possible pain.

  From enrollment to five days later.

Secondary Outcomes (3)

• Change in quality of life between enrolment and five days later (expressed as a percentage), measured using the EQ-5D-5L questionnaire

  From enrollment to five days later

• Waiting time for an appointment with a healthcare professional

  Between enrollment to five days later

• Patient satisfaction, as measured by perceptions of the quality of overall care and satisfaction with the pathway through the care process

  Assessed on the 5th day

Study Arms (2)

Monitoring by a telephone call from the pharmacist three days after the pharmaceutical intervention

EXPERIMENTAL

Three days after carrying out a pharmaceutical intervention prompted by the patient's request for self-medication for pain - during which the patient was advised to consult a healthcare professional and was given a referral form - the community pharmacist conducts a follow-up by telephone to optimise the patient's care and assess the urgency of the situation.

Other: Care monitoring by the pharmacist's telephone call

Standard of care

NO INTERVENTION

Referral to a healthcare professional following a pharmaceutical intervention after the patient had self-medicated for pain, without any follow-up by the pharmacist.

Interventions

Care monitoring by the pharmacist's telephone call OTHER

The pharmacist completes a referral form for the healthcare professional and gives it to the patient. Three days later, he calls the patient to follow up and optimise the patient's care and assess the urgency of the situation.

Monitoring by a telephone call from the pharmacist three days after the pharmaceutical intervention

Eligibility Criteria

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

You may qualify if:

• An adult patient visiting the pharmacy, who has been issued with a referral following a spontaneous request for a medicine to treat pain and has been referred for a consultation with a healthcare professional.
• Enrolled in a social security scheme,
• Able to read and understand the information leaflet, and to give informed consent to take part.
• Pregnant and breastfeeding women will be included in the study in accordance with the available literature

You may not qualify if:

• Patients who cannot be monitored for psychological reasons,
• Patients under guardianship or trusteeship, deprived of their liberty or subject to judicial protection,
• Patients who refuse to take part in the study,
• A person acting on behalf of a third party,
• A patient for whom a pharmaceutical intervention is initiated following:
• a request accompanied by a prescription,
• a request for advice,
• a request for a veterinary medicine,
• a request for a medicine from abroad,
• a request for a medicine that has been withdrawn from the French market,
• a request concerning a health product other than a medicine.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chantal Savanovitch

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

0473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A regional, multicentre, sequential-phase, cluster-randomised, comparative, interventional trial.

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): November 28, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-02