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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Patients taking part in another interventional research study involving an exclusion period that is still ongoing at the time of inclusion,

Trial design

Design model

Sequential

Treatments tested in this trial

  • Care monitoring by the pharmacist's telephone call

    Other intervention

    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.

Treatment groups

376 Participants
are divided into 2 treatment groups
Group A: Monitoring by a telephone call from the pharmacist three days after the pharmaceutical interventionExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions

Trial outcomes

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.

Time frame
From enrollment to five days later.

Secondary outcomes

1

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

Using the EQ-5D-5L questionnaire

Time frame
From enrollment to five days later
2

Waiting time for an appointment with a healthcare professional

In days

Time frame
Between enrollment to five days later
3

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

5-point Likert scales

Time frame
Assessed on the 5th day

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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