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Not yet recruitingNCT07867301AUTOMED'IP-DOLUpdated Oct 9, 2026

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

An interventional study of Care monitoring by the pharmacist's telephone call in Self-medication for Pain and Limits on Advice From Community Pharmacists and Referral to a Primary Care Practitioner, sponsored by University Hospital, Clermont-Ferrand. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Prevention

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
376
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Self-medication is the use of a medicinal product by a person on their own initiative, to treat simple, previously experienced symptoms or minor illnesses. It is a widespread practice and is not without risk, as previous studies have shown. The French national health insurance website, Ameli, therefore stresses the importance of asking one's pharmacist for advice and reading the patient information leaflet carefully.

When a patient makes a spontaneous request for a medicine, the pharmacist's role is to identify potential dangers (risk of overdose, drug interactions, etc.) and to propose a solution, such as adjusting the dosage, suggesting an alternative medicine, or referring the patient for a consultation. These recommendations, made to ensure patient safety, are known as "pharmaceutical interventions".

Recording and following up on pharmaceutical interventions, particularly when the community pharmacist reaches the limit of what they can advise and decides to refer the patient to another healthcare professional, would help ensure continuity of patient care.

This study will test the benefits of a liaison form and a follow-up telephone interview with the pharmacist for patients who come to the pharmacy seeking pain relief and whom the pharmacist chooses to refer to a healthcare professional, specifically a general practitioner, a midwife or a dentist. 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.

02

Conditions studied

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

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Keywords

  • self-medication
  • pain
  • community pharmacists' intervention
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's planned enrollment of 376 is above the median of 70 across 2,101 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 854 studies on the registry; 180 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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,
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
376 participants (estimated)

Study arms

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

    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

  • No intervention
    Standard of care

    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

  • OtherCare monitoring by the pharmacist's telephone call

    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.

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.

Of 1,253 non-industry interventional studies with no phase under Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's planned 13 months is above that.

Counting every sponsor, half of 1,276 studies reached it within 11 months; a quarter within 5 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2026
First posted
Oct 9, 2026
StartEst.
Nov 28, 2026
Primary completionEst.
Dec 2027
CompletionEst.
Jan 2028
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07867301
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Nov 28, 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Jan 2028 (estimated)
Last update
Oct 9, 2026

Study contacts

Lise Laclautre
Contact
promo_interne_drci@chu-clermontferrand.fr
0473754963
Chantal Savanovitch
principal investigator · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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