Self-medication for PainAUTOMED'IP-DOLNCT07867301
Impact of Pharmaceutical Intervention in Self-Medication: Focus on Pain Management in Pharmacies
A study testing Care monitoring by the pharmacist's telephone call in people with Self-medication for Pain and Limits on Advice From Community Pharmacists and Referral to a Primary Care Practitioner, run by University Hospital, Clermont-Ferrand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self-medication for Pain, Limits on Advice From Community Pharmacists and Referral to a Primary Care Practitioner
- What is being tested?
- Care monitoring by the pharmacist's telephone call
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Self-medication for Pain, Limits on Advice From Community Pharmacists and Referral to a Primary Care Practitioner
- Being tested
- Care monitoring by the pharmacist's telephone call
- Keywords
- self-medication, pain, community pharmacists' intervention
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care monitoring by the pharmacist's telephone callOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Using the EQ-5D-5L questionnaire
Measured: From enrollment to five days later
Waiting time for an appointment with a healthcare professional
In days
Measured: 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
5-point Likert scales
Measured: Assessed on the 5th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start28 Nov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-medication for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A regional, multicentre, sequential-phase, cluster-randomised, comparative, interventional trial.
- Masking
- None (open label)
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chantal Savanovitch, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867301
- Sponsor's protocol ID
- RESP-IR 2023 BEDHOMME
- Acronym
- AUTOMED'IP-DOL
- Status last verified
- Feb 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pharmaceutical Intervention in Self-Medication: Focus on Pain Management in Pharmacies
- ClinicalTrials.gov ID
- NCT07867301
- Acronym / sponsor ID
- AUTOMED'IP-DOL / RESP-IR 2023 BEDHOMME
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 28 Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A regional, multicentre, sequential-phase, cluster-randomised, comparative, interventional trial.
| Arm | Type | Receives |
|---|---|---|
| Monitoring by a telephone call from the pharmacist three days after the pharmaceutical intervention | Experimental | Other: Care monitoring by the pharmacist's telephone callThree 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care monitoring by the pharmacist's telephone callThe 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. | Other | Monitoring by a telephone call from the pharmacist three days after the pharmaceutical intervention |
Primary outcome
Change in pain levels between enrollment and five days later, measured on a numerical scale ranging from 0 to 10.
Time frame: From enrollment to five days later.
Zero is equivalent to no pain and 10 indicates the worst possible pain.
3 secondary outcomes
Change in quality of life between enrolment and five days later (expressed as a percentage), measured using the EQ-5D-5L questionnaire
Time frame: From enrollment to five days later
Waiting time for an appointment with a healthcare professional
Time frame: 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
Time frame: Assessed on the 5th day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chantal Savanovitch principal investigator
University Hospital, Clermont-Ferrand
Questions about this trial
What is this clinical trial studying?
A study testing Care monitoring by the pharmacist's telephone call in people with Self-medication for Pain and Limits on Advice From Community Pharmacists and Referral to a Primary Care Practitioner, run by University Hospital, Clermont-Ferrand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (0473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain levels between enrollment and five days later, measured on a numerical scale ranging from 0 to 10. (time frame: From enrollment to five days later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.