Decision Making, SharedDECIdENCT06052917
DECIdE, Shared DECIsion in hEalth : the Real-life Impact Study
A study testing DECIdE in people with Decision Making, Shared, run by University Hospital, Clermont-Ferrand at 4 sites in France.
Trial summary
The aim of the DECIdE study is to evaluate the effect of a decision aid (the DECIdE tool) for shared decision making concerning optional prescription drugs on the level of uncertainty-certainty or comfort-inconfort (= decisional conflict) experienced by patients, compared with a condition of routine care without the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Decision Making, Shared
- What is being tested?
- DECIdE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 4 sitesFrance
- Study dates
- 5 May 2024to Sep 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 consulting a general practitioner or community pharmacy
- Patient complaining of a symptom or requesting a optional prescription drug (clinical situations and medicines pre-defined by expert consensus)
- First use of DECIdE with the healthcare professional for this situation
- Agreeing to take part in the study and to sign the written consent form
- Speaks and understands French
Who cannot join
- minor patients
- Patients under guardianship, curatorship or safeguard of justice
- Pregnant or breast-feeding women
- Second use of the DECIdE tool in the same situation / for the same drug
- Refusal to take part in the study
- Patient not affiliated to a medical insurance
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CHU Clermont-ferrand
Clermont-Ferrand
Lise Laclautre
Hélène VAILLANT-ROUSSEL, MD-PhD
- Recruiting
Département de Médecine Générale, UFR Médecine, Université Grenoble Alpes
Grenoble
Lise Laclautre
Yoan Gaboreau, MD
- Recruiting
Collège des Universités de Médecine Générale de Lyon, faculté de médecine Lyon Est
Lyon
Lise Laclautre
Rémy Boussageon, MD-PhD
- Recruiting
Département de Médecine Générale de St-Etienne, Faculté de Médecine Jacques Lisfranc, Université Jean Monnet
Saint-Etienne
Lise Laclautre
Xavier Gocko, MD
About this study
Official title: Impact Study of the Decision Aid DECIdE on the Decisional Conflict of Primary Care Patients About Optional Prescription Drugs.
The aim of the DECIdE study is to evaluate the effect of a decision aid (the DECIdE tool) for shared decision making concerning optional prescription drugs on the level of uncertainty-certainty or comfort-inconfort (= decisional conflict) experienced by patients, compared with a condition of routine care without the use of a decision aid.
General practitionners and pharmacists will propose to their patients, complaining of a common symptom for which a drug is usually prescribed or dispensed, to discuss this drug and the symptom in order to reach a shared decision on whether to take it or choose another alternative.
- Conditions
- Decision Making, Shared
- Being tested
- DECIdE
- Keywords
- primary care, decision aid, decisional conflict
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DECIdEOther
Also called Shared DECIsion in hEalth
DECIdE is a decision aid. Its a communication tool to help health providers as general practitioners or community pharmacists, to practice shared medical decision about optional prescription drug. DECIdE provide robust scientific data about benefit and risks associated to the drug under consideration. DECIdE was built based on the consensus of potentials users ( care providers and patients ), tested on users testing and finally validated by a expert consensus ( DELPHI method).
| Study group | Role | What they receive |
|---|---|---|
| DECIdE | Experimental | General practitionners and pharmacists will propose to their patients, complaining of a common symptom for which a drug is usually prescribed or dispensed, to discuss this drug and the symptom in order to reach a shared decision, using DECIdE as a support, on whether to take it or choose another alternative. Receives: Other: DECIdE |
| routine without decision aid | No intervention | General practitionners and pharmacists will prescribe or dispense to their patients, complaining of a common symptom, the drug they usually use and advise them or discuss the benefits and risks as they are used to doing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
decisional conflict
decisional conflict scale score
Measured: Day 1
Secondary outcomes (5)
effect on decisional conflict categories
decision conflict scale scores for each category
Measured: day 1
effect on health professionals' decisional conflict
health professionals' decision conflict scale
Measured: day 1
effect on the final choose drug
Rate of change in patient choice of therapeutic option after use of the tool
Measured: day 1
medical and economic impact of the choice of drug
price of the chosen option
Measured: day 1
Identify for which type of patient DECIdE reduces decisional conflict
age, sex, socio economic category of patient for which the decisional conflict scale is the more reduced.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start5 May 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision Making, SharedStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial with waiting list
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Vaillant-Roussel, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052917
- Sponsor's protocol ID
- RESP-IR 2021 VAILLANT-ROUSSEL
- Other IDs
- 2022-A00071-42
- Acronym
- DECIdE
- Status last verified
- Apr 2025
- First submitted
- 13 Sep 2023
- Last updated
- 13 Apr 2025
- 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 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Study of the Decision Aid DECIdE on the Decisional Conflict of Primary Care Patients About Optional Prescription Drugs.
- ClinicalTrials.gov ID
- NCT06052917
- Acronym / sponsor ID
- DECIdE / RESP-IR 2021 VAILLANT-ROUSSEL
- Conditions
- Decision Making, Shared
- Keywords
- primary care, decision aid, decisional conflict
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 25 Sep 2023 (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.
The aim of the DECIdE study is to evaluate the effect of a decision aid (the DECIdE tool) for shared decision making concerning optional prescription drugs on the level of uncertainty-certainty or comfort-inconfort (= decisional conflict) experienced by patients, compared with a condition of routine care without the use of a decision aid.
General practitionners and pharmacists will propose to their patients, complaining of a common symptom for which a drug is usually prescribed or dispensed, to discuss this drug and the symptom in order to reach a shared decision on whether to take it or choose another alternative.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial with waiting list
| Arm | Type | Receives |
|---|---|---|
| DECIdE | Experimental | Other: DECIdEGeneral practitionners and pharmacists will propose to their patients, complaining of a common symptom for which a drug is usually prescribed or dispensed, to discuss this drug and the symptom in order to reach a shared decision, using DECIdE as a support, on whether to take it or choose another alternative. |
| routine without decision aid | No intervention | –General practitionners and pharmacists will prescribe or dispense to their patients, complaining of a common symptom, the drug they usually use and advise them or discuss the benefits and risks as they are used to doing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over 18 consulting a general practitioner or community pharmacy
- Patient complaining of a symptom or requesting a optional prescription drug (clinical situations and medicines pre-defined by expert consensus)
- First use of DECIdE with the healthcare professional for this situation
- Agreeing to take part in the study and to sign the written consent form
- Speaks and understands French
Key exclusion criteria (6 listed)
- minor patients
- Patients under guardianship, curatorship or safeguard of justice
- Pregnant or breast-feeding women
- Second use of the DECIdE tool in the same situation / for the same drug
- Refusal to take part in the study
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 |
|---|---|---|
| DECIdEAlso: Shared DECIsion in hEalthDECIdE is a decision aid. Its a communication tool to help health providers as general practitioners or community pharmacists, to practice shared medical decision about optional prescription drug. DECIdE provide robust scientific data about benefit and risks associated to the drug under consideration. DECIdE was built based on the consensus of potentials users ( care providers and patients ), tested on users testing and finally validated by a expert consensus ( DELPHI method). | Other | DECIdE |
Primary outcome
decisional conflict
Time frame: Day 1
decisional conflict scale score
5 secondary outcomes
effect on decisional conflict categories
Time frame: day 1
effect on health professionals' decisional conflict
Time frame: day 1
effect on the final choose drug
Time frame: day 1
medical and economic impact of the choice of drug
Time frame: day 1
Identify for which type of patient DECIdE reduces decisional conflict
Time frame: day 1
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 13 Apr 2025.
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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.
Hélène Vaillant-Roussel, PhD principal investigator
University Hospital, Clermont-Ferrand
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DECIdE in people with Decision Making, Shared, run by University Hospital, Clermont-Ferrand at 4 sites in France.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 (334.73.754.963, 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?
decisional conflict (time frame: Day 1). 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 13 Apr 2025.