Evaluating a decision aid for shared decision making in healthcare
Impact Study of the Decision Aid DECIdE on the Decisional Conflict of Primary Care Patients About Optional Prescription Drugs.
This study tests a new tool to help patients and doctors work together better when deciding about optional prescription drugs to see if it reduces confusion and improves comfort with their choices.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 4 sites (Clermont-Ferrand and 3 other locations) |
| Trial ID | NCT06052917 on ClinicalTrials.gov |
What this trial studies
The DECIdE study aims to assess the effectiveness of a decision aid tool designed to facilitate shared decision making between patients and healthcare providers regarding optional prescription drugs. Patients experiencing common symptoms will engage in discussions with general practitioners or pharmacists to determine whether to proceed with a prescribed medication or consider alternative options. The study compares the level of decisional conflict experienced by patients using the DECIdE tool against those receiving routine care without the aid. This approach seeks to enhance patient comfort and certainty in their healthcare decisions.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who are consulting a general practitioner or pharmacist for a common symptom and are considering an optional prescription drug.
Not a fit: Patients who are minors, pregnant or breastfeeding, or those who have previously used the DECIdE tool for the same situation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could empower patients to make more informed decisions about their treatment options, reducing uncertainty and improving satisfaction with care.
How similar studies have performed: Other studies have shown promise in using decision aids for shared decision making, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Clermont-Ferrand and 3 other locations
- CHU Clermont-ferrand — Clermont-Ferrand, France (Recruiting)
- Département de Médecine Générale, UFR Médecine, Université Grenoble Alpes — Grenoble, France (Recruiting)
- Collège des Universités de Médecine Générale de Lyon, faculté de médecine Lyon Est — Lyon, France (Recruiting)
- Département de Médecine Générale de St-Etienne, Faculté de Médecine Jacques Lisfranc, Université Jean Monnet — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: Hélène Vaillant-Roussel, PhD — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.