DECIdE, Shared DECIsion in hEalth : the Real-life Impact Study

Not Applicable

Recruiting

• Conditions: Decision Making, Shared
• Interventions: Other: DECIdE

• Registration Number: NCT06052917
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-25
• Study Start: 2024-05-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 288

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DECIdE	DECIdE	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.

Primary Outcome Measures

Name	Time	Method
decisional conflict	Day 1	decisional conflict scale score

Secondary Outcome Measures

Name	Time	Method
Identify for which type of patient DECIdE reduces decisional conflict	day 1	age, sex, socio economic category of patient for which the decisional conflict scale is the more reduced.
medical and economic impact of the choice of drug	day 1	price of the chosen option
effect on decisional conflict categories	day 1	decision conflict scale scores for each category
effect on the final choose drug	day 1	Rate of change in patient choice of therapeutic option after use of the tool
effect on health professionals' decisional conflict	day 1	health professionals' decision conflict scale

Trial Locations

Locations (4)

CHU Clermont-ferrand; 🇫🇷 Clermont-Ferrand, France

Département de Médecine Générale, UFR Médecine, Université Grenoble Alpes; 🇫🇷 Grenoble, France

Collège des Universités de Médecine Générale de Lyon, faculté de médecine Lyon Est; 🇫🇷 Lyon, France

Département de Médecine Générale de St-Etienne, Faculté de Médecine Jacques Lisfranc, Université Jean Monnet; 🇫🇷 Saint Etienne, France