Clinical trial NCT06052917: DECIdE, Shared DECIsion in hEalth : the Real-life Impact Study
Official title: Impact Study of the Decision Aid DECIdE on the Decisional Conflict of Primary Care Patients About Optional Prescription Drugs.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Decision Making, Shared
Keywords: primary care
decision aid
decisional conflict
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial with waiting list
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: decisional conflict
timeFrame: Day 1
Secondary outcomes:
measure: effect on decisional conflict categories
timeFrame: day 1
measure: effect on health professionals' decisional conflict
timeFrame: day 1
measure: effect on the final choose drug
timeFrame: day 1
measure: medical and economic impact of the choice of drug
timeFrame: day 1
measure: Identify for which type of patient DECIdE reduces decisional conflict
timeFrame: day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-ferrand
city: Grenoble
country: France
facility: Département de Médecine Générale, UFR Médecine, Université Grenoble Alpes
city: Lyon
country: France
facility: Collège des Universités de Médecine Générale de Lyon, faculté de médecine Lyon Est
city: Saint Etienne
country: France
facility: Département de Médecine Générale de St-Etienne, Faculté de Médecine Jacques Lisfranc, Université Jean Monnet
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Hélène Vaillant-Roussel, PhD
role: PRINCIPAL_INVESTIGATOR
References: