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

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Decision Making, Shared

Treatments: Other: DECIdE

Study type: Interventional

Funder types: Other

Identifiers

NCT06052917

RESP-IR 2021 VAILLANT-ROUSSEL

2022-A00071-42 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 288 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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288 participants in 2 patient groups

DECIdE

Experimental group

Description:

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.

Treatment:

Other: DECIdE

routine without decision aid

No Intervention group

Description:

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.