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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-05

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Decision Making, Shared

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial with waiting list

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

DECIdE

Intervention Type OTHER

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).

routine without decision aid

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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DECIdE

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).

Intervention Type OTHER

Other Intervention Names

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Shared DECIsion in hEalth

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes