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

University Hospital, Clermont-Ferrand288 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

288

Conditions

Decision Making, Shared

Interventions

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).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

decisional conflict

decisional conflict scale score

Time frame: Day 1

Secondary Outcomes

effect on decisional conflict categories

decision conflict scale scores for each category

Time frame: day 1

effect on health professionals' decisional conflict

health professionals' decision conflict scale

Time frame: day 1

effect on the final choose drug

Rate of change in patient choice of therapeutic option after use of the tool

Time frame: day 1

medical and economic impact of the choice of drug

price of the chosen option

Time frame: day 1

Identify for which type of patient DECIdE reduces decisional conflict

age, sex, socio economic category of patient for which the decisional conflict scale is the more reduced.

Time frame: day 1

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

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts