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

Study Overview
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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.

Official Title
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Impact Study of the Decision Aid DECIdE on the Decisional Conflict of Primary Care Patients About Optional Prescription Drugs.

Conditions
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Decision Making, Shared

Intervention / Treatment
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* Other: DECIdE


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial with waiting list
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DECIdE<br>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. | Other: DECIdE<br>* 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).<br>* Other names: Shared DECIsion in hEalth;|
| No Intervention: routine without decision aid<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decisional conflict | decisional conflict scale score | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect on decisional conflict categories | decision conflict scale scores for each category | day 1 | 
| effect on health professionals' decisional conflict | health professionals' decision conflict scale | day 1 | 
| effect on the final choose drug | Rate of change in patient choice of therapeutic option after use of the tool | day 1 | 
| medical and economic impact of the choice of drug | price of the chosen option | 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. | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary care, decision aid, decisional conflict