NCT06052917
Recruiting
N/A
Impact Study of the Decision Aid DECIdE on the Decisional Conflict of Primary Care Patients About Optional Prescription Drugs.
University Hospital, Clermont-Ferrand4 sites in 1 country288 target enrollmentMay 5, 2024
ConditionsDecision Making, Shared
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Decision Making, Shared
- Sponsor
- University Hospital, Clermont-Ferrand
- Enrollment
- 288
- Locations
- 4
- Primary Endpoint
- decisional conflict
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
decisional conflict
Time Frame: Day 1
decisional conflict scale score
Secondary Outcomes
- Identify for which type of patient DECIdE reduces decisional conflict(day 1)
- effect on health professionals' decisional conflict(day 1)
- medical and economic impact of the choice of drug(day 1)
- effect on decisional conflict categories(day 1)
- effect on the final choose drug(day 1)
Study Sites (4)
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