Decision Making, Shared
Conditions
Keywords
primary care, decision aid, decisional conflict
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.
Interventions
OTHERDECIdE
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).
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomised controlled trial with waiting list
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| decisional conflict | Day 1 | decisional conflict scale score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effect on decisional conflict categories | day 1 | decision conflict scale scores for each category |
| effect on health professionals' decisional conflict | day 1 | health professionals' decision conflict scale |
| effect on the final choose drug | day 1 | Rate of change in patient choice of therapeutic option after use of the tool |
| medical and economic impact of the choice of drug | day 1 | price of the chosen option |
| Identify for which type of patient DECIdE reduces decisional conflict | day 1 | age, sex, socio economic category of patient for which the decisional conflict scale is the more reduced. |
Countries
France
Contacts
Primary ContactLise Laclautre
Outcome results
None listed