DECIdE, Shared DECIsion in hEalth : the Real-life Impact Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DECIdE.
- Who it may be relevant to
- Registry conditions: Decision Making, Shared. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact Study of the Decision Aid DECIdE on the Decisional Conflict of Primary Care Patients About Optional Prescription Drugs.
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.
Interventions
- Other 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).
Primary outcome measures
- decisional conflict [Time frame: Day 1]
Secondary outcome measures (5)
- effect on decisional conflict categories [Time frame: day 1]
- effect on health professionals' decisional conflict [Time frame: day 1]
- effect on the final choose drug [Time frame: day 1]
- medical and economic impact of the choice of drug [Time frame: day 1]
- Identify for which type of patient DECIdE reduces decisional conflict [Time frame: day 1]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 4 centers
- CHU Clermont-ferrand — Clermont-Ferrand
- Département de Médecine Générale, UFR Médecine, Université Grenoble Alpes — Grenoble
- Collège des Universités de Médecine Générale de Lyon, faculté de médecine Lyon Est — Lyon
- Département de Médecine Générale de St-Etienne, Faculté de Médecine Jacques Lisfranc, Univ — Saint-Etienne
Identifiers
NCT: NCT06052917 · RESP-IR 2021 VAILLANT-ROUSSEL · 2022-A00071-42