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

Decision Making, Shared Clinical Trial

— DECIdE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06052917
• Other study ID #: RESP-IR 2021 VAILLANT-ROUSSEL
• Secondary ID: 2022-A00071-42
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 288
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Decision Making, Shared

Intervention

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).

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decisional conflict	decisional conflict scale score	Day 1
Secondary	effect on decisional conflict categories	decision conflict scale scores for each category	day 1
Secondary	effect on health professionals' decisional conflict	health professionals' decision conflict scale	day 1
Secondary	effect on the final choose drug	Rate of change in patient choice of therapeutic option after use of the tool	day 1
Secondary	medical and economic impact of the choice of drug	price of the chosen option	day 1
Secondary	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