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

April 10, 2025 updated by: University Hospital, Clermont-Ferrand

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Clermont-Ferrand, France
        • Recruiting
        • Chu Clermont-Ferrand
        • Contact:
          • Lise LACLAUTRE
        • Principal Investigator:
          • Hélène VAILLANT-ROUSSEL, MD-PhD
        • Sub-Investigator:
          • Elodie CHARUEL, MD
      • Grenoble, France
        • Recruiting
        • Département de Médecine Générale, UFR Médecine, Université Grenoble Alpes
        • Contact:
          • Lise LACLAUTRE
        • Principal Investigator:
          • Yoan Gaboreau, MD
      • Lyon, France
        • Recruiting
        • Collège des Universités de Médecine Générale de Lyon, faculté de médecine Lyon Est
        • Contact:
          • Lise LACLAUTRE
        • Principal Investigator:
          • Rémy Boussageon, MD-PhD
      • Saint Etienne, France
        • Recruiting
        • Département de Médecine Générale de St-Etienne, Faculté de Médecine Jacques Lisfranc, Université Jean Monnet
        • Contact:
          • Lise LACLAUTRE
        • Principal Investigator:
          • Xavier Gocko, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DECIdE
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
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).
Other Names:
  • Shared DECIsion in hEalth
No Intervention: routine without decision aid
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
decisional conflict
Time Frame: Day 1
decisional conflict scale score
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect on decisional conflict categories
Time Frame: day 1
decision conflict scale scores for each category
day 1
effect on health professionals' decisional conflict
Time Frame: day 1
health professionals' decision conflict scale
day 1
effect on the final choose drug
Time Frame: day 1
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
Time Frame: day 1
price of the chosen option
day 1
Identify for which type of patient DECIdE reduces decisional conflict
Time Frame: day 1
age, sex, socio economic category of patient for which the decisional conflict scale is the more reduced.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Hélène Vaillant-Roussel, PhD, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RESP-IR 2021 VAILLANT-ROUSSEL
  • 2022-A00071-42 (Other Identifier: 2022-A00071-42)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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