NCT06052917

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

May 5, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

April 13, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

September 13, 2023

Last Update Submit

April 10, 2025

Conditions

Decision Making, Shared

Keywords

primary caredecision aiddecisional conflict

Outcome Measures

Primary Outcomes (1)

  • decisional conflict

    decisional conflict scale score

    Day 1

Secondary Outcomes (5)

  • effect on decisional conflict categories

    day 1

  • effect on health professionals' decisional conflict

    day 1

  • effect on the final choose drug

    day 1

  • medical and economic impact of the choice of drug

    day 1

  • Identify for which type of patient DECIdE reduces decisional conflict

    day 1

Study Arms (2)

DECIdE

EXPERIMENTAL

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

routine without decision aid

NO INTERVENTION

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.

Interventions

DECIdEOTHER

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).

Also known as: Shared DECIsion in hEalth
DECIdE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Clermont-ferrand

Clermont-Ferrand, France

RECRUITING

Département de Médecine Générale, UFR Médecine, Université Grenoble Alpes

Grenoble, France

RECRUITING

Collège des Universités de Médecine Générale de Lyon, faculté de médecine Lyon Est

Lyon, France

RECRUITING

Département de Médecine Générale de St-Etienne, Faculté de Médecine Jacques Lisfranc, Université Jean Monnet

Saint-Etienne, France

RECRUITING

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Hélène Vaillant-Roussel, PhD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomised controlled trial with waiting list
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 25, 2023

Study Start

May 5, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

April 13, 2025

Record last verified: 2025-04

Locations

FR(4)