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NCT Number: NCT06052917

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

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.

Recruiting

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Key information

Conditions

Decision Making, Shared

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-ferrand, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DECIdE

Other

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

Primary outcomes

  1. decisional conflict

    Time frame: Day 1

    decisional conflict scale score

Secondary outcomes

  1. effect on decisional conflict categories

    Time frame: day 1

    decision conflict scale scores for each category

  2. effect on health professionals' decisional conflict

    Time frame: day 1

    health professionals' decision conflict scale

  3. effect on the final choose drug

    Time frame: day 1

    Rate of change in patient choice of therapeutic option after use of the tool

  4. medical and economic impact of the choice of drug

    Time frame: day 1

    price of the chosen option

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: DECIdE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2023
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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