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

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06052917
Collaborator
(none)
288
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
26.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: DECIdE
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
288 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomised controlled trial with waiting listRandomised controlled trial with waiting list
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Impact Study of the Decision Aid DECIdE on the Decisional Conflict of Primary Care Patients About Optional Prescription Drugs.
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. decisional conflict [Day 1]

      decisional conflict scale score

    Secondary Outcome Measures

    1. effect on decisional conflict categories [day 1]

      decision conflict scale scores for each category

    2. effect on health professionals' decisional conflict [day 1]

      health professionals' decision conflict scale

    3. effect on the final choose drug [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 [day 1]

      price of the chosen option

    5. Identify for which type of patient DECIdE reduces decisional conflict [day 1]

      age, sex, socio economic category of patient for which the decisional conflict scale is the more reduced.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU clermont-ferrand Clermont-Ferrand France

    Sponsors and Collaborators

    • University Hospital, Clermont-Ferrand

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Clermont-Ferrand
    ClinicalTrials.gov Identifier:
    NCT06052917
    Other Study ID Numbers:
    • RESP-IR 2021 VAILLANT-ROUSSEL
    • 2022-A00071-42
    First Posted:
    Sep 25, 2023
    Last Update Posted:
    Sep 25, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Clermont-Ferrand
    primary care
    decision aid
    decisional conflict

    Study Results

    No Results Posted as of Sep 25, 2023