Health TrialsbyHealthPanel

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

ConditionDecision Making, Shared
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • DECIdE

    Other intervention

    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).

Treatment groups

288 Participants
are divided into 2 treatment groups
Group A: DECIdEExperimental treatment 1 intervention
Group B: routine without decision aidNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

decisional conflict

decisional conflict scale score

Time frame
Day 1

Secondary outcomes

1

effect on decisional conflict categories

decision conflict scale scores for each category

Time frame
day 1
2

effect on health professionals' decisional conflict

health professionals' decision conflict scale

Time frame
day 1
3

effect on the final choose drug

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

Time frame
day 1
4

medical and economic impact of the choice of drug

price of the chosen option

Time frame
day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Clermont-Ferrand

Lead sponsor

Source ClinicalTrials.gov
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