Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that implementation of a shared decision making care plan for prophylactic treatment will help therapeutic adherence of bipolar patients. They also anticipate that patients treated according to a shared decision making plan will have an elevated satisfaction of their care, quality of life and functionment, as well as a lower number of relapses

Official Title
-----------------
Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Other: Shared-decision making process
* Other: standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have given their free and informed consent and signed the consent form The patient must be a member or beneficiary of a health insurance plan The patient must be available for the 12 months of follow-up The patient is at least 18 years old Patients is suffering from bipolar disorder (I or II) according to DSM-5 criteria Following resolution of a mood episode (manic or depressive according to DSM-5 criteria) according to the criteria of l'International Society for Bipolar Disorder (Recovery, clinical remission of at least 4 weeks) Followed by at least one of the practitioner belonging to one of the participating centers Without comprehension problems of fluent French Exclusion Criteria: The subject is participating in an interventional study, or has participated in another interventional study within the previous 3 months The subject is in a period of exclusion determined by a previous study The patient is under safeguard of justice or state guardianship It is impossible to give the subject informed information, or the subject refuses to sign the consent The subject has already participated in this study The patient has troubles linked to the usage of severe intensive substances (such as those defined by the DMS-5) The patient has a revision of the initial diagnosis of bipolar disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Shared Decision making for care<br> | Other: Shared-decision making process<br>* Completion of the Ottawa Personal Decision Guide to help guide care with the support of online and printed material describing the therapeutic options available<br>|
| Standard decision making for care<br> | Other: standard care<br>* Care of patients according to standard practice of managing patients with bipolar disorder<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the difference of prophylactic treatment compliance between bipolar patients receiving treatment according to standard care versus a shared decision making care plan following a mood episode. | Clinician Rating Scale (1-7) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the clinician-reported difference between the 2 groups in medication adherence | Clinician Rating Scale (1-7) | 3 months | 
| Study the clinician-reported difference between the 2 groups in medication adherence | Clinician Rating Scale (1-7) | 6 months | 
| Study the clinician-reported difference between the 2 groups in medication adherence | Clinician Rating Scale (1-7) | 9 months | 
| Study the self-reported difference between the 2 groups in medication adherence | Medication Adherence Rating Scale( 0-10), | 3 months | 
| Study the self-reported difference between the 2 groups in medication adherence | Medication Adherence Rating Scale( 0-10), | 6 months | 
| Study the self-reported difference between the 2 groups in medication adherence | Medication Adherence Rating Scale( 0-10), | 9 months | 
| Study the self-reported difference between the 2 groups in medication adherence | Medication Adherence Rating Scale( 0-10), | 12 months | 
| Clinical evaluation of the difference between the 2 groups in medication adherence | Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants | 3 months | 
| Clinical evaluation of the difference between the 2 groups in medication adherence | Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants | 6 months | 
| Clinical evaluation of the difference between the 2 groups in medication adherence | Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants | 9 months | 
| Clinical evaluation of the difference between the 2 groups in medication adherence | Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants | 12 months | 
| Compare difference in the adherence to personalized follow-up between groups | percentage of consultations missed | 3 months | 
| Compare difference in the adherence to personalized follow-up between groups | percentage of consultations missed | 6 months | 
| Compare difference in the adherence to personalized follow-up between groups | percentage of consultations missed | 9 months | 
| Compare difference in the adherence to personalized follow-up between groups | percentage of consultations missed | 12 months | 
| Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups | decisional conflict scale (0-100) | 3 months | 
| Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups | decisional conflict scale (0-100) | 6 months | 
| Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups | decisional conflict scale (0-100) | 9 months | 
| Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups | decisional conflict scale (0-100) | 12 months | 
| Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups | adapted QSH-45: 3 questions scored 1-5 | 3 months | 
| Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups | adapted QSH-45: 3 questions scored 1-5 | 6 months | 
| Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups | adapted QSH-45: 3 questions scored 1-5 | 9 months | 
| Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups | adapted QSH-45: 3 questions scored 1-5 | 12 months | 
| Compare difference in patient satisfaction concerning the decision-making process between groups | Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5 | 3 months | 
| Compare difference in patient satisfaction concerning the decision-making process between groups | Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5 | 6 months | 
| Compare difference in patient satisfaction concerning the decision-making process between groups | Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5 | 9 months | 
| Compare difference in patient satisfaction concerning the decision-making process between groups | Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5 | 12 months | 
| Compare difference in therapeutic alliance between groups | 4-Point ordinal Alliance Scale | 3 months | 
| Compare difference in therapeutic alliance between groups | 4-Point ordinal Alliance Scale | 6 months | 
| Compare difference in therapeutic alliance between groups | 4-Point ordinal Alliance Scale | 9 months | 
| Compare difference in therapeutic alliance between groups | 4-Point ordinal Alliance Scale | 12 months | 
| Compare difference in knowledge of disease and treatment necessary to making decisions between groups | Knowledge questionnaire: % correct answers | 3 months | 
| Compare difference in knowledge of disease and treatment necessary to making decisions between groups | Knowledge questionnaire: % correct answers | 6 months | 
| Compare difference in knowledge of disease and treatment necessary to making decisions between groups | Knowledge questionnaire: % correct answers | 9 months | 
| Compare difference in knowledge of disease and treatment necessary to making decisions between groups | Knowledge questionnaire: % correct answers | 12 months | 
| Compare difference in patient attitude towards the treatment between groups | Beliefs about Medicines Questionnaire: 18 questions 1-5 | 3 months | 
| Compare difference in patient attitude towards the treatment between groups | Beliefs about Medicines Questionnaire: 18 questions 1-5 | 6 months | 
| Compare difference in patient attitude towards the treatment between groups | Beliefs about Medicines Questionnaire: 18 questions 1-5 | 9 months | 
| Compare difference in patient attitude towards the treatment between groups | Beliefs about Medicines Questionnaire: 18 questions 1-5 | 12 months | 
| Compare number and duration of mood episodes between groups months | number of events; number of days | 3 months | 
| Compare number and duration of mood episodes between groups months | number of events; number of days | 6 months | 
| Compare number and duration of mood episodes between groups months | number of events; number of days | 9 months | 
| Compare number and duration of mood episodes between groups months | number of events; number of days | 12 months | 
| Compare number and duration of hospitalizations in psychiatric service between groups | number of events; number of days | 3 months | 
| Compare number and duration of hospitalizations in psychiatric service between groups | number of events; number of days | 6 months | 
| Compare number and duration of hospitalizations in psychiatric service between groups | number of events; number of days | 9 months | 
| Compare number and duration of hospitalizations in psychiatric service between groups | number of events; number of days | 12 months | 
| Compare manic symptomatology during evaluations between groups | Young Mania Rating Scale | 3 months | 
| Compare manic symptomatology during evaluations between groups | Young Mania Rating Scale | 6 months | 
| Compare manic symptomatology during evaluations between groups | Young Mania Rating Scale | 9 months | 
| Compare manic symptomatology during evaluations between groups | Young Mania Rating Scale | 12 months | 
| Compare the depressive symptomatology during evaluations between groups | Montgomery-Asberg Depression Rating Scale | 3 months | 
| Compare the depressive symptomatology during evaluations between groups | Montgomery-Asberg Depression Rating Scale | 6 months | 
| Compare the depressive symptomatology during evaluations between groups | Montgomery-Asberg Depression Rating Scale | 9 months | 
| Compare the depressive symptomatology during evaluations between groups | Montgomery-Asberg Depression Rating Scale | 12 months | 
| Compare severity and intensity of suicidal ideas between groups | Columbia-Suicide Severity Rating Scale | 3 months | 
| Compare severity and intensity of suicidal ideas between groups | Columbia-Suicide Severity Rating Scale | 6 months | 
| Compare severity and intensity of suicidal ideas between groups | Columbia-Suicide Severity Rating Scale | 9 months | 
| Compare severity and intensity of suicidal ideas between groups | Columbia-Suicide Severity Rating Scale | 12 months | 
| Compare the psychosocial functioning between groups | Functioning Assessment Short Test (0-72) | 3 months | 
| Compare the psychosocial functioning between groups | Functioning Assessment Short Test (0-72) | 6 months | 
| Compare the psychosocial functioning between groups | Functioning Assessment Short Test (0-72) | 9 months | 
| Compare the psychosocial functioning between groups | Functioning Assessment Short Test (0-72) | 12 months | 
| Compare quality of life between groups | WHOQOL-BREF (0-100) | 3 months | 
| Compare quality of life between groups | WHOQOL-BREF (0-100) | 6 months | 
| Compare quality of life between groups | WHOQOL-BREF (0-100) | 9 months | 
| Compare quality of life between groups | WHOQOL-BREF (0-100) | 12 months | 
| Compare length of consultations between groups | minutes | every consultation for 12 months | 
| Clinician satisfaction concerning the therapeutic decisions taken between groups | adapted QSH-45 doctor version 3 questions scored 1-5 | 3 months | 
| Clinician satisfaction concerning the therapeutic decisions taken between groups | adapted QSH-45 doctor version 3 questions scored 1-5 | 6 months | 
| Clinician satisfaction concerning the therapeutic decisions taken between groups | adapted QSH-45 doctor version 3 questions scored 1-5 | 9 months | 
| Clinician satisfaction concerning the therapeutic decisions taken between groups | adapted QSH-45 doctor version 3 questions scored 1-5 | 12 months | 
| Clinician satisfaction concerning the decision-making process between groups | Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5 | 3 months | 
| Clinician satisfaction concerning the decision-making process between groups | Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5 | 6 months | 
| Clinician satisfaction concerning the decision-making process between groups | Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5 | 9 months | 
| Clinician satisfaction concerning the decision-making process between groups | Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5 | 12 months | 
| Clinician perceptions related to the uncertainty of the medical decisions taken between groups | decisional conflict scale doctor version (0-100) | 3 months | 
| Clinician perceptions related to the uncertainty of the medical decisions taken between groups | decisional conflict scale doctor version (0-100) | 6 months | 
| Clinician perceptions related to the uncertainty of the medical decisions taken between groups | decisional conflict scale doctor version (0-100) | 9 months | 
| Clinician perceptions related to the uncertainty of the medical decisions taken between groups | decisional conflict scale doctor version (0-100) | 12 months |