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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shared Decision making for care | Experimental |
| |
| Standard decision making for care | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared-decision making process | Other | Completion of the Ottawa Personal Decision Guide to help guide care with the support of online and printed material describing the therapeutic options available |
| 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 |
| 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 |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ludovic Samalin | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ch Beziers | Béziers | 34500 | France | |||
| CH Charles Perrens |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29653535 | Derived | Samalin L, Honciuc M, Boyer L, de Chazeron I, Blanc O, Abbar M, Llorca PM. Efficacy of shared decision-making on treatment adherence of patients with bipolar disorder: a cluster randomized trial (ShareD-BD). BMC Psychiatry. 2018 Apr 13;18(1):103. doi: 10.1186/s12888-018-1686-y. |
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| standard care | Other | Care of patients according to standard practice of managing patients with bipolar disorder |
|
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 |
| Bordeaux |
| 33076 |
| France |
| CH le Vinatier | Bron | 69678 | France |
| CHU de Clermont Ferrand - Hôpital Gabriel-Montpied | Clermont-Ferrand | 63003 | France |
| Chu Gabriel Montpied Clermont Ferrand | Clermont-Ferrand | 63003 | France |
| CH Sainte-Marie de Clermont-Ferrand | Clermont-Ferrand | 63037 | France |
| APHP - Centre Hospitalier Henri Mondor | Créteil | 94010 | France |
| CHU de Grenoble - Hôpital Albert Michallon | Grenoble | 38043 | France |
| CH Limoges | Limoges | 87025 | France |
| APHM - Hôpital Sainte-Marguerite | Marseille | 13274 | France |
| CHU de Montpellier - Hôpital Lapeyronie | Montpellier | 34295 | France |
| CHU Nancy | Nancy | 54000 | France |
| CHU Nantes | Nantes | 44000 | France |
| Clinique des troubles thymiques | Nîmes | 30000 | France |
| CHU Nimes | Nîmes | 30029 | France |
| APHP - Hôpital Saint Louis-Lariboisière-Fernand-Widal | Paris | 75475 | France |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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