Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377189
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-03-01
Brief Title:
Psychiatric Consultation-Liaison Intervention in Primary Care A Pilot Study
Sponsor:
Center for Primary Care and Public Health Unisante University of Lausanne Switzerland
Organization:
Center for Primary Care and Public Health Unisante University of Lausanne Switzerland
Study Overview
Official Title:
A Pilot Study on the Impact of a Psychiatric Consultation-Liaison Intervention in Primary Care Medical Consultations in French Speaking Switzerland PLIMeC-P A Mixed Method Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLIMeC-P
Brief Summary:
The pilot study on the impact of a Psychiatric Consultation-Liaison Intervention in Primary Care Medical Consultations in French-speaking Switzerland PLIMeC-P is a mixed method randomized controlled trial The investigated health-related intervention is a brief Consultation-Liaison CL psychiatry intervention in primary care
Primary Care Physicians PCPs have a key role in preventing detecting and managing mental disorders Therefore the optimization of both the quality of their interventions and their cooperation with psychiatric and psychological care networks are important challenges It is well demonstrated that multidisciplinary interventions improve the efficacy of mental health care CL psychiatry being one such type of intervention Therefore community CL-psychiatry for example in private primary care group practices are rare The impact of such community primary care CL-psychiatry interventions should be investigated
The mixed methods randomized controlled trial PLIMeC study will examine the impact of a CL-psychiatric intervention in primary care settings for newly reported mental illness versus a Treatment As Usual TAU control arm The intervention consists of a CL-psychiatric intervention into private medical practices provided to patients suffering from mental health problems a group of patients generally under-treated The CL-psychiatrist will receive and discuss PCPs referrals for patients with mental distress who dont have a psychiatric follow-up After a brief intervention 1-4 sessions feedback conjoint PCP-psychiatrist session will be organized to complete the intervention and provide proposals
The pilot study PLIMeC-P will determine whether the main planned study PLIMeC is feasible and practicable It will be conducted on two sites the Neuchâtel Psychiatry Centre CNP and the North-west Adult Psychiatry Service SPANO Department of Psychiatry of CHUV Yverdon For the pilot study PLIMeC-P 15 eligible participants are expected for each group 30 participants in total They will be recruited in three private primary care group practices After eligibility and randomization 15 participants will be included for the intervention arm brief CL-psychiatric intervention and 15 for the control arm TAU The expected number of participants for the main trial PLIMeC will be estimated through analysis of the initial results of the PLIMeC-P
Primary Care Physicians PCPs have a key role in preventing detecting and managing mental disorders Therefore the optimization of both the quality of their interventions and their cooperation with psychiatric and psychological care networks are important challenges It is well demonstrated that multidisciplinary interventions improve the efficacy of mental health care CL psychiatry being one such type of intervention Therefore community CL-psychiatry for example in private primary care group practices are rare The impact of such community primary care CL-psychiatry interventions should be investigated
The mixed methods randomized controlled trial PLIMeC study will examine the impact of a CL-psychiatric intervention in primary care settings for newly reported mental illness versus a Treatment As Usual TAU control arm The intervention consists of a CL-psychiatric intervention into private medical practices provided to patients suffering from mental health problems a group of patients generally under-treated The CL-psychiatrist will receive and discuss PCPs referrals for patients with mental distress who dont have a psychiatric follow-up After a brief intervention 1-4 sessions feedback conjoint PCP-psychiatrist session will be organized to complete the intervention and provide proposals
The pilot study PLIMeC-P will determine whether the main planned study PLIMeC is feasible and practicable It will be conducted on two sites the Neuchâtel Psychiatry Centre CNP and the North-west Adult Psychiatry Service SPANO Department of Psychiatry of CHUV Yverdon For the pilot study PLIMeC-P 15 eligible participants are expected for each group 30 participants in total They will be recruited in three private primary care group practices After eligibility and randomization 15 participants will be included for the intervention arm brief CL-psychiatric intervention and 15 for the control arm TAU The expected number of participants for the main trial PLIMeC will be estimated through analysis of the initial results of the PLIMeC-P
Detailed Description:
1 BACKGROUND AND RATIONALE
According to the WHO mental health is a central component of personal health and well-being Mental disorders claim a heavy toll on individuals their families and society and are a major public health issue In Switzerland 18-21 of the population suffers from psychological distress of which 127 have been diagnosed with a psychiatric disorder Primary care physicians PCP are usually the first contact with healthcare for patients suffering from psychological distress or mental disorders More precisely a prevalence of 25-60 is reported for mental disorders in primary care and this is the case worldwide as well as in Switzerland More than half of those patients have no specialized psychiatric care and PCPs tend to base their treatment on pharmacotherapy support therapy and psycho-education PCPs are therefore key stakeholders in the detection prevention and adjusted treatment management of mental disorders
Therefore the optimization of both the quality of primary care interventions and cooperation with psychiatric care networks are important challenges Patients with mental disorders are often considered complex patients and tend to be frequent care users PCPs feeling lacking competency in dealing with them Close collaboration between psychiatrists and PCPs and multidisciplinary interventions can reinforce PCPs skills and help them gain confidence in managing mental disorders A wide range of collaboration models between psychiatrists and PCP exist the Consultation Liaison CL interventions being one of them However various barriers are described regarding such a collaboration notably because of different treatment paradigms and of lack of accessibility
In Switzerland CL-psychiatric interventions are mainly used in hospital settings To introduce a model of care that offers optimal management of mental disorders in primary care ensuring an adequate continuity and good coordination of care for patients with complex needs a multidisciplinary collaboration project between PCP and CL-psychiatrists has been developed in a region of French-speaking Switzerland A CL-psychiatric consultation within primary care practices has been implemented to promote the quality of mental health care and facilitate communication between healthcare professionals The need for further research on the implementation of psychiatric interventions in primary care is clearly highlighted Moreover the experience of patients of PCPs and of psychiatrists during such interventions is rarely investigated whereas emotional experiences seem to present one of the central obstacles to the optimal management of mental disorders in primary care
Our study will investigate the impact of a CL-psychiatric intervention for patients with mental health problems in private primary care group practices in French-speaking Switzerland using mixed methods qualitative and quantitative In parallel the lived experience of PCPs and CL-psychiatrists will be investigated during their collaboration in order to better understand the factors that influence this type of intervention and to better qualify its results Initially a pilot study PLIMeC-P of the multi-center multi-method PLIMeC study will be conducted to determine whether the PLIMeC study is feasible
2 STUDY OBJECTIVES AND DESIGN
21 Hypothesis and primary objective
211 For the Pilot study PLIMeC-P
To determine whether the planned multicentric mixed method design randomized controlled trial is feasible and practicable
Essential activities in the PLIMeC-P will include testing procedures for assessment methods conducting initial semi-structured individual interviews to test and adjust the moderators guide questions concerning PCPs CL-psychiatrists and patients lived experience of the intervention first evaluation and analysis of initial results These activities will be carried out through ongoing collaboration between the study sites
212 For the PLIMeC main study
The primary objective is to compare the efficacy of a CL psychiatry intervention case discussion brief intervention and conjoint feedback session - intervention arm introduced in a primary care setting with treatment as usual TAU - control arm for patients suffering from mental health problems More precisely the investigators will focus on the effect of such an intervention on the psychiatric symptoms and the quality of life of participants The investigators hypothesize that a significant clinical change will be produced in the intervention arm in comparison with the control arm
The secondary objective is to explore qualitatively the participants lived experience of the management of their mental health problems in primary care and the effect of a CL psychiatry intervention on this as well as on doctor-patient relationship and in parallel the PCPs and psychiatrists lived experience of their collaboration barriers andor facilitators needs affects thoughts etc
An exploratory objective is to investigate aspects of public health efficiency in order to answer the question of at what level to best meet psychiatric outpatients and to where best allocate psychiatric resources The investigators expect a high level of complexity in the basis evaluation of the clinical situations and hypothesize that healthcare professionals collaboration will ameliorate with the CL psychiatry intervention
22 Endpoints are detailed in the Outcome Measures session
23 Study design
The PLIMeC multicenter study is a randomized controlled trial with a mixed methods design ie using both quantitative and qualitative assessment including a control arm CL-psychiatry intervention and an intervention arm Treatment as Usual - TAU in primary care settings in which the intervention of a CL-psychiatrist was implemented
A potential problem associated with the proposed study design could be the specificity of different local primary care settings different regions different organization different clinical experiences of PCPs different sizes etc To minimize potential bias first both arms will be studied in the same primary care settings with patients naturally seeking help at primary care practices and being randomized Second the investigators will use complementary qualitative data to further interpret the quantitative data employ a mixed-method design Finally a variety of private primary care practices with different demographic variables will be included in a large region of French-speaking Switzerland for the main study already 3 different private primary care practices in different regions of two different cantons for the pilot study The employment of validated questionnaires which will be monitored during the pilot study will also ensure the quality of our data
In addition the investigators are aware that the sensitivity of PCPs to mental health problems and their training in these issues may vary from one practitioner to another Nevertheless such heterogeneity characterizes the current state of practice Consequently the investigators do not consider this heterogeneity to be a source of bias as the aim of the PLIMeC study is to estimate the effect of the intervention in the current healthcare context real-world data On the other hand PCPs working in practices that agreed to take part in the study may be on average more sensitive to education about mental health issues than their colleagues not taking part in the study thereby constituting a recruitment bias In order to reduce this bias with the pilot study PLIMeC-P a first analysis will be conducted of the different private primary care practices 3 practices in different regions with the participating PCPs The investigators will identify the level of training andor awareness of mental health issues among the PCPs included in the study demographic elements collected before the start of the study to identify trends to better calibrate the main study and carry out sample size calculations
Regarding the qualitative part of the design a potential problem could be the fact that the local PI supervises the clinical project To minimize potential bias reflexivity will be applied during the research process and the investigators will ensure that the research assistant who will conduct the individual semi-structured interviews will not be directly involved in the clinical project and will have no hierarchical link with the participating PCPs and CL-psychiatrists Moreover to ensure the quality of our qualitative data the investigators will use a moderator guide drawn upon three previous qualitative research studies a a study on the referral process as experienced by PCPs b a study on psychiatristPCP discussion groups with a sociological perspective observation in situ c a qualitative study on the experience of PCP regarding consultation-liaison psychiatry interventions in primary care Finally the interview guide will be monitored during the PLIMeC-P
24 Regarding the study intervention see Arms and Interventions session
3 STUDY POPULATION AND STUDY PROCEDURES
31 Study population
The study population will be composed of patients who present mental distress in primary care consultations They will be part of the PCP patient list new or regular patients For the PLIMeC-P two private primary care group practices in the canton of Neuchâtel in two distinct regions and one private primary care practice in the North Vaud in Yverdon will be mobilized a total of three primary care practices in three different regions Participants will be indicated by their PCP working in these practices and will be enrolled by the local PIs or delegates More precisely firstly the patient will be orally asked to consent in order that hisher details are communicated by the PCP to the respective local PI or delegates Afterwards the local PI or hisher delegates will hold recruitment if the inclusion criteria are met and if there are no exclusion criteria after transmitting the necessary information concerning the study to their patients Interested patients will be asked to review the information and consent form and sign it if they consent to participate in the study
For Inclusion and Exclusion criteria see Eligibility session
For the PLIMeC-P 15 eligible participants are expected for the control arm TAU and 15 eligible participants for the intervention arm with a total number of 30 participants The investigators will include 10 participants from each of the three sites 5 participants in each arm per site In parallel part of the participating patients 3 from TAU arm and 3 from the intervention arm who will be chosen for their mixed sociodemographic characteristics will be asked to participate in individual semi-structured interviews in order to explore qualitatively their perception regarding usual mental health care and the proposed intervention
Moreover the participating PCPs and psychiatrists will also be invited to undergo individual semi-structured interviews for the qualitative part of the study in order to obtain a global understanding of the impact of the intervention They will decide if they want or not to participate having all the liberty to refuse the invitation No health-related data will be collected
No compensation or payment is intended to be given to the participants or the collaborating PCPs
32 Study procedures
Demographic data and baseline questionnaires will be addressed to the participants together with the informed consent by email or Post depending on the participants choice Only participants completing the baseline assessment will be included in the study The baseline questionnaire assessment lasts around 15 minutes It will include demographic variables and the PHQ PHQ-9 GAD-7 PHQ-15 WHOQOL-BREF and INTERMED self-assessment scales The PHQ is based on five modules covering common types of mental disorders 1 depressive 2 anxiety 3 somatoform 4 Alcohol and 5 Eating disorders The first three modules PHQ-9 GAD-7 PHQ-15 screen symptom severity with a threshold of 10 The WHOQOL is a quality-of-life instrument containing 26 items each is rated on a scale of 1 to 5 The score is then transformed linearly to a 0-100 scale with a cut-off 60 The INTERMED self-assessment is an instrument to determine the relationship between biopsychosocial complexity and healthcare and social cost and containing 20 questions each is rated on a scale of 0 to 3 with a maximal score of 60 and a threshold of 21 Only the subscale regarding healthcare system complexity Questions 1314151620 will be included in the baseline questionnaire
After the final eligibility check and completeness of the baseline questionnaire participants will be attributed a study code The key linking the participants name and the study identifier will be stored at each site The enrolled participants will be then randomly assigned by the local PIs or delegated collaborators to the control or intervention arm They will complete follow-up assessments for both arms at 3 6 and 12 months T1 T2 and T3 post baseline The follow-up questionnaire will include the Patient Health Questionnaire Somatic Anxiety and Depressive Symptom Scales PHQ-15 GAD-7 PHQ-9 and WHOQOL-BREF self-assessment scales and the questions 16 and 20 of the INTERMED self-assessment scale Similar procedures will apply Depending on the participants choice they will receive either an email or a paper questionnaire by Post at 3 6 and 12 months
Regarding qualitative assessment for the PLIMeC-P 6 participants of both arms control and intervention arm 3 and 3 participants will be invited to participate in one-to-one semi-structured interviews In parallel PCPs and CL-psychiatrists will also be asked to participate in individual semi-structured interviews Interviews will be conducted by phone or face-to-face depending on participants preference and they will be audio-recorded A qualitative assessment will be conducted by a research collaborator
4 STATISTICS AND METHODOLOGY
To answer the research question of the PLIMeC-P Pilot study aiming to determine the feasibility and practicability of the main PLIMeC study in the initial phase the statistical procedures will be limited to questions of practicability and quality
For the main PLIMeC study the investigators will use a mixed-method approach combining various data collection and analysis methods qualitative and quantitative Mixed methods research links elements from both qualitative and quantitative paradigms to produce converging findings in the context of complex research questions such as the psychological impact of an exceptional situation as investigated in our study This combination can provide a better understanding of such research issues than either approach alone On the one hand quantitative methods will be used to obtain a breadth of understanding of the phenomenon of interest and on the other hand qualitative methods will be used to explore and obtain a depth of this understanding
More specifically in our study the combination of methods is used for complementarity using qualitative data to examine how the participants patients and healthcare providers experience this specific CL-psychiatric intervention and quantitative methods to examine the impact of such an intervention on patients A fixed mixed methods design will be used quantitative measurements will be firstly carried out and afterward qualitative ones In data analysis the priority among the two methods will be equal and the nature of integration of partial qualitative findings expands on the first-phase quantitative results at the same time helping their interpretation through data convergence The potential added value of mixed methods includes producing greater insight than a single method could improving quantitative data interpretation and enhancing the external validity of these findings
41 Statistical analysis plan Statistical procedures will be limited to practicability and quality issues in the initial phase The first statistical and qualitative analyses performed in this pilot study PLIMeC-P will also be used to obtain a more accurate estimate of expected observable differences between groups help in defining the number of participants and clusters ie centres required for the main study and in adjusting the moderators guide
42 Regarding the main PLIMeC study
421 Quantitative analysis plan
The investigators shall consider a total of 4 primary outcomes consisting in continuous scores measured on the PHQ-9 GAD-7 PHQ-15 and WHOQOL-BREF psychological domain The longitudinal follow-up scores will be modeled using a linear mixed-effect regression The level of statistical significance in this study will be fixed at 5 However since a total of 4 primary outcomes will be investigated the statistical significance of the intervention effects in each outcome at a given timepoint will be corrected for multiple testing using the Holm-Bonferroni procedure
Sample size calculations for the main phase will be precised on the basis of results from the pilot study Regarding each of the 3 subscales of the PRIME-MD a difference of more than 5 points will be deemed as clinically relevant Regarding the WHOQOL-BREF it reports a standard deviation of 28 points for the typical inter-individual variability in scores on the psychological domain Without further knowledge at this point the investigators shall postulate a moderate effect of the intervention on each outcome eg at T3 with a standardized mean difference D05 according to Cohens definition of effect sizes 02weak 05moderate 08large Following calculations in Vierron and Giraudeau for multicenter randomized trials and allowing for a family-wise error rate of 5 while assuming an intraclass correlation of 01 a minimum of 81 individuals should be included per arm 162 total in order to reach 80 power This sample size should be further inflated to account for dropouts As mentioned above in all cases this sample size will be re-evaluated following the pilot study results and if necessary modified by means of a protocol amendment before the start of the main study and results from the pilot study will be used to estimate the dropout rate on each occasion
For the exploratory objective the investigators will investigate the healthcare system complexity of clinical situations in the basis evaluation T0 measured by the INTERMED Self-Assessment Version scale Questions 13141516 20 and the question 24 of the WHOQOL-Bref questionnaire and will compare the evolution of the collaboration of healthcare professionals for participants of the intervention arm CL psychiatry intervention with them of the control arm TAU the moment they are enrolled by their PCP in the T0 in 3 months T1 and 12 months T3 later measured by the INTERMED Self-Assessment Version scale Questions 16 and 20 and the question 24 of the WHOQOL-Bref questionnaire in T0 T1 and T3 Firstly data will be screened for missing cases and outliers using descriptive statistics and plots Afterwards descriptive statistics ie means and standard deviations will be used to report the levels of healthcare system complexity of clinical situations at T0 T1 3 months and at T3 12 months Descriptive statistics will also be used to report frequencies of healthcare system complexity of clinical situations at T0 T1 and T3 following screening guidelines as proposed by the authors of the scales
422 Qualitative analysis plan
The secondary objective is to explore qualitatively the lived experience of participating healthcare staff PCPs and psychiatrists and patients of this multidisciplinary intervention collaboration including their impact on the management of mental disorders complexity barriers and encountered difficulties for the first and whereby such an intervention has an effect on the doctor-patient relationship and how it responds to the mental health care needs for the latter Qualitative semi-structured interviews will be conducted by local co-investigators in each center CNP and SPANO The interviews will be audiotaped transcribed coded and analyzed using ATLASti software The analysis of the coded interviews will be based on thematic content analysis and will be carried out by the local co-instigators and the Sponsor-PI initially in parallel without one seeing the categories created by the other from the same raw data These categories will then be compared to establish the extent of possible overlap in the categories Thus these different sets of categories will then be combined or reorganized Once the new categories have been established a clarity check will be conducted by external stakeholders primary care physicians and psychiatrists and their feedback will be incorporated for further revision and refinement of the categories
Another objective is to deepen our understanding of the complexity of the investigated healthcare systems and to better interpret the evolution of the collaboration of healthcare professionals both for the intervention and the control arm the investigators will also explore qualitatively i the patients mental health care needs and the PCPs mental health service needs ii to what extent they are satisfied or not by the intervention iii interaction between complexity and these needs as also how complexity is addressed
A combination of quantitative and qualitative data will be performed qualitative findings expanding quantitative results and at the same time helping their interpretation through data convergence
5 Handling of missing data and drop-outs
During the study every effort will be made to gather all the required data and guarantee good quality of data
According to the WHO mental health is a central component of personal health and well-being Mental disorders claim a heavy toll on individuals their families and society and are a major public health issue In Switzerland 18-21 of the population suffers from psychological distress of which 127 have been diagnosed with a psychiatric disorder Primary care physicians PCP are usually the first contact with healthcare for patients suffering from psychological distress or mental disorders More precisely a prevalence of 25-60 is reported for mental disorders in primary care and this is the case worldwide as well as in Switzerland More than half of those patients have no specialized psychiatric care and PCPs tend to base their treatment on pharmacotherapy support therapy and psycho-education PCPs are therefore key stakeholders in the detection prevention and adjusted treatment management of mental disorders
Therefore the optimization of both the quality of primary care interventions and cooperation with psychiatric care networks are important challenges Patients with mental disorders are often considered complex patients and tend to be frequent care users PCPs feeling lacking competency in dealing with them Close collaboration between psychiatrists and PCPs and multidisciplinary interventions can reinforce PCPs skills and help them gain confidence in managing mental disorders A wide range of collaboration models between psychiatrists and PCP exist the Consultation Liaison CL interventions being one of them However various barriers are described regarding such a collaboration notably because of different treatment paradigms and of lack of accessibility
In Switzerland CL-psychiatric interventions are mainly used in hospital settings To introduce a model of care that offers optimal management of mental disorders in primary care ensuring an adequate continuity and good coordination of care for patients with complex needs a multidisciplinary collaboration project between PCP and CL-psychiatrists has been developed in a region of French-speaking Switzerland A CL-psychiatric consultation within primary care practices has been implemented to promote the quality of mental health care and facilitate communication between healthcare professionals The need for further research on the implementation of psychiatric interventions in primary care is clearly highlighted Moreover the experience of patients of PCPs and of psychiatrists during such interventions is rarely investigated whereas emotional experiences seem to present one of the central obstacles to the optimal management of mental disorders in primary care
Our study will investigate the impact of a CL-psychiatric intervention for patients with mental health problems in private primary care group practices in French-speaking Switzerland using mixed methods qualitative and quantitative In parallel the lived experience of PCPs and CL-psychiatrists will be investigated during their collaboration in order to better understand the factors that influence this type of intervention and to better qualify its results Initially a pilot study PLIMeC-P of the multi-center multi-method PLIMeC study will be conducted to determine whether the PLIMeC study is feasible
2 STUDY OBJECTIVES AND DESIGN
21 Hypothesis and primary objective
211 For the Pilot study PLIMeC-P
To determine whether the planned multicentric mixed method design randomized controlled trial is feasible and practicable
Essential activities in the PLIMeC-P will include testing procedures for assessment methods conducting initial semi-structured individual interviews to test and adjust the moderators guide questions concerning PCPs CL-psychiatrists and patients lived experience of the intervention first evaluation and analysis of initial results These activities will be carried out through ongoing collaboration between the study sites
212 For the PLIMeC main study
The primary objective is to compare the efficacy of a CL psychiatry intervention case discussion brief intervention and conjoint feedback session - intervention arm introduced in a primary care setting with treatment as usual TAU - control arm for patients suffering from mental health problems More precisely the investigators will focus on the effect of such an intervention on the psychiatric symptoms and the quality of life of participants The investigators hypothesize that a significant clinical change will be produced in the intervention arm in comparison with the control arm
The secondary objective is to explore qualitatively the participants lived experience of the management of their mental health problems in primary care and the effect of a CL psychiatry intervention on this as well as on doctor-patient relationship and in parallel the PCPs and psychiatrists lived experience of their collaboration barriers andor facilitators needs affects thoughts etc
An exploratory objective is to investigate aspects of public health efficiency in order to answer the question of at what level to best meet psychiatric outpatients and to where best allocate psychiatric resources The investigators expect a high level of complexity in the basis evaluation of the clinical situations and hypothesize that healthcare professionals collaboration will ameliorate with the CL psychiatry intervention
22 Endpoints are detailed in the Outcome Measures session
23 Study design
The PLIMeC multicenter study is a randomized controlled trial with a mixed methods design ie using both quantitative and qualitative assessment including a control arm CL-psychiatry intervention and an intervention arm Treatment as Usual - TAU in primary care settings in which the intervention of a CL-psychiatrist was implemented
A potential problem associated with the proposed study design could be the specificity of different local primary care settings different regions different organization different clinical experiences of PCPs different sizes etc To minimize potential bias first both arms will be studied in the same primary care settings with patients naturally seeking help at primary care practices and being randomized Second the investigators will use complementary qualitative data to further interpret the quantitative data employ a mixed-method design Finally a variety of private primary care practices with different demographic variables will be included in a large region of French-speaking Switzerland for the main study already 3 different private primary care practices in different regions of two different cantons for the pilot study The employment of validated questionnaires which will be monitored during the pilot study will also ensure the quality of our data
In addition the investigators are aware that the sensitivity of PCPs to mental health problems and their training in these issues may vary from one practitioner to another Nevertheless such heterogeneity characterizes the current state of practice Consequently the investigators do not consider this heterogeneity to be a source of bias as the aim of the PLIMeC study is to estimate the effect of the intervention in the current healthcare context real-world data On the other hand PCPs working in practices that agreed to take part in the study may be on average more sensitive to education about mental health issues than their colleagues not taking part in the study thereby constituting a recruitment bias In order to reduce this bias with the pilot study PLIMeC-P a first analysis will be conducted of the different private primary care practices 3 practices in different regions with the participating PCPs The investigators will identify the level of training andor awareness of mental health issues among the PCPs included in the study demographic elements collected before the start of the study to identify trends to better calibrate the main study and carry out sample size calculations
Regarding the qualitative part of the design a potential problem could be the fact that the local PI supervises the clinical project To minimize potential bias reflexivity will be applied during the research process and the investigators will ensure that the research assistant who will conduct the individual semi-structured interviews will not be directly involved in the clinical project and will have no hierarchical link with the participating PCPs and CL-psychiatrists Moreover to ensure the quality of our qualitative data the investigators will use a moderator guide drawn upon three previous qualitative research studies a a study on the referral process as experienced by PCPs b a study on psychiatristPCP discussion groups with a sociological perspective observation in situ c a qualitative study on the experience of PCP regarding consultation-liaison psychiatry interventions in primary care Finally the interview guide will be monitored during the PLIMeC-P
24 Regarding the study intervention see Arms and Interventions session
3 STUDY POPULATION AND STUDY PROCEDURES
31 Study population
The study population will be composed of patients who present mental distress in primary care consultations They will be part of the PCP patient list new or regular patients For the PLIMeC-P two private primary care group practices in the canton of Neuchâtel in two distinct regions and one private primary care practice in the North Vaud in Yverdon will be mobilized a total of three primary care practices in three different regions Participants will be indicated by their PCP working in these practices and will be enrolled by the local PIs or delegates More precisely firstly the patient will be orally asked to consent in order that hisher details are communicated by the PCP to the respective local PI or delegates Afterwards the local PI or hisher delegates will hold recruitment if the inclusion criteria are met and if there are no exclusion criteria after transmitting the necessary information concerning the study to their patients Interested patients will be asked to review the information and consent form and sign it if they consent to participate in the study
For Inclusion and Exclusion criteria see Eligibility session
For the PLIMeC-P 15 eligible participants are expected for the control arm TAU and 15 eligible participants for the intervention arm with a total number of 30 participants The investigators will include 10 participants from each of the three sites 5 participants in each arm per site In parallel part of the participating patients 3 from TAU arm and 3 from the intervention arm who will be chosen for their mixed sociodemographic characteristics will be asked to participate in individual semi-structured interviews in order to explore qualitatively their perception regarding usual mental health care and the proposed intervention
Moreover the participating PCPs and psychiatrists will also be invited to undergo individual semi-structured interviews for the qualitative part of the study in order to obtain a global understanding of the impact of the intervention They will decide if they want or not to participate having all the liberty to refuse the invitation No health-related data will be collected
No compensation or payment is intended to be given to the participants or the collaborating PCPs
32 Study procedures
Demographic data and baseline questionnaires will be addressed to the participants together with the informed consent by email or Post depending on the participants choice Only participants completing the baseline assessment will be included in the study The baseline questionnaire assessment lasts around 15 minutes It will include demographic variables and the PHQ PHQ-9 GAD-7 PHQ-15 WHOQOL-BREF and INTERMED self-assessment scales The PHQ is based on five modules covering common types of mental disorders 1 depressive 2 anxiety 3 somatoform 4 Alcohol and 5 Eating disorders The first three modules PHQ-9 GAD-7 PHQ-15 screen symptom severity with a threshold of 10 The WHOQOL is a quality-of-life instrument containing 26 items each is rated on a scale of 1 to 5 The score is then transformed linearly to a 0-100 scale with a cut-off 60 The INTERMED self-assessment is an instrument to determine the relationship between biopsychosocial complexity and healthcare and social cost and containing 20 questions each is rated on a scale of 0 to 3 with a maximal score of 60 and a threshold of 21 Only the subscale regarding healthcare system complexity Questions 1314151620 will be included in the baseline questionnaire
After the final eligibility check and completeness of the baseline questionnaire participants will be attributed a study code The key linking the participants name and the study identifier will be stored at each site The enrolled participants will be then randomly assigned by the local PIs or delegated collaborators to the control or intervention arm They will complete follow-up assessments for both arms at 3 6 and 12 months T1 T2 and T3 post baseline The follow-up questionnaire will include the Patient Health Questionnaire Somatic Anxiety and Depressive Symptom Scales PHQ-15 GAD-7 PHQ-9 and WHOQOL-BREF self-assessment scales and the questions 16 and 20 of the INTERMED self-assessment scale Similar procedures will apply Depending on the participants choice they will receive either an email or a paper questionnaire by Post at 3 6 and 12 months
Regarding qualitative assessment for the PLIMeC-P 6 participants of both arms control and intervention arm 3 and 3 participants will be invited to participate in one-to-one semi-structured interviews In parallel PCPs and CL-psychiatrists will also be asked to participate in individual semi-structured interviews Interviews will be conducted by phone or face-to-face depending on participants preference and they will be audio-recorded A qualitative assessment will be conducted by a research collaborator
4 STATISTICS AND METHODOLOGY
To answer the research question of the PLIMeC-P Pilot study aiming to determine the feasibility and practicability of the main PLIMeC study in the initial phase the statistical procedures will be limited to questions of practicability and quality
For the main PLIMeC study the investigators will use a mixed-method approach combining various data collection and analysis methods qualitative and quantitative Mixed methods research links elements from both qualitative and quantitative paradigms to produce converging findings in the context of complex research questions such as the psychological impact of an exceptional situation as investigated in our study This combination can provide a better understanding of such research issues than either approach alone On the one hand quantitative methods will be used to obtain a breadth of understanding of the phenomenon of interest and on the other hand qualitative methods will be used to explore and obtain a depth of this understanding
More specifically in our study the combination of methods is used for complementarity using qualitative data to examine how the participants patients and healthcare providers experience this specific CL-psychiatric intervention and quantitative methods to examine the impact of such an intervention on patients A fixed mixed methods design will be used quantitative measurements will be firstly carried out and afterward qualitative ones In data analysis the priority among the two methods will be equal and the nature of integration of partial qualitative findings expands on the first-phase quantitative results at the same time helping their interpretation through data convergence The potential added value of mixed methods includes producing greater insight than a single method could improving quantitative data interpretation and enhancing the external validity of these findings
41 Statistical analysis plan Statistical procedures will be limited to practicability and quality issues in the initial phase The first statistical and qualitative analyses performed in this pilot study PLIMeC-P will also be used to obtain a more accurate estimate of expected observable differences between groups help in defining the number of participants and clusters ie centres required for the main study and in adjusting the moderators guide
42 Regarding the main PLIMeC study
421 Quantitative analysis plan
The investigators shall consider a total of 4 primary outcomes consisting in continuous scores measured on the PHQ-9 GAD-7 PHQ-15 and WHOQOL-BREF psychological domain The longitudinal follow-up scores will be modeled using a linear mixed-effect regression The level of statistical significance in this study will be fixed at 5 However since a total of 4 primary outcomes will be investigated the statistical significance of the intervention effects in each outcome at a given timepoint will be corrected for multiple testing using the Holm-Bonferroni procedure
Sample size calculations for the main phase will be precised on the basis of results from the pilot study Regarding each of the 3 subscales of the PRIME-MD a difference of more than 5 points will be deemed as clinically relevant Regarding the WHOQOL-BREF it reports a standard deviation of 28 points for the typical inter-individual variability in scores on the psychological domain Without further knowledge at this point the investigators shall postulate a moderate effect of the intervention on each outcome eg at T3 with a standardized mean difference D05 according to Cohens definition of effect sizes 02weak 05moderate 08large Following calculations in Vierron and Giraudeau for multicenter randomized trials and allowing for a family-wise error rate of 5 while assuming an intraclass correlation of 01 a minimum of 81 individuals should be included per arm 162 total in order to reach 80 power This sample size should be further inflated to account for dropouts As mentioned above in all cases this sample size will be re-evaluated following the pilot study results and if necessary modified by means of a protocol amendment before the start of the main study and results from the pilot study will be used to estimate the dropout rate on each occasion
For the exploratory objective the investigators will investigate the healthcare system complexity of clinical situations in the basis evaluation T0 measured by the INTERMED Self-Assessment Version scale Questions 13141516 20 and the question 24 of the WHOQOL-Bref questionnaire and will compare the evolution of the collaboration of healthcare professionals for participants of the intervention arm CL psychiatry intervention with them of the control arm TAU the moment they are enrolled by their PCP in the T0 in 3 months T1 and 12 months T3 later measured by the INTERMED Self-Assessment Version scale Questions 16 and 20 and the question 24 of the WHOQOL-Bref questionnaire in T0 T1 and T3 Firstly data will be screened for missing cases and outliers using descriptive statistics and plots Afterwards descriptive statistics ie means and standard deviations will be used to report the levels of healthcare system complexity of clinical situations at T0 T1 3 months and at T3 12 months Descriptive statistics will also be used to report frequencies of healthcare system complexity of clinical situations at T0 T1 and T3 following screening guidelines as proposed by the authors of the scales
422 Qualitative analysis plan
The secondary objective is to explore qualitatively the lived experience of participating healthcare staff PCPs and psychiatrists and patients of this multidisciplinary intervention collaboration including their impact on the management of mental disorders complexity barriers and encountered difficulties for the first and whereby such an intervention has an effect on the doctor-patient relationship and how it responds to the mental health care needs for the latter Qualitative semi-structured interviews will be conducted by local co-investigators in each center CNP and SPANO The interviews will be audiotaped transcribed coded and analyzed using ATLASti software The analysis of the coded interviews will be based on thematic content analysis and will be carried out by the local co-instigators and the Sponsor-PI initially in parallel without one seeing the categories created by the other from the same raw data These categories will then be compared to establish the extent of possible overlap in the categories Thus these different sets of categories will then be combined or reorganized Once the new categories have been established a clarity check will be conducted by external stakeholders primary care physicians and psychiatrists and their feedback will be incorporated for further revision and refinement of the categories
Another objective is to deepen our understanding of the complexity of the investigated healthcare systems and to better interpret the evolution of the collaboration of healthcare professionals both for the intervention and the control arm the investigators will also explore qualitatively i the patients mental health care needs and the PCPs mental health service needs ii to what extent they are satisfied or not by the intervention iii interaction between complexity and these needs as also how complexity is addressed
A combination of quantitative and qualitative data will be performed qualitative findings expanding quantitative results and at the same time helping their interpretation through data convergence
5 Handling of missing data and drop-outs
During the study every effort will be made to gather all the required data and guarantee good quality of data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None