Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda

Study Overview
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Brief Summary
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Background: Mental health services are most effective and equitable when designed, delivered, and evaluated in collaboration with people with lived experience of mental health conditions. Unfortunately, people with lived experience are rarely involved in health systems strengthening or are limited to specific components (e.g., peer helpers) rather than multi-tiered collaboration in the continuum of health services (e.g., ranging from home- to community- to clinic-based services). Moreover, programs that do involve people with lived experience, typically involve people with a history of a substance use conditions or common mental disorders. In contrast, the collaboration of people with lived experience of psychosis is especially rare. A pilot cluster randomized controlled trial will be conducted in urban and peri-urban areas around Kampala, Uganda, to evaluate the benefits of an implementation strategy for mental health services with engagement of people with lived experience of psychosis throughout the home-to-community-to-clinic care continuum, this is a hybrid type-III implementation-effectiveness pilot focusing on the differences in implementation strategy. This implementation strategy, entitled Strengthening CAre in collaboration with People with lived Experience of psychosis in Uganda, will include training people with lived experience of psychosis using PhotoVoice and other methods to participate at three levels: in-home services, community engagement, and primary health care facilities. The investigators will compare a standard task-sharing implementation arm using training by mental health specialists with an experimental implementation arm that includes collaboration with people with lived experience. The primary objective is to evaluate the feasibility and acceptability of this strategy in the context of assuring safety and wellbeing of people with lived experience of psychosis who collaborate in health systems strengthening. By collaborating on health systems strengthening across these multiple levels, we foresee a more in-depth contribution that can lead to rethinking how best to design and deliver care for people with lived experience of psychosis. Successful completion of this pilot will be the foundation for a fully powered trial to evaluate the benefits of multi-level collaboration with people with lived experience of psychosis.

Detailed Description
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The aim of the current study is to conduct a pilot cluster randomized controlled trial to determine feasibility and acceptability of people with lived experience of psychosis collaborating in training primary care and community health care workers and co-delivering services in the home. This pilot study will consist of two trial arms: - Training- As- Usual vs the experimental arm. It will be implemented across three-tiers - in primary health care, community, and home settings. The pilot will also determine the parameters needed for appropriate design and implementation of a fully-power future cluster randomized controlled trial. Objective 1 - To assess the feasibility and acceptability of the implementation strategy from the perspective of people with lived experience of psychosis, family members and primary and community care providers. Objective 2 - To demonstrate proof-of-concept for the benefit of the implementation strategy for service users (i.e., patients with psychosis receiving primary care services) and their families, including changes in psychosis symptoms, quality of life, frequency of hospitalization and the potential impacts on family members. Objective 3 - To evaluate changes in health systems outcomes in terms of primary care provider knowledge, attitudes, competency in psychosis diagnosis and management, accuracy of diagnosis and fidelity to treatment guidelines in actual care settings as well as trial procedures. Objective 4: To evaluate costing, recruitment and retention, and data collection procedures and protocols to determine the optimal design for a future fully powered cluster Randomized Controlled Trial. Objective 5: To establish and demonstrate ethics and safety in collaborating with service users.

Official Title
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Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda

Conditions
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Psychosis

Intervention / Treatment
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* Other: Primary care health worker training
* Other: Community Health Workers Training
* Other: Home visits


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Facilitators of the implementation strategy: At least 18 years of age Confirmed diagnosis of a primary psychotic disorder (e.g., schizophrenia) by a psychiatrist or psychiatric clinical officer Completion of the YouBelongHOME (YBH) program Provision of informed consent, Fluency in the local language (Luganda) Good functioning with respect to performance of daily chores,engagement with family members, comprehension and community participation as assessed by the YBH team A supportive family member. Primary care providers: Provides primary care in health facility of Kampala/Wakiso District Selected by facility in-charge Community health workers Provides community based health service in health facility where primary care providers are trained (from Kampala/Wakiso district) Selected by facility in-charge Patients (Primary beneficiaries) Persons diagnosed with psychosis at a primary health care facility in Kampala/Wakiso District; For this study, a diagnosis of psychosis will include the following diagnoses according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5):schizophrenia spectrum and other psychotic disorders [brief psychotic disorder, schizophreniform disorder, schizoaffective disorder, schizophrenia, and organic psychosis (i.e., psychosis secondary to a medical condition such as HIV or an alcohol- or substance-use disorder)];bipolar affective disorder and related disorders; Ability of the patient or responsible surrogate to consent to study enrolment and procedures; Persons eligible for outpatient management of psychosis Family members a. Family member or caregiver of the patients above. Exclusion Criteria: Facilitators of the implementation strategy: a. Inability to provide informed consent. Primary care providers: None Community health workers: None Patients Persons diagnosed with psychosis requiring inpatient management/services; and Persons for whom consent for participation in the study cannot be obtained. Patients found to be severely ill beyond the capacity of the health facility to treat. Family members a. Family members who doesn't provide consent for participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as usual<br>Training primary care workers in diagnosis and treatment; training community health workers in detection and referral. | Other: Primary care health worker training<br>* Training primary care workers to detect and treat psychosis.<br>Other: Community Health Workers Training<br>* training community health workers in detection and referral<br>|
| Experimental: Strengthening care in collaboration with people with lived experience of psychosis in Uganda<br>Trainings done in collaboration with people with lived experience of psychosis; as well as additional home visits conducted by people with lived experience of psychosis. | Other: Primary care health worker training<br>* Training primary care workers to detect and treat psychosis.<br>Other: Community Health Workers Training<br>* training community health workers in detection and referral<br>Other: Home visits<br>* home visits conducted by people with lived experience of psychosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Symptoms of Schizophrenia (PANSS) scale | Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse | baseline - immediately after enrollment | 
| Positive and Negative Symptoms of Schizophrenia (PANSS) scale | Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse | 4 months post enrollment | 
| Positive and Negative Symptoms of Schizophrenia (PANSS) scale | Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse | 8 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization Quality of Life-Brief Scale | Brief quality of life scale, minimum = 0, maximum = 100, Higher score refers to better quality of life | immediately after enrollment | 
| World Health Organization Quality of Life-Brief Scale | Brief quality of life scale, minimum = 0, maximum = 100, Higher score refers to better quality of life | 4 months post enrollment | 
| World Health Organization Quality of Life-Brief Scale | Brief quality of life scale, minimum = 0, maximum = 100, Higher score refers to better quality of life | 8 months post enrollment | 
| Service user collaboration checklist | Benefits and challenges of service users' collaboration, minimum = 12, maximum = 48, higher number refers to strong collaboration experience | immediately after enrollment | 
| Service user collaboration checklist | Benefits and challenges of service users' collaboration, minimum = 12, maximum = 48, higher number refers to strong collaboration experience | 4 months post enrollment | 
| Service user collaboration checklist | Benefits and challenges of service users' collaboration, minimum = 12, maximum = 48, higher number refers to strong collaboration experience | 8 months post enrollment | 
| EuroQuality of Life 5-Dimension 5-Level | Quality of Life (for health economics analyses), minimum = 5, maximum=25, higher score is worse | immediately after enrollment | 
| EuroQuality of Life 5-Dimension 5-Level | Quality of Life (for health economics analyses), minimum = 5, maximum=25, higher score is worse | 4 months post enrollment | 
| EuroQuality of Life 5-Dimension 5-Level | Quality of Life (for health economics analyses), minimum = 5, maximum=25, higher score is worse | 8 months post enrollment | 
| Discrimination and Stigma Scale-Brief version | Stigma experienced by persons living with mental illness, minimum = 0, maximum = 33, Higher score refers to higher experience of stigma | immediately after enrollment | 
| Discrimination and Stigma Scale-Brief version | Stigma experienced by persons living with mental illness, minimum = 0, maximum = 33, Higher score refers to higher experience of stigma | 4 months post enrollment | 
| Discrimination and Stigma Scale-Brief version | Stigma experienced by persons living with mental illness, minimum = 0, maximum = 33, Higher score refers to higher experience of stigma | 8 months post enrollment | 
| Social Inclusion Scale | Social Inclusion of service users, minimum = 10, maximum = 50, Higher score refers to better experience of social inclusion | immediately after enrollment | 
| Social Inclusion Scale | Social Inclusion of service users, minimum = 10, maximum = 50, Higher score refers to better experience of social inclusion | 4 months post enrollment | 
| Social Inclusion Scale | Social Inclusion of service users, minimum = 10, maximum = 50, Higher score refers to better experience of social inclusion | 8 months post enrollment | 
| Hospitalization Record | no minimum or maximum, score is total number of days patient was hospitalized during study period | immediately after enrollment | 
| Hospitalization Record | no minimum or maximum, score is total number of days patient was hospitalized during study period | 4 months post-enrollment | 
| Hospitalization Record | no minimum or maximum, score is total number of days patient was hospitalized during study period | 8 months post enrollment | 
| Client Service Receipt Inventory | Costs of care to patients, there is no maximum or minimum score, the outcome is total cost for patient to get healthcare | immediately after enrollment | 
| Client Service Receipt Inventory | Costs of care to patients, there is no maximum or minimum score, the outcome is total cost for patient to get healthcare | 4 months post enrollment | 
| Client Service Receipt Inventory | Costs of care to patients, there is no maximum or minimum score, the outcome is total cost for patient to get healthcare | 8 months post enrollment | 
| Family Interview Schedule-Impact on Caregivers | Impact on family members and caregivers of people with mental illness, minimum = 0, maximum = 48, higher score means higher burden on the families | immediately after enrollment | 
| Family Interview Schedule-Impact on Caregivers | Impact on family members and caregivers of people with mental illness, minimum = 0, maximum = 48, higher score means higher burden on the families | 4 months post enrollment | 
| Family Interview Schedule-Impact on Caregivers | Impact on family members and caregivers of people with mental illness, minimum = 0, maximum = 48, higher score means higher burden on the families | 8 months post enrollment | 
| Community Health Workers: Social Distance Scale | Attitudes of community health workers towards people with psychosis, 12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome | pre training | 
| Community Health Workers: Social Distance Scale | Attitudes of community health workers towards people with psychosis, 12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome | immediately after training | 
| Community Health Workers: Assessment tool | Accuracy of detection, no score - will check if their detection matches with the gold standard - Structured Clinical Interview for Diagnostic Statistical Manual -V Mini International Neuropsychiatric Interview, psychosis module | monthly throughout the study period : average of 8 months, However accuracy check during SCID diagnosis check | 
| Community Health Workers: Village health team referral | no maximum or minimum, outcome is the number of patients referred by community health workers to the health post | monthly throughout the study period (average of 8 months), starts immediately after training | 
| Community Health Workers: Village health team referral with psychosis | no maximum or minimum, outcome is the number of patients diagnosed with psychosis by PCP and referred by community health workers to the health post | monthly throughout the study period (average of 8 months), starts immediately after training | 
| Primary care workers: Social Distance Scale | 12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome | pre training | 
| Primary care workers: Social Distance Scale | 12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome | immediately after training | 
| Primary care workers: Social Distance Scale | 12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome | final supervision: 8 months post training | 
| Primary care workers: Mental health Gap Action Program Knowledge | Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome | pre training | 
| Primary care workers: Mental health Gap Action Program Knowledge | Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome | immediately after training | 
| Primary care workers: Mental health Gap Action Program Knowledge | Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome | final supervision: 8 months post training | 
| Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis | Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better | pre training | 
| Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis | Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better | immediately after training | 
| Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis | Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better | final supervision - 8 months post training | 
| Health Facility Record | no minimum or maximum, score is the total number of patient diagnosed with psychosis : clinical records reviewed by Research Assistants | pre training | 
| Health Facility Record | no minimum or maximum, score is the total number of patient diagnosed with psychosis : clinical records reviewed by Research Assistants | immediately after training | 
| Health Facility Record | no minimum or maximum, score is the total number of patient diagnosed with psychosis : clinical records reviewed by Research Assistants | final supervision - 8 months post training | 
| Structured Clinical Interview for Diagnostic Statistical Manual -V Mini International Neuropsychiatric Interview, psychosis module | Accuracy of patient diagnosis by study mental health specialist | 3 months post patient enrollment |